Helixate NexGen 1000 IU

Helixate NexGen 1000 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Helixate NexGen 1000 IU is and what it is used for


• 2. Before you use Helixate NexGen 1000 IU


• 3. How to use Helixate NexGen 1000 IU


• 4. Possible side effects


• 5. How to store Helixate NexGen 1000 IU


• 6. Further information

WHAT Helixate NexGen 1000 IU IS AND WHAT IT IS USED FOR

Helixate NexGen 1000 IU belongs to a pharmacotherapeutic group called blood coagulation Factor VIII (ATC-Code B02B D02).

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

One vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units). After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 400 IU/ml.

BEFORE YOU USE Helixate NexGen 1000 IU

Do not use Helixate NexGen 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 1000 IU.

If you are unsure about this, ask your doctor.

Take special care with Helixate NexGen 1000 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction). If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 1000 IU. If this occurs, stop administering the product immediately and seek medical advice.

Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 1000 IU is sufficient to reach and maintain adequate factor VIII levels.

If your bleeding is not being controlled with Helixate NexGen 1000 IU, consult your doctor immediately. You may have developed factor VIII inhibitors and your doctor may wish to carry out tests to confirm this. Factor VIII inhibitors are antibodies in the blood which block the factor VIII you are using. This makes factor VIII less effective in controlling bleeding.

If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.

Using other medicines

Interactions with other medicines are not known. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 1000 IU during pregnancy and breast-feeding is not available. Therefore, if you are pregnant or breast-feeding consult your doctor before using this product.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Important information about some of the ingredients of Helixate NexGen 1000 IU

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.

HOW TO USE Helixate NexGen 1000 IU

Helixate NexGen 1000 IU is intended for intravenous administration only and must be administered immediately after reconstitution. Aseptic conditions (meaning clean and germ free) are required during reconstitution and administration. Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 1000 IU. Helixate NexGen 1000 IU must not be mixed with other infusion solutions. Do not use solutions containing visible particles or that are cloudy. Follow the directions given by your doctor closely and use the instructions below as a guide:

• 1. Wash hands thoroughly using soap and warm water.


• 2. Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).


• 3. Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.

• 4. Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!

• 5. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.

• 6. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.

• 7. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.

• 8. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces. Discard the solvent vial with the blue Mix2Vial adapter attached.

• 9. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

• 10. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting. Inject air into the product vial.

• 11. While keeping the syringe plunger pressed, invert the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

• 12. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe. Hold the syringe upright and push the plunger until no air is left in the syringe.


• 13. Apply a tourniquet.


• 14. Determine the point of injection and prepare antiseptically.


• 15. Puncture the vein and secure the venipuncture set with a plaster.


• 16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution. Make sure that no blood enters the syringe.


• 17. Remove tourniquet.


• 18. Inject the solution intravenously over several minutes, keeping an eye on the position of the needle. The rate of administration should be determined by the patient’s comfort (maximum rate of infusion: 2 ml/min).


• 19. If a further dose needs to be administered, use a new syringe with product reconstituted as described above.


• 20. If no further dose is required, remove the venipuncture set and syringe. Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes. Finally, apply a small pressure dressing to the wound.

The amount of Helixate NexGen 1000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of factor VIII inhibitors that you may have and the factor VIII level required.

Your doctor will calculate the dose of Helixate NexGen 1000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood. He will do this according to your particular needs using the formulae below.

I. Required IU = body weight (kg) × desired factor VIII rise as % of normal × 0.5

II. Expected factor VIII rise as % of normal = 2 × administered IU ÷ bodyweight in kg

The following information provides a guide for factor VIII minimum blood levels. In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:

Degree of haemorrhage : Factor VIII level required (% or IU/dl) : Frequency of doses in hours; duration of therapy in days

Early haemathrosis, muscle bleed or oral bleed : 20 to 40 : Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemathrosis, muscle bleed or haematoma : 30 to 60 : Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and disability are resolved.

Life-threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed : 60 to 100 : Repeat infusion every 8 to 24 hours until threat is resolved.

Type of surgical procedure : Factor VIII level required (% or IU/dl) : Frequency of doses in hours; duration of therapy in days

Minor, including tooth extraction : 30 to 60 : Every 24 hours for at least 1 day until healing is achieved.

Major : 80 to 100 (pre-and post-operatively) : a) By bolus infusions. Repeat infusion every 8 to 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30 to 60 %. b) By continuous infusion. Raise factor VIII activity pre-surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/kg/h) adjusting according to patient’s daily clearance and desired factor VIII levels for at least 7 days.

Your doctor should always adapt the amount of Helixate NexGen 1000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case. Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.

If you are using Helixate NexGen 1000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you. This will usually be in the range of 20 to 60 IU of octocog alfa per kg of body weight, administered at intervals of 2 to 3 days. However, in some cases, especially younger patients, shorter dose intervals or higher doses may be necessary.

Although dosage can be estimated by the calculations presented above, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained. In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis is indispensable.

If the factor VIII level of your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dosage, the presence of factor VIII inhibitors should be suspected. By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.

If you have the impression that the effect of Helixate NexGen 1000 IU is too strong or too weak, talk to your doctor.

Patients with inhibitors

If you have been informed by your doctor that you have developed factor VIII inhibitors you will possibly be required to use a larger amount of Helixate NexGen than previously to control a bleeding. If this dose does not control your bleeding your doctor may consider the use of an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate. Do not increase the dose of Helixate NexGen you use to control your bleeding without consulting your doctor. Speak to your doctor if you would like further information on this.

These therapies should be directed by doctors with experience in the care of patients with haemophilia A.

Helixate NexGen 1000 IU should be injected intravenously over several minutes. The rate of administration should be determined by the patient’s comfort level (maximal rate of infusion: 2 ml/min).

Your doctor will tell you, how often and at what intervals Helixate NexGen 1000 IU is to be administered.

Usually, the substitution therapy with Helixate NexGen 1000 IU is a life-time treatment.

If you use more Helixate NexGen 1000 IU than you should

No symptoms of overdosage with recombinant coagulation factor VIII have been reported.

If you have used more Helixate NexGen 1000 IU than you should, please inform your doctor.

If you forget to use Helixate NexGen 1000 IU

• Proceed with the next administration immediately and continue at regular intervals as advised by your doctor.


• Do not take a double dose to make up for a forgotten dose.

If you stop using Helixate NexGen 1000 IU

Do not stop using Helixate NexGen 1000 IU without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Helixate NexGen 1000 IU can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Side effects where frequency is common:

You may notice any of the following side effects after administration of Helixate NexGen 1000 IU:

• rash/itchy rash


• local reactions at the injection site (e.g. burning sensation, temporary redness)

Side effects where frequency is rare:

You may notice any of the following side effects after administration of Helixate NexGen 1000 IU:

• hypersensitivity reactions (e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)


• fever.

Furthermore, the possibility of an anaphylactic shock cannot be completely excluded. If you notice any of the following symptoms during injection/infusion:

• chest tightness/general feeling of being unwell


• dizziness


• mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)


• nausea

this can constitute an early warning for hypersensitivity and anaphylactic reactions. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately. Please consult your doctor immediately.

During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients.

The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A. In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.

You should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.

In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days). Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors: Overall 6 out of 60 (10%) with a titre above 10 BU and 3 out of 60 (5%) with a titre below 10 BU. The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).

The median number of exposure days in the clinical studies was 114 (range: 4-478). Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titre inhibitor. The fifth patient was lost to follow-up.

In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.

In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors. In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE Helixate NexGen 1000 IU

Keep out of the reach and sight of children.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light.

You may store the product when kept in its outer carton at ambient room temperature (up to 25°C) for a single period of up to 3 months. In this case, the product expires at the end of this 3-month period; you must note the new expiry date on the top of the outer carton.

Do not refrigerate the solution after reconstitution. The reconstituted solution should be used immediately. This product is for single use only. Any unused solution must be discarded.

Do not use Helixate NexGen 1000 IU after the expiry date which is stated on labels and cartons. The expiry date refers to the last day of that month.

Do not use Helixate NexGen 1000 IU if you notice any particles or the solution is cloudy.

Further Information

What Helixate NexGen 1000 IU contains

Powder:

The active substance is recombinant coagulation factor VIII (octocog alfa).

The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose.

Solvent:

Water for injections.

What Helixate NexGen 1000 IU looks like and content of the pack

Helixate NexGen 1000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake. After reconstitution the solution is clear. Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 1000 IU.

Marketing Authorisation Holder:

Bayer Schering Pharma AG

13342 Berlin

Germany

Manufacturer:

Bayer HealthCare Manufacturing S.r.l.

Via delle Groane 126

20024 Garbagnate Milanese (MI)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

CSL Behring UK Limited

Tel:+44-(0)1444 447400

This leaflet was last approved in 03/2010

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.

Savient Pharmaceuticals, Inc.

Address Savient Pharmaceuticals, Inc., One Tower Center 14th Floor East Brunswick, NJ 08816 Contact Details Phone: (732) 418-9300 Website: http://www.savientpharma.com Careers: http://www.savientpharma.com/careers...

Colestid Flavored

Generic Name: colestipol (koe LES ti pol)

Brand Names: Colestid, Colestid Flavored

What is Colestid Flavored (colestipol)?

Colestipol is a cholesterol-lowering drug.

Colestipol lowers "bad" cholesterol in the blood, which is also called LDL (low-density lipoprotein) cholesterol. Lowering your LDL cholesterol may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.

Lowering high cholesterol levels is an important part of preventing heart disease and arteriosclerosis (hardening of the arteries).

Colestipol may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Colestid Flavored (colestipol)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

Before taking colestipol, tell your doctor if have trouble swallowing, constipation or hemorrhoids, a stomach or intestinal disorder, liver disease, a thyroid disorder, a bleeding disorder, a history of major stomach or bowel surgery, or if you have a vitamin A, D, E, or K deficiency.

Before taking colestipol, tell your doctor if you are pregnant or breast-feeding a baby.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Do not take other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol. Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener. Call your doctor at once if you have severe constipation or stomach pain.

To be sure colestipol is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before taking Colestid Flavored (colestipol)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

Before taking colestipol, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  trouble swallowing;

  
  


• 
  

  constipation or hemorrhoids;

  
  


• 
  

  a stomach, intestinal, or digestive disorder;

  
  


• 
  

  liver disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a bleeding disorder;

  
  


• 
  

  a history of major stomach or bowel surgery; or

  
  


• 
  

  if you have a vitamin A, D, E, or K deficiency.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take colestipol.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking colestipol can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not take colestipol without telling your doctor if you are breast-feeding a baby.

Some forms of this medication may contain phenylalanine. Talk to your doctor before using colestipol if you have phenylketonuria (PKU).

How should I take Colestid Flavored (colestipol)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Colestipol is usually taken 1 or 2 times per day with meals. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Dissolve the colestipol granules in a small amount of water, broth soup, applesauce, crushed pineapple, or hot or cold cereal. Stir this mixture and drink or eat all of it right away. Swallow the mixture without chewing or holding it in your mouth. Colestipol can damage your teeth if left in contact with them for too long.

If you mix colestipol granules with a liquid, after drinking the mixture add a little more water to the same glass, swirl gently and drink right away. This will assure that you get the entire dose.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

It may take 2 weeks to several months of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store colestipol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe stomach pain or constipation.

What should I avoid while taking Colestid Flavored (colestipol)?

Avoid taking other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol. Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener.

Colestid Flavored (colestipol) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  trouble swallowing;

  
  


• 
  

  severe constipation or stomach pain;

  
  


• 
  

  black, bloody, or tarry stools; or

  
  


• 
  

  easy bruising or bleeding, muscle or joint pain, loss of appetite.

  
  

Less serious side effects may include:

• 
  

  mild or occasional constipation;

  
  


• 
  

  gas, indigestion, heartburn;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  hemorrhoids or rectal irritation.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Colestid Flavored (colestipol)?

Taking colestipol can make it harder for your body to absorb many other medications. Below is just a partial list of these medications. Tell your doctor if you are using:

• 
  

  steroid drugs such as hydrocortisone (Cortef, Hydrocortone);

  
  


• 
  

  heart medication such as digoxin (Lanoxin, Lanoxicaps), propranolol (Inderal), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), chlorothiazide (Diuril);

  
  


• 
  

  a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), or chlorothiazide (Diuril);

  
  


• 
  

  an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  other cholesterol-lowering medications such as atorvastatin (Caduet, Lipitor), lovastatin (Altocor, Mevacor, Advicor), ezetimibe (Zetia, Vytorin), fenofibrate (Antara, Lipofen, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), clofibrate (Atromid-S), nicotinic acid (niacin), or ursodiol (Actigall, Urso, Urso Forte).

  
  

This list is not complete and there may be other drugs that can interact with colestipol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Colestid Flavored resources

• Colestid Flavored Side Effects (in more detail)
• Colestid Flavored Use in Pregnancy & Breastfeeding
• Colestid Flavored Drug Interactions
• Colestid Flavored Support Group
• 0 Reviews for Colestid Flavored - Add your own review/rating

• Colestipol Prescribing Information (FDA)


• Colestid Prescribing Information (FDA)


• Colestid Monograph (AHFS DI)


• Colestid Advanced Consumer (Micromedex) - Includes Dosage Information


• Colestid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Colestid Flavored with other medications

• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

Where can I get more information?

• Your pharmacist can provide more information about colestipol.

See also: Colestid Flavored side effects (in more detail)

Prednisolone Sodium Phosphate Solution

Pronunciation: pred-NIS-oh-lone SO-dee-uhm FOSS-fate
Generic Name: Prednisolone Sodium Phosphate
Brand Name: Orapred

Prednisolone Sodium Phosphate Solution is used for:

Treating severe allergies, arthritis, asthma, certain blood disorders, and skin conditions. It may also be used for other conditions as determined by your doctor.

Prednisolone Sodium Phosphate Solution is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.

Do NOT use Prednisolone Sodium Phosphate Solution if:

• you are allergic to any ingredient in Prednisolone Sodium Phosphate Solution


• you have a systemic fungal infection, a certain type of malaria, inflammation of the optic nerve, or herpes infection of the eye


• you are scheduled to have a live or attenuated live vaccination (eg, smallpox)


• you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prednisolone Sodium Phosphate Solution:

Some medical conditions may interact with Prednisolone Sodium Phosphate Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart problems (eg, congestive heart failure), heart attack, high blood pressure, kidney problems, liver problems, diabetes, seizures, an underactive thyroid, adrenal gland problems, or any mental or mood problems


• if you have or have recently had a fungal, bacterial, viral, or other type of infection; herpes infection of the eye; chickenpox; measles; or shingles


• if you have HIV infection or tuberculosis (TB) infection, or if you have had ever had a positive TB skin test


• if you have any stomach problems (eg, ulcers), intestinal problems (eg, blockage, perforation, or infection; unexplained diarrhea; diverticulitis; ulcerative colitis), recent intestinal surgery, or inflammation of the esophagus


• if you have weak bones (eg, osteoporosis) or muscle problems (eg, myasthenia gravis)


• if you have had a recent vaccination (eg, smallpox)

Some MEDICINES MAY INTERACT with Prednisolone Sodium Phosphate Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, ephedrine, hydantoins (eg, phenytoin), or rifampin because they may decrease Prednisolone Sodium Phosphate Solution's effectiveness


• Clarithromycin, cyclosporine, estrogens (eg, estradiol), oral contraceptives (eg, birth control pills), or ketoconazole because they may increase the risk of Prednisolone Sodium Phosphate Solution's side effects


• Anticholinesterases (eg, pyridostigmine), aspirin, diuretics, furosemide, hydrochlorothiazide, live or attenuated live vaccines (eg, smallpox), methotrexate, mifepristone, or ritodrine because the risk of their side effects may be increased by Prednisolone Sodium Phosphate Solution


• Anticoagulants (eg, warfarin) or killed or inactivated vaccines because their effectiveness may be decreased by Prednisolone Sodium Phosphate Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prednisolone Sodium Phosphate Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prednisolone Sodium Phosphate Solution:

Use Prednisolone Sodium Phosphate Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prednisolone Sodium Phosphate Solution by mouth with food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Prednisolone Sodium Phosphate Solution and you are taking 1 dose daily, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisolone Sodium Phosphate Solution.

Important safety information:

• Prednisolone Sodium Phosphate Solution may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.


• Report to your doctor any injuries or signs of infection (fever, sore throat, pain during urination, or muscle aches) for up to 12 months after stopping Prednisolone Sodium Phosphate Solution.


• Carry an ID card at all times that says you take Prednisolone Sodium Phosphate Solution.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Prednisolone Sodium Phosphate Solution. Talk with your doctor before you receive any vaccine.


• Tell your doctor or dentist that you take Prednisolone Sodium Phosphate Solution before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Prednisolone Sodium Phosphate Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including adrenal function tests, may be performed while you use Prednisolone Sodium Phosphate Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Prednisolone Sodium Phosphate Solution in CHILDREN; they may be more sensitive to its effects.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisolone Sodium Phosphate Solution.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisolone Sodium Phosphate Solution while you are pregnant. Prednisolone Sodium Phosphate Solution is found in breast milk. If you are or will be breast-feeding while you use Prednisolone Sodium Phosphate Solution, check with your doctor. Discuss any possible risks to your baby.

If you are on long-term or high dosage therapy and you suddenly stop taking Prednisolone Sodium Phosphate Solution, you may have WITHDRAWAL symptoms, including fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, or joint or muscle pain.

Possible side effects of Prednisolone Sodium Phosphate Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; clumsiness; dizziness; facial flushing; feeling of a whirling motion; general body discomfort; headache; increased appetite; increased sweating; nausea; nervousness; sleeplessness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; infection (eg, fever, chills, sore throat); mental or mood changes (eg, depression); muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; tendon or bone pain; thinning of skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prednisolone Sodium Phosphate Solution:

Check with your pharmacist for storage instructions. Some brands of Prednisolone Sodium Phosphate Solution (eg, Orapred) must be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Others may be stored at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Keep Prednisolone Sodium Phosphate Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Prednisolone Sodium Phosphate Solution, please talk with your doctor, pharmacist, or other health care provider.


• Prednisolone Sodium Phosphate Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prednisolone Sodium Phosphate Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Familial Mediterranean Fever Medications

Definition of Familial Mediterranean Fever: Familial Mediterranean fever is an inherited disorder characterized by recurrent fever and inflammation, often involving the abdomen or the lung.

Drugs associated with Familial Mediterranean Fever

The following drugs and medications are in some way related to, or used in the treatment of Familial Mediterranean Fever. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Familial Mediterranean Fever

Medical Encyclopedia:

• Familial Mediterranean fever

Drug List:

Colcrys

Mutamycin

Generic Name: Mitomycin
Class: Antineoplastic Agents
VA Class: AN200
Molecular Formula: C₁₅H₁₈N₄O₅
CAS Number: 50-07-7

• Experience of Supervising Clinician


• 
  

  Administer only under the supervision of a qualified clinician experienced in therapy with chemotherapeutic agents.^{100 d} Use only when adequate treatment facilities for appropriate management of therapy and complications are available.^{100 d} (See Toxicity under Cautions.)

  
  

• Myelosuppression


• 
  

  Risk of dose-limiting, cumulative myelosuppression and potentially life-threatening secondary infections (e.g., septicemia).^{100 c d} (See Hematologic Effects under Cautions.)

  
  

• Hemolytic Uremic Syndrome


• 
  

  Undefined risk of severe and often fatal syndrome consisting principally of microangiopathic hemolytic anemia (hematocrit ≤25%), thrombocytopenia (platelet count ≤100,000/mm³), and irreversible renal failure (S_cr ≥1.6 mg/dL).^{100 101 102 103 104 105 106 107 108 d} (See Hemolytic Uremic Syndrome under Cautions.)

  
  


• 
  

  May occur at any time during therapy (with or without other antineoplastic agents); however, most cases occur at mitomycin doses ≥60 mg.^{100 d} Blood transfusion may exacerbate the symptoms associated with this syndrome.^{100 d}

  
  

Introduction

Antineoplastic agent; an antibiotic produced by Streptomyces caespitosus.^{100 c d}

Uses for Mutamycin

Adenocarcinoma of Stomach and Pancreas

Component of combination chemotherapeutic regimens for treatment of disseminated adenocarcinoma of the stomach or pancreas and as palliative treatment of these tumors when other treatment modalities are ineffective.^{100 121 d}

Response rates generally low (10–17%) and of short duration.^c

Not recommended for use as single-agent, primary therapy or as a replacement for appropriate surgery and/or radiation therapy.^{100 d}

Anal Cancer

A preferred regimen, in combination with fluorouracil, for primary treatment of anal cancer†.¹²¹

Bladder Cancer

Has been used for intravesical† treatment of residual tumor and/or as adjuvant therapy for prophylaxis of superficial bladder cancer†.^{113 115 120 121 130 131 138}

Causes regression of existing papillary tumor and reduces the rate of short-term tumor recurrence but has no effect on disease progression or overall survival.^{119 123 124 129 139}

Cervical Cancer

Has been used in cisplatin-containing combination chemotherapy regimens (e.g., bleomycin, cisplatin, mitomycin, and vincristine) for treatment of metastatic or recurrent cervical cancer†.^{132 135}

Other agents generally preferred for treatment of advanced cervical cancer†.^{136 137}

Non-small Cell Lung Cancer

Has been used for treatment of non-small cell lung cancer† in combination with cisplatin and vinblastine (MVP) ^{121 146 149} or ifosfamide with mesna (MIC).^{121 150}

Other chemotherapeutic regimens (e.g., cisplatin with paclitaxel, vinorelbine, or gemcitabine) currently preferred for treatment of advanced non-small cell lung cancer†.^{121 146}

Malignant Mesothelioma

Has been used for treatment of malignant mesothelioma†.¹²¹

Head and Neck Carcinoma

Has been used as an adjunct to radiation therapy for treatment of squamous cell carcinoma of head and neck†.¹⁴⁷

Breast Cancer

Has shown activity for treatment of metastatic breast cancer†.¹⁴⁸

Mutamycin Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.^{100 d}

  
  


• 
  

  Administer mitomycin only after complete hematologic recovery from any previous chemotherapy occurs.¹⁰⁰

  
  

Administration

Administer IV.^{100 c d}

Has been administered intravesically†; not an approved route of administration.^{100 115 120 121 130 131 138 d}

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer via a functioning IV catheter;^{100 c d} some clinicians recommend administering the drug through tubing of an IV infusion.^c Use care to avoid extravasation.^{100 d} (See Mucocutaneous Effects under Cautions.)

Reconstitution

Reconstitute vial containing 5, 20, or 40 mg of mitomycin with 10, 40, or 80 mL of sterile water for injection, respectively, to provide a solution containing approximately 0.5 mg/mL.^{100 c d}

Shake vial to dissolve.^{100 c d} If the powder does not dissolve immediately, allow the vial to stand at room temperature until complete dissolution occurs.^{100 c d}

Dosage

Consult published protocols for dosages of mitomycin and other chemotherapeutic agents and the method and sequence of administration.^c

Individualize dosage based on clinical and hematologic response and tolerance of the patient and whether or not other myelosuppressive therapy also is being used.^{100 c d}

Reevaluate patients after each course of therapy and adjust dosages as needed.^{100 d}

Adults

Adenocarcinoma of Stomach and Pancreas

IV

Initially, 20 mg/m² as a single IV dose every 6–8 weeks.^{100 d} Doses >20 mg/m² are not more effective and increase risk of toxicity.^{100 d}

Adjust subsequent dosages according to the hematologic response to the previous dose.^{100 d} (See Table 1.) Do not administer repeat dosage until leukocyte count has returned to 4000/mm³ and platelet count to 100,000/mm³.^{100 d}

Table 1: Dosage Modification for Myelosuppression Based on Nadir After Prior Dose100d

Leukocytes (cells/ mm3)	Platelets (cells/ mm3)	Percentage of Prior Dose to Be Given
>4000	>100,000	100%
3000–3999	75,000–99,999	100%
2000–2999	25,000–74,999	70%
<2000	<25,000	50%

If disease continues to progress after 2 courses of therapy, discontinue the drug since likelihood of response is minimal.^{100 d}

Bladder Cancer†

Treatment of Superficial Bladder Cancer†

Intravesical†

Usual dosage: 20–60 mg once weekly,^{115 116 118 120 125 126 127 128} administered as soon as possible following transurethral resection (TUR).^{117 128} For patients treated within 6–24 hours following TUR, a 6-month course of therapy generally is sufficient; however, for patients in whom intravesical therapy is instituted ≥24 hours following surgery, a 12-month course usually is recommended.^{117 128} No additional benefit demonstrated for continued maintenance therapy.^{115 116 120 124 128 131}

Special Populations

Hepatic Impairment

No special dosage recommendations at this time.^{100 d}

Renal Impairment

Do not administer if S_cr >1.7 mg/dL.^{100 d} (See Renal Effects under Cautions.)

Geriatric Patients

No special dosage recommendations at this time.^{100 d}

Cautions for Mutamycin

Contraindications

• 
  

  Thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.^{100 c d} (See Hematologic Effects under Cautions.)

  
  


• 
  

  Known hypersensitivity or idiosyncratic reaction to mitomycin.^{100 c d}

  
  

Warnings/Precautions

Warnings

Toxicity

Highly toxic drug with a low therapeutic index.^c Administer only under the supervision of a qualified clinician experienced in use of cancer chemotherapeutic agents.^{100 c d} (See Boxed Warning and also see Hematologic Effects, Renal Effects, Hemolytic Uremic Syndrome, and Respiratory Effects under Cautions.)

Hematologic Effects

High incidence of cumulative myelosuppression, principally thrombocytopenia and leukopenia.^{100 c d} (See Boxed Warning.) Not related to total dose; however, occurs more frequently with certain dosage regimens.^c

Monitor hematologic status (platelet count, leukocyte count, differential, PT, bleeding time, and hemoglobin) repeatedly during therapy and for ≥8 weeks afterwards.^{100 c d} Withhold therapy if leukocyte count <4000/mm³, platelet count <100,000/mm³, or if a progressive decline in either occurs.^{100 d} (See Table 1.)

Myelosuppression may occur anytime within 8 weeks after initiation of therapy; may be severe (e.g., platelet count ≤50,000/mm³, leukocyte count ≤2000/mm³).^{100 c d} Nadir during 4–6 weeks of therapy.^c Recovery usually occurs ≤10 weeks after therapy discontinued; however, about 25% of cases may be irreversible.^{100 d}

Hemorrhagic Complications

Bleeding due to thrombocytopenia may occur.^c Platelet transfusions may be needed.^c

Infectious Complications

Life-threatening infections secondary to leukopenia (e.g., septicemia) reported.^{100 c d}

Renal Effects

Renal toxicity (e.g., increased BUN and/or S_cr) reported.^{100 c d} Possibly related to total dose administered (e.g., low risk at cumulative doses <50 mg/m²; substantially increases with higher cumulative doses);^{101 108} however, not clearly established.^{100 d}

Monitor renal function.¹⁰⁰ Do not administer if S_cr >1.7 mg/dL.^{100 d}

Renal failure also may occur as a component of hemolytic uremic syndrome.^{100 101 102 103 104 105 106 107 108} (See Hemolytic Uremic Syndrome under Cautions and also see Boxed Warning.)

Fetal/Neonatal Morbidity

May cause fetal harm; teratogenicity demonstrated in animals.^{100 d}

Safe use of mitomycin in pregnant women not established.^{100 d}

Major Toxicities

Hemolytic Uremic Syndrome

Hemolytic uremic syndrome, a severe and often fatal syndrome of microangiopathic hemolytic anemia (hematocrit ≤25%), thrombocytopenia (platelet count ≤100,000/mm³), and irreversible renal failure (S_cr ≥1.6 mg/dL), reported.^{100 101 102 103 104 105 106 107 108 d} Pulmonary edema also may be a component; may be a particularly grave prognostic factor.^{100 104 d} Other complications include neurologic abnormalities and hypertension.^{100 d} (See Boxed Warning.)

Syndrome can vary from a chronic course with mild anemia and slowly progressive renal impairment to a fulminant course with severe anemia, rapid deterioration of renal function, and death.^{101 102 103 104 105 106 107 108}

May occur at any time during therapy (with or without other antineoplastic agents); however, most cases occur at doses ≥60 mg.^{100 d} Blood transfusion may exacerbate symptoms.^{100 d}

Closely monitor patients receiving mitomycin doses ≥60 mg for unexplained anemia with fragmented cells on peripheral blood smear, thrombocytopenia, and decreased renal function.^{100 d}

Optimum management of syndrome not established; use of systemic corticosteroids, plasma exchange, plasmapheresis, and/or IV vincristine beneficial in some patients, and early treatment may be preferred.^{103 104 105 106 107 108} (See Specific Drugs under Interactions.) Manufacturer states that therapy for syndrome is investigational.^{100 d}

General Precautions

Mucocutaneous Effects

Extremely irritating to tissues.^c Mucocutaneous toxicity (e.g., mouth ulcers, alopecia, desquamation, pruritus) may occur; appears related to the total dose given.^{c d}

Extravasation possible; may cause severe cellulitis, ulceration, and tissue sloughing.^{100 d} May occur with or without symptoms (e.g., stinging or burning during administration) and even when blood returns well during initial aspiration of infusion needle.^{100 d} (See IV Administration under Dosage and Administration.)

Possible pain on injection, induration, thrombophlebitis, and paresthesia.^c Delayed erythema and/or ulceration at or distant from the injection site possible weeks to months after administration despite the lack of apparent evidence of extravasation.^{100 d}

Respiratory Effects

Possibly severe or life-threatening acute bronchospasm and/or dyspnea may occur a few minutes to several hours after administration of a vinca alkaloid (e.g., vinblastine) in patients who have been previously or simultaneously treated with mitomycin.^{100 c d} Bronchodilators, corticosteroids, and/or oxygen may produce symptomatic relief.^{100 d}

ARDS reported in some patients receiving mitomycin in combination with other antineoplastic agents and maintained at fraction of inspired oxygen (FIO₂) concentrations >50% perioperatively.^{100 d} Use only enough oxygen to provide adequate arterial saturation.^{100 d}

Monitor patients for evidence of pulmonary toxicity (e.g., dyspnea with a nonproductive cough, radiographic evidence of pulmonary infiltrates) and for changes in fluid balance; avoid overhydration.^{100 d} If pulmonary toxicity develops, discontinue therapy if other etiologies can be excluded.^{100 d}

Intravesical Instillation

Bladder fibrosis/contraction reported;^{100 d} may require cystectomy.^{100 d}

Asymptomatic ulcers at the site of resected carcinoma of the bladder^{109 110 111} and calcification of bladder wall reported.¹¹²

Possible local irritation (i.e., cystitis); local toxicity increases with the number and frequency of instillations and with the dose administered.¹¹⁵

GI Effects

Nausea and vomiting may occur within 1–2 hours of IV administration.^{100 c d} Vomiting usually subsides rapidly but nausea can continue for 2–3 days.^c

Specific Populations

Pregnancy

Category C.^{100 d} (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Not known whether mitomycin is distributed into milk.^{100 d} Discontinue nursing during mitomycin therapy.^{100 d}

Pediatric Use

Safety and efficacy not established.^{100 d}

Renal Impairment

Do not use if S_cr >1.7 mg/dL.^{100 d} Monitor renal function prior to and periodically during therapy.^{100 d} (See Renal Effects under Cautions.)

Common Adverse Effects

IV administration: Myelosuppression, nausea, vomiting, anorexia, stomatitis, fever, alopecia.^{100 d}

Intravesical† instillation: Local irritation (i.e., cystitis).¹¹⁵

Interactions for Mutamycin

Specific Drugs

Drug	Interaction	Comments
Antineoplastic agents	Risk of acute pulmonary reactions following administration of vinca alkaloids (e.g., vinblastine, vincristine, vinorelbine) in patients previously or concomitantly treated with mitomycin100 d (see Respiratory Effects under Cautions) Risk of ARDS in patients receiving mitomycin in combination with other chemotherapeutic agents and oxygen therapy100 c d (see Respiratory Effects under Cautions)	Bronchodilators, corticosteroids, and/or oxygen may produce symptomatic relief from acute bronchospasm and/or dyspnea100 d Use only enough oxygen to provide adequate arterial saturation during ARDS100 d
Myelosuppressive agents		Adjust dosages accordingly when used concomitantly100 d

Mutamycin Pharmacokinetics

Distribution

Extent

Rapidly distributed into tissues.^c

In animals, highest concentrations found in the kidneys, followed by muscles, eyes, lungs, intestines, and stomach; not detectable in the liver, spleen, or brain (rapidly inactivate mitomycin).^c

Higher concentrations of the drug are generally present in cancer tissues than in normal tissues.^c

Not known whether mitomycin is distributed into milk.^{100 d}

Elimination

Metabolism

Rapidly inactivated in microsomal fraction of the liver and also in the kidneys, spleen, brain, and heart, which contain high concentrations of enzymes capable of metabolizing the drug.^{100 c}

Elimination Route

Excreted principally in urine (about 10% as active drug) and to a small extent in bile.^{100 c d}

Rate of clearance inversely proportional to the maximum serum concentration because of saturation of degradative pathways.^{100 d}

Half-life

For 30-mg IV injection: 17 minutes.^{100 d}

Stability

Storage

Parenteral

Powder for Injection

15–30°C.^{c d} Protect from light^c and avoid excessive heat (>40°C).^{100 c d} Commercially available mitomycin powder is stable for at least 4 years at room temperature.^c

Reconstituted solutions are stable for 7 days at room temperature and for 14 days at 2–8°C.^{100 c d} Protect from light.^d

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^{100 a}

Solutions of mitomycin diluted to a concentration of 20–40 mcg/mL are stable at room temperature for 3 hours in 5% dextrose injection, 12 hours in 0.9% sodium chloride, and 24 hours in sodium lactate injection.^{100 c d}

Compatible
Ringer’s injection, lactated
Sodium chloride 0.4 or 0.6%
Incompatible
Dextrose 3.3% in sodium chloride 0.3%
Variable
Dextrose 5%
Dextrose 5% in water
Sodium chloride 0.9%
Sodium lactate

Drug Compatibility

The combination of mitomycin 5–15 mg and heparin 1000–10,000 units in 30 mL of 0.9% sodium chloride injection is stable for 48 hours at room temperature.^{100 d}

Admixture Compatibilitya

Compatible
Dexamethasone sodium phosphate
Hydrocortisone sodium succinate
Incompatible
Bleomycin sulfate
Variable
Heparin sodium

Y-Site Compatibilitya

Compatible
Amifostine
Bleomycin sulfate
Cisplatin
Cyclophosphamide
Doxorubicin HCl
Droperidol
Fluorouracil
Furosemide
Granisetron HCl
Heparin sodium
Leucovorin calcium
Melphalan HCl
Methotrexate sodium
Metoclopramide HCl
Ondansetron HCl
Teniposide
Thiotepa
Vinblastine sulfate
Vincristine sulfate
Incompatible
Aztreonam
Cefepime HCl
Etoposide phosphate
Filgrastim
Gemcitabine HCl
Piperacillin sodium–tazobactam sodium
Sargramostim
Topotecan HCl
Vinorelbine tartrate

Actions and SpectrumActions

• 
  

  Mechanism of antineoplastic activity similar to that of other alkylating agents.^c

  
  


• 
  

  Enzymatic reduction of mitomycin within susceptible cells may be necessary for antineoplastic activity.^c

  
  


• 
  

  Activated mitomycin appears to selectively inhibit the synthesis of deoxyribonucleic acid (DNA) by causing cross-linking of DNA.^{100 c d} In high concentrations, may also inhibit RNA and protein synthesis.^{100 d}

  
  


• 
  

  Active against gram-positive bacteria and some viruses; however cytotoxicity precludes use as an anti-infective agent.^c

  
  

Advice to Patients

• 
  

  Importance of advising patients of potentially life-threatening hematologic (e.g., myelosuppression), respiratory, and renal toxicities associated with mitomycin therapy.^{100 c d}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{100 d}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., bleeding disorders).^{100 d}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{100 d} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Mitomycin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	5 mg*	Mitomycin for Injection
			Mutamycin	Bristol-Myers Squibb
		20 mg*	Mitomycin for Injection
			Mutamycin	Bristol-Myers Squibb
		40 mg	Mitomycin for Injection
			Mutamycin	Bristol-Myers Squibb

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Bristol-Myers Squibb. Mutamycin (mitomycin for injection) prescribing information. Princeton, NJ; 2000 Jan.

101. Valavaara R, Nordman E. Renal complications of mitomycin C therapy with special reference to the total dose. Cancer. 1985; 55:47-50. [IDIS 194940] [PubMed 3917353]

102. Pavy MD, Wiley EL, Abeloff MD. Hemolytic-uremic syndrome associated with mitomycin therapy. Cancer Treat Rep. 1982; 66:457-61. [IDIS 148370] [PubMed 7060035]

103. Rabadi SJ, Khandekar JD, Miller HJ. Mitomycin-induced hemolytic uremic syndrome: case presentation and review of literature. Cancer Treat Rep. 1982; 66:1244-7. [IDIS 151626] [PubMed 7083229]

104. Sheldon R, Slaughter D. A syndrome of microangiopathic hemolytic anemia, renal impairment, and pulmonary edema in chemotherapy-treated patients with adenocarcinoma. Cancer. 1986; 58:1428-36. [IDIS 221489] [PubMed 3091244]

105. Price TM, Murgo AJ, Keveney JJ et al. Renal failure and hemolytic anemia associated with mitomycin C: a case report. Cancer. 1985; 55:51-6. [IDIS 194941] [PubMed 3917354]

106. Lyman NW, Michaelson R, Viscuso RL et al. Mitomycin-induced hemolytic-uremic syndrome: successful treatment with corticosteroids and intense plasma exchange. Arch Intern Med. 1983; 143:1617-8. [IDIS 173701] [PubMed 6870446]

107. Grem JL, Merritt JA, Carbone PP. Treatment of mitomycin-associated microangiopathic hemolytic anemia with vincristine. Arch Intern Med. 1986; 146:566-8. [IDIS 213427] [PubMed 3954531]

108. Hamner RW, Verani R, Weinman EJ. Mitomycin-associated renal failure: case report and review. Arch Intern Med. 1983; 143:803-7. [IDIS 168369] [PubMed 6340628]

109. Richards B, Tolley D. Benign ulcers after bladder instillation of mitomycin C. Lancet. 1986; 1:45. [IDIS 209156] [PubMed 2867287]

110. Hetherington JW, Whelan P. Persistent ulcers after bladder instillation of mitomycin C. Lancet. 1986; 1:324. [PubMed 2868188]

111. Tolley DA, Hargreave TB, Smith PH et al. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). BMJ. 1988; 296:1759-61. [IDIS 243431] [PubMed 3136828]

112. Alter AJ, Malek GH. Bladder wall calcification after topical mitomycin C. J Urol. 1987; 138:1239-40. [IDIS 247282] [PubMed 3118058]

113. Bladder cancer. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2008 May 16.

114. Scher HI, Shipley WU, Herr HW. Cancer of the bladder. In: DeVita VT Jr, Hellman S, Rosenberg SA eds. Cancer: principles and practice of oncology. 5th ed. Philadelphia: Lippincott-Raven Publishers; 1997:1300-22.

115. Witjes JA. Current recommendations for the management of bladder cancer: drug therapy. Drugs. 1997; 53:404-14. [PubMed 9074842]

116. Raghaven D, Huben R. Management of bladder cancer. Curr Prob Cancer. 1995; 19:1-64.

117. Kurth KH. Diagnosis and treatment of superficial transitional cell carcinoma of the bladder: facts and perspectives. Eur Urol. 1997; 31(Suppl 1):10-9. [PubMed 9076481]

118. Boccardo F, Cannata D, Rubagotti A et al. Prophylaxis of superficial bladder cancer with mitomycin or interferon alfa-2b: results of a multicentric Italian study. J Clin Oncol. 1994; 12:7-13. [IDIS 324682] [PubMed 8270987]

119. Lamm DL, Griffith JG. Intravesical therapy: does it affect the natural history of superficial bladder cancer? Semin Urol. 1992; 10:39-44.

120. Tolley DA, Parmar MKB, Grigor KM et al. The effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: a further report with 7 years of followup. J Urol. 1996; 155:1233-8. [IDIS 363699] [PubMed 8632538]

121. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52.

122. Bouffioux C. Intravesical adjuvant treatment in superficial bladder cancer: a review of the question after 15 years of experience with the EORTC GU group. Scand J Urol Nephrol Suppl. 1991; 138:167-77. [PubMed 1838428]

123. Nseyo UO, Lamm DL. Therapy of superficial bladder cancer. Semin Oncol. 1996; 23:598-604. [PubMed 8893870]

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