Arranon

nelarabine

Dosage Form: injection
FULL PRESCRIBING INFORMATION

WARNING: NEUROLOGIC ADVERSE REACTIONS

Severe neurologic adverse reactions have been reported with the use of Arranon. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions (5.1)].

Full recovery from these adverse reactions has not always occurred with cessation of therapy with Arranon. Close monitoring for neurologic adverse reactions is strongly recommended, and Arranon should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria grade 2 or greater [see Warnings and Precautions (5.1)].

Indications and Usage for Arranon

Arranon® is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Arranon Dosage and Administration

Recommended Dosage

This product is for intravenous use only.

The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for bone marrow transplant, or the patient no longer continued to benefit from treatment.

Adult Dosage: The recommended adult dose of Arranon is 1,500 mg/m² administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days. Arranon is administered undiluted.

Pediatric Dosage: The recommended pediatric dose of Arranon is 650 mg/m² administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days. Arranon is administered undiluted.

Dosage Modification

Arranon administration should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria grade 2 or greater. Dosage may be delayed for other toxicity including hematologic toxicity. [See Boxed Warning and Warnings and Precautions (5.1, 5.2).]

Adjustment of Dose in Special Populations

Arranon has not been studied in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6, 8.7)]. No dose adjustment is recommended for patients with a creatinine clearance (CLcr) ≥50 mL/min [see Clinical Pharmacology (12.3)]. There are insufficient data to support a dose recommendation for patients with a CLcr <50 mL/min.

Prevention of Hyperuricemia

Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia [see Warnings and Precautions (5.4)].

Instructions for Handling, Preparation, and Administration

Handling: Arranon is a cytotoxic agent. Caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended. Proper aseptic technique should be used. Guidelines for proper handling and disposal of anticancer drugs have been published.1-4

Preparation and Administration: Do not dilute Arranon prior to administration. The appropriate dose of Arranon is transferred into polyvinylchloride (PVC) infusion bags or glass containers and administered as a two-hour infusion in adult patients and as a one-hour infusion in pediatric patients.

Prior to administration, inspect the drug product visually for particulate matter and discoloration.

Stability: Arranon Injection is stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hours at up to 30° C.

Dosage Forms and Strengths

250 mg/50 mL (5 mg/mL) vial

Contraindications

None.

Warnings and Precautions

Neurologic Adverse Reactions

Neurotoxicity is the dose-limiting toxicity of nelarabine. Patients undergoing therapy with Arranon should be closely observed for signs and symptoms of neurologic toxicity [see Boxed Warning and Dosage and Administration (2.2)]. Common signs and symptoms of nelarabine-related neurotoxicity include somnolence, confusion, convulsions, ataxia, paresthesias, and hypoesthesia. Severe neurologic toxicity can manifest as coma, status epilepticus, craniospinal demyelination, or ascending neuropathy similar in presentation to Guillain-Barré syndrome.

Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.

Hematologic Adverse Reactions

Leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia have been associated with nelarabine therapy. Complete blood counts including platelets should be monitored regularly [see Dosage and Administration (2.2) and Adverse Reactions (6.1)].

Pregnancy

Pregnancy Category D

Arranon can cause fetal harm when administered to a pregnant woman.

Nelarabine administered during the period of organogenesis caused increased incidences of fetal malformations, anomalies, and variations in rabbits (see Use in Specific Populations (8.1)].

There are no adequate and well-controlled studies of Arranon in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant while receiving treatment with Arranon.

Hyperuricemia

Patients receiving Arranon should receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumor lysis syndrome. Consideration should be given to the use of allopurinol in patients at risk of hyperuricemia [see Dosage and Administration (2.4)].

Vaccinations

Administration of live vaccines to immunocompromised patients should be avoided.

Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Neurologic [see Boxed Warning and Warnings and Precautions (5.1)]


• Hematologic [see Warnings and Precautions (5.2)]


• Hyperuricemia [see Warnings and Precautions (5.4)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Arranon was studied in 459 patients in Phase I and Phase II clinical trials.

Adults: The safety profile of Arranon is based on data from 103 adult patients treated with the recommended dose and schedule in 2 studies: an adult T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL) study and an adult chronic lymphocytic leukemia study.

The most common adverse reactions in adults, regardless of causality, were fatigue; gastrointestinal (GI) disorders (nausea, diarrhea, vomiting, and constipation); hematologic disorders (anemia, neutropenia, and thrombocytopenia); respiratory disorders (cough and dyspnea); nervous system disorders (somnolence and dizziness); and pyrexia.

The most common adverse reactions in adults, by System Organ Class, regardless of causality, including severe or life threatening adverse reactions (NCI Common Toxicity Criteria grade 3 or grade 4) and fatal adverse reactions (grade 5) are shown in Table 1.

Table 1. Most Commonly Reported (≥5% Overall) Adverse Reactions Regardless of Causality in Adult Patients Treated with 1,500 mg/m2 of Arranon Administered Intravenously Over 2 Hours on Days 1, 3, and 5 Repeated Every 21 Days

System Organ Class    Preferred Term	Percentage of Patients (N = 103)
	Toxicity Grade
	Grade 3 %	Grade 4 and 5a %	All Grades %
Blood and Lymphatic System Disorders
Anemia	20	14	99
Thrombocytopenia	37	22	86
Neutropenia	14	49	81
Febrile neutropenia	9	1	12
Cardiac Disorders
Sinus tachycardia	1	0	8
Gastrointestinal Disorders
Nausea	0	0	41
Diarrhea	1	0	22
Vomiting	1	0	22
Constipation	1	0	21
Abdominal pain	1	0	9
Stomatitis	1	0	8
Abdominal distension	0	0	6
General Disorders and Administration Site Conditions
Fatigue	10	2	50
Pyrexia	5	0	23
Asthenia	0	1	17
Edema, peripheral	0	0	15
Edema	0	0	11
Pain	3	0	11
Rigors	0	0	8
Gait, abnormal	0	0	6
Chest pain	0	0	5
Non-cardiac chest pain	0	1	5
Infections
Infection	2	1	9
Pneumonia	4	1	8
Sinusitis	1	0	7
Hepatobiliary Disorders
AST increased	1	1	6
Metabolism and Nutrition Disorders
Anorexia	0	0	9
Dehydration	3	1	7
Hyperglycemia	1	0	6
Musculoskeletal and Connective Tissue Disorders
Myalgia	1	0	13
Arthralgia	1	0	9
Back pain	0	0	8
Muscular weakness	5	0	8
Pain in extremity	1	0	7
Nervous System Disorders (see Table 2)
Psychiatric Disorders
Confusional state	2	0	8
Insomnia	0	0	7
Depression	1	0	6
Respiratory, Thoracic, and Mediastinal Disorders
Cough	0	0	25
Dyspnea	4	2	20
Pleural effusion	5	1	10
Epistaxis	0	0	8
Dyspnea, exertional	0	0	7
Wheezing	0	0	5
Vascular Disorders
Petechiae	2	0	12
Hypotension	1	1	8

a Five patients had a fatal adverse reaction. Fatal adverse reactions included hypotension (n = 1), respiratory arrest (n = 1), pleural effusion/pneumothorax (n = 1), pneumonia (n = 1), and cerebral hemorrhage/coma/leukoencephalopathy (n = 1).

Other Adverse Events: Blurred vision was also reported in 4% of adult patients.

There was a single report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult patient population.

Neurologic Adverse Reactions: Nervous system adverse reactions, regardless of drug relationship, were reported for 76% of adult patients across the Phase I and Phase II studies. The most common neurologic adverse reactions (≥2%) in adult patients, regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 2.

Table 2. Neurologic Adverse Reactions (≥2%) Regardless of Causality in Adult Patients Treated with 1,500 mg/m2 of Arranon Administered Intravenously Over 2 Hours on Days 1, 3, and 5 Repeated Every 21 Days

Nervous System Disorders    Preferred Term	Percentage of Patients (N =103)
	Grade 1 %	Grade 2 %	Grade 3 %	Grade 4 %	All Grades %
Somnolence	20	3	0	0	23
Dizziness	14	8	0	0	21
Peripheral neurologic disorders, any adverse reaction	8	12	2	0	21
Neuropathy	0	4	0	0	4
Peripheral neuropathy	2	2	1	0	5
Peripheral motor neuropathy	3	3	1	0	7
Peripheral sensory neuropathy	7	6	0	0	13
Hypoesthesia	5	10	2	0	17
Headache	11	3	1	0	15
Paresthesia	11	4	0	0	15
Ataxia	1	6	2	0	9
Depressed level of consciousness	4	1	0	1	6
Tremor	2	3	0	0	5
Amnesia	2	1	0	0	3
Dysgeusia	2	1	0	0	3
Balance disorder	1	1	0	0	2
Sensory loss	0	2	0	0	2

One patient had a fatal neurologic adverse reaction, cerebral hemorrhage/coma/leukoencephalopathy.

Most nervous system adverse reactions in the adult patients were evaluated as grade 1 or 2. The additional grade 3 adverse reactions in adult patients, regardless of causality, were aphasia, convulsion, hemiparesis, and loss of consciousness, each reported in 1 patient (1%). The additional grade 4 adverse reactions, regardless of causality, were cerebral hemorrhage, coma, intracranial hemorrhage, leukoencephalopathy, and metabolic encephalopathy, each reported in one patient (1%).

The other neurologic adverse reactions, regardless of causality, reported as grade 1, 2, or unknown in adult patients were abnormal coordination, burning sensation, disturbance in attention, dysarthria, hyporeflexia, neuropathic pain, nystagmus, peroneal nerve palsy, sciatica, sensory disturbance, sinus headache, and speech disorder, each reported in one patient (1%).

Pediatrics: The safety profile for children is based on data from 84 pediatric patients treated with the recommended dose and schedule in a T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL) treatment study.

The most common adverse reactions in pediatric patients, regardless of causality, were hematologic disorders (anemia, leukopenia, neutropenia, and thrombocytopenia). Of the non-hematologic adverse reactions in pediatric patients, the most frequent adverse reactions reported were headache, increased transaminase levels, decreased blood potassium, decreased blood albumin, increased blood bilirubin, and vomiting.

The most common adverse reactions in pediatric patients, by System Organ Class, regardless of causality, including severe or life threatening adverse reactions (NCI Common Toxicity Criteria grade 3 or grade 4) and fatal adverse reactions (grade 5) are shown in Table 3.

Table 3. Most Commonly Reported (≥5% Overall) Adverse Reactions Regardless of Causality in Pediatric Patients Treated with 650 mg/m2 of Arranon Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days

System Organ Class    Preferred Term	Percentage of Patients (N = 84)
	Toxicity Grade
	Grade 3 %	Grade 4 and 5a %	All Grades %
Blood and Lymphatic System Disorders
Anemia	45	10	95
Neutropenia	17	62	94
Thrombocytopenia	27	32	88
Leukopenia	14	7	38
Hepatobiliary Disorders
Transaminases increased	4	0	12
Blood albumin decreased	5	1	10
Blood bilirubin increased	7	2	10
Metabolic/Laboratory
Blood potassium decreased	4	2	11
Blood calcium decreased	1	1	8
Blood creatinine increased	0	0	6
Blood glucose decreased	4	0	6
Blood magnesium decreased	2	0	6
Nervous System Disorders (see Table 4)
Gastrointestinal Disorders
Vomiting	0	0	10
General Disorders & Administration Site Conditions
Asthenia	1	0	6
Infections & Infestations
Infection	2	1	5

a Three patients had a fatal adverse reaction. Fatal adverse reactions included neutropenia and pyrexia (n = 1), status epilepticus/seizure (n = 1), and fungal pneumonia (n = 1).

Neurologic Adverse Reactions: Nervous system adverse reactions, regardless of drug relationship, were reported for 42% of pediatric patients across the Phase I and Phase II studies. The most common neurologic adverse reactions (≥2%) in pediatric patients, regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 4.

Table 4. Neurologic Adverse Reactions (≥2%) Regardless of Causality in Pediatric Patients Treated with 650 mg/m2 of Arranon Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days

Nervous System Disorders    Preferred Term	Percentage of Patients (N = 84)
	Grade 1 %	Grade 2 %	Grade 3 %	Grade 4 and 5a %	All Grades %
Headache	8	2	4	2	17
Peripheral neurologic disorders, any adverse reaction	1	4	7	0	12
Peripheral neuropathy	0	4	2	0	6
Peripheral motor neuropathy	1	0	2	0	4
Peripheral sensory neuropathy	0	0	6	0	6
Somnolence	1	4	1	1	7
Hypoesthesia	1	1	4	0	6
Seizures	0	0	0	6	6
Convulsions	0	0	0	3	4
Grand mal convulsions	0	0	0	1	1
Status epilepticus	0	0	0	1	1
Motor dysfunction	1	1	1	0	4
Nervous system disorder	1	2	0	0	4
Paresthesia	0	2	1	0	4
Tremor	1	2	0	0	4
Ataxia	1	0	1	0	2

a One (1) patient had a fatal neurologic adverse reaction, status epilepticus.

The other grade 3 neurologic adverse reaction in pediatric patients, regardless of causality, was hypertonia reported in 1 patient (1%). The additional grade 4 neurologic adverse reactions, regardless of causality, were 3rd nerve paralysis, and 6th nerve paralysis, each reported in 1 patient (1%).

The other neurologic adverse reactions, regardless of causality, reported as grade 1, 2, or unknown in pediatric patients were dysarthria, encephalopathy, hydrocephalus, hyporeflexia, lethargy, mental impairment, paralysis, and sensory loss, each reported in 1 patient (1%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Arranon. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: Fata

metoclopramide Intravenous

met-oh-KLOE-pra-mide

Injection route(Solution)

Metoclopramide treatment can cause tardive dyskinesia, a serious movement disorder that is often irreversible. Risk is increased with duration of treatment and total cumulative dose. Discontinue metoclopramide therapy in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia, although symptoms may lessen or resolve after metoclopramide discontinuation. Prolonged treatment with metoclopramide (greater than 12 weeks) should be avoided in all but rare cases where therapeutic benefit outweighs the risks .

Commonly used brand name(s)

In the U.S.

• Reglan

Available Dosage Forms:

• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Dopamine Antagonist

Uses For metoclopramide

Metoclopramide injection is a medicine that increases the movements or contractions of the stomach and intestines. It is used to help diagnose certain problems in the stomach or intestines. metoclopramide is also used to prevent the nausea and vomiting that may occur after surgery or after treatment with cancer medicines. Another medicine may be used with metoclopramide injection to prevent side effects that may occur when it is used with cancer medicines.

Metoclopramide injection is also used to relieve symptoms (such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite) that are caused by a stomach problem called gastroparesis in patients with diabetes.

metoclopramide is available only with your doctor's prescription.

Before Using metoclopramide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For metoclopramide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to metoclopramide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of metoclopramide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metoclopramide injection in the elderly. However, elderly patients are more likely to have side effects such as tardive dyskinesia, confusion, or drowsiness, and age-related kidney problems, which may require an adjustment in the dose for patients receiving metoclopramide injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving metoclopramide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using metoclopramide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline


• Amoxapine


• Aripiprazole


• Asenapine


• Bupropion


• Chlorpromazine


• Citalopram


• Clomipramine


• Clozapine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluphenazine


• Fluvoxamine


• Haloperidol


• Iloperidone


• Imipramine


• Loxapine


• Lurasidone


• Maprotiline


• Mesoridazine


• Mirtazapine


• Molindone


• Nefazodone


• Nortriptyline


• Olanzapine


• Paliperidone


• Paroxetine


• Perphenazine


• Pimozide


• Prochlorperazine


• Promazine


• Promethazine


• Protriptyline


• Quetiapine


• Risperidone


• Rivastigmine


• Thioridazine


• Thiothixene


• Trazodone


• Trifluoperazine


• Trimethobenzamide


• Venlafaxine


• Ziprasidone

Using metoclopramide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isocarboxazid


• Linezolid


• Milnacipran


• Phenelzine


• Rasagiline


• Selegiline


• Tranylcypromine

Using metoclopramide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Didanosine


• Digoxin


• Levodopa


• Mivacurium


• Posaconazole


• Sertraline


• Succinylcholine


• Tacrolimus


• Thiopental

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of metoclopramide. Make sure you tell your doctor if you have any other medical problems, especially:

• Abdominal or stomach bleeding or


• Intestinal blockage or


• Pheochromocytoma (adrenal gland tumor) or


• Seizures or epilepsy—Should not be used in patients with these conditions.

• Asthma or


• Cirrhosis (liver disease) or


• Congestive heart failure or


• Diabetes or


• Hypertension (high blood pressure) or


• Mental depression, history of or


• Neuroleptic malignant syndrome, history of or


• Parkinson's disease—Use with caution. May make these conditions worse.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem) or


• Nicotinamide adenine dinucleotide (NADH) cytochrome reductase deficiency (an enzyme problem)—May increase the risk for side effects affecting the blood.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of metoclopramide

A nurse or other trained health professional will give you metoclopramide in a hospital. metoclopramide is given through a needle placed in one of your veins or as a shot into one of your muscles.

Your doctor will give you a few doses of metoclopramide until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using metoclopramide

It is very important that your doctor check your progress while you receive metoclopramide to make sure that it is working properly.

Tell your doctor or nurse right away if you have any of the following symptoms after receiving metoclopramide: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Check with your doctor right away if you have any of the following symptoms: difficulty with speaking; drooling; loss of balance control; muscle trembling, jerking, or stiffness; restlessness; shuffling walk; stiffness of the limbs; twisting movements of the body; or uncontrolled movements of the face, neck, and back.

metoclopramide may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using metoclopramide: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

metoclopramide may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to metoclopramide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

metoclopramide will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using metoclopramide.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

metoclopramide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Convulsions


• difficulty in breathing


• fast heartbeat


• high fever


• high or low blood pressure


• inability to move the eyes


• increased blinking or spasms of the eyelid


• increased sweating


• loss of bladder control


• seeing, hearing, or feeling things that are not there


• severe muscle stiffness


• sticking out of the tongue


• tiredness


• trouble in breathing, speaking, or swallowing


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unusual facial expressions


• unusually pale skin

Incidence not known

• Abdominal or stomach pain or tenderness


• black, tarry stools


• bluish-colored lips, fingernails, or palms


• blurred vision


• chest pain or discomfort


• chills


• clay colored stools


• confusion


• cough or hoarseness


• dark urine


• decrease in the amount of urine


• decreased appetite


• decreased urine output


• difficulty in swallowing


• dilated neck veins


• dizziness or lightheadedness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• extreme fatigue


• fainting


• fast, slow, pounding, or irregular heartbeat or pulse


• fatigue


• feeling of warmth


• fever with or without chills


• fluid-filled skin blisters


• general feeling of tiredness or weakness


• headache


• inability to sit still


• increased need to urinate


• incremental or ratchet-like movement of the muscle


• itching of the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of balance control


• lower back or side pain


• mask-like face


• mental depression


• mood or mental changes


• muscle discomfort


• nausea and vomiting


• need to keep moving


• nervousness


• noisy, rattling breathing


• painful or difficult urination


• pale skin


• palpitations


• passing urine more often


• pounding in the ears


• pounding, slow heartbeat


• rapid heart rate


• redness of the face, neck, arms and occasionally, upper chest


• restlessness of the arms legs, hands, or feet


• rigid or stiff muscles


• sensitivity to the sun


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• shuffling walk


• skin rash


• skin thinness


• slow movement


• slow or irregular breathing


• slow reflexes


• slowed movements


• slurred speech


• sore throat and fever


• sores, ulcers, or white spots on the lips or in the mouth


• stiffness of the arms and legs


• sweating


• swelling of the face, fingers, feet, or lower legs


• thoughts of killing oneself changes in behavior


• tic-like (jerky) movements of the head, face, mouth, and neck


• tightness in the chest


• trembling and shaking of the fingers and hands


• troubled breathing at rest


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain


• wheezing


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion about identity, place, and time


• drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Absent, missed, or irregular menstrual periods


• blurred or loss of vision


• cough


• decreased interest in sexual intercourse


• diarrhea


• disturbed color perception


• double vision


• halos around lights


• hives or welts


• inability to have or keep an erection


• itching


• loss in sexual ability, desire, drive, or performance


• loss of strength or energy


• muscle pain or weakness


• night blindness


• noisy breathing


• overbright appearance of lights


• redness of the skin


• sleeplessness


• stopping of menstrual bleeding


• swelling of the breasts or unusual milk production


• swelling of the breasts or breast soreness in both females and males


• trouble sleeping


• tunnel vision


• unable to sleep


• unexpected or excess milk flow from the breasts


• unusual weak feeling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: metoclopramide Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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• Metoclopramide Intravenous Side Effects (in more detail)
• Metoclopramide Intravenous Use in Pregnancy & Breastfeeding
• Drug Images
• Metoclopramide Intravenous Drug Interactions
• Metoclopramide Intravenous Support Group
• 46 Reviews for Metoclopramide Intravenous - Add your own review/rating

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Perflutren (Protein-Type A Microspheres)

Pronunciation: per-FLOO-tren
Generic Name: Perflutren (Protein-Type A Microspheres)
Brand Name: Optison

Serious and sometimes fatal heart and lung problems have occurred during and within 30 minutes after administration of Perflutren (Protein-Type A Microspheres). Do not use Perflutren (Protein-Type A Microspheres) if you have certain heart problems (eg, cardiac shunt). Tell your doctor if you have heart problems (eg, QT prolongation, recent heart attack, serious irregular heartbeat, worsening or unstable heart failure). Tell your doctor if you have lung problems (eg, blood clot in the lungs, high blood pressure in the lungs, respiratory failure, severe emphysema). Your heart function and vital signs will be monitored during and for at least 30 minutes after treatment with Perflutren (Protein-Type A Microspheres).

Perflutren (Protein-Type A Microspheres) is used for:

Making the heart easier to see during certain diagnostic procedures (eg, echocardiogram).

Perflutren (Protein-Type A Microspheres) is a contrast agent. It works in the blood to help create a clearer picture of the heart.

Do NOT use Perflutren (Protein-Type A Microspheres) if:

• you are allergic to any ingredient in Perflutren (Protein-Type A Microspheres)


• you have had an allergic reaction to blood, blood products, or albumin


• you have certain serious heart problems (eg, cardiac shunt)

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

Before using Perflutren (Protein-Type A Microspheres):

• 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 lung problems (eg, blood clot in the lungs, high blood pressure in the lungs, respiratory failure, severe emphysema) or heart problems (eg, congenital heart defect, heart attack, heart blood vessel problems, heart failure, irregular heartbeat, QT prolongation)


• if you have had recent worsening of heart or lung problems

Some MEDICINES MAY INTERACT with Perflutren (Protein-Type A Microspheres). However, no specific interactions with Perflutren (Protein-Type A Microspheres) are known at this time.

Ask your health care provider if Perflutren (Protein-Type A Microspheres) 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 Perflutren (Protein-Type A Microspheres):

Use Perflutren (Protein-Type A Microspheres) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Perflutren (Protein-Type A Microspheres) will be given as an injection at your doctor's office, hospital, or clinic.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Perflutren (Protein-Type A Microspheres), contact your doctor right away.

Ask your health care provider any questions you may have about how to use Perflutren (Protein-Type A Microspheres).

Important safety information:

• Perflutren (Protein-Type A Microspheres) may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Perflutren (Protein-Type A Microspheres) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Perflutren (Protein-Type A Microspheres) contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Perflutren (Protein-Type A Microspheres).


• Lab tests, including heart function and vital signs, may be performed while you use Perflutren (Protein-Type A Microspheres). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Perflutren (Protein-Type A Microspheres) should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Perflutren (Protein-Type A Microspheres) while you are pregnant. It is not known if Perflutren (Protein-Type A Microspheres) is found in breast milk. If you are or will be breast-feeding while you are using Perflutren (Protein-Type A Microspheres), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Perflutren (Protein-Type A Microspheres):

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:

Dizziness; flushing; headache; nausea.

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); chest pain; fainting; fever; irregular heartbeat; numbness or pain of the arm, leg, or back; seizure; shortness of breath; sudden severe headache, dizziness, nausea, or vomiting.

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 Perflutren (Protein-Type A Microspheres):

Perflutren (Protein-Type A Microspheres) is usually handled and stored by a health care provider. If you are using Perflutren (Protein-Type A Microspheres) at home, store Perflutren (Protein-Type A Microspheres) as directed by your pharmacist or health care provider. Keep Perflutren (Protein-Type A Microspheres) out of the reach of children and away from pets.

General information:

• If you have any questions about Perflutren (Protein-Type A Microspheres), please talk with your doctor, pharmacist, or other health care provider.


• Perflutren (Protein-Type A Microspheres) 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 Perflutren (Protein-Type A Microspheres). 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.

More Perflutren (Protein-Type A Microspheres) resources

• Perflutren (Protein-Type A Microspheres) Use in Pregnancy & Breastfeeding
• Perflutren (Protein-Type A Microspheres) Drug Interactions
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• 0 Reviews · Be the first to review/rate this drug

somatropin, mammalian derived Subcutaneous, Injection

soe-ma-TROE-pin, mam-MAY-lee-un dee-RIVED

Commonly used brand name(s)

In the U.S.

• Saizen


• Serostim


• Zorbtive

In Canada

• Nutropin


• Nutropin Aq

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatropin

Uses For somatropin, mammalian derived

Somatropin is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have growth failure caused by growth hormone deficiency (inability to produce enough growth hormone).

Somatropin is also used together with a proper diet to treat short bowel syndrome (SBS), which is a condition that prevents the intestine or gut from absorbing food properly.

somatropin, mammalian derived is available only with your doctor's prescription.

Before Using somatropin, mammalian derived

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For somatropin, mammalian derived, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to somatropin, mammalian derived or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of somatropin in children with growth hormone deficiency.

Appropriate studies have not been performed on the relationship of age to the effects of somatropin in children with short bowel syndrome. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of somatropin in the elderly. However, elderly patients are more sensitive to the effects of somatropin, which may require an adjustment of dosage in patients receiving somatropin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of somatropin, mammalian derived. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain tumor or


• Cancer, active or


• Closed epiphyses (normal bone growth stopped) in children or


• Diabetic retinopathy (eye condition) or


• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or


• Severe illness after surgery or major medical emergency (e.g., open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions .

• Cancer, history of or


• Fluid retention, history of or


• Hypopituitarism (pituitary gland produces low hormone levels) or


• Hypothyroidism (underactive thyroid gland) or


• Otitis media (ear infection) in children, history of or


• Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse .

• Diabetes, or a family history of—Use with caution. May prevent insulin from working properly .

• Kidney disease or


• Liver disease—Effects of somatropin may be increased because of slower removal from the body .

• Turner syndrome—May increase risk of having thyroid problems .

Proper Use of somatropin, mammalian derived

somatropin, mammalian derived is given as a shot under your skin or into a muscle. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using somatropin, mammalian derived at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

If you are using somatropin, mammalian derived to treat short bowel syndrome, carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.

somatropin, mammalian derived comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of somatropin, mammalian derived will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of somatropin, mammalian derived. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of growth hormone deficiency:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 milligram (mg) per kilogram (kg) of body weight, given three times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed.
    
    
  
  
  • For treatment of short bowel syndrome:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

somatropin, mammalian derived needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened vials of somatropin, mammalian derived at room temperature, away from heat and direct light. Do not freeze.

Store the medicine that has been mixed in the refrigerator. The Saizen® vials and Zorbtive® that has been mixed should be used within 14 days. The Saizen® click.easy® cartridge that has been mixed should be used within 21 days. Make sure you understand how long you can store the medicine after it has been mixed. Throw away any mixed medicine that has not been used within this time.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using somatropin, mammalian derived

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by somatropin, mammalian derived.

somatropin, mammalian derived may cause a serious allergic reaction that requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you get the injection.

somatropin, mammalian derived may cause a dislocation in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you or your child has a limp or pain in the hip or knee.

Pancreatitis (an inflamed pancreas) may occur while you are using somatropin, mammalian derived. Check with your doctor right away if you are having more than one of these symptoms: bloating; chills; constipation; darkened urine; fast heartbeat; fever; indigestion; loss of appetite; nausea; pains in stomach, side, or abdomen possibly radiating to the back; vomiting; or yellow eyes or skin.

somatropin, mammalian derived may affect blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests or if you have any questions.

somatropin, mammalian derived may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

somatropin, mammalian derived may cause fluid retention (extra water in the body). Tell your doctor if you have burning, numbness, pain, or tingling in all fingers except smallest finger; swelling of the hands and feet; or pain, swelling, or stiffness of the muscles. Your doctor may adjust your dose to reduce these side effects.

somatropin, mammalian derived is usually mixed with Bacteriostatic Water for Injection. You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. If this is a concern, ask your doctor about other ways to mix somatropin, mammalian derived.

somatropin, mammalian derived Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abnormal or decreased touch sensation


• bleeding after defecation


• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site


• bloating or swelling of face, arms, hands, lower legs, or feet


• blood in urine


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• changes in skin color


• cold flu-like symptoms


• cold hands and feet


• confusion


• constipation


• cough or hoarseness


• darkened urine


• decreased urination


• diarrhea


• difficult urination


• difficulty in moving


• dizziness


• dry mouth


• fainting or loss of consciousness


• fast heartbeat


• fast or irregular breathing


• feeling unusually cold


• fever or chills


• frequent or painful urination


• full or bloated feeling


• general feeling of discomfort or illness


• headache


• increase in heart rate


• indigestion


• itching


• joint pain


• light-colored stools


• lightheadedness


• loss of appetite


• lower back or side pain


• muscle aching or cramping


• muscle pain or stiffness


• nausea


• pain


• pain or burning while urinating


• pain, redness, or swelling in arm or leg


• pains in stomach, side, or abdomen, possibly radiating to the back


• pressure in the stomach


• rapid, shallow breathing


• rapid weight gain


• rectal bleeding


• runny nose


• shivering


• skin rash


• sneezing


• sore mouth or tongue


• sore throat


• stomach bloating, burning, cramping, or pain


• sudden decrease in amount of urine


• sunken eyes


• sweating


• swelling of abdominal or stomach area


• swelling of eyes or eyelids


• swelling or puffiness of face


• swollen joints


• thirst


• tightness in chest and/or wheezing


• tingling of hands or feet


• trouble in breathing


• trouble sleeping


• uncomfortable swelling around anus


• unpleasant breath odor


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• vomiting of blood


• white patches in mouth, tongue, or throat


• wrinkled skin


• yellow eyes or skin

Less common

• Bone or skeletal pain


• burning, numbness, pain, or tingling in all fingers except smallest finger


• chest pain


• depressed mood


• dry skin and hair


• feeling cold


• hair loss


• hoarseness or husky voice


• slowed heartbeat


• swelling of ankles

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose

• Anxiety


• blurred vision


• changes in vision


• cold sweats


• coma


• cool, pale skin


• decrease in amount of urine


• depression


• excessive sweating


• extreme weakness


• fatigue


• flushed, dry skin


• frequent urination


• fruit-like breath odor


• increase in hands and feet size


• increased hunger


• increased thirst


• increased urination


• increased volume of pale, diluted urine


• nervousness


• nightmares


• noisy, rattling breathing


• pain in extremities


• seizures


• shakiness


• shortness of breath


• slurred speech


• stop in menstruation


• swelling of fingers or hands


• troubled breathing at rest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain


• breast pain


• change in the color, amount, or odor of vaginal discharge


• congestion


• difficulty having a bowel movement (stool)


• discoloration of fingernails or toenails


• dryness or soreness of throat


• excess air or gas in stomach or intestines


• frequent urge to defecate


• increased sweating


• passing gas


• rash


• sneezing


• straining while passing stool


• stuffy nose


• tender, swollen glands in neck


• trouble in swallowing


• voice changes

Less common

• Discouragement


• feeling sad or empty


• irritability


• lack of appetite


• loss of interest or pleasure


• sleeplessness


• tiredness


• trouble concentrating


• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: somatropin, mammalian derived Subcutaneous, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More somatropin, mammalian derived Subcutaneous, Injection resources

• Somatropin, mammalian derived Subcutaneous, Injection Side Effects (in more detail)
• Somatropin, mammalian derived Subcutaneous, Injection Use in Pregnancy & Breastfeeding
• Somatropin, mammalian derived Subcutaneous, Injection Drug Interactions
• Somatropin, mammalian derived Subcutaneous, Injection Support Group
• 13 Reviews for Somatropin, mammalian derived Subcutaneous, Injection - Add your own review/rating

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