Somatropin

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with somatropin, especially:

• birth control pills or hormone replacement therapy
• insulin or oral diabetes medicine; or
• steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Patients being treated with Nutropin (and/or their parents) should be informed about the potential benefits and risks associated with Nutropin treatment [see ADVERSE REACTIONS], including a review of the contents of the INSTRUCTIONS FOR USE. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects.

Patients and caregivers who will administer Nutropin should receive appropriate training and instruction on the proper use of Nutropin from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication.

Please see the accompanying directions for use of the delivery device.

The recommended dosage of Nutropin Depot (somatropin (rdna origin) for inj) should not be exceeded. Acute overdosage could lead to fluid retention, headache, nausea, vomiting, and/or hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly, consistent with the known effects of excess GH. (See recommended dosage instructions given below.)

Your pharmacist can provide more information about somatropin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 12.01. Revision date: 8/10/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

As with all protein pharmaceuticals, patients may develop antibodies to the protein. GH antibody-binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients who were treated with Nutropin Depot (somatropin (rdna origin) for inj) , 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months.

In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy.

In studies involving 138 pediatric patients treated with Nutropin Depot (somatropin (rdna origin) for inj) , the most frequent adverse reactions were injection-site reactions, which occurred in nearly all patients. On average, 2 to 3 injection-site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post-injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%).

Adverse reactions observed less frequently in the Nutropin Depot (somatropin (rdna origin) for inj) studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1-3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self-limited and well-tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Nutropin Depot (somatropin (rdna origin) for inj) .

Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences.

Other adverse drug reactions that have been reported in GH-treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema ( < 1% of patients) and arthralgia (4%) were reported as related to drug in the Nutropin Depot (somatropin (rdna origin) for inj) studies.

Read the entire FDA prescribing information for Nutropin Depot (Somatropin (rDNA origin) for Inj)

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious breathing problems may occur in patients with Prader-Willi syndrome who use somatropin. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also call your doctor at once if you have:

• vision changes with sudden and severe pain behind your eyes and nausea or vomiting;

• pain in your knees or hips, or walking with a limp;

• ear pain, swelling, warmth, or drainage;

• numbness or tingling in your wrist, hand, or fingers;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

• swelling, rapid weight gain;

• muscle or joint pain;

• headache; or

• pain, itching, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Subcutaneous:

Norditropin FlexPro: 5 mg/1.5 mL (1.5 mL); 10 mg/1.5 mL (1.5 mL); 15 mg/1.5 mL (1.5 mL); 30 mg/3 mL (3 mL) [contains phenol]

Norditropin NordiFlex Pen: 30 mg/3 mL (3 mL [DSC]) [contains phenol]

Nutropin AQ NuSpin 5: 5 mg/2 mL (2 mL) [contains phenol]

Nutropin AQ NuSpin 10: 10 mg/2 mL (2 mL) [contains phenol]

Nutropin AQ NuSpin 20: 20 mg/2 mL (2 mL) [contains phenol]

Nutropin AQ Pen: 10 mg/2 mL (2 mL [DSC])

Nutropin AQ Pen: 20 mg/2 mL (2 mL [DSC]) [contains phenol]

Omnitrope: 5 mg/1.5 mL (1.5 mL) [contains benzyl alcohol]

Omnitrope: 10 mg/1.5 mL (1.5 mL) [contains phenol]

Solution Reconstituted, Injection:

Humatrope: 5 mg (1 ea)

Humatrope: 6 mg (1 ea); 12 mg (1 ea); 24 mg (1 ea) [contains glycerin, metacresol]

Saizen: 5 mg (1 ea); 8.8 mg (1 ea)

Saizen Click.Easy: 8.8 mg (1 ea)

Saizenprep: 8.8 mg (1 ea) [contains metacresol]

Solution Reconstituted, Subcutaneous:

Genotropin: 5 mg (1 ea); 12 mg (1 ea) [contains metacresol]

Nutropin: 10 mg (1 ea [DSC]) [contains benzyl alcohol]

Omnitrope: 5.8 mg (1 ea)

Serostim: 4 mg (1 ea); 5 mg (1 ea); 6 mg (1 ea)

Tev-Tropin: 5 mg (1 ea [DSC])

Zomacton: 5 mg (1 ea) [contains benzyl alcohol]

Zomacton: 10 mg (1 ea) [contains metacresol]

Zorbtive: 8.8 mg (1 ea) [contains benzyl alcohol]

Solution Reconstituted, Subcutaneous [preservative free]:

Genotropin MiniQuick: 0.2 mg (1 ea); 0.4 mg (1 ea); 0.6 mg (1 ea); 0.8 mg (1 ea); 1 mg (1 ea); 1.2 mg (1 ea); 1.4 mg (1 ea); 1.6 mg (1 ea); 1.8 mg (1 ea); 2 mg (1 ea)

Reduction in clearance has been noted in patients with severe hepatic impairment.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, loss of strength and energy, muscle rigidity, insomnia, or nausea. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), shortness of breath, mood changes, depression, vision changes, angina, numbness or tingling of hands or feet, swelling of arms or legs, bone pain, severe muscle pain, severe joint pain, mole changes, hematuria, injection site redness or edema, skin thinning, injection site skin breakdown, or signs of increased intracranial pressure (vision changes, severe headache, nausea, or vomiting) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.