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Nutropin Depot

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Nutropin Depot

Nutropin Depot Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nutropin Depot [somatropin (rDNA origin) for injectable suspension] is a form of recombinant human growth hormone (rhGH) used for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include injection-site reactions such as nodules, redness, pain, bruising, itching, localized loss of fatty tissue, and swelling or puffiness

The Nutropin Depot dosage and administration schedule should be individualized for each patient. Nutropin Depot may interact with glucocorticoids, steroids, anticonvulsants, and cyclosporine. Tell your doctor all medications and supplements you use. During pregnancy, Nutropin Depot should be taken only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Nutropin Depot [somatropin (rDNA origin) for injectable suspension] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nutropin Depot Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nutropin Depot (Somatropin (rDNA origin) for Inj)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nutropin Depot FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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