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Accretropin

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Accretropin

Accretropin

Accretropin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Accretropin (recombinant human growth hormone (r-hGH); somatropin) is a protein used to treat pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, and to treat short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include injection site reactions (such as bruising, redness, swelling, itching, rash), nausea, headache, fatigue, and scoliosis.

The dose regimen for Accretropin is individualized for each patient and depends on the condition being treated. Accretropin may interact with glucocorticoids, corticosteroids, sex steroids, anticonvulsants, cyclosporine, insulin and/or oral diabetes medications. Tell your doctor all medications and supplements you use. During pregnancy, Accretropin should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Accretropin (recombinant human growth hormone (r-hGH); somatropin) 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 Prescribing information?

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

Accretropin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

As with all protein pharmaceuticals, some patients may develop antibodies to the protein. Over 3 years of Accretropin™ (somatropin injection) therapy, no patient with growth hormone deficiency or Turner syndrome developed anti-GH antibodies with binding capacities greater than 0.67 mg/L, which is below the threshold at which attenuation of growth velocity has been observed. Anti-GH antibody titers peaked by 6-12 months and remained stable or declined subsequently. Anti-E.coli antibody titers increased slightly during Accretropin™ (somatropin injection) treatment. No growth attenuation was noted in any patient who developed anti-hGH or anti-E. coli antibodies.

Pediatric Growth Hormone-Deficient Patients

In the clinical study conducted in children with GHD injection site reactions were the most frequent treatment-related adverse event reported in 50% of patients (includes the following descriptions: bruising, erythema, hemorrhage, edema, pain, pruritis, rash, swelling). Other treatment-related adverse events (as assessed by the investigators) with a frequency ≥ 3% were nausea, headache, fatigue, and scoliosis. One patient with pre- existing type-1 diabetes required adjustment of the insulin dose under observation. See also growth hormone associated adverse events under PRECAUTIONS and WARNINGS.

Turner Syndrome Patients

In the clinical study conducted in pediatric patients with Turner Syndrome the only treatment-related adverse event (as assessed by the investigators) that occurred in ≥ 3% of patients was injection site reaction which occurred in 32% of patients (includes the following descriptions: erythema, edema, pain, pruritis). See also growth hormone associated adverse events under PRECAUTIONS and WARNINGS.

Read the entire FDA prescribing information for Accretropin (Somatropin Injection) »

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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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