August 10, 2009
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Somatropin injection pen available for children who require larger GH doses

Prefilled pens hold up to 6 mg.

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Novo Nordisk has announced the availability of somatropin injection 30 mg/3 mL in a prefilled, preloaded pen for children with growth failure.

The 30 mg/3 mL pen (Norditropin NordiFlex) was approved by the FDA earlier this year and is now available for patient use. The pen provides a larger dose of growth hormone — twice the volume of the 15-mg pen — so patients can take just one injection instead of two. The dose can be adjusted up or down as needed in 0.1-mg increments up to 6 mg.

Somatropin injection is indicated for children with growth failure caused by little to no production of GH. It is also used to treat children who have short stature associated with Noonan syndrome and Turner syndrome; children with short stature born small for gestational age with no catch-up growth by age 2 to 4 years; and adults who do not make enough GH. In the United Sates, 18,000 to 20,000 children receive recombinant GH to treat growth failure, according to Novo Nordisk.

The pens can be used with NovoFine 30-gauge, NovoFine Autocover 30-gauge and NovoFine 32-gauge tip needles.

“Solutions that allow for more convenient use ultimately help make life easy for the patient,” Mark Sperling, MD, professor, department of pediatrics, University of Pittsburgh and Children’s Hospital of Pittsburgh, and Endocrine Today Editorial Board member, said in a press release. The new prefilled pen “allows the patient or parent to adjust the dose increments.”

Adverse events are mild and temporary and may include headache, muscle pain, joint stiffness, weakness, hyperglycemia, glucosuria, fluid retention and redness or itching at the injection site.

For more information, visit the Novo Nordisk website.