Friday, March 5, 2010

FDA approved somatropin injection pen for GH disorders

The FDA has approved somatropin pre-filled injection pens for the treatment of children and adults with growth hormone disorders.

Norditropin FlexPro (Novo Nordisk) has a user-friendly design and an audible click to confirm that the medication has left the pen. It requires no reconstitution and no loading of cartridges.

Study results indicate that 100% of patients found the injection pen easy to use, according to Novo Nordisk.

Somatropin is approved to treat children with growth failure caused by very low or no production of GH and in adults who do not produce enough GH. This product is also indicated for children who have short stature associated with Noonan and Turner syndromes and children with short stature born small for gestational age with no catch-up growth by age 2 to 4 years.

Norditropin FlexPro is available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens. After initial use, the 5 mg/1.5 mL and 10 mg/1.5 mL pens may be left at room temperature for up to three weeks without risk for spoilage.

The product is contraindicated in people who have a critical illness caused by heart or stomach surgery, trauma or respiratory problems; Prader-Willi syndrome, severe obesity or breathing problems such as sleep apnea; cancer or other tumors; eye problems associated with diabetes; epiphyses; and allergies to any ingredients in the product.

The most common adverse events associated with include headache, muscle pain, joint stiffness, hyperglycemia, glucosuria, swollen hands and feet due to fluid retention and redness and itching at the injection side. Other more serious adverse events include reports of intracranial hypertension, worsening of scoliosis and slipped capital femoral epiphysis in children. Patients with Noonan and Turner syndromes should be closely monitored by health care professionals due to increased risk for congenital heart disease.

Health care professionals should be aware if patients also take glucocorticoid medication, thyroid hormone, insulin or other medicines for diabetes, oral estrogen replacement therapy or medicines that are metabolized by the liver, such as corticosteroids, sex steroids, anticonvulsants or cyclosporine.

Novo Nordisk introduced somatropin (Norditropin) in 1988 and the first pre-filled GH pen Norditropin NordiFlex in 2004.

The Norditropin FlexPro pen will be available in the second quarter of 2010, according to Novo Nordisk.



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