A Safety Profile You Can Rely On

TEV-TROPIN^® promotes growth safely because it is essentially replacing a hormone that your child's body should naturally produce on its own. Testing showed no clinically significant changes in blood chemistry, hormones, antibodies to growth hormone (GH), or other important areas.¹

Although unlikely, headaches and injection-site reactions such as pain or bruises could occur.

If your child is GH deficient, take him/her to see a pediatric endocrinologist or a pediatrician on a regular basis. The doctor will observe the progress and check to make sure your child's treatment is working as planned. The doctor will determine how often your child needs to be evaluated.

Subcutaneous injection of greater than 1 mL of reconstituted solution is not recommended. For doses above 1 mL, consult your physician.

Growth hormone may be used in children with confirmed Prader-Willi Syndrome only when diagnosed with growth hormone deficiency (GHD). Children who are severely overweight, have breathing problems while awake or asleep, and have unidentified lung infections should not use GH.

Patients should be observed for elevated blood glucose, underactive thyroid, development of a limp, or complaint of hip or knee pain. Patients with rapid onset critical illness as a complication of open heart or abdominal surgery, multiple accidental trauma, rapid onset respiratory failure, injury or active cancer in the brain, or bones that have stopped growing should not receive recombinant human growth hormone (rhGH). The liquid provided to mix TEV-TROPIN^® should not be used in newborns because of possible toxicity.

In studies of GHD children, headaches occurred infrequently. Injection-site reactions (e.g., pain, bruising) occurred in 8 of the 164 treated patients.

Reference: 1. Data on file. TEVA Pharmaceuticals USA. 2004.

Growth Solutions^SM is a service mark of TEVA Pharmaceuticals USA.
TEV-TROPIN^® is a registered trademark of TEVA Pharmaceuticals USA.