TEV-TROPIN® [somatropin (rDNA origin) for injection] is indicated for the treatment of children who have growth failure due to growth hormone deficiency (GHD).
Important Safety Information
Growth hormone may be used in children with confirmed Prader-Willi
Syndrome only when diagnosed with GHD. Children who are severely
overweight, have breathing problems while awake or asleep, and have lung
infections should stop use of growth hormone and consult a physician. This
may occur more in boys. Tell your doctor if you have severe abdominal pain as
inflammation of the pancreas has been reported in children and adults.
Changes in eyesight, headaches, nausea, and vomiting may occur. Frequent eye
examinations should be done before and during treatment. Patients should be
observed for elevated blood glucose, underactive thyroid, underactive pituitary,
skin cancers, development of a limp, or complaint of hip or knee pain. Patients
with rapid onset critical illness as a result of open heart or abdominal surgery,
multiple accidental trauma, or rapid onset respiratory failure should not be started
on TEV-TROPIN®. Patients with injury or active cancer in the brain, eye
problems related to diabetes, or bones that have stopped growing should not
receive recombinant growth hormone.
When TEV-TROPIN® is administered at the same site over a long period of time,
damage to the tissue may result. This can be avoided by rotating the injection site.
Because TEV-TROPIN® increases growth rate, patients with a history of curvature
of the spine (scoliosis) should be monitored.
TEV-TROPIN® may interfere with other drugs removed from the body by the
liver and careful monitoring is advisable.
The liquid provided to mix TEV-TROPIN® should not be used in newborns
because of associated toxicity. Doses of reconstituted TEV-TROPIN® greater than
1 mL are not recommended. Consult your child's physician for doses greater
than 1 mL. Do not exceed the dose recommended by your child's physician.
Headaches, enlargement of the breast tissue in children (gynecomastia), and inflammation of the
pancreas (pancreatitis) have been reported during appropriate use. In studies of GHD children,
injection-site reactions, for instance pain or bruising, occurred in 8 of the 164 treated
patients. Type 2 diabetes mellitus has been reported.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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