Humatrope (Somatropin) treats growth hormone deficiencies. A "man made" form of growth hormone (somatropin). Humatrope is the same in its chemical structure as the growth hormone that is naturally produced by the pituitary gland. Humatrope (Somatropin)
Humatrope is administered by injecting subcutaneously.
Side effects that tended to go away or become less noticeable with a decrease in dose were swelling, muscle pain, joint pain, and joint problems.
Ingredients:
Somatropin [rDNA origin]
Available in 3 sizes:
18 IU 6mg 1 cartridge
36 IU 12mg 1 cartridge
72 IU 24mg 1 cartridge
Humatrope (Somatropin)
For more information about
Humatrope, see the Important Safety Information below, the full Prescribing Information and Patient Information links listed above, or call 1-800-LillyRx.
Indication for Humatrope
Humatrope is used to treat:
Children with short stature or growth failure associated with growth hormone deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and failure to catch up in height after small for gestational age birth.
Adults with either childhood-onset or adult-onset growth hormone deficiency.
Important Safety Information for Humatrope
WHO SHOULD NOT TAKE HUMATROPE?
You should not take Humatrope if you are having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life-threatening breathing problems. Deaths have been reported in such cases.
Somatropin should not be used in children who have Prader-Willi syndrome and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with Prader-Willi syndrome who are very overweight, have a history of blocked upper airways, sleep apnea (pauses in breathing during sleeping), or other severe breathing problems.
Humatrope should not be used if you have active cancer. Because growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland, the presence of these types of tumors should be ruled out by your doctor before you start Humatrope.
Humatrope should not be used in children whose growth plates in their bones have closed.
Humatrope should not be used in adults or children with diabetic retinopathy.
If you are allergic to metacresol or glycerin, you should not mix Humatrope with the supplied diluent. Reactions at the injection site are the most common allergic reactions. If you have had an allergic reaction to somatropin, you should not take Humatrope.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING HUMATROPE?
Tell your doctor if you take cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted while taking Humatrope.
There have been reports of death in children with Prader-Willi syndrome who recently started somatropin therapy and had one or more of the following risk factors: obesity, history of severe breathing problems or sleep apnea (pauses in breathing during sleeping), or unidentified respiratory infection. Boys with one or more of these risk factors may be at greater risk than girls. A child with Prader-Willi syndrome should be evaluated by a doctor for signs of severe breathing problems or sleep apnea before starting somatropin therapy.
If you have pre-existing tumors or growth hormone deficiency caused by abnormal tissue in the brain, you should be watched closely for worsening or returning of this condition. If you had cancer as a child, an increased risk of a new tumor, particularly certain brain tumors, has been reported in patients taking somatropin.
Your doctor should check your blood sugar regularly while you are taking Humatrope, especially if you have risk factors for diabetes. If you have diabetes or impaired glucose tolerance, your doctor should monitor your blood sugar closely during Humatrope therapy. New cases of Type 2 diabetes have been reported in patients taking Humatrope.
Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving somatropin. Consult a doctor if you develop abdominal pain while taking Humatrope.
Tell your doctor if you have any visual changes accompanied by headache, nausea, and/or vomiting while taking Humatrope. This may be a sign of increased pressure in the brain.
Adults may retain water during therapy with Humatrope. This may be brief but may increase with higher doses of Humatrope.
If you have hypopituitarism and are on standard hormone replacement therapy, your doctor should monitor your hormone replacement therapy closely while taking Humatrope.
You should have your thyroid function tested periodically during Humatrope therapy. Thyroid hormone treatment may need to be started or adjusted.
Slipped capital femoral epiphysis (fracture in the ball of the hip joint) can occur in children who have endocrine problems and in children who have rapid growth. Any child taking Humatrope who develops a limp or complains of hip or knee pain should be seen by a doctor to check for this.
Progression of scoliosis (curvature of the spine) can occur in children who have rapid growth. Humatrope has not been shown to increase the occurrence of this condition.
Children with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems while taking Humatrope.
You should rotate your injection sites to avoid breakdown of skin and fat. Seek prompt medical attention for any allergic reaction you experience to the injection of Humatrope.
If you are pregnant or nursing, you should talk to your doctor before using Humatrope. It is not known whether Humatrope is excreted in human milk. Humatrope should be used during pregnancy only when clearly needed.
Clinical studies in patients over 65 years of age have not been done. Elderly patients may be more sensitive to Humatrope and may experience more side effects.
Because Humatrope may affect how two hormones, cortisol and cortisone, are processed in the body, people may discover they have hypoadrenalism after starting Humatrope therapy. In these cases, glucocorticoid replacement therapy would need to be started.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF HUMATROPE?
Common side effects reported in adults and children taking Humatrope include injection site reactions, allergic reactions to the diluent, and hypothyroidism. Additional common side effects in adults include swelling, joint pain, muscle pain, carpal tunnel syndrome, unusual skin sensations, and high blood sugar. 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.
HOW SHOULD I STORE HUMATROPE?
Humatrope must be kept refrigerated (36 degrees to 46 degrees F [2 degrees to 8 degrees C]) before and after it is mixed. Do not freeze. Once Humatrope has been mixed and is in liquid form, it must be used within 28 days. Throw away any mixed Humatrope left over after 28 days. Before giving an injection, check the date on the cartridge. Do not use the cartridge if it has expired.
