Genotropin

Serious side effects have been reported with Genotropin. See the “Genotropin Precautions” section.

Common side effects of Genotropin include the following:

• joint pain
• muscle pain
• swelling of extremities
• stiffness of extremities
• joint pain
• extremity pain 
• headache
• upper respiratory tract infections

This is not a complete list of Genotropin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you take too much Genotropin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store your pen (with cartridge) in the refrigerator at 36°F to 46°F (2°C to 8°C)
• Do not freeze
• Keep this and all medicines out of the reach of children

You should not use this medicine if you are allergic to somatropin or benzyl alcohol, or if you have:

• a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma;

• cancer;

• eye problems caused by diabetes (diabetic retinopathy); or

• if you are being treated for Prader-Willi syndrome and you are overweight or have severe breathing problems (including sleep apnea).

To make sure somatropin is safe for you, tell your doctor if you have:

• diabetes;

• a pituitary gland disorder;

• abnormal curvature of the spine (scoliosis);

• underactive thyroid;

• history of head injury or brain tumor; or

• a history of childhood brain cancer and radiation treatment.

Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive.

It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• birth control pills or hormone replacement therapy

• insulin or oral diabetes medicine; or

• steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Somatropin is a man-made version of human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children. Man-made growth hormone may be used in adults or children who have certain conditions that prevent normal growth. These conditions include growth hormone deficiency (inability to produce enough growth hormone), chronic kidney disease, idiopathic short stature (unexplained shortness), Noonan syndrome, Turner syndrome, short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years of age.

This medicine is available only with your doctor's prescription.

Pediatric Patients

Genotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

Genotropin is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing (see CONTRAINDICATIONS).

Genotropin is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.

Genotropin is indicated for the treatment of growth failure associated with Turner syndrome.

Genotropin is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

Adult Patients

Genotropin is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or

Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with Genotropin. No potential mutagenicity of Genotropin was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (mouse L5178Y cells), and chromosomal damage in intact animals (bone marrow cells in rats). See PREGNANCY section for effect on fertility.

NDC 0013-2655-02

Pfizer

Genotropin®
somatropin [rDNA origin] for injection
1.4 mg Genotropin MiniQuick®

For single subcutaneous injection only
Growth Hormone Delivery Device
7 Pack

Rx only

PRINCIPAL DISPLAY PANEL - 1.6 mg MiniQuick® Label

Genotropin® 1.6 mg
somatropin [rDNA origin] for injection
Genotropin MiniQuick®
Growth Hormone Delivery Device
Pharmacia & Upjohn Co
Div of Pfizer Inc, NY, NY 10017

MADE IN
GERMANY

8Q3774

LOT
EXP

NDC 0013-2656-02

Pfizer

Genotropin®
somatropin [rDNA origin] for injection
1.6 mg Genotropin MiniQuick®

For single subcutaneous injection only
Growth Hormone Delivery Device
7 Pack

Rx only

PRINCIPAL DISPLAY PANEL - 1.8 mg MiniQuick® Label

Genotropin® 1.8 mg
somatropin [rDNA origin] for injection
Genotropin MiniQuick®
Growth Hormone Delivery Device
Pharmacia & Upjohn Co
Div of Pfizer Inc, NY, NY 10017

MADE IN
GERMANY

8Q3772

LOT
EXP