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Genotropin

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Genotropin

Genotropin

INDICATIONS

Pediatric Patients

GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.

GENOTROPIN (somatropin [rDNA origin] for injection) 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 (somatropin [rDNA origin] for injection) 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.

GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of growth failure associated with Turner syndrome.

GENOTROPIN (somatropin [rDNA origin] for injection) 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 (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

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

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.

DOSAGE AND ADMINISTRATION

The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN (somatropin [rdna origin]) must not be injected intravenously.

Therapy with GENOTROPIN (somatropin [rdna origin]) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.

Dosing of Pediatric Patients

General Pediatric Dosing Information

The GENOTROPIN (somatropin [rdna origin]) dosage and administration schedule should be individualized based on the growth response of each patient.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with GENOTROPIN (somatropin [rdna origin]) for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.

Prader-Willi Syndrome

Generally, a dose of 0.24 mg/kg body weight/week is recommended.

Small for Gestational Age

Generally, a dose of 0.48 mg/kg body weight/week is recommended.

Turner Syndrome

Generally, a dose of 0.33 mg/kg body weight/week is recommended.

Idiopathic Short Stature

Generally, a dose up to 0.47 mg/kg of body weight/week is recommended.

Dosing of Adult Patients

Adult Growth Hormone Deficiency (GHD)

Based on the weight-based dosing utilized in the original pivotal studies described herein, the recommended dosage at the start of therapy is not more than 0.04 mg/kg/week given as a daily subcutaneous injection. The dose may be increased at 4- to 8-week intervals according to individual patient requirements to a maximum of 0.08 mg/kg/week. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I levels may be used as guidance in dose titration.

Alternatively, taking into account recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-I concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse events and/or serum IGF-I levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

Preparation and Administration

The GENOTROPIN (somatropin [rdna origin]) 5 and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN (somatropin [rdna origin]) Pen delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GENOTROPIN (somatropin [rdna origin]) MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

GENOTROPIN (somatropin [rdna origin]) may be given in the thigh, buttocks, or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.

HOW SUPPLIED

Dosage Forms And Strengths

GENOTROPIN (somatropin [rdna origin]) lyophilized powder:

  • 5 mg two-chamber cartridge (green tip, with preservative)
    concentration of 5 mg/mL (approximately 15 IU/mL)
  • 12 mg two-chamber cartridge (purple tip, with preservative)
    concentration of 12 mg/mL (approximately 36 IU/mL)

GENOTROPIN (somatropin [rdna origin]) MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (somatropin [rdna origin]) (without preservative)

  • 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, and 2.0 mg

GENOTROPIN (somatropin [rdna origin]) lyophilized powder is available in the following packages:

5 mg two-chamber cartridge (with preservative)

concentration of 5 mg/mL (approximately 15 IU/mL)

For use with the GENOTROPIN (somatropin [rdna origin]) PEN® 5 Growth Hormone Delivery Device and/or the GENOTROPIN (somatropin [rdna origin]) MIXER™ Growth Hormone Reconstitution Device.

Package of 5.........NDC 0013-2626-94
Package of 1.........NDC 0013-2626-81

12 mg two-chamber cartridge (with preservative)

concentration of 12 mg/mL (approximately 36 IU/mL)

For use with the GENOTROPIN (somatropin [rdna origin]) PEN 12 Growth Hormone Delivery Device and/or the GENOTROPIN (somatropin [rdna origin]) MIXER Growth Hormone Reconstitution Device.

Package of 5.........NDC 0013-2646-94
Package of 1.........NDC 0013-2646-81

GENOTROPIN (somatropin [rdna origin]) MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (somatropin [rdna origin]) (without preservative)

After reconstitution, each GENOTROPIN (somatropin [rdna origin]) MINIQUICK delivers 0.25 mL, regardless of strength. Available in the following strengths, each in a package of 7:

0.2 mg NDC 0013-2649-02
0.4 mg NDC 0013-2650-02
0.6 mg NDC 0013-2651-02
0.8 mg NDC 0013-2652-02
1.0 mg NDC 0013-2653-02
1.2 mg NDC 0013-2654-02
1.4 mg NDC 0013-2655-02
1.6 mg NDC 0013-2656-02
1.8 mg NDC 0013-2657-02
2.0 mg NDC 0013-2658-02

Storage and Handling

Except as noted below, store GENOTROPIN (somatropin [rdna origin]) lyophilized powder under refrigeration at 2° to 8°C (36° to 46°F). Do not freeze. Protect from light.

The 5 mg and 12 mg cartridges of GENOTROPIN (somatropin [rdna origin]) contain a diluent with a preservative. Thus, after reconstitution, they may be stored under refrigeration for up to 28 days.

The GENOTROPIN (somatropin [rdna origin]) MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 25°C (77°F) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN (somatropin [rdna origin]) MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN (somatropin [rdna origin]) MINIQUICK should be used only once and then discarded.

Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG Ravensburg, Germany Or Vetter Pharma-Fertigung GmbH & Co. KG Langenargen, Germany. Distributed by: Pharmacia & Upjohn Company. Division of Pfizer Inc, NY, NY, 10017. Revised January 2009

Last reviewed on RxList: 6/16/2009
This monograph has been modified to include the generic and brand name in many instances.

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