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Genotropin

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Genotropin

Indications
Dosage
How Supplied

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 years.

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 (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.

DOSAGE AND ADMINISTRATION

The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN must not be injected intravenously.

Therapy with GENOTROPIN 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 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 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.

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 body weight/week is recommended.

Small for Gestational Agea

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

aRecent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.48 mg/kg/week), especially in very short children (i.e., height SDS < –3), and/or older/ pubertal children, and that a reduction in dosage (e.g., gradually towards 0.24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately < 4 years) (who respond the best in general) with less severe short stature (i.e., baseline height SDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary.

Dosing Of Adult Patients

Adult Growth Hormone Deficiency (GHD)

Either of two approaches to GENOTROPIN dosing may be followed: a non-weight based regimen or a weight based regimen.

Non-weight based — based on published consensus guidelines, 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 insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age-and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.

Weight based — based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.04 mg/kg/week. The dose may be increased according to individual patient requirements to not more than 0.08 mg/kg/week at 4–8 week intervals. Clinical response, side effects, and determination of age-and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.

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 5 and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN 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 MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

GENOTROPIN 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 Lyophilized Powder
  • 5 mg two-chamber cartridge (green tip, with preservative) concentration of 5 mg/mL
  • 12 mg two-chamber cartridge (purple tip, with preservative) concentration of 12 mg/mL
Genotropin Miniquick Growth Hormone Delivery Device Containing A Two-Chamber Cartridge Of Genotropin (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 lyophilized powder is available in the following packages:

5 mg two-Chamber Cartridge (with preservative)

Concentration of 5 mg/mL

For use with the GENOTROPIN PEN® 5 Growth Hormone Delivery Device and/or the GENOTROPIN MIXER™ Growth Hormone Reconstitution Device.

Package of 1 NDC 0013-2626-81

12 mg Two-chamber Cartridge (with preservative)

Concentration of 12 mg/mL

For use with the GENOTROPIN PEN 12 Growth Hormone Delivery Device and/or the GENOTROPIN MIXER Growth Hormone Reconstitution Device.

Package of 1 NDC 0013-2646-81

Genotropin Miniquick Growth Hormone Delivery Device Containing A Two-Chamber Cartridge Of Genotropin (Without Preservative)

After reconstitution, each GENOTROPIN 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
12 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 lyophilized powder under refrigeration at 36°F to 46°F (2°C to 8°C).Do not freeze. Protect from light.

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

The GENOTROPIN MINIQUICK Growth Hormone Delivery Device should be refrigerated prior to dispensing, but may be stored at or below 77°F (25°C) for up to three months after dispensing. The diluent has no preservative. After reconstitution, the GENOTROPIN MINIQUICK may be stored under refrigeration for up to 24 hours before use. The GENOTROPIN 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. Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised: Sep 2014

Last reviewed on RxList: 10/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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