Omnitrope

Indications
Dosage
How Supplied

INDICATIONS

Pediatric Patients

Omnitrope® (somatropin [rDNA origin] injection) is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). Omnitrope® [somatropin (rDNA origin) 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 CONTRAINDICATONS and WARNINGS AND PRECAUTIONS].

Omnitrope® [somatropin (rDNA origin) 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.

Omnitrope® (somatropin [rDNA origin] 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

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

  • Adult Onset (AO): Patients who have GHD, 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 GH 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. 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 over 6 or 7 days of subcutaneous injections. Therapy with Omnitrope® should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Prader-Willi Syndrome (PWS), those who were born small for gestational age (SGA), Idiopathic Short Stature (ISS) and adult patients with either childhood onset or adult onset GHD.

Dosing of Pediatric Patients

General Pediatric Dosing Information

The Omnitrope® 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 Omnitrope® for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

Generally, a dosage of 0.16 to 0.24 mg/kg body weight /week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.

Prader-Willi Syndrome (PWS)

Generally, a dosage of 0.24 mg/kg body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.

Small for Gestational Age (SGA)

Generally, a dosage of up to 0.48 mg/kg body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.

Idiopathic Short Stature (ISS)

Generally, a dose up to 0.47 mg/kg of body weight/week is recommended. The weekly dose should be divided over 6 or 7 days of subcutaneous injections.

Dosing of Adult Patients

Adult Growth Hormone Deficiency (GHD)

Based on the weight-based dosing utilized in clinical studies with another somatropin product, 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 not more than 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 to 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

Omnitrope® Cartridge 5 mg/1.5 mL and Cartridge 10 mg/1.5 mL

Each cartridge of Omnitrope® must be inserted into its corresponding Omnitrope® Pen 5 or Omnitrope® Pen 10 delivery system. Instructions for delivering the dosage are provided in the Omnitrope® INSTRUCTIONS FOR USE booklet enclosed with the Omnitrope® drug and the Omnitrope® Pens.

Omnitrope® for injection 5.8 mg/vial

Instructions for delivering the dosage are provided in the INSTRUCTIONS FOR USE leaflets enclosed with the Omnitrope® drug.

Once the diluent is added to the lyophilized powder, swirl gently; do not shake. Shaking may cause denaturation of the active ingredient.

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Omnitrope® MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless. Omnitrope must be refrigerated at 2° to 8°C (36° to 46°F).

Patients and caregivers who will administer Omnitrope® in medically unsupervised situations should receive appropriate training and instruction on the proper use of Omnitrope® from the physician or other suitably qualified health professional.

The dosage of Omnitrope® must be adjusted for the individual patient. The dose should be given daily by subcutaneous injections (administered preferably in the evening). Omnitrope® may be given in the thigh, buttocks, or abdomen.

Injection sites should always be rotated to avoid lipoatrophy.

HOW SUPPLIED

Dosage Forms And Strengths

Omnitrope® Cartridges and vials (for injection) are available:

  • 5 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution containing benzyl alcohol in a glass cartridge ready to be administered with the Omnitrope® Pen 5.
  • 10 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution in a glass cartridge ready to be administered with the Omnitrope® Pen 10.
  • 5.8 mg/vial is supplied with two vials, one containing somatropin as a powder and the other vial containing diluent (Bacteriostatic Water for Injection containing benzyl alcohol as a preservative).

Storage And Handling

Storage

Store Omnitrope® refrigerated at 2° to 8°C (36° to 46°F).

Do not freeze.

Omnitrope® is light sensitive and should be stored in the carton.

OMNITROPE® Cartridge 5 mg/1.5 mL

Omnitrope® Cartridge (somatropin-[rDNA origin]) 5 mg/1.5 mL is supplied in the following package sizes:

  • One cartridge (NDC 0781-3001-07)
  • Five cartridges (NDC 0781-3001-26)

For use only with the Omnitrope® Pen 5 delivery system, which is sold separately After the first use the cartridge should remain in the pen and has to be kept in a refrigerator at 2° to 8°C (36° to 46°F) for a maximum of 28 days (see Table 10).

OMNITROPE® Cartridge 10 mg/1.5 mL

OMNITROPE® Cartridge 10 mg/1.5 mL Omnitrope® Cartridge (somatropin-[rDNA origin]) 10 mg/1.5 mL is supplied in the following package sizes:

  • One cartridge (NDC 0781-3004-07)
  • Five cartridges (NDC 0781-3004-26)

For use only with the Omnitrope® Pen 10 delivery system, which is sold separately. After the first use the cartridge should remain in the pen and has to be kept in a refrigerator at 2° to 8°C (36° to 46°F) for a maximum of 28 days (see Table 10).

OMNITROPE® (somatropin [rDNA origin]) for injection 5.8 mg/vial

After reconstitution, the concentration is 5 mg/mL.

  • Carton contains 8 vials of Omnitrope® 5.8 mg and 8 vials of diluent (Bacteriostatic Water for Injection containing 1.5% benzyl alcohol as a preservative.)

NDC 0781-4004-36

Omnitrope® 5.8 mg is supplied with a diluent containing benzyl alcohol as a preservative. After reconstitution, the contents of the vial must be used within 3 weeks. After the first injection, the vial should be stored in the carton in a refrigerator at 2° to 8°C (36° to 46°F) (see Table 10.).

Table 10: Storage Options

Omnitrope® Product Formulation Storage Requirement Before Use In-use (after 1st injection)
5 mg/1.5 mL cartridge 2-8°C/36-46 °F Until exp date 2-8 °C/36-46 °F 4 weeks
10 mg/1.5 mL cartridge 2-8 °C/36-46 °F 4 weeks
5.8 mg/vial 2-8 °C/36-46 °F 3 weeks

Rev: 12-2010. Manufactured in Austria by Sandoz GmbH. Distributed by Sandoz Inc., Princeton, NJ 08540

Last reviewed on RxList: 6/1/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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