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Valtropin

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Valtropin

Indications
Dosage
How Supplied

INDICATIONS

Pediatric Patients:

Valtropin (somatropin injection) ® is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone.

Valtropin (somatropin injection) ® is indicated for the treatment of growth failure associated with Turner syndrome in patients who have open epiphyses.

Adult Patients:

Valtropin (somatropin injection) ® is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following criteria:

  1. 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
  2. Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.

DOSAGE AND ADMINISTRATION

Dosage

Pediatric Patients

The Valtropin (somatropin injection) ® dosage and administration schedule should be individualized for each patient. Therapy should not be continued if epiphyseal fusion has occurred. Response to somatropin therapy in pediatric patients tends to decrease with time. However, failure to increase growth rate, particularly during the first year of therapy, should prompt careful assessment of compliance, a determination as to whether anti-rhGH neutralizing antibodies have developed, and an evaluation to rule out other causes of growth failure including hypothyroidism, under-nutrition, advanced bone age.

Pediatric Growth Hormone Deficiency (GHD)

The amount administered during the pivotal study described herein was 0.23 mg/kg of body weight/week (0.033 mg/kg/day). Generally, the recommended dosage is 0.17 - 0.3 mg/kg of body weight/week. The weekly dose should be divided into equal amounts given either daily or 6 days a week by subcutaneous injection.

Children with Turner Syndrome

The amount administered during the pivotal study utilizing the 5 mg (15 IU) formulation of Valtropin (somatropin injection) ® described herein was 0.37 mg/kg of body weight/week (0.053 mg/kg/day). Generally, the recommended dose is up to 0.375 mg/kg of body weight/week. The weekly dose should be divided into equal amounts given either daily or 6 days a week by subcutaneous injection.

Adult Patients
Adult Growth Hormone Deficiency (GHD)

Based on the pivotal study described herein, the recommended dosage at the start of therapy is 0.33 mg/day (or 0.1 mL of reconstituted solution) (equivalent to 0.005 mg/kg/day in a 66 kg adult) (6 days/week) given as a subcutaneous injection. The dosage may be increased according to individual patient requirements to a maximum of 0.66 mg/day (equivalent to 0.010 mg/kg/day in a 66 kg adult) (6 days/week) after 4 weeks. 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. 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.

Administration

The thighs are recommended as the preferred sites of injection and the injection site should be rotated to avoid lipoatrophy.

After determining the appropriate patient dose, each vial of Valtropin (somatropin injection) ® should be reconstituted using the accompanying diluent. For use in patients with a known sensitivity to metacresol, Valtropin (somatropin injection) ® should not be reconstituted with the supplied diluent, but instead with water for injection. The diluent supplied in the prefilled syringe or water for injection should be injected entirely into the vial of Valtropin (somatropin injection) ® by aiming the stream of liquid against the glass wall. Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved, providing a 3.33 mg/mL solution of somatropin. DO NOT SHAKE. If the solution is shaken, the solution may become cloudy or develop particulate matter. The Valtropin (somatropin injection) ® solution should be clear immediately after reconstitution. DO NOT INJECT the Valtropin (somatropin injection) ® solution if it is cloudy or contains particulate matter immediately after reconstitution or after refrigeration. These kinds of solutions should be discarded.

If reconstituted with water for injection, do not store but discard after use, since it lacks preservative. If reconstituted with the supplied diluent, which contains preservative, label the vial with the date on which you prepared the solution and store in a refrigerator.

It is recommended that the volume of reconstituted Valtropin (somatropin injection) ® solution required to provide the prescribed dose of Valtropin (somatropin injection) ® should be withdrawn from the reconstituted solution and administered using sterile, disposable syringes and needles (a new disposable syringe and needle should be used for every injection).

The disposable syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy, and the needle should be fine enough to ensure patient comfort.

In order to prevent contamination of the contents of the reconstituted vial of Valtropin (somatropin injection) ® by repeated needle insertions, ensure that before every injection, the septum of the vial (e.g., the rubber vial stopper) is wiped with an antiseptic solution before puncturing it with the needle, and after every injection the rubber vial stopper is also wiped with an antiseptic solution. Return the multiuse vial, reconstituted with supplied diluent, to the refrigerator after each use.

Stability and Storage

Before Reconstitution

Valtropin (somatropin injection) ® powder or diluent should be stored under refrigeration (2°C-8°C/36°F-46°F). Do not freeze. Expiration dates are stated on the labels.

The product should be refrigerated prior to dispensing, but may be stored at or below 25°C (77°F) for up to three months after dispensing.

After Reconstitution With The Diluent Provided

When reconstituted with the diluent provided, the reconstituted solution may be stored under refrigeration (2°C-8°C/36°F-46°F) for up to 21 days. Avoid freezing reconstituted vials of Valtropin (somatropin injection) ®.

If Reconstituted With Water For Injection

When reconstituted with sterile Water for Injection, use only one dose per Valtropin (somatropin injection) ® vial and discard the unused portion if not needed immediately.

The use of Sterile Water for Injection without preservative should be reserved only for patients who have an allergy or sensitivity to metacresol or when the supplied diluent is unavailable.

HOW SUPPLIED

Valtropin (somatropin injection) ® is a sterile, non-pyrogenic, white to almost white, lyophilized powder supplied as a single pack containing:

-     1 vial of powder containing 5 mg somatropin

-     1 single use pre-filled syringe containing 1.5 mL diluent (Metacresol in Water for Injection).

FDA rev date: 4/18/2007

Last reviewed on RxList: 4/30/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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