Recommended Topic Related To:

Nutropin Depot

"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...

Nutropin Depot

INDICATIONS

Nutropin Depot® [somatropin (rDNA origin) for injectable suspension] is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.

Considerations for use: - As with any GH treatment, patients should be monitored closely throughout therapy for growth response to Nutropin Depot (somatropin (rdna origin) for inj) . Failure to respond adequately requires careful assessment, as described under DOSAGE AND ADMINISTRATION. Patients for whom no discernible cause is found should be considered for a course of treatment with a daily form of rhGH. Experience in patients who were treated with daily GH and switched to Nutropin Depot is limited.

DOSAGE AND ADMINISTRATION

The Nutropin Depot (somatropin (rdna origin) for inj) dosage and administration schedule should be individualized for each patient. Response to GH therapy in pediatric patients tends to decrease over time. However in pediatric patients, failure to increase growth rate, particularly during the first year of therapy, suggests the need for close assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, undernutrition, and advanced bone age.

Once-Monthly Injection - It is recommended that an SC injection at a dosage of 1.5 mg/kg body weight be administered on the same day of each month. Dosages above the recommended once-monthly regimen have not been studied in clinical trials. Note: subjects over 15 kg will require more than one injection per dose.

Twice-Monthly Injections - It is recommended that an SC injection at a dosage of 0.75 mg/kg body weight be administered twice each month on the same days of each month (e.g., Days 1 and 15 of each month). Dosages above the recommended twice-monthly regimen have not been studied in clinical trials. Note: subjects over 30 kg will require more than one injection per dose.

The table below indicates the required number of injections per dose.

Patient Weight (kg) Number of Injections Per Dose
0.75 mg/kg twice monthly 1.5 mg/kg once monthly
≤ 15 1 1
> 15-30 1 2
> 30-45 2 3
> 45-60 2 *
> 60 3 *
*Twice-monthly dosing recommended

Preparation of Dose

Nutropin Depot (somatropin (rdna origin) for inj) powder may only be suspended in Diluent for Nutropin Depot supplied in the kit and administered with the supplied needles.

1. Using the chart below, determine the volume of diluent needed to suspend Nutropin Depot (somatropin (rdna origin) for inj) . Withdraw the diluent into a 3 cc syringe using the needle supplied in the kit. Only the diluent supplied in the kit should be used for reconstitution, and any remaining diluent should be discarded.

Vial Size (mg somatropin) Volume of Diluent to Be Added (mL)
13.5 0.8
18 1.0
22.5 1.2

Note: Since the suspension is viscous and prevents complete withdrawal of the entire vial contents, the vials are overfilled to ensure delivery of the labeled amount of somatropin. Using these diluent volumes for final suspension results in a final concentration of 19 mg/mL somatropin in each vial size.

2. Inject the diluent into the vial against the vial wall. Swirl the vial vigorously for up to 2 minutes to disperse the powder in the diluent. Mixing is complete when the suspension appears uniform, thick, and milky, and all the powder is fully dispersed. Do not store the vial after reconstitution or the suspension may settle.

3. Withdraw the required dose. Only one vial should be used for each injection. Replace the needle with a new needle from the kit and administer the dose immediately to avoid settling of the suspension in the syringe. Deliver the dose from the syringe at a continuous rate over not more than 5 seconds. Discard unused vial contents as the product contains no preservative. An extra needle has been provided in the kit.

Stability and Storage

Before Suspension - Nutropin Depot (somatropin (rdna origin) for inj) and diluent vials must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Nutropin Depot (somatropin (rdna origin) for inj) and Diluent for Nutropin Depot (somatropin (rdna origin) for inj) . Do not expose the Nutropin Depot (somatropin (rdna origin) for inj) vial to temperatures above 25°C (77°F). Expiration dates are stated on the labels.

After Suspension - Because Nutropin Depot (somatropin (rdna origin) for inj) contains no preservatives, all injections must be given immediately. Do not allow the suspension to settle prior to withdrawal of the dose. Suspended solution cannot be stored or used to suspend another vial of Nutropin Depot (somatropin (rdna origin) for inj) .

HOW SUPPLIED

Nutropin Depot (somatropin (rdna origin) for inj) is supplied as single-use vials with 13.5 mg, 18 mg, or 22.5 mg sterile, preservative-free somatropin powder per vial.

Each 13.5 mg kit contains one single-use 13.5 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Nutropin Depot (somatropin (rdna origin) for inj) , and three 21-gauge, 1/2" needles: NDC 50242-032-35.

Each 18 mg kit contains one single-use 18 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Nutropin Depot (somatropin (rdna origin) for inj) , and three 21-gauge, 1/2" needles: NDC 50242-034-41.

Each 22.5 mg kit contains one single-use 22.5 mg vial of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], one 1.5 mL single-use vial of Diluent for Nutropin Depot (somatropin (rdna origin) for inj) , and three 21-gauge, 1/2" needles: NDC 50242-036-54.

Nutropin Depot™ [somatropin (rDNA origin) for injectable suspension] and Diluent for Nutropin Depot (somatropin (rdna origin) for inj) are manufactured for: Genentech, Inc. 1 DNA Way, South San Francisco, CA 94080-4990.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.