Recommended Topic Related To:

Nutropin

"Below is a list of the most popular prescription drugs dispensed in 2011 with links to drug monographs. The list may include the medication brand name and generic name.

Note: This information pertains to U.S. prescriptions only./"...

Nutropin

Indications
Dosage
How Supplied

INDICATIONS

Pediatric Patients

Growth Hormone Deficiency (GHD)

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

Growth Failure Secondary to Chronic Kidney Disease (CKD)

Nutropin is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropintherapy should be used in conjunction with optimal management of CKD.

Idiopathic Short Stature (ISS)

Nutropin is indicated for the treatment of ISS, also called non-GHD short stature, defined by height 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.

Short Stature Associated with Turner Syndrome (TS)

Nutropin is indicated for the treatment of short stature associated with TS.

Adult Patients

Nutropin is indicated for the replacement of endogenous GH in adults with GHD who meet eitherof the following two criteria:

Adult Onset

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

Patients who were GH deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

Patients who were treated with somatropin for GHD in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH deficient adults. According to current standards, confirmation of the diagnosis of adult GHD in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GHD.

DOSAGE AND ADMINISTRATION

For subcutaneous injection.

Therapy with Nutropin should be supervised by a physician who is experienced in the diagnosisand management of pediatric patients with short stature associated with growth hormone deficiency(GHD), chronic kidney disease, Turner syndrome, idiopathic short stature, or adult patients with either childhood-onset or adult-onset GHD.

Dosing for Pediatric Patients

Nutropin dosage and administration schedule should be individualized for each patient. Response to growth hormone (GH) therapy in pediatric patients tends to decrease with 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, under-nutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with Nutropin for short stature should be discontinued when the epiphyses are fused.

Pediatric Growth Hormone Deficiency (GHD)

A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.

Growth Failure Secondary to Chronic Kidney Disease (CKD)

A weekly dosage of up to 0.35 mg/kg of body weight divided into daily subcutaneous injection is recommended.

Nutropin therapy may be continued up to the time of renal transplantation.

In order to optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:

  • Hemodialysis patients should receive their injection at night just prior to going to sleep or at least3 to 4 hours after their hemodialysis to prevent hematoma formation due to the heparin.
  • Chronic Cycling Peritoneal Dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis.
  • Chronic Ambulatory Peritoneal Dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange.
Idiopathic Short Stature (ISS)

A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injections is recommended.

Short Stature Associated with Turner Syndrome (TS)

A weekly dosage of up to 0.375 mg/kg of body weight divided into equal doses 3 to 7 times per week by subcutaneous injection is recommended.

Dosing for Adult Patients

Adult Growth Hormone Deficiency (GHD)

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

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 0.006 mg/kg daily. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily inpatients ≤35 years and to a maximum of 0.0125 mg/kg daily in patients over 35 years old. Clinical response, side effects, and determination of age- and gender-adjusted serum insulin-like growth factor (IGF-1) concentrations should be used as guidance in dose titration.

Non-weight based

Alternatively, taking into account the published literature, a starting dose of approximately 0.2 mg/day (range, 0.15 to 0.30 mg/day) may be used without consideration of bodyweight. This dose can be increased gradually every 1 to 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-1 concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-1 concentrations above the age- and gender-specific normal range.

Maintenance dosages vary considerably from person to person, and between male and female patients.

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

After the dose has been determined, reconstitute as follows: each 10 mg vial should be reconstituted with 1 to 10 mL of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), only. The pH of Nutropin after reconstitution with Bacteriostatic Water for Injection, USP (benzylalcohol preserved), is approximately 7.4.

For use in newborns or if sensitivity to the diluent occurs, Nutropin may be reconstituted with Sterile Water for Injection, USP. When Nutropin is reconstituted in this manner, the reconstituted solution should be used immediately and any unused solution should be discarded. [see WARNINGS AND PRECAUTIONS].

To prepare the Nutropin solution, inject the Bacteriostatic Water for Injection, USP (benzylalcohol preserved) into the Nutropin vial, aiming the stream of liquid against the glass wall. Then swirl the product vial with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. Because Nutropin is a protein, shaking can result in a cloudy solution. The Nutropin solution should be clear immediately after reconstitution. Occasionally, after refrigeration, you may notice that small colorless particles of protein are present in the Nutropin solution. This is not unusual for solutions containing proteins. If the solution is cloudy immediately after reconstitution or refrigeration, the contents MUST NOT be injected.

Before needle insertion, wipe the septum of both the Nutropin and diluent vials with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that Nutropin be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.

Injection sites should always be rotated to avoid lipotrophy.

HOW SUPPLIED

Dosage Forms And Strengths

Nutropin 10 mg vial and 10 mL diluent.

10 mg per vial and one 10 mL multiple dose vial of NDC 50242-018-21

Bacteriostatic Water for Injection, USP (benzyl alcohol preserved)

Storage and Handling

Before Reconstitution - Nutropin and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), must be stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the vials of Nutropin and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). Expiration dates are stated on the labels.

After Reconstitution - Vial contents are stable for 14 days when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), and stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing the reconstituted vial of Nutropin and Bacteriostatic Water for Injection, USP (benzyl alcohol preserved).

When reconstituting with Sterile Water for Injection, USP, use only one dose per Nutropin vial and discard the unused portion.

Manufactured by: Genentech, Inc., A Member of the Roche Group 1 DNA Way, South San Francisco, CA 94080-4990. Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), Manufactured for: Genentech, Inc. A Member of the Roche Group

Last reviewed on RxList: 5/25/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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.


NIH talks about Ebola on WebMD