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Nutropin AQ

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Nutropin AQ

Nutropin AQ

INDICATIONS

Pediatric Patients

Growth Hormone Deficiency (GHD) - Nutropin AQ® 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 AQ is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of CKD.

Idiopathic Short Stature (ISS)- Nutropin AQ 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 AQ is indicated for the treatment of short stature associated with TS.

Adult Patients

Nutropin AQ is indicated for the replacement of endogenous GH in adults with GHD who meet either of 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 AQ should be supervised by a physician who is experienced in the diagnosis and 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 AQ 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 AQ 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 AQ 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 least 3 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 AQ 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 in patients ≤ 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 body weight. 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

The solution should be clear immediately after removal from the refrigerator. Occasionally, after refrigeration, you may notice that small colorless particles of protein are present in the solution. This is not unusual for solutions containing proteins. Allow the vial, pen cartridge or NuSpin® to come to room temperature and gently swirl. If the solution is cloudy, the contents MUST NOT be injected.

Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should always be rotated to avoid lipoatrophy.

Nutropin AQ Vial

Before needle insertion, wipe the septum of the vial 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 AQ 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.

Nutropin AQ Pen Cartridge

The Nutropin AQ Pen 10 and 20 mg Cartridges are color-banded to help ensure appropriate use with the Nutropin AQ Pen delivery device. Each cartridge must be used with its corresponding color-coded Nutropin AQ Pen [See Dosage Forms and Strengths].

Wipe the septum of the Nutropin AQ Pen Cartridge 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 AQ be administered using sterile, disposable needles. Follow the directions provided in the Nutropin AQ Pen Instructions for Use.

The Nutropin AQ Pen 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.

The Nutropin AQ Pen 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 8.0 mg, in 0.2 mg increments.

Nutropin AQ NuSpin

The Nutropin AQ NuSpin 5, 10 and 20 are multi-dose, dial-a-dose injection devices prefilled with Nutropin AQ in a 5 mg/2 mL, 10 mg/2 mL or 20 mg/ 2 mL cartridge, respectively, for subcutaneous use. It is recommended that Nutropin AQ be administered using sterile, disposable needles. Follow the directions provided in the Nutropin AQ NuSpin 5, 10 or 20 Instructions for Use.

The Nutropin AQ NuSpin 5 allows for administration of a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg.

The Nutropin AQ NuSpin 10 allows for administration of a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg.

The Nutropin AQ NuSpin 20 allows for administration of a minimum dose of 0.2 mg to a maximum dose of 7.0 mg, in increments of 0.2 mg.

HOW SUPPLIED

Dosage Forms and Strengths

Nutropin AQ is available in the following vial, pen cartridge and NuSpin forms:

  • Vial: 10 mg/2 mL
  • Pen Cartridge: 10 mg/2 mL (yellow color band), and 20 mg/2 mL (purple color band)
  • NuSpin: 5 mg/2 mL (clear device), 10 mg/2 mL (green device), and 20 mg/2 mL (blue device)

Vial (2 mL): 10 mg NDC 50242-022-20
Pen Cartridge (2 mL): 10 mg NDC 50242-043-14
20 mg NDC 50242-073-01
Nutropin AQ NuSpin (2 mL): 5 mg NDC 50242-075-01
10 mg NDC 50242-074-01
20 mg NDC 50242-076-01

Storage and Handling

Nutropin AQ vial, cartridge, and NuSpin injection device contents are stable for 28 days after initial use when stored at 2-8°C/36-46°F (under refrigeration). Avoid freezing Nutropin AQ in the vial, cartridge, or NuSpin injection device. Nutropin AQ is light sensitive and the vial, cartridges, and Nutropin AQ NuSpin should be protected from light. Store the vial, cartridge, and Nutropin AQ NuSpin injection device refrigerated in a dark place when they are not in use.

Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990

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

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Nutropin AQ - User Reviews

Nutropin AQ User Reviews

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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.


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