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Humatrope

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Humatrope

Humatrope

INDICATIONS

Pediatric Patients

Growth Hormone Deficiency

Humatrope (somatropin rdna origin) is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH).

Short Stature Associated with Turner Syndrome

Humatrope (somatropin rdna origin) is indicated for the treatment of short stature associated with Turner syndrome [see Clinical Studies].

Idiopathic Short Stature

Humatrope (somatropin rdna origin) is indicated for the treatment of idiopathic short stature, also called non-GH-deficient 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 for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means [see Clinical Studies];

SDS = standard deviation scores.

SHOX Deficiency

Humatrope (somatropin rdna origin) is indicated for the treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency [see Clinical Studies].

Small for Gestational Age

Humatrope (somatropin rdna origin) is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age two to four years [see Clinical Studies].

Adult Patients

Humatrope (somatropin rdna origin) is indicated for the replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria [see Clinical Studies]:

Adult-Onset (AO)

Patients who have GH deficiency, 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 GH deficiency 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 GH deficiency in both groups involves an appropriate GH provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic GH deficiency.

DOSAGE AND ADMINISTRATION

For subcutaneous injection

Therapy with Humatrope (somatropin rdna origin) should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GH deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, small for gestational age birth, or adult patients with either childhood-onset or adult-onset GH deficiency.

Reconstitution

Vial

Each 5-mg vial of Humatrope (somatropin rdna origin) should be reconstituted with 1.5 to 5 mL of Diluent for Humatrope (somatropin rdna origin) . The diluent should be injected into the vial of Humatrope (somatropin rdna origin) by aiming the stream of liquid gently against the vial wall. Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved. DO NOT SHAKE. The resulting solution should be clear. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected.

If sensitivity to the diluent should occur, the vials may be reconstituted with Bacteriostatic Water for Injection (Benzyl Alcohol preserved), USP or Sterile Water for Injection, USP. When Humatrope (somatropin rdna origin) is reconstituted with Bacteriostatic Water for Injection, USP, the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 14 days. It is important to note that benzyl alcohol used as a preservative in Bacteriostatic Water has been associated with toxicity in newborns. Therefore, Bacteriostatic Water for Injection must not be used to reconstitute Humatrope (somatropin rdna origin) for use in a newborn infant. When Humatrope (somatropin rdna origin) is to be administered to a newborn infant it should be reconstituted with the diluent provided or, if the infant is sensitive to the diluent, Sterile Water for Injection, USP. When reconstituted with Sterile Water for Injection the solution should be kept refrigerated at 36° to 46°F (2° to 8°C) and used within 24 hours.

Cartridge

The Humatrope (somatropin rdna origin) cartridge has been designed for use only with the Humatrope (somatropin rdna origin) injection device. Each cartridge of Humatrope (somatropin rdna origin) should be reconstituted using only the diluent syringe that accompanies the cartridge and should not be reconstituted with the Diluent for Humatrope (somatropin rdna origin) provided with Humatrope (somatropin rdna origin) vials. The reconstituted solution should be clear. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected. Humatrope (somatropin rdna origin) cartridges should not be used if the patient is allergic to metacresol or glycerin.

The somatropin concentrations for the reconstituted Humatrope (somatropin rdna origin) cartridges are as follows:

6 mg cartridge (gold) 2.08 mg/mL
12 mg cartridge (teal) 4.17 mg/mL
24 mg cartridge (purple) 8.33 mg/mL

[See HOW SUPPLIED and PATIENT INFORMATION for comprehensive directions on Humatrope (somatropin rdna origin) cartridge reconstitution].

General Administration Guidelines

For all indications, the following general principles for administration should be followed:

  • When using the Humatrope (somatropin rdna origin) vial the septum of the vial should be wiped with an alcoholic antiseptic solution before and after each injection to prevent contamination of the contents by repeated needle insertions. Sterile disposable syringes and needles should be used. The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
  • When using the Humatrope (somatropin rdna origin) cartridge a sterile disposable needle should be used for each injection.
  • Humatrope (somatropin rdna origin) should be administered by subcutaneous injection with regular rotation of injection sites to avoid lipoatrophy.
  • For pediatric patients the calculated weekly Humatrope (somatropin rdna origin) dosage should be divided into equal doses given either 6 or 7 days per week.
  • For adult patients the prescribed dose should be administered daily.

Dosing for Pediatric Patients

The Humatrope (somatropin rdna origin) dosage and administration schedule should be individualized for each patient based on the growth response. Failure to increase height velocity, particularly during the first year of treatment, should prompt close assessment of compliance and evaluation of other causes of poor growth, such as hypothyroidism, under–nutrition, advanced bone age and antibodies to recombinant human growth hormone. Response to somatropin treatment tends to decrease with time. Somatropin treatment for stimulation of linear growth should be discontinued once epiphyseal fusion has occurred.

The recommended weekly dosages in milligrams (mg) per kilogram (kg) of body weight for pediatric patients are:

Growth hormone deficiency 0.026 to 0.043 mg/kg/day (0.18 to 0.30 mg/kg/week)
Turner syndrome up to 0.054 mg/kg/day (0.375 mg/kg/week)
Idiopathic short stature up to 0.053 mg/kg/day (0.37 mg/kg/week)
SHOX deficiency 0.050 mg/kg/day (0.35 mg/kg/week)
Small for gestational age up to 0.067 mg/kg/day (0.47 mg/kg/week) a
a Recent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.067 mg/kg/day), especially in very short children (i.e., height SDS < –3), and/or older pubertal children, and that a reduction in dosage (e.g., gradually towards 0.033 mg/kg/day) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately < 4 years) (who respond the best in general) with less severe short stature (i.e., baseline height SDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.033 mg/kg/day), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary.

Dosing for Patients with Adult Growth Hormone Deficiency

Either of two approaches to Humatrope (somatropin rdna origin) dosing may be followed: a non-weight-based regimen or a weight-based regimen.

Non-weight based - based on published consensus guidelines, 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 0.1-0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor I (IGF-I) concentrations. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients.

Weight-based - based on the dosing regimen used in the original adult GH deficiency registration trials, the recommended dosage at the start of treatment is not more than 0.006 mg/kg (6 μg/kg) daily. The dose may be increased according to individual patient requirements to a maximum of 0.0125 mg/kg (12.5 μg/kg) daily. Clinical response, side effects, and determination of age- and gender-adjusted serum IGF-I concentrations should be used as guidance in dose titration.

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. Estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

HOW SUPPLIED

Dosage Forms And Strengths

Humatrope (somatropin rdna origin) is a sterile, white lyophilized powder available in the following vial and cartridge sizes:

  • 5 mg vial and a 5-mL vial of Diluent for Humatrope (somatropin rdna origin)
  • 6 mg cartridge (gold) and a prefilled syringe of Diluent for Humatrope (somatropin rdna origin)
  • 12 mg cartridge (teal) and a prefilled syringe of Diluent for Humatrope (somatropin rdna origin)
  • 24 mg cartridge (purple) and a prefilled syringe of Diluent for Humatrope (somatropin rdna origin)

Humatrope (somatropin rdna origin) cartridges should be used only with the appropriate corresponding pen device.

Storage And Handling

Vials

Vial Kit — (6s) NDC 0002-7335-16

5 mg vial (no. 7335) and 5-mL vial of Diluent for Humatrope (somatropin rdna origin) (No. 7336)

Cartridges

Cartridge Kit (MS8147) NDC 0002-8147-01 (gold)

6 mg cartridge (gold) (VL7554), and prefilled syringe of Diluent for Humatrope (somatropin rdna origin) (VL7618)

Cartridge Kit (MS8148) NDC 0002-8148-01 (teal)

12 mg cartridge (teal) (VL7555), and prefilled syringe of Diluent for Humatrope (somatropin rdna origin) (VL7619)

Cartridge Kit (MS8149) NDC 0002-8149-01 (purple)

24 mg cartridge (purple) (VL7556), and prefilled syringe of Diluent for Humatrope (somatropin rdna origin) (VL7619)

Storage and Handling

Vials

Before Reconstitution Vials of Humatrope (somatropin rdna origin) and Diluent for Humatrope (somatropin rdna origin) are stable when refrigerated at 2° to 8°C (36° to 46°F). Avoid freezing Diluent for Humatrope (somatropin rdna origin) . Expiration dates are stated on the labels.

After Reconstitution Vials of Humatrope (somatropin rdna origin) are stable for up to 14 days when reconstituted with Diluent for Humatrope (somatropin rdna origin) or Bacteriostatic Water for Injection, USP and refrigerated at 2° to 8°C (36° to 46°F). Avoid freezing the reconstituted vial of Humatrope (somatropin rdna origin) .

After Reconstitution with Sterile Water, USP Use only one dose per Humatrope (somatropin rdna origin) vial and discard the unused portion. If the solution is not used immediately, it must be refrigerated at 2° to 8°C (36° to 46°F) and used within 24 hours.

Cartridges

Before Reconstitution Cartridges of Humatrope (somatropin rdna origin) and Diluent for Humatrope (somatropin rdna origin) are stable when refrigerated at 2° to 8°C (36° to 46°F). Avoid freezing Diluent for Humatrope (somatropin rdna origin) . Expiration dates are stated on the labels.

After Reconstitution Cartridges of Humatrope (somatropin rdna origin) are stable for up to 28 days when reconstituted with Diluent for Humatrope (somatropin rdna origin) and refrigerated at 2° to 8°C (36° to 46°F). Store the Humatrope (somatropin rdna origin) injection device without the needle attached. Avoid freezing the reconstituted cartridge of Humatrope (somatropin rdna origin) . Cartridges should be reconstituted only with the supplied diluent. Cartridges should not be reconstituted with the Diluent for Humatrope (somatropin rdna origin) provided with Humatrope (somatropin rdna origin) vials, or with any other solution.

Manufactured by Lilly France F-67640 Fegersheim, France for Eli Lilly and Company. Indianapolis, IN 46285, USA.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

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