Saizen

Indications
Dosage
How Supplied

INDICATIONS

Pediatric Patients

Saizen® [somatropin (rDNA origin) for injection] is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.

Adult Patients

Saizen® is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

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

Childhood Onset

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

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

DOSAGE AND ADMINISTRATION

For subcutaneous injection.

Saizen® therapy should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with either childhood-onset or adult-onset growth hormone deficiency.

Pediatric Growth Hormone Deficiency (GHD)

Saizen® dosage and administration schedule should be individualized for each patient. The recommended weekly dosage is 0.18 mg/kg of body weight by subcutaneous injection. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human growth hormone.

Treatment with Saizen® of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused.

Adult Growth Hormone Deficiency (GHD)

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

Weight-based

Based on the dosing utilized in the original pivotal study described herein, the recommended dosage at the start of therapy is not more than 0.005 mg/kg given as a daily subcutaneous injection. The dosage may be increased to not more than 0.01 mg/kg/day after 4 weeks according to individual patient requirements. Clinical response, side effects, and determination of age-and gender-adjusted serum insulin-like growth factor (IGF-1) levels may be used as guidance in dose titration.

Non-weight-based

Alternatively, taking into account more recent literature, 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 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. During therapy, the dose should be decreased if required by the occurrence of adverse reactions and/or serum IGF-1 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.

Preparation And Administration

Vials

To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Saizen® 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.

After determining the appropriate patient dose, reconstitute each vial of Saizen® as follows: 5 mg vial with 1 to 3 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved); 8.8 mg vial with 23 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved). Approximately 10% mechanical loss can be associated with reconstitution and multidose administration.

If sensitivity to the diluent occurs, Saizen® may be reconstituted with Sterile Water for Injection, USP. When Saizen® is reconstituted in this manner, the reconstituted solution should be used immediately and any unused solution should be discarded [see WARNINGS AND PRECAUTIONS].

To reconstitute Saizen®, inject the diluent into the vial of Saizen® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. SAIZEN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Click.easy® Cartridges

For drug preparation instructions for Saizen® click.easy®cartridges, please refer to the instructions for use provided with click.easy®reconstitution device.

HOW SUPPLIED

Dosage Forms And Strengths

Saizen® lyophilized powder (to be reconstituted with Bacteriostatic Water for Injection):

  • 5 mg per vial
  • 8.8 mg per vial

Saizen® click.easy® reconstitution device:

  • One vial Saizen® containing 8.8 mg somatropin and one cartridge diluent containing 1.51 ml 0.3% (w/v) metacresol in Sterile Water for Injection

Saizen® can be administered using (1) a standard sterile disposable syringe and needle, (2) a compatible Saizen® needle-free injection device or (3) a compatible Saizen® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.

Saizen® is a sterile, non pyrogenic, white, lyophilized powder supplied in packages containing:

1 vial of 5 mg Saizen® and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2

1 vial of 8.8 mg Saizen® and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1

1 click.easy® cartridge of 8.8 mg Saizen®and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol as a antimicrobial preservative NDC 44087-1080-1

Storage And Handling

Before Reconstitution - Saizen® should be stored at room temperature (15°-30°C/59°-86°F). Expiration dates are stated on the labels.

After Reconstitution -Saizen® 5 mg and 8.8 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (2°–8°C/36°–46°F) for up to 14 days.

Saizen® 8.8 mg click.easy® cartridge reconstituted with the Sterile Water for Injection, 0.3% (w/v) metacresol provided should be stored under refrigeration (2°–8°C/36°–46°F) for up to 21 days.

Avoid freezing reconstituted vials or cartridges of Saizen®.

Manufactured for: EMD Serono, Inc., Rockland, MA 02370 USA. Revised: June 2014

Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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