FOLLISTIM AQ- follitropin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

follitropin (UNII: 076WHW89TW) (follitropin - UNII:076WHW89TW)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

follitropin

Composition:

follitropin 350 [iU] in 0.42 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Follistim® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: Prior to initiation of treatment with Follistim AQ Cartridge: - Women should have a complete gynecologic and endocrinologic evaluation. - Primary ovarian failure should be excluded. - The possibility of pregnancy should be excluded. - Tubal patency should be demonstrated. - The fertility status of the male partner should be evaluated. Prior to initiation of treatment with Follistim AQ Cartridge: - Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. - The possibility of pregnancy should be excluded. - The fertility status of the male partner should be evaluated. In Men for: Prior to initiation of treatment with Follistim AQ Cartridge: - Men should have a complete medical and endocrinologic evaluation. - Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. - Serum testosterone levels should be normalized with human chorionic

Product summary:

Follistim AQ Cartridge (follitropin beta) injection is a clear and colorless solution in a disposable, prefilled single-patient-use glass cartridge with grey rubber piston and an aluminum crimp-cap with grey rubber inlay supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with Follistim Pen available separately) and in the following presentations: NDC 0052-0313-01 Follistim AQ Cartridge 300 international units per 0.36 mL with silver crimp-caps and 5 BD Micro-Fine Pen Needles NDC 0052-0316-01 Follistim AQ Cartridge 600 international units per 0.72 mL with gold crimp-caps and 7 BD Micro-Fine Pen Needles NDC 0052-0326-01 Follistim AQ Cartridge 900 international units per 1.08 mL with blue crimp-caps and 10 BD Micro-Fine Pen Needles Pharmacy Storage: Store refrigerated 2°C to 8°C (36°F to 46°F) until dispensed. Do not freeze. Patient Storage: Store unused cartridge refrigerated at 2°C to 8°C (36°F to 46°F) until the expiration date, or at room temperature at up to 25°C (77°F) for 3 months or until expiration date, whichever occurs first. After first use, store at 2°C to 25°C (36°F to 77°F) and discard after 28 days. Store in the original carton to protect from light. Do not freeze.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FOLLISTIM AQ- FOLLITROPIN INJECTION, SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOLLISTIM AQ CARTRIDGE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FOLLISTIM
AQ CARTRIDGE.
FOLLISTIM AQ CARTRIDGE (FOLLITROPIN BETA) INJECTION, FOR SUBCUTANEOUS
USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Follistim AQ Cartridge is a gonadotropin indicated:
IN WOMEN FOR:
Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in
Whom the Cause of Infertility is
Functional and Not Due to Primary Ovarian Failure (1.1)
Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian
Stimulation as Part of an In Vitro
Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle
(1.2)
IN MEN FOR:
Induction of Spermatogenesis in Men with Primary and Secondary
Hypogonadotropic Hypogonadism
(HH) in Whom the Cause of Infertility is Not Due to Primary Testicular
Failure (1.3)
DOSAGE AND ADMINISTRATION
SEE DOSE CONVERSION TABLE 1 FOR FOLLISTIM AQ CARTRIDGE WITH PEN
INJECTOR (2.1)
_IN ANOVULATORY WOMEN UNDERGOING OVULATION INDUCTION (2.2):_
Starting daily dose of 50 international units of Follistim AQ
Cartridge is administered subcutaneously for
at least the first 7 days. The dose is increased by 25 or 50
international units at weekly intervals until
follicular growth and/or serum estradiol levels indicate an adequate
response.
When an acceptable pre-ovulatory state is achieved, final oocyte
maturation is achieved with 5,000
to 10,000 international units of urinary human chorionic gonadotropin
(hCG).
The woman and her partner should have intercourse daily, beginning on
the day prior to the
administration of hCG and until ovulation becomes apparent.
_IN NORMAL OVULATORY WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION
AS PART OF AN IN_
_VITRO FERTILIZATION OR INTRACYTOPLASMIC SPERM INJECTION CYCLE (2.3):_
Starting dose of 200 international units (actual cartridge doses) of
Follistim AQ Cartridge is