These highlights do not include all the information needed to use Gonal-f ® RFF* Redi-ject™ safely and effectively. See full prescribing information for Gonal-f ® RFF Redi-ject™
Gonal-f ® RFF* Redi-ject™ (follitropin alfa injection) for subcutaneous use
*revised formulation female
Initial U.S. Approval: 1997
RECENT MAJOR CHANGES
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Dosage and Administration |
|
|
Redi-ject™ auto-injection device (2.1) |
10/13 |
|
Contraindications (4) |
10/13 |
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Warnings and Precautions |
|
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Hypersensitivity Reactions and Anaphylaxis (5.1) |
10/13 |
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Ovarian Hyperstimulation Syndrome (OHSS) (5.3) |
10/13 |
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Pulmonary and Vascular Complications (5.4) |
10/13 |
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Ovarian Torsion (5.5) |
10/13 |
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Multi-fetal Gestation and Birth (5.6) |
10/13 |
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Congenital Malformations (5.7) |
10/13 |
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Ectopic Pregnancy (5.8) |
10/13 |
|
Spontaneous Abortion (5.9) |
10/13 |
|
Ovarian Neoplasms (5.10) |
10/13 |
INDICATIONS AND USAGE
Gonal-f® RFF Redi-ject™ is a prefilled gonadotropin-containing auto-injection device indicated for:
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Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1)
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Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2)
DOSAGE AND ADMINISTRATION
Ovulation Induction (2.2)
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Initial starting dose of the first cycle - 75 International Units of Gonal-f® RFF Redi-ject™ per day for 14 days, administered subcutaneously
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Individualization doses after 14 days
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Doses larger than 300 International Units of FSH per day are not recommended
Assisted Reproductive Technology (2.3)
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Initial starting dose of the first cycle - 150 International Units per day, administered subcutaneously
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Dosage adjustments after 3-5 days and by 75-150 International Units at each adjustment
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Do not administer doses greater than 450 International Units per day
DOSAGE FORMS AND STRENGTHS
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Injection: Gonal-f® RFF Redi-ject™ 300 International Units per 0.5 mL in prefilled, multiple dose disposable delivery system (3)
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Injection: Gonal-f® RFF Redi-ject&tr
