GONAL

Generic Name/API: follitropin alfa injection

Manufacturer: MERCK

Dosage Forms & Strength & Pack Size:

Injection: Gonal-f RFF Redi-ject 300 International Units per 0.5 mL in prefilled, multiple dose
disposable delivery system
Injection: Gonal-f RFF Redi-ject 450 International Units per 0.75 mL in prefilled, multiple dose
disposable delivery system
Injection: Gonal-f RFF Redi-ject 900 International Units per 1.5 mL in prefilled, multiple dose
disposable delivery system

Storage:
Store the Gonal-f RFF Redi-ject refrigerated 2°C to 8°C (36°F to 46°F) until dispensed. Upon dispensing, store Redi-ject refrigerated 2°C to 8°C (36°F to 46°F) until the expiration date, or at room temperature 20° to 25°C (68° to 77°F) for up to three months or until the expiration date, whichever occurs first. After the first injection, store refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature 20°C to 25°C (68°F to 77°F) for up to 28 days. Protect from light. Do not freeze. Discard unused material after 28 days.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

GONAL‑f® is the world’s most prescribed r‑hFSH treatment1

With 25 years of experience,2 GONAL‑f® has demonstrated efficacy2‑6 and effectiveness in routine clinical practice7‑10 with a well‑established safety profile2,11‑13 in a wide range of patients.

In women undergoing ART, GONAL‑f® is indicated both to stimulate multifollicular development during controlled ovarian stimulation (COS), and to stimulate follicular development in cases of severe LH and FSH deficiency.2

GONAL‑f® is also indicated for the stimulation of spermatogenesis in men with congenital or acquired hypogonadotrophic hypogonadism, alongside concomitant human chorionic gonadotropin (hCG) therapy.2

CONTRAINDICATIONS
Gonal-f RFF Redi-ject is contraindicated in women who exhibit:
Prior hypersensitivity to recombinant FSH products
High levels of FSH indicating primary gonadal failure
Pregnancy
Gonal-f RFF Redi-ject may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Gonal-f RFF Redi-ject is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1, 1.2)]
Sex hormone dependent tumors of the reproductive tract and accessory organs
Tumors of pituitary gland or hypothalamus
Abnormal uterine bleeding of undetermined origin
Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome

WARNINGS AND PRECAUTIONS
Gonal-f RFF Redi-ject should only be used by physicians who are experienced in infertility treatment. Gonal-f RFF Redi-ject contains a gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5)] and multiple births [see Warnings and Precautions (5.6)]. Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.11)].
The lowest effective dose should be used.
Careful attention should be given to the diagnosis of infertility and the selection of candidates for Gonal-f RFF Redi-ject therapy [see Indications and Usage (1.1, 1.2) and Dosage and Administration (2.2, 2.3)].

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