Gonal-f Rff Redi-ject
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Uses
Prior to initiation of treatment with Gonal-f® RFF Redi-ject™:
- Perform a complete gynecologic and endocrinologic evaluation
- Exclude primary ovarian failure
- Exclude the possibility of pregnancy
- Demonstrate tubal patency
- Evaluate the fertility status of the male partner
Prior to initiation of treatment with Gonal-f® RFF Redi-ject™:
- Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
- Exclude the possibility of pregnancy
- Evaluate the fertility status of the male partner
History
There is currently no drug history available for this drug.
Other Information
Gonal-f® RFF Redi-ject™ contains human follicle stimulating hormone (hFSH), a glycoprotein hormone manufactured by recombinant DNA technology. The active drug substance, follitropin alfa, has a dimeric structure consisting of two non-covalently linked, non-identical glycoproteins designated as the α-and β-subunits. The α-and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone.
Recombinant human FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The protein content is assessed by size exclusion high pressure liquid chromatography. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. The in vivo biological activity of follitropin alfa has been calibrated against the first International Standard for recombinant human follicle stimulating hormone established in 1995 by the Expert Committee on Biological Standards of the World Health Organization. Gonal-f® RFF Redi-ject™ contains no luteinizing hormone (LH) activity. Based on available data derived from physico-chemical tests and bioassays, follitropin alfa and follitropin beta, another recombinant follicle stimulating hormone product, are indistinguishable.
Gonal-f® RFF Redi-ject™ is a disposable, prefilled drug delivery system intended for the subcutaneous injection of multiple and variable doses of a liquid formulation of follitropin alfa.
Each Gonal-f® RFF Redi-ject™ is filled with 415 International Units (30 mcg), 568 International Units (41 mcg), or 1026 International Units (75 mcg) follitropin alfa to deliver at least 300 International Units (22 mcg) in 0.5 mL, 450 International Units (33 mcg) in 0.75 mL, or 900 International Units (66 mcg) in 1.5 mL, respectively. Each Redi-ject™ also contains 60 mg/mL sucrose, 3.0 mg/mL m-cresol, 1.1 mg/mL di-sodium hydrogen phosphate dihydrate, 0.45 mg/mL sodium dihydrogen phosphate monohydrate, 0.1 mg/mL methionine, 0.1 mg/mL Poloxamer 188. O-phosphoric acid and/or sodium hydroxide may be used for pH adjustment.
Under current storage conditions, Gonal-f® RFF Redi-ject™ may contain up to 10% of oxidized follitropin alfa.
Therapeutic Class: Infertility
Sources
Gonal-f Rff Redi-ject Manufacturers
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Emd Serono, Inc.
![Gonal-f Rff Redi-ject (Follitropin) Injection, Solution [Emd Serono, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gonal-f Rff Redi-ject | Emd Serono, Inc.
2.1 General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Gonal-f® RFF Redi-ject™ is a pre-filled disposable auto-injection device intended for multiple dose use. Gonal-f® RFF Redi-ject™ can be set in 12.5 International Units increments. Administer Gonal-f® RFF Redi-ject™ subcutaneously in the abdomen as described in Instructions for Use Do not attempt to mix any other medications inside of the device with Gonal-f® RFF Redi-ject™. Instruct women to remove the Gonal-f® RFF Redi-ject™ from the refrigerator at least 30 minutes prior to use in order to allow Gonal-f® RFF Redi-ject™ to warm to room temperature and avoid the discomfort of a cold injection. 2.2 Recommended Dosing for Ovulation InductionThe dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)]. Starting doses less than 37.5 International Units have not been studied in clinical trials and are not recommended.
A starting daily dose of 75 International Units of Gonal-f® RFF Redi-ject™ is administered subcutaneously daily for 14 days in the first cycle of use.In subsequent cycles of treatment, the starting dose (and dosage adjustments) of Gonal-f® RFF Redi-ject™ should be determined based on the history of the ovarian response to Gonal-f® RFF Redi-ject™.
The following should be considered when planning the woman's individualized dose: - Appropriate Gonal-f ® RFF Redi-ject™ dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. - The maximum, individualized, daily dose of Gonal-f ® RFF Redi-ject™ is 300 International Units per day. - In general, do not exceed 35 days of treatment. If indicated by the ovarian response after the initial 14 days, make an incremental adjustment in dose, up to 37.5 International Units. If indicated by the ovarian response, make additional incremental adjustments in dose, up to 37.5 International Units, every 7 days. Treatment should continue until follicular growth and/or serum estradiol levels indicate an adequate ovarian response. When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of Gonal-f® RFF Redi-ject™ therapy [see Warnings and Precautions (5.2, 5.3, 5.11)].
Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2, 5.3)].
2.3 Recommended Dosing for Assisted Reproductive TechnologyThe dosing scheme follows a stepwise approach and is individualized for each woman.
Beginning on cycle day 2 or 3, a starting dose of 150 International Units of Gonal-f® RFF Redi-ject™ is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 10 days.
In women under 35 years of age whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject™ administration at a dose of 150 International Units per day.
In women 35 years of age and older whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject™ administration at a dose of 225 International Units per day. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 3-5 days or by more than 75-150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG.
The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Gonal-f® RFF Redi-ject™ therapy [see Warnings and Precautions (5.2, 5.3, 5.11)]. Doses greater than 450 International Units per day are not recommended.
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