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Gonal-f RFF Redi-ject

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Overview

What is Gonal-f RFF Redi-ject?

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



What does Gonal-f RFF Redi-ject look like?



What are the available doses of Gonal-f RFF Redi-ject?

What should I talk to my health care provider before I take Gonal-f RFF Redi-ject?

How should I use Gonal-f RFF Redi-ject?

Prior to initiation of treatment with Gonal-f RFF Redi-ject:

Initial starting dose of the first cycle - 75 International Units of Gonal-f RFF Redi-ject per day for 14 days, administered subcutaneously

Individualization doses after 14 days

Doses larger than 300 International Units of FSH per day are not recommended


What interacts with Gonal-f RFF Redi-ject?

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What are the warnings of Gonal-f RFF Redi-ject?

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What are the precautions of Gonal-f RFF Redi-ject?

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What are the side effects of Gonal-f RFF Redi-ject?

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What should I look out for while using Gonal-f RFF Redi-ject?

Gonal-f RFF Redi-ject is contraindicated in women who exhibit:


What might happen if I take too much Gonal-f RFF Redi-ject?

Aside from possible OHSS and multiple gestations there is no additional information on the consequences of acute overdosage with Gonal-f RFF Redi-ject.


How should I store and handle Gonal-f RFF Redi-ject?

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.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Follicle stimulating hormone (FSH), the active component in Gonal-f RFF Redi-ject, is required for normal follicular growth, follicular maturation, and gonadal steroid production. The level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.

Gonal-f RFF Redi-ject stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis, and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with Gonal-f RFF Redi-ject when monitoring of the woman indicates that appropriate follicular development parameters have been achieved. There is inter-woman variability in response to FSH administration.

Non-Clinical Toxicology
Gonal-f RFF Redi-ject is contraindicated in women who exhibit:

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 and multiple births Gonadotropin therapy requires the availability of appropriate monitoring facilities . 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 .

The following serious adverse reactions are discussed elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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