Generic Name
Follitropin
Brand Names
Gonal-f, Follistim, Gonal-f RFF, Gonal-f RFF Redi-ject
FDA approval date: March 24, 2004
Classification: Gonadotropin
Form: Injection, Kit
What is Gonal-f (Follitropin)?
Gonal-F is indicated for: GONAL-F is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.
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Brand Information
Gonal-f (follitropin alfa)
1INDICATIONS AND USAGE
GONAL-f is indicated for:
2DOSAGE FORMS AND STRENGTHS
- For Injection: 450 International Units of white lyophilized powder in a multiple-dose vial
- For Injection: 1050 International Units of white lyophilized powder in a multiple-dose vial
3CONTRAINDICATIONS
GONAL-f is contraindicated in women and men who exhibit:
- Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis
- High levels of FSH indicating primary gonadal failure
- The presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders)
- Sex hormone dependent tumors of the reproductive tract and accessory organs
- Tumors of pituitary gland or hypothalamus
GONAL-f is also contraindicated in women who exhibit:
- Abnormal uterine bleeding of undetermined origin
- Ovarian cyst or enlargement of undetermined origin
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity Reactions and Anaphylaxis
- Ovarian Hyperstimulation Syndrome
- Pulmonary and Vascular Complication
- Ovarian Torsion
- Abnormal Ovarian Enlargement
- Multi-fetal Gestation and Birth
- Embryofetal Toxicity
- Ectopic Pregnancy
- Spontaneous Abortion
- Ovarian Neoplasms
4.1Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
In addition to adverse events reported from clinical trials, the following adverse reactions have been reported during postmarketing use of GONAL-f. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to GONAL-f cannot be reliably determined.
Body as a Whole - General: Hypersensitivity reactions including anaphylaxis
Respiratory System: Asthma exacerbation
Vascular Disorders: Thromboembolism
5OVERDOSAGE
Ovarian hyperstimulation syndrome (OHSS) and multiple gestations have been observed in women with GONAL-f overdosage
6DESCRIPTION
Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit).
GONAL-f (follitropin alfa) for injection is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution.
Each multiple-dose vial of GONAL-f containing either 450 International Units (33 mcg) or 1050 International Units (77 mcg) follitropin alfa and the inactive ingredients dibasic sodium phosphate (0.89 mg), monobasic sodium phosphate (0.39 mg), and sucrose (30 mg). Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. After reconstitution with supplied 1 mL of with Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP, the resultant concentration is 600 IU/mL with a pH of approximately 6.5 to 7.5.
Under current storage conditions, GONAL-f may contain up to 10% of oxidized follitropin alfa.
7PATIENT COUNSELING INFORMATION
Advise women and men to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
8Instructions for Use
GONAL-f
(follitropin alfa) for injection
for subcutaneous use
(follitropin alfa) for injection
for subcutaneous use
Important
- Read these instructions completely before you begin.
- GONAL-f is for use under the skin only (subcutaneous).
- Only use GONAL-f if your healthcare provider trains you on how to use it correctly.
Warning:
- Do not reuse needles.
- Do not share your GONAL-f needles or syringes with another person. You may get a serious infection from other people or other people may get a serious infection from you.
- The syringes and needles that come with your GONAL-f are meant for use with GONAL-f only.
Supplies needed to give your GONAL-f injection.
- a clean flat surface like a table
- 1 GONAL-f Multi-Dose vial
- 1 GONAL-f Multi-Dose Custom Dosing Injection Syringe
- 1 Prefilled Syringe of Bacteriostatic Water for Injection, USP
- 1 FDA-cleared sharps container
- 2 alcohol pads
- 1 gauze or cotton ball
Gather your supplies
- Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
If the vial with the GONAL-f liquid mixed (reconstituted) solution is stored in the refrigerator, allow at least 30 minutes before you inject to let it warm to room temperature.
Caution: Do not use a microwave or other heating element to warm up the reconstituted liquid.
Step 1 Mixing (reconstituting)
- Wash your hands with soap and water.
Using your thumb, flip off the plastic cap of the GONAL-f vial. Wipe the top of the vial stopper with an alcohol pad. Carefully twist and pull off the protective cap of the prefilled syringe of Bacteriostatic Water. Do not touch the needle or allow it to touch any surface. - Hold the vial of GONAL-f powder firmly on a flat surface.
- Position the prefilled syringe of Bacteriostatic Water in a straight, upright position over the marked center circle of the rubber stopper on the vial of the GONAL-f powder.
Insert the needle through the center circle of the rubber stopper on the vial of the GONAL-f powder while keeping it in a straight, upright position. Slowly inject the Bacteriostatic Water into the vial of GONAL-f powder by pressing down on the syringe plunger. - Gently, rotate the vial between your fingers until the powder is dissolved.
When all of the Bacteriostatic Water has been injected into the vial of GONAL-f powder, remove your finger from the syringe plunger and withdraw the needle from the vial. Immediately throw away (dispose of) the needle and syringe into your FDA-cleared sharps container (See
Step 2 Preparing the dose
- Check that the GONAL-f liquid solution is clear. Do not use if the liquid is discolored or contains any particles. If this happens, throw it away and call your healthcare provider or pharmacist right away.
- Allow the liquid solution to come to room temperature before giving your injection.
- Wipe the rubber stopper of the vial with an alcohol swab.
- Remove the wrapper and carefully, pull the needle cap off the Custom-Dosing Injection Syringe.
Firmly hold the vial of GONAL-f liquid mixed (reconstituted) solution on a flat surface and insert the needle through the marked center circle of the rubber stopper. While keeping the needle in the vial, lift the vial and turn it upside down so that the needle points towards the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the syringe fills to slightly more than the mark for your prescribed dose. Next, with the syringe pointing upward and keeping the needle in the vial, slowly push the syringe plunger to your prescribed dose and until all air bubbles are gone and a drop of liquid appears on the tip of the needle. - Remove the syringe needle from the vial and recap the needle and set on a clean, flat surface.
- The syringe is now ready for giving your prescribed dose of GONAL-f.
Step 3 Injecting the dose
- Your healthcare provider should show you how to set the prescribed dose and use the syringe.
- Change your injection site each day to decrease discomfort. GONAL-f is injected under the skin (subcutaneously) of your stomach area, upper arm, or upper leg.
Uncap the syringe and inject the prescribed dose as directed by your healthcare provider. - Lightly press a cotton ball or gauze on the site if needed.
Step 4 How to throw away used needles and syringes
Put used needles and syringes in an FDA-cleared sharps disposal container immediately after use.
Warning: Do not throw away loose needles in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
For more information, go to http:/www.fda.gov/safesharpsdisposal.
Step 5 How to store your GONAL-f vials
- Store all vials with GONAL-f away from light.
- Store vials in the refrigerator between 36° F and 46° F (2°C and 8° C) until the expiration date, or at room temperature between 68° F and 77° F (20°C and 25°C) until the expiration date.
- If you have medicine left in a vial after injecting, store it in the refrigerator or at room temperature for a maximum of 28 days from the day the powder was mixed with Bacteriostatic Water. After 28 days, you must throw away (discard) your vial with unused solution.
- Keep the GONAL-f vials and all medicines out of the reach of children.
Manufactured by:
EMD Serono, Inc. is an affiliate of Merck KGaA, Darmstadt, Germany
©2017 EMD Serono, Inc.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised 03/2025
9PRINCIPAL DISPLAY PANEL - Kit Carton - 450 IU
NDC 44087-9030-1
GONAL-f
For subcutaneous injection
1 Multiple-dose vial
EMD
10PRINCIPAL DISPLAY PANEL - Kit Carton - 1050 IU
NDC 44087-9070-1
GONAL-f
For subcutaneous injection
1 Multiple-dose vial
EMD
