Gonal-F RFF
Gonal-f (follitropin alfa) is used to treat infertility in females and males. It's a man-made version of follicle-stimulating hormone (FSH), which plays an important role in follicle and sperm development. Gonal-f (follitropin alfa) is injected under the skin, typically once daily. The dosage of Gonal-f (follitropin alfa) and the duration of treatment can differ from person to person, so follow your fertility specialist's instructions carefully. It's available under different brand names (Gonal-f, Gonal-f RFF, Gonal-f RFF Redi-ject), but not a generic. Some common side effects of this medication include headache and stomach pain.
What is Gonal-f (follitropin alfa)?
What is Gonal-f (follitropin alfa) used for?
Infertility treatment in females who have trouble ovulating
To develop multiple follicles in females going through assisted reproductive technologies (ART), such as in vitro fertilization (IVF)
Infertility treatment in males who have hypogonadotropic hypogonadism, a hormone-related condition (Gonal-F only)
How Gonal-f (follitropin alfa) works
Gonal-f (follitropin alfa) contains a lab-made form of follicle-stimulating hormone (FSH), which is a gonadotropin. In females, FSH helps the ovaries develop follicles and helps the eggs mature. In males, FSH causes healthy sperm to grow.
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What are the side effects of Gonal-f (follitropin alfa)?
Common Side Effects
- Ovarian cysts (14%)
- Headache (up to 13%)
- Stomach pain (8%)
- Nausea (7%)
- Pelvic pain (7%)
- Ovarian hyperstimulation (7%)
- Nausea (6%)
- Passing gas (6%)
- Acne (27%)
- Injection-site pain (11%)
- Tiredness (10%)
Other Side Effects
- Bleeding between menstrual periods
- Pain
- Oily, flakey skin
- Growth of breast tissue
- Lower sex drive
Serious Side Effects
- Allergic reactions: trouble breathing, facial swelling, itchy skin, rash
- Ovarian hyperstimulation syndrome: severe pelvic or stomach pain and swelling along with nausea, vomiting, sudden weight gain, diarrhea, trouble breathing, trouble urinating
- Lung problems: trouble breathing, fluid in the lungs, worsening of any current lung problems
- Heart attack: chest pain or tightness, pain that radiates up to your shoulder, arm, neck, or jaw
- Stroke: sudden trouble talking, trouble walking, numbness on one side of your body or face
- Ectopic pregnancy: severe, unexplainable pelvic pain along with unusual vaginal bleeding
Source:Â DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Acid or sour stomach
backache
belching
chest pain or tightness
confusion
difficulty breathing
difficulty in speaking
dizziness or lightheadedness
double vision
excess air or gas in the stomach or intestines
fainting
fast heartbeat
fast, weak pulse
full feeling
headache
inability to move the arms, legs, or facial muscles
indigestion
loss of appetite
noisy breathing
passing gas
pelvic pain, discomfort, aching, or heaviness
rapid weight gain
severe nausea
slow speech
stomach discomfort, upset, or pain, or swelling
sudden increase in stomach or shoulder pain
sweating
trouble breathing
unusual or large amount of vaginal bleeding
uterine bleeding between menstrual periods
vomiting
Incidence not known
Difficulty swallowing
dizziness
pain the chest, groin, or legs, especially the calves
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
slurred speech
sudden loss of coordination
sudden, severe weakness or numbness in the arm or leg
unusual tiredness or weakness
vision changes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
dandruff
oily skin
swelling of the breasts or breast soreness in both females and males
Less common
Decreased interest in sexual intercourse
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Gonal-f (follitropin alfa)
Pros
Can inject yourself at home
Can be stored at room temperature or in the refrigerator
Available as an easy-to-use pre-filled pen (Gonal-f RFF Redi-ject)
Cons
Only available as an injection
Multi-dose vials and single-dose vials need to be mixed before injection, which can be inconvenient
Brand name only; no generics available
Pharmacist tips for Gonal-f (follitropin alfa)
If appropriate, your fertility specialist can teach you how to give Gonal-f (follitropin alfa) injections to yourself at home. Ask your healthcare team about home self-injections.
The dose of Gonal-f (follitropin alfa) and the number of days you will use it for will depend on how your body responds to this medication. Follow your fertility specialist's directions carefully to give the medication the best chance to work.
Let your healthcare team know right away if you notice symptoms of ovarian hyperstimulation syndrome (OHSS), such as severe pelvic pain, nausea, or weight gain. OHSS is a potentially serious side effect of Gonal-f (follitropin alfa) in females and needs medical attention right away.
Tips on storing Gonal-f (follitropin alfa)
Gonal-f multi-dose vial and Gonal-f RFF single-use vial come as powders that first need to be mixed with sterile water before using. The powders can be stored either at room temperature or in the refrigerator.
After mixing, Gonal-f multi-dose vial is only good for 28 days (either in the fridge or at room temperature), while Gonal-f RFF single-use vial must be used right away.
Gonal-f RFF Redi-ject is an autoinjector that can be used for multiple injections. Before you open it, you can store it in the refrigerator until the expiration date on the box or at room temperature for up to 3 months. But once you start to use it, this medication is only good for 28 days (in the fridge or at room temperature).
Tips on using Gonal-f (follitropin alfa)
Always wash your hands with soap and water before injecting Gonal-f (follitropin alfa), and make sure to wipe the area of skin you are going to inject the medication into with an alcohol swab before injecting. Use a different area of the body for every dose. This will help prevent discomfort and pain during injections.
If you've stored the mixed Gonal-f multi-dose vial or Gonal-f RFF Redi-ject in the refrigerator, let the medication warm to room temperature on its own (at least 30 minutes) before injecting. Don't warm it up any other way.
If you're using Gonal-f RFF Redi-ject, you should inject it in your stomach around your belly button area. If you're using Gonal-f or Gonal-f RFF, you can inject it in your upper arms, upper legs, or your stomach around your belly button area.
Use a new needle and syringe each time you give yourself Gonal-f (follitropin alfa). Throw away the used syringes and needles in a protective (sharps) container. These containers might be given to you by your fertility team, but if not, they can be purchased at most pharmacies. Don't throw needles and syringes away in the regular trash.
Frequently asked questions about Gonal-f (follitropin alfa)
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What are the risks and warnings for Gonal-f (follitropin alfa)?
Gonal-f (follitropin alfa) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Swollen ovaries
Risk factors: High doses of Gonal-f (follitropin alfa) | Using Gonal-f (follitropin alfa) too long
Gonal-f (follitropin alfa) can cause females' ovaries to grow or swell. This is more likely to happen if you're using high doses of this medication or have used it for too long. Your fertility provider will monitor your ovaries closely with ultrasounds to make sure they aren't growing too much. If your ovaries are ever too swollen on an ultrasound, your fertility provider will tell you to stop injecting Gonal-f (follitropin alfa) and avoid having sex. Tell your healthcare team right away if you feel any cramps or pain in the pelvic or lower belly area while using this medication.
Ovarian hyperstimulation syndrome (OHSS)
Risk factors: Pregnancy
In females, Gonal-f (follitropin alfa) can cause OHSS, a condition that occurs when the ovaries grow too large after you've finished your injections. It's very painful and can cause vomiting and diarrhea. It can also cause more serious conditions, including trouble breathing and bursting ovaries. It usually goes away on its own once your menstrual period starts. People who develop OHSS and also successfully become pregnant tend to have more severe OHSS symptoms. If you feel extreme belly pain, nausea, vomiting, or diarrhea within 7 to 10 days after finishing Gonal-f (follitropin alfa), tell your fertility provider right away.
Lung problems and blood clots
Risk factors: Personal or family history of blood clots | Smoking | Ovarian hyperstimulation syndrome (OHSS) | People who are overweight
In females, Gonal-f (follitropin alfa) can raise your risk of life-threatening lung problems and blood clots. Smoking, a history of blood clots, and OHSS raise this risk even more. Blood clots can lead to a heart attack, a stroke, or a pulmonary embolism (life-threatening blood clot in the lungs). Be sure to discuss all your past and present medical conditions with your fertility provider before starting Gonal-f (follitropin alfa). Call 911 or get medical help right away if you have pain in your legs or arms, chest pain, sudden severe headaches, trouble breathing, or sudden changes in your speech or vision.
Ovarian twisting
Risk factors: Ovarian hyperstimulation syndrome (OHSS) | Pregnancy | Previous stomach surgery | History of ovarian twisting | History of or current ovarian cysts | Polycystic ovary syndrome (PCOS)
Gonal-f (follitropin alfa) raises your risk of ovarian twisting in the future. This can cause blood flow to the ovary to be cut off. It's more likely to happen if you have polycystic ovary syndrome (PCOS), had stomach surgery in the past, or have OHSS. Tell your fertility provider before you start Gonal-f (follitropin alfa) if you have a history of cysts on your ovaries and/or any surgeries you have had in the past.
Getting pregnant with more than one baby
All gonadotropin fertility treatments, including Gonal-f (follitropin alfa), make females much more likely to conceive and deliver more than one baby (twins, triplets). This is due to how the medication works to prepare the body to ovulate. Please discuss this possibility with your partner before starting Gonal-f (follitropin alfa).
Problems during pregnancy
All gonadotropin fertility treatments, including Gonal-f (follitropin alfa), make it more likely for you to experience problems during pregnancy than if you were to conceive without medication. These include birth defects, miscarriages, and pregnancies outside the uterus. It isn't clear why this happens. Your fertility provider might want to follow up with you more often to make sure you and your baby are healthy.
Allergic reactions
Severe allergic reactions to Gonal-f (follitropin alfa) are possible, including life-threatening problems like anaphylaxis (closing of the throat). Call 911 if this happens. If you notice hives, a rash, swelling of the lips or tongue, or difficulty breathing after using Gonal-f (follitropin alfa), call your healthcare professional right away.
Gonal-f (follitropin alfa) dosage forms
Typical dosing for Gonal-f (follitropin alfa)
The dose of Gonal-f (follitropin alfa), how often you take it, and the length of treatment are unique for every person. Follow your fertility specialist's instructions carefully and double check with them if you're unsure of your dose.
The typical dose of Gonal-f (follitropin alfa) ranges from 75 to 300 international units (IU) injected beneath the skin (subcutaneously). Typically, females will receive injections daily, while males will receive injections 3 times a week. Your fertility specialist will adjust the dose based on how your body responds to the medication.
Interactions between Gonal-f (follitropin alfa) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Gonal-f (follitropin alfa) cost?
Gonal-f (follitropin alfa) contraindications
High levels of FSH that could be a sign of ovarian failure
Currently pregnant
Uncontrolled disease(s) of the endocrine glands (caused by a hormonal imbalance)
Sex hormone dependent tumors
Tumors of pituitary gland or hypothalamus
Abnormal uterine bleeding (with an unknown cause)
Ovarian cysts or enlargement (with an unknown cause)
What are alternatives to Gonal-f (follitropin alfa)?
Infertility treatment in females who have trouble ovulating
To develop multiple follicles in females going through assisted reproductive technologies (ART), such as in vitro fertilization (IVF)
Infertility treatment in males who have hypogonadotropic hypogonadism, a hormone-related condition (Gonal-F only)
Female infertility not caused by ovarian failure
Male infertility not caused by testicular failure
Helping the ovaries make mature eggs as part of fertility treatments, such as IVF, for people who have trouble becoming pregnant
What is the latest news about Gonal-f (follitropin alfa)?
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References
Best studies we foundEMD Serono, Inc. (2023). Gonal-F RFF- follitropin alfa kit [package insert]. DailyMed.
EMD Serono, Inc. (2024). Gonal-F- follitropin alfa kit [package insert]. DailyMed.
EMD Serono, Inc. (2024). Gonal-F RFF Redi-Ject- follitropin injection, solution [package insert]. DailyMed.
Kumar, P., et al. (2011). Ovarian hyperstimulation syndrome. Journal of Human Reproductive Sciences.
MedlinePlus. (2023). Follicle-stimulating hormone (FSH) levels test.
MedlinePlus. (2023). Hypogonadotropic hypogonadism.
National Institute of Diabetes and Digestive and Kidney Disease. (2018). Gonadotropins. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury.
Orlowski, M., et al. (2023). Physiology, follicle stimulating hormone. StatPearls.
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