Gonal F Side Effects

Also, Gonal-f is contraindicated for safety reasons where the following exist:

Gonal-F Side Effects Center

Gonal-F (follitropin alfa) Injection is a naturally occurring hormone used to stimulate a follicle (egg) to develop and mature. Gonal-F is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone (FSH) is also used to stimulate the development of multiple eggs for in vitro fertilization. FSH can be used by men to increase the production of sperm.

What Are Side Effects of Gonal-F?

Common side effects of Gonal-F include:

• headache,
• nausea,
• vomiting,
• mild stomach/abdominal pain,
• pelvic pain or tenderness,
• bloating,
• injection site reactions (redness, pain, bruising, irritation),
• breast swelling/tenderness/pain,
• numbness or tingly feeling,
• runny or stuffy nose,
• sore throat,
• acne, or
• skin rash.

Tell your doctor if you have unlikely but serious side effects of Gonal-F including:

• unusual bleeding from the vagina/uterus,
• pain/redness/swelling of the calf muscles,
• cold/numb/pale skin of the arms/legs/hands/feet, or
• swelling of ankles/hands/feet.

Dosage for Gonal-F

The dose of Gonal-F to stimulate development of the follicle is individualized. The recommended initial dose of the first cycle is 75 IU. Doses may range up to 300 IU per day depending on patient response.

What Drugs, Substances, or Supplements Interact with Gonal-F?

It is not known if other medications will interact with Gonal-F. Tell doctor all prescription or over-the-counter medicines and supplements you use.

Gonal-F During Pregnancy and Breastfeeding

Gonal-F must not be used during pregnancy. Stop using Gonal-F when you become pregnant. It is unknown if this drug passes into breast milk. Because of possible harm to a nursing infant, consult your doctor before breastfeeding.

Additional Information

Our Gonal-F (follitropin alfa) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Gonal-F Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using follicle stimulating hormone:

• severe pain in your lower stomach, nausea, vomiting, diarrhea;
• bloating, rapid weight gain;
• little or no urination; or
• trouble breathing.

Also call your doctor at once if you have:

• severe pelvic pain on one side;
• a cough with bloody mucus;
• fever, sore throat, swollen glands;
• a lump or swelling in your testicles;
• signs of acute respiratory distress syndrome–fever with shortness of breath or rapid breathing; or
• signs of a blood clot–sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects may include:

• redness, swelling, or bruising where an injection was given;
• an ovarian cyst;
• headache, tiredness;
• breast pain or swelling;
• stuffy nose, sneezing, sinus pain;
• acne; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Gonal-F Professional Information

SIDE EFFECTS

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

• Hypersensitivity Reactions and Anaphylaxis [see WARNINGS AND PRECAUTIONS]
• Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
• Pulmonary and Vascular Complication[see WARNINGS AND PRECAUTIONS]
• Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
• Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
• Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
• Embryofetal Toxicity [see WARNINGS AND PRECAUTIONS]
• Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
• Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
• Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]

Clinical 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.

Women

The safety of GONAL-F was examined in four clinical trials that enrolled 691 women [two trials for ovulation induction (454 women) and two trials for ART (237 women)].

Induction of Ovulation

In a randomized, open-labeled, multicenter, active-controlled trial in oligo-anovulatory infertile women, conducted in the U.S., a total of 118 oligo-anovulatory infertile women were randomized to and underwent ovulation induction with GONAL-F versus a comparator urofollitropin. Adverse reactions occurring in at least 5.0% of women receiving GONAL-F are listed in Table 1.

Table 1: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. Ovulation Induction Trial

Development of Multiple Follicles as part of an Assisted Reproductive Technology (ART) Cycle

In a randomized, open-labeled, active-comparator trial conducted in the U.S., a total of 56 normal ovulatory infertile women were randomized and received GONAL-F versus a urofollitropin comparator as part of an ART [in vitro fertilization (IVF) or intracytoplasmic sperm injection cycle (ICSI)] cycle. All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring in at least 5.0% of women are listed in Table 2.

Table 2: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. ART Trial

Induction Of Spermatogenesis

The safety of GONAL-F for induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism was examined in 3 open-label, non-randomized, multi-center, multi-national, escalating dose clinical trials (Trials 1, 2 and 3) conducted in in 76 adult men (aged 16 to 48 years) with primary or secondary hypogonadotropic hypogonadism (defined as serum testosterone

During these trials, there was one serious adverse reaction of gynecomastia requiring surgical excision of breast tissue in a 50 year old man who received 9 months of therapy with Gonal-F. Pathology report showed gynecomastia with no atypia.

There were no discontinuations due to adverse reactions.

Adverse reactions reported in Trials 1, 2 and 3 by ≥2 patients during treatment with Gonal-f are shown in Table 3.

Table 3. Common Adverse Reactions in Men with Azoospermia and Primary orSecondary Hypogonadotropic Hypogonadism Receiving Gonal-F in Trials 1, 2 and 3 for Induction for Spermatogensis

Postmarketing 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

Read the entire FDA prescribing information for Gonal-F (Follitropin Alfa)

© Gonal-F Patient Information is supplied by Cerner Multum, Inc. and Gonal-F Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Gonal-f Injection for IVF – Uses, Dosage, Price & Side Effects

Gonal-f injection is a fertility drug that contains gonadotropins, which are used for ovarian stimulation cycles in fertility treatment cycles, like IVF. Dosages available range from 75 IU to 1050 IU, although the most common are Gonal-f 300, Gonal-f 450, and Gonal-f 900.

Some dosages of Gonal-f are preassembled in a disposable delivery pen designed for subcutaneous injection. Depending on the dosage, it may be used in IVF or IUI cycles.

Provided below is an index with the 11 points we are going to expand on in this article.

Description & price

Gonal-f contains a type of hormone called recombinant FSH (r-FSH). Its function is to promote the growth and development of ovarian follicles. Recombinant FSH has not a human origin (as in the case of Menopur), but is created using genetic engineering techniques in the lab.

Gonal-f contains the active ingredient follitropin alfa. Depending on the concentration of this hormone, Gonal-f is sold in different types and each one has a specific composition.

Gonal-f can be found in two formats that differ in the mode of administration.

Each type of Gonal-f contains a different amount of follitropin alfa. Your doctor will prescribe the one that matches the amount of FSH you need for your fertility treatment cycle. The following are the dosages available and their prices:

Gonal-f 75 75 IU/0.5 ml (5.5 microgram). $100/per unit approximately. Gonal-f 300 300 IU/0.5 ml (22 microgram). $160/per unit approximately. Gonal-f 450 450 IU/0.75 ml (33 microgram). $260/per unit approximately. Gonal-f 900 900 IU/1.5 ml (66 microgram). $490/per unit approximately. Gonal-f 1050 1,050 IU/1.75 ml (77 microgram). Price varies.

When to start treatment with Gonal-f

Treatment with Gonal-f should be started under the supervision of a physician experienced in the treatment of fertility disorders. The following are the most common indications:

Anovulation As in the case of women with PCOS (Polycystic Ovary Syndrome) and those who lack ovulatory cycles in spite of having used clomiphene citrate (Clomid) or Letrozole (Femara) previously. Stimulated IVF cycles To induce ovarian follicle growth in women undergoing in vitro fertilization. Hypogonadotropic hypogonadism (HH) The purpose of using Gonal is to promote sperm production in males with issues with the production of sperm, either congenital or acquired.

Precautions

Before administering this drug, you should tell your doctor or pharmacist if you are allergic to it, other products that contain FSH, or if you have any other allergies.

Gonal-f may contain inactive ingredientes that can cause allergic reactions or other problems in some patients. Talk to your pharmacist before using it.

Also, tell your doctor or pharmacist about your medical history, especially if you have experienced or are experiencing other fertility or health problems.

Self-administration of Gonal-f should only be performed by patients who are very well motivated and adequately trained. Access to expert advice is crucial to this end. Special attention should be given to specific instructions for the use of the pre-filled pen.

In patients with known hypersensitivity to gonadotropins that do not contain FSH, there is a high risk of cross-sensitivity. For this reason, the first injection of Gonal-f should be performed under direct medical supervision.

How to use

Although Gonal-f is available in different pack sizes, the preparation and application is exactly the same in all cases.

In the case of women undergoing an IVF cycle, the staff at the clinic will teach you how to use Gonal-f step by step. In any case, you should read the information pamphlet carefully before using it.

These are the steps to follow to use Gonal-f correctly:

1. Reconstitute the product by mixing the liquid with the medication until it looks homogeneous, without suspended particles. Do not use it if particles are present.
2. Place a new needle into the pen and adjust it to the dose prescribed.
3. Clean the injection site with rubbing alcohol before injecting each dose. The lower abdomen is a recommended injection site.
4. Inject Gonal-f under the skin or into a muscle as indicated by your doctor.
5. Discard the needle and medical supplies each time.

Gonal-f should be administered once a day at the same time each day. We recommend that you change the injection site each time to lessen injury under the skin.

This information will not replace, in any case, the instructions given by your physician. Contact your doctor immediately if you are concerned that you have given yourself too much Gonal-f or in case of misuse.

Dosage

The dose of Gonal-f varies on a case-by-case basis as well as on the treatment it has been prescribed for. The ultimate goal of using this medicine is not the same in IVF and IUI cycles, as one shall see below:

Gonal-f injection for IUI

In IUI cycles, patients usually undergo mild ovarian stimulation. In fact, the goal is not stimulating the ovary but to induce ovulation, since is is required that at least 2-3 follicles develop.

For this reason, the dose of Gonal-f required in Intrauterine Insemination cycles is typically 75 IU or 150 IU. The daily dosage is rarely greater than 225 IU.

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Gonal-f injection for IVF/ICSI

Contrary to what happens in IUI cycles, IVF patients do undergo controlled ovarian stimulation (COS). In this case, the goal is to obtain between 8 and 15 mature follicles that can be harvested later via follicle puncture. To this end, the recommended dose of Gonal-f can range between 150 and 450 IU once a day.

Irrespective of the the infertility treatment, your physician will schedule a series of monitoring visits to evaluate the estradiol levels and growth of the follicles. The dose administered can be adjusted depending on what your doctor sees with each visit.

Whether you need to undergo IUI or IVF to become a mother, we recommend that you get your Fertility Report now. In 3 simple steps, it will show you a list of clinics that fit your preferences and meet our strict quality criteria. Moreover, you will receive a report via email with useful tips to visit a fertility clinic for the first time.

Contraindications

Do not use this drug if you are allergic or hipersensitive to follitropin alfa, FSH, or any of the excipients this medication is composed of.

Also, Gonal-f is contraindicated for safety reasons where the following exist:

• Tumours of the hypothalamus or pituitary gland
• Large ovarian cysts that are not caused by PCOS
• Vaginal bleeding of unknown origin
• Ovarian, uterine or breast carcinoma
• Lactation or pregnancy
• Primary ovarian insufficiency or primary testicular failure
• Developmental abnormalities of the female reproductive organs that are incompatible with pregnancy
• Uterine fibroids that prevent pregnancy

Also, one must keep in mind that Gonal-f should not be used in children or the elderly.

Interactions & side effects

First of all, it should be clear that no clinically significant drug interactions have been reported during Gonal-f therapy.

However, Gonadorelin or GnRH is a product that may interact with Gonal-f by increasing the dosage of Gonal-f needed to achieve an adequate ovarian response.

Many patients have no side effects during or after using Gonal-f, whereas others may develop mild side effects or adverse reactions, including injection site reactions (e.g. bruising, irritation, pain, swelling. ), headaches, or develop ovarian cysts.

Gonal-f Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 15, 2022.

Note: This document contains side effect information about follicle stimulating hormone. Some dosage forms listed on this page may not apply to the brand name Gonal-f.

Applies to follicle stimulating hormone: subcutaneous powder for solution, subcutaneous solution. Other dosage forms:

Serious side effects of Gonal-f

Along with its needed effects, follicle stimulating hormone (the active ingredient contained in Gonal-f) 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 while taking follicle stimulating hormone:

More common

• Acid or sour stomach
• anxiety
• backache
• belching
• bloating
• chest pain or tightness
• confusion
• cough
• diarrhea
• 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
• heartburn
• 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
• hives, itching, skin rash
• 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

Other side effects of Gonal-f

Some side effects of follicle stimulating hormone 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

• Acne
• 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

For Healthcare Professionals

Applies to follicle stimulating hormone: injectable powder for injection, injectable solution, subcutaneous powder for injection, subcutaneous solution.

General

The most common adverse events were headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection). [Ref]

Genitourinary

Very common (10% or more): Multiple births (up to 35.1%), ovarian cysts, mild to moderate ovarian enlargement

Common (1% to 10%): Mild or moderate OHSS (including symptomatology), intermenstrual bleeding, pelvic discomfort, ovarian hyperstimulation, ectopic pregnancy, miscarriage, gynecomastia (males), varicocele, epididymal cyst, vaginal hemorrhage, pelvic pain

Uncommon (0.1% to 1%): Severe OHSS (including symptomatology), breast complaints, metrorrhagia, ovarian cyst, ovarian enlargement, ovarian torsion, uterine enlargement, vaginal hemorrhage

Rare (less than 0.1%): Complications of severe OHSS, adnexal torsion associated with ovarian enlargement

Frequency not reported: Ectopic pregnancy, miscarriage, multiple gestations

Postmarketing reports: Breast tenderness [Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 23.2%), abdomen enlarged (13.9%)

Common (1% to 10%): Abdominal distension, abdominal discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain lower, flatulence

Uncommon (0.1% to 1%): Swollen abdomen [Ref]

Nervous system

Very common (10% or more): Headache (up to 26.5%), dizziness

Local

Very common (10% or more): Injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection) [Ref]

Dermatologic

Common (1% to 10%): Acne, rash, dermoid cyst

Frequency not reported: Bruising, swelling, erythema, urticaria, pruritus [Ref]

Metabolic

Common (1% to 10%): Weight gain [Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Generalized hypersensitivity reaction

Very rare (less than 0.01%): Mild to severe hypersensitivity reactions including anaphylactic reactions and shock [Ref]

Cardiovascular

Very rare (less than 0.01%): Thromboembolism, usually associated with severe OHSS [Ref]

Other

Uncommon (0.1% to 1%): Pain, influenza-like symptoms [Ref]

Respiratory

Very rare (less than 0.01%): Exacerbation or aggravation of asthma [Ref]

More about Gonal-f (follicle stimulating hormone)

• Check interactions
• Compare alternatives
• Reviews (2)
• Dosage information
• During pregnancy
• Drug class: gonadotropins
• En español

Patient resources

• Drug Information
• Gonal-F (Advanced Reading)

Other brands

Professional resources

Other formulations

Related treatment guides

• Hypogonadism, Male
• Follicle Stimulation
• Ovulation Induction

References

1. “Product Information. Follistim (follicle stimulating hormone).” Organon (2002):

2. “Product Information. Gonal-F (follicle stimulating hormone).” Serono Laboratories Inc (2002):

3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

4. Cerner Multum, Inc. “Australian Product Information.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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