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Gonal-f RFF

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Gonal-f RFF

Gonal-f RFF Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Gonal-f RFF (follitropin alfa for injection) (*revised formulation female) is a manmade form of follicle stimulating hormone (FSH) used to treat infertility in women who cannot ovulate and do not have primary ovarian failure. It is also used to stimulate sperm production in men. Gonal-f RFF is often used with another medication called human chorionic gonadotropin (hCG). Common side effects include headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain.

The dose of Gonal-f RFF to stimulate development of the follicle is individualized. Doses may range up to 300 IU per day depending on the individual patient response. Gonal-f RFF may interact with other drugs. Tell your doctor all medications and supplements you use. Stop using Gonal-f RFF when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible harm to a nursing infant, consult your doctor before breastfeeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gonal-f RFF in Detail - Patient Information: Side Effects

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;
  • nausea, vomiting, diarrhea, bloating;
  • feeling short of breath;
  • swelling in your hands or legs;
  • weight gain;
  • urinating less than usual.

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

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness (especially on one side of the body);
  • pain, swelling, warmth, or redness in your arms or legs; or
  • severe pelvic pain on one side.

Less serious side effects may include:

  • headache;
  • mild nausea or stomach pain;
  • mild numbness or tingly feeling;
  • mild pelvic pain, tenderness, or discomfort;
  • runny or stuffy nose, sore throat;
  • breast swelling or tenderness;
  • acne;
  • mild skin rash; or
  • pain, bruising, redness, or irritation where the injection was given.

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.

Read the entire detailed patient monograph for Gonal-f RFF (Follitropin Alfa Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Gonal-f RFF Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, vomiting, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bleeding from the vagina/uterus, pain/redness/swelling of the calf muscles, cold/numb/pale skin of the arms/legs/hands/feet, swelling of ankles/hands/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, chest pain, shortness of breath.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during treatment and after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, difficult/painful breathing, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Gonal-f RFF (Follitropin Alfa Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gonal-f RFF FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The safety of Gonal-f® RFF (follitropin alfa injection) was examined in two clinical studies [(one ovulation induction study (n=83) and one study in ART (n=237)].

Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 22240 (ovulation induction) are listed in Table 4.

Table 4: Safety Profile in Ovulation Induction Study 22240

Body System
Preferred Term
Gonal-f® RFF (follitropin alfa injection)
Patients (%) Experiencing Events
Treatment cycles = 176*
n=83†
Central and Peripheral Nervous System
Headache 22 (26.5%)
Dizziness 2 (2.4%)
Migraine 3 (3.6%)
Gastro-intestinal System
Abdominal Pain 10 (12.0%)
Nausea 3 (3.6%)
Flatulence 3 (3.6%)
Diarrhea 3 (3.6%)
Toothache 3 (3.6%)
Dyspepsia 2 (2.4%)
Constipation 2 (2.4%)
Stomatitis Ulcerative 2 (2.4%)
Neoplasm
Ovarian Cyst 3 (3.6%)
Reproductive, Female
Ovarian Hyperstimulation 6 (7.2%)
Breast Pain Female 5 (6.0%)
Vaginal Haemorrhage 5 (6.0%)
Gynecological-related pain 2 (2.4%)
Uterine haemorrhage 2 (2.4%)
Respiratory System
Sinusitis 5 (6.0%)
Pharyngitis 6 (7.2%)
Rhinitis 6 (7.2%)
Coughing 2 (2.4%)
Application Site
Injection Site Pain 4 (4.8%)
Injection Site Inflammation 2 (2.4%)
Body as a Whole- General
Back Pain 3 (3.6%)
Pain 2 (2.4%)
Fever 2 (2.4%)
Hot Flushes 2 (2.4%)
Malaise 2 (2.4%)
Skin and Appendages
Acne 3 (3.6%)
Urinary System
Micturition Frequency 2 (2.4%)
Cystitis 2 (2.4%)
Resistance Mechanism
Infection viral 2 (2.4%)
* up to 3 cycles of therapy
† total patients treated with Gonal-f® RFF

Headache occurred in greater than 20% of patients receiving Gonal-f® RFF (follitropin alfa injection) in this study.

Adverse events (without regard to causality assessment) occurring in at least 2.0% of patients in Study 21884 (ART) are listed in Table 5.

Table 5: Safety Profile in Assisted Reproductive Technologies Study 21884

Body System
Preferred Term
Gonal-f® RFF (follitropin alfa injection)
Patients (%) Experiencing
Events
n=237†
Gastro-intestinal System
Abdominal Pain 55 (23.2%)
Nausea 19 (8.0%)
Body as a Whole- General
Abdomen Enlarged 33 (13.9%)
Pain 7 (3.0%)
Central and Peripheral Nervous System
Headache 44 (18.6%)
Dizziness 5 (2.1)%
Application Site Disorders
Injection site bruising 23 (9.7%)
Injection site pain 13 (5.5%)
Injection site inflammation 10 (4.2%)
Injection site reaction 10 (4.2%)
Application site edema 6 (2.5%)
Reproductive, Female
Ovarian Hyperstimulation 11 (4.6%)
Intermenstrual Bleeding 9 (3.8%)
† total patients treated with Gonal-f® RFF

Headache and abdomen enlargement occurred in more than 10% of patients and abdominal pain occurred in more than 20% of patients.

The following medical events have been reported subsequent to pregnancies resulting from Gonal-f® RFF (follitropin alfa injection) therapy in controlled clinical studies:

  1. Spontaneous Abortion
  2. Ectopic Pregnancy
  3. Premature Labor
  4. Postpartum Fever

There are no indications that use of gonadotropins during ART is associated with an increased risk of congenital malformations.

The following adverse reactions have been previously reported during Gonal-f® RFF (follitropin alfa injection) therapy:

  1. Pulmonary and vascular complications (see WARNINGS),
  2. Adnexal torsion (as a complication of ovarian enlargement),
  3. Mild to moderate ovarian enlargement,
  4. Hemoperitoneum

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Post Marketing Reports

During post-market surveillance, reports of hypersensitivity reactions including anaphylactoid reactions have been reported with the use of Gonal-f® RFF (follitropin alfa injection) .

Read the entire FDA prescribing information for Gonal-f RFF (Follitropin Alfa Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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