Note: This document contains side effect information about urofollitropin. Some dosage forms listed on this page may not apply to the brand name Bravelle.

Applies to urofollitropin: injectable powder for injection.

Get emergency medical help if you have any of these signs of an allergic reaction while taking urofollitropin (the active ingredient contained in Bravelle) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

• stomach pain, bloating;

• nausea, vomiting, diarrhea;

• rapid weight gain, especially in your face and midsection;

• little or no urinating; or

• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have signs of a stroke or blood clot, such as:

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• stomach cramps or bloating;

• headache, general pain;

• nausea;

• trouble breathing;

• hot flashes; or

• mild pelvic pain, pain after an egg is removed for in-vitro fertilization.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to urofollitropin: injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection.

General

The most common adverse events were multi-fetal gestation and birth, abdominal cramps, headache, and ovarian hyperstimulation syndrome (OHSS).^[Ref]

Genitourinary

Very common (10% or more): Multi-fetal gestation and birth (up to 66.7%), ovarian hyperstimulation syndrome (OHSS) (11.4%)

Common (1% to 10%): Hot flashes, vaginal hemorrhage, ovarian disorder (pain, cyst), urinary tract infection, cervix disorder, post retrieval pain, uterine spasms, vaginal spotting, breast tenderness, vaginal discharge, infection fungal, pelvic pain

Frequency not reported: Abnormal ovarian enlargement

Postmarketing reports: Ovarian enlargement, pelvic pain, hot flushes^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension^[Ref]

Dermatologic

Common (1% to 10%): Acne, exfoliative dermatitis, rash^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal cramps (14%), abdominal pain

Common (1% to 10%): Nausea, enlarged abdomen, vomiting, diarrhea, constipation, abdominal discomfort^[Ref]

Local

Common (1% to 10%): Injection site pain and reactions (redness, bruising, swelling, and/or itching)^[Ref]

Metabolic

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

Musculoskeletal

Common (1% to 10%): Neck pain

Postmarketing reports: Muscle spasm^[Ref]

Nervous system

Very common (10% or more): Headache (12.7%)^[Ref]

Other

Common (1% to 10%): Pain, fever, accidental injury^[Ref]

Psychiatric

Common (1% to 10%): Emotional lability, depression^[Ref]

Respiratory

Common (1% to 10%): Respiratory disorder, sinusitis

Postmarketing reports: Nasopharyngitis^[Ref]

Hypersensitivity

Frequency not reported: Allergic, local or generalized skin reactions, delayed-type hypersensitivity^[Ref]