Applies to urofollitropin: injectable powder for injection.
Warning
You should not use this medicine if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, breast cancer, uterine or ovarian cancer, a pituitary gland tumor, or infertility that is not caused by lack of ovulation.
Do not use urofollitropin if you are pregnant.
Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms: stomach pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, little or no urinating, or pain when you breathe, rapid heart rate, or shortness of breath.
Get emergency medical help if you have any of these signs of an allergic reaction while taking urofollitropin: 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:
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stomach pain, bloating;
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nausea, vomiting, diarrhea;
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rapid weight gain, especially in your face and midsection;
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little or no urinating; or
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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:
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sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
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pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
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stomach cramps or bloating;
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headache, general pain;
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nausea;
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trouble breathing;
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hot flashes; or
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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]
