Bravelle

Before using Bravelle, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Bravelle or to any of its ingredients
• have been told by a healthcare provider that you are at an increased risk for blood clots (thrombosis)
• have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot
• had stomach (abdominal) surgery
• had twisting of your ovaries (ovarian torsion)
• had or have cysts in your ovaries
• have any other medical conditions
• are pregnant or suspect that you might be pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

• Store at room temperature or in a refrigerator. Do not freeze.
• Protect from light.
• Use right away after mixing.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Bravelle, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bravelle. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Bravelle (urofollitropin).

Review Date: October 4, 2017

Bravelle® is contraindicated in women who exhibit:

• Prior hypersensitivity to Bravelle® or urofollitropins
• High levels of FSH indicating primary ovarian failure [see Indications and Usage (1.1, 1.2)]
• Pregnancy
  Bravelle® may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Bravelle® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
• Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1, 1.2)]
• Sex hormone dependent tumors of the reproductive tract and accessory organ
• Tumors of pituitary gland or hypothalamus
• Abnormal uterine bleeding of undetermined origin
• Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Pregnancy

Teratogenic effects

Pregnancy Category X [see Contraindications (4)].

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Bravelle®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Renal and Hepatic Insufficiency

Safety and effectiveness in women with renal and hepatic sufficiency have not been established.

Aside from possible ovarian hyperstimulation [see Warnings and Precautions (5.3)] and multiple gestations [see Warnings and Precautions (5.6)], little is known concerning the consequences of acute overdosage with Bravelle®.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using urofollitropin.

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]

Some side effects of Bravelle may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.