BICALUTAMIDE

Common side effects:

• flushing and sweating (hot flashes)
• body aches and pains
• breast swelling/tenderness/pain
• headache
• dizziness
• drowsiness
• trouble sleeping
• weakness
• hair loss
• weight changes
• constipation
• diarrhea
• stomach upset
• gas
• nausea
• vomiting
• loss of appetite

Tell your doctor right away if you have any serious side effects, including: decreased sexual ability/desire, vision changes, numbness/tingling of the hands or feet, swelling of the arms/legs, unusual or easy bleeding/bruising, change in the amount of urine, painful urination, signs of infection (e.g., fever, chills, persistent sore throat), trouble breathing, persistent cough, mental/mood changes (e.g., anxiety, depression).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain.

Rarely, bicalutamide may cause growth of other types of tumors. Consult your doctor immediately if new lumps or growths occur.

This medication may rarely cause serious (possibly fatal) liver disease. Get medical help right away if any of these side effects occur: dark urine, yellowing of the eyes/skin, unusual tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.

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

Precautions

• Allergy: Before taking bicalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, lung/breathing problems.
• This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• Bicalutamide should not be used in women or children. It must not be used in a woman who may be pregnant or breast-feeding. This medication may cause harm to an unborn or breast-feeding baby.

Pregnancy Risk:  Category X.  Not for use in pregnancy.

Breastfeeding:  Do not prescribe to breastfeeding women.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes: Do not share this medication with others.

Laboratory and/or medical tests (e.g., prostate specific antigen-PSA levels, liver and kidney function tests, blood sugar, complete blood counts) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Available Brands

• Bicadex [ Sandoz ]
• Bicapros [ Biomedis Oncology ]
• Bypro [ Fresenius Kabi ]
• MPL Bica [ MPL ]

Also marketed as

• Calumide [ Gedeon Richter ]
• Calumin [ Intas ]
• Casodex [ AstraZeneca ]