Index
It belongs to a group of drugs known as nonsteroidal antiandrogens.
Nonsteroidal antiandrogens such as bicalutamide block the effect of the male hormone testosterone in the body.
Bicalutamide is used in combination with another treatment that lowers the amount of testosterone in the body (either with drugs called luteinizing hormone-releasing hormone (HLHL) analogs or with surgery to remove the testicles) to treat prostate cancer in late-stage ( metastatic ).
Your doctor may have suggested this drug for different conditions. If you have not discussed this with your doctor or are unsure why you are taking this medicine, talk to your doctor. Do not stop taking this medicine without consulting your doctor.
Do not give this medicine to anyone else, even if they have the same symptoms as you. It can be harmful to people to take this medicine if their doctor has not prescribed it.
How should I use this medicine?
The recommended dose for bicalutamide is one 50 mg tablet taken once a day at around the same time each day.
Bicalutamide can be taken with or without food. This treatment should be started simultaneously as treatment with an HLHL analog (e.g., Goserelin) or after surgical removal of the testes.
Many things can affect the dose of medicine a person needs, such as body weight, other medical conditions, and other drugs. If your doctor has recommended a different amount than those listed here, do not change how you take medicine without consulting your doctor.
If you miss a dose, take it as soon as possible and continue on your regular schedule. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double amount to make up for the one you forgot. Contact your doctor or pharmacist if you are unsure what to do after you miss a dose.
Store this medicine at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medicines in sewage (for example, in the sink or toilet) or household waste. Ask your pharmacist how to dispose of medications that are no longer needed or no longer valid.
Contraindications
Do not take if:
- You are allergic to bicalutamide or any ingredient in the medication.
- You have early-stage (localized) prostate cancer.
- This medicine is not intended for use by women or children.
What side are effects possible with this drug?
Many medications can cause side effects. A side effect is an unwanted response to a drug when taken in regular doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by all people taking this drug. If you are concerned, discuss the risks and benefits of this medicine with your doctor.
The following side effects have been reported by at least 1% of the people taking this medicine. Many of these side effects can be controlled, and some may go away on their own over time.
Contact your doctor if you experience these effects and if they are severe or bothersome. Your pharmacist can advise you on managing side effects.
- Constipation .
- Decreased appetite.
- Dizziness.
- Dry Skin.
- Feeling weak
- Flatulence.
- Hair loss or hair regrowth.
- Hot flushes.
- Impotence or reduction in sexual desire.
- Increased sensitivity of the skin to the sun; increased risk of sunburn.
- Indigestion.
- Itch.
- Nausea.
- Acne.
- Swelling of the breasts with pain or tenderness.
- Fatigue.
- Weight gain.
Although most of the side effects listed below don’t happen very often, they could lead to severe problems if you don’t seek medical attention.
Contact your doctor as soon as possible if the following side effects occur:
- Abdominal pain.
- Blood in the urine.
- Chest pain.
- Severe itching
- Signs of anemia (low red blood cells, e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath).
- Signs of depression (for example, poor concentration, weight changes, sleep changes, decreased interest in activities, thoughts of suicide).
- Signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools).
- Symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive food intake, unexplained weight loss, poor wound healing, infections, fruity breath odor).
- Symptoms of heart failure (for example, tiredness, shortness of breath, especially when lying down, swelling of the feet or ankles).
Stop taking medicine and seek immediate medical attention if any of the following occur:
- Pain or tenderness in the stomach.
- Signs of a heart attack (e.g., chest pain or pressure, pain spreading through the shoulder and arm, nausea and vomiting, sweating).
- Symptoms of lung problems (e.g., shortness of breath, painful breathing, sudden shortness of breath, cough, fever).
- Signs of a severe allergic reaction (e.g., hives, difficulty breathing, difficulty swallowing, swelling of the face, lips, tongue, or throat).
- Some people may experience side effects other than those listed. Check with your doctor if you notice any symptoms that concern you while taking this medicine.
Are there any other precautions or warnings for this drug?
Before you start using a medication, tell your doctor about any medical conditions or allergies you may have, any medications you are taking, if you are pregnant or breastfeeding, and any other important information about your health.
These factors can affect the way you should use this medicine.
Abnormal heart rhythm: This drug can cause changes in the heart’s normal rhythm, called QT prolongation. QT prolongation is a serious, life-threatening condition.
If you are at risk for heart rhythm problems, talk with your doctor about how this drug may affect your medical condition, how your medical condition may affect the dosage and effectiveness of this drug, and if any special monitoring is needed.
Anemia: Bicalutamide can cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia), such as shortness of breath, unusual tired feeling, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests periodically to check the number of specific blood cells in your blood, including red blood cells.
Diabetes: the dose can cause a spike in blood sugar levels. People with diabetes may find it necessary to check their blood sugar more often while using this medicine.
If you have diabetes or are at risk of developing diabetes, talk with your doctor about how this drug may affect your medical condition, how your medical condition may affect the dosage and effectiveness of this drug, and if any special monitoring is needed.
Drowsiness / Reduced Alertness: This drug may cause drowsiness. Do not drive, operate machinery, or do other dangerous tasks until you have determined how this medicine affects you.
Heart disease: The risk of heart attack or heart failure increases for taking bicalutamide.
If you have risk factors for heart disease ( obesity, high cholesterol, smoking), talk with your doctor about how this medication may affect your medical condition, how your medical condition may affect the dosage and effectiveness of this medication, and if there are any exceptional control is necessary.
Liver function: Bicalutamide is broken down in the liver. Liver disease or reduced liver function can cause this drug to build up in the body, causing side effects.
If you have liver problems, talk to your doctor about how this drug may affect your medical condition, how your medical condition may affect the dosage and effectiveness, and if any special monitoring is needed.
Your doctor may want to check your liver function regularly with blood tests while taking this medicine.
This medicine can also cause liver problems. Contact your doctor immediately if you experience liver problems such as fatigue, malaise, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.
Lung disease: On rare occasions, notably when higher doses are used, cases of interstitial lung disease have been reported with this drug. Contact your doctor immediately if you experience lung problems, such as shortness of breath, wheezing, cough, fever, or shortness of breath.
Osteoporosis: Long-term use of bicalutamide has been shown to reduce bone strength and increase the risk of bone fractures.
If you have osteoporosis or are at increased risk of developing osteoporosis, talk with your doctor about how this drug may affect your medical condition, how your medical condition may affect the dosage and effectiveness of this drug, and if any special monitoring is needed.
What other drugs could interact with this medicine?
There may be an interaction between bicalutamide and any of the following:
- Amiodarone .
- Antipsychotics (eg, chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone).
- Antifúngicos «azoles» (p. ej., ketoconazol, fluconazol).
- Calcium channel blockers (eg, amlodipine, diltiazem, nifedipine, verapamil ).
- Disopyramide.
- Dofetilide.
- Dronedarone.
- Flecainide.
- Lomitapide.
- Macrolide antibiotics (e.g., clarithromycin, erythromycin).
- Methadone.
- Pimozide.
- Propafenone.
- Quinidine.
- Quinine.
- Quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin).
- Salmeterol.
- Serotonin antagonists (antiemetic drugs, e.g., granisetron, ondansetron).
- Sotalol.
- Antidepresivos tricíclicos (p. ej., amitriptilina, clomipramina, desipramina, trimipramina).
- Warfarin .
If you are taking any of these medications, talk to your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- Stop taking one of the medications.
- Change one of the medicines for another.
- Change the way you are taking one or both medicines.
- Leave everything as is.
