Bicalutamide

Bicalutamide is a prescription medicine used to treat the symptoms of prostate cancer.

• Bicalutamide is available under the following different brand names: Casodex

Adult dosage

Tablet

• 50mg

Prostate Cancer

Adult dosage

• 50 mg orally once daily
• Use in combination with LHRH analog

Locally Advanced Prostate Cancer

Adult dosage

• 150 mg orally once daily as monotherapy

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Bicalutamide include:

• hot flashes,
• pain in the back,
• pelvic pain,
• abdominal pain,
• swelling in hands, ankles, or feet,
• increased night-time urination,
• weakness,
• dizziness,
• nausea,
• diarrhea,
• constipation, and
• fever, chills, flu-like symptoms.

Serious side effects of Bicalutamide include:

• breast pain or swelling,
• blood in urine,
• sudden chest pain or discomfort,
• wheezing,
• dry cough,
• rapid heart rate,
• trouble concentrating,
• drowsiness,
• dry skin,
• blurred vision, 
• weight loss,
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet,
• liver problems--nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills, and
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Rare side effects of Bicalutamide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Bicalutamide has severe interactions with the following drugs:
  • flibanserin
  • lomitapide
  • lonafarnib
• Bicalutamide has serious interactions with at least 29 other drugs.
• Bicalutamide has moderate interactions with at least 45 other drugs.
• Bicalutamide has minor interactions with the following drugs:
  • estradiol vaginal
  • levamlodipine
  • maitake
  • taurine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Female patients (esp pregnant-may harm fetus)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bicalutamide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bicalutamide?”

Cautions

• Hepatic impairment
• Severe liver injury resulting in hospitalization or death reported
• Spermatogenesis inhibition reported
• Gynecomastia and breast pain were reported during therapy when used as a single agent
• May reduce glucose tolerance in males when used in combination with LHRH; monitor blood glucose
• Monitor prostate-specific antigen (PSA) progression if PSA increases
• Antiandrogen therapy may cause morphological changes in spermatozoa; based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after administering final dose administered
• Based on animal studies, therapy can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential; long-term effects on male fertility not studied

Pregnancy and Lactation

• Contraindicated for use in pregnant women because it can cause fetal harm; not indicated for use in females; there are no human data on use in pregnant women; in animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose
• Lactation
  • Not indicated for use in pregnant women; there is no information available on the presence of bicalutamide in human milk or effects on the breastfed infant or milk production; bicalutamide has been detected in rat milk