bye-ka-LOOT-a-mide

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antiandrogens

• Metastatic prostate cancer (in combination with a luteinizing hormone-releasing hormone (LHRH) analog).

• Antagonizes the effects of androgen at the cellular level.

• Decreased spread of prostate cancer.

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 96%.

Metabolism/Excretion: Mostly metabolized by the liver. Excreted in the urine and feces.

Half-life: 5.8 days.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity.

Use Cautiously in:

• Moderate to severe liver impairment
• Men with female partners of reproductive potential.

CV: chest pain, hypertension, peripheral edema.

Derm: hot flashes, alopecia, photosensitivity, rash, sweating.

Endo: breast pain, gynecomastia, hyperglycemia.

GI: constipation, diarrhea, nausea, ↑ liver enzymes, abdominal pain, HEPATOTOXICITY, vomiting.

GU: ↓fertility, erectile dysfunction, hematuria, incontinence, nocturia, urinary tract infections.

Hemat: anemia.

Metab: ↓weight.

MS: pain.

Neuro: weakness, dizziness, headache, insomnia, paresthesia.

Resp: dyspnea.
Misc: flu-like syndrome, infection.

Drug-Drug:

• May ↑ the effect of warfarin.

• PO (Adults): 50 mg once daily.

(Generic available)

• Tablets: 50 mg;

• Assess patient for adverse GI effects. Diarrhea is the most common cause of discontinuation of therapy.

• Monitor serum prostate-specific antigen periodically to determine response to therapy. If levels rise, assess patient for disease progression. May require periodic LHRH analog administration without bicalutamide.
  • Monitor serum transaminases before, regularly during first 4 mo of therapy, and periodically during therapy. May cause ↑ serum alkaline phosphatase, AST, ALT, and bilirubin concentrations. If patient is jaundiced or if transaminases ↑>2 times upper limit of normal, discontinue bicalutamide; levels usually return to normal after discontinuation.
  • May cause ↑ BUN and serum creatinine, and ↓ hemoglobin and WBCs.
  • May cause ↓ glucose tolerance in males taking LHRH agonists concurrently; monitor blood glucose in patients receiving bicalutamide in combination with LHRH analog.
  • Monitor PT/INR closely in patients taking warfarin. May lead to severe bleeding.

• Start treatment with bicalutamide at the same time as LHRH analog.
• PO: May be administered in the morning or evening, without regard to food.

• Instruct patient to take bicalutamide along with the LHRH analog as directed at the same time each day. If a dose is missed, omit and take the next dose at regular time; do not double doses. Do not discontinue without consulting health care professional. Advise patient to read Patient Information prior to starting and with each Rx refill in case of changes.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient to stop taking bicalutamide and notify health care professional immediately of symptoms of liver dysfunction (nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness) or interstitial lung disease (trouble breathing with or without a cough or fever).
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any new medications.
• Instruct patient to report severe or persistent diarrhea.
• Discuss with patient the possibility of hair loss, breast enlargement and breast pain. Explore methods of coping.
• Advise patient to use sunscreen, avoid sunlight or sunlamps and tanning beds, and wear protective clothing to prevent photosensitivity reactions.
• Advise male patients with female partners of reproductive potential to use effective contraception during and for 130 days after last dose of therapy. Advise male patients that bicalutamide may impair fertility.
• Emphasize the importance of regular follow-up exams and blood tests to determine progress; monitor for side effects.

• Decreased spread of prostate cancer.

Casodex