bye-ka-LOOT-a-mide

• Treatment of metastatic prostate carcinoma in conjunction with luteinizing hormone–releasing hormone (LHRH) analogs (goserelin, leuprolide).

• Antagonizes the effects of androgen at the cellular level.

• Decreased spread of prostate carcinoma.

Absorption: Well absorbed after oral administration.

Distribution: Unknown.

Protein Binding: 96%.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-life: 5.8 days.

Contraindicated in:

• Hypersensitivity
• Women.

Use Cautiously in:

• Moderate to severe liver impairment
• Rep: Men with female partners of reproductive potential
• Pedi: Safety not established.

CV: chest pain, hypertension, peripheral edema.

Derm: alopecia, photosensitivity, rash, sweating.

Endo: breast pain, gynecomastia.

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

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

Hemat: anemia.

Metab: hyperglycemia, weight loss.

MS: back pain, pelvic pain, bone pain.

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

Resp: dyspnea.

Misc: generalized pain, hot flashes, flu-like syndrome, infection.

Drug-Drug:

• May ↑ the effect of warfarin.

• PO (Adults): 50 mg once daily (must be given concurrently with LHRH analog).

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

Casodex

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antiandrogens

(Generic available)

• Tablets: 50 mg;

(blood levels)

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

• Monitor serum prostate-specific antigen (PSA) periodically to determine response to therapy. If levels rise, assess patient for disease progression. May require periodic LHRH analogue 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 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 agonists.
  • Monitor PT/INR closely in patients taking warfarin. May lead to severe bleeding.

• Diarrhea (Adverse Reactions).

• 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.
• Rep: Advise female and male patients to use effective contraception during and for 130 days after last dose of therapy. Female patients should avoid breast feeding during therapy. Advise male patients 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 carcinoma.

NDC Code^*

• 0904- Major Pharmaceuticals
  • 0904-6019- Bicalutamide
    • 0904-6019-46- 30 TABLET in 1 BOTTLE (0904-6019-46)

• 16714- Northstar RxLLC
  • 16714-816- Bicalutamide
    • 16714-816-01- 30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01)

• 16714- Northstar RxLLC
  • 16714-816- Bicalutamide
    • 16714-816-02- 100 TABLET, FILM COATED in 1 BOTTLE (16714-816-02)

• 16729- Accord Healthcare Inc.
  • 16729-023- Bicalutamide
    • 16729-023-01- 100 TABLET in 1 BOTTLE (16729-023-01)

• 16729- Accord Healthcare Inc.
  • 16729-023- Bicalutamide
    • 16729-023-10- 30 TABLET in 1 BOTTLE (16729-023-10)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-485- bicalutamide
    • 47335-485-08- 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-485- bicalutamide
    • 47335-485-18- 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-485- bicalutamide
    • 47335-485-83- 30 TABLET, FILM COATED in 1 BOTTLE (47335-485-83)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-485- bicalutamide
    • 47335-485-88- 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-88)

• 60429- Golden State Medical Supply, Inc.
  • 60429-177- Bicalutamide
    • 60429-177-01- 100 TABLET, FILM COATED in 1 BOTTLE (60429-177-01)

• 60429- Golden State Medical Supply, Inc.
  • 60429-177- Bicalutamide
    • 60429-177-05- 500 TABLET, FILM COATED in 1 BOTTLE (60429-177-05)

• 60429- Golden State Medical Supply, Inc.
  • 60429-177- Bicalutamide
    • 60429-177-30- 30 TABLET, FILM COATED in 1 BOTTLE (60429-177-30)

• 60505- Apotex Corp.
  • 60505-2642- Bicalutamide
    • 60505-2642-1- 100 TABLET in 1 BOTTLE (60505-2642-1)

• 60505- Apotex Corp.
  • 60505-2642- Bicalutamide
    • 60505-2642-3- 30 TABLET in 1 BOTTLE (60505-2642-3)

• 62559- ANI Pharmaceuticals, Inc.
  • 62559-680- CASODEX
    • 62559-680-30- 30 TABLET in 1 BOTTLE (62559-680-30)

• 65841- Cadila Healthcare Limited
  • 65841-613- Bicalutamide
    • 65841-613-01- 100 TABLET, FILM COATED in 1 BOTTLE (65841-613-01)

• 65841- Cadila Healthcare Limited
  • 65841-613- Bicalutamide
    • 65841-613-05- 500 TABLET, FILM COATED in 1 BOTTLE (65841-613-05)

• 65841- Cadila Healthcare Limited
  • 65841-613- Bicalutamide
    • 65841-613-06- 30 TABLET, FILM COATED in 1 BOTTLE (65841-613-06)

• 65841- Cadila Healthcare Limited
  • 65841-613- Bicalutamide
    • 65841-613-10- 1000 TABLET, FILM COATED in 1 BOTTLE (65841-613-10)

• 65841- Cadila Healthcare Limited
  • 65841-613- Bicalutamide
    • 65841-613-30- 10 BLISTER PACK in 1 CARTON (65841-613-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-224- Bicalutamide
    • 68382-224-01- 100 TABLET, FILM COATED in 1 BOTTLE (68382-224-01)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-224- Bicalutamide
    • 68382-224-05- 500 TABLET, FILM COATED in 1 BOTTLE (68382-224-05)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-224- Bicalutamide
    • 68382-224-06- 30 TABLET, FILM COATED in 1 BOTTLE (68382-224-06)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-224- Bicalutamide
    • 68382-224-10- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-224-10)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-224- Bicalutamide
    • 68382-224-77- 100 BLISTER PACK in 1 CARTON (68382-224-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-224-30)

• 71335- Bryant Ranch Prepack
  • 71335-0765- Bicalutamide
    • 71335-0765-1- 30 TABLET, FILM COATED in 1 BOTTLE (71335-0765-1)

• 71335- Bryant Ranch Prepack
  • 71335-0765- Bicalutamide
    • 71335-0765-2- 100 TABLET, FILM COATED in 1 BOTTLE (71335-0765-2)

• 71335- Bryant Ranch Prepack
  • 71335-0765- Bicalutamide
    • 71335-0765-3- 90 TABLET, FILM COATED in 1 BOTTLE (71335-0765-3)