Bicalutamide (Casodex) is an anti-androgen drug that inhibits the binding of testosterone and dihydrotestosterone to its receptors. It is used to treat the following conditions:

• • Therapy of stage D metastatic prostate cancer in blend with an LHRH ( Luteinizing hormone-releasing hormone) agonist.

  • Therapy of locally advanced prostatic cancer as monotherapy (Off Label Use).

Bicalutamide (casodex) Dose in Adults

Bicalutamide (Casodex) in the therapy of metastatic Prostate cancer:

• 50 mg orally once a day in combination with an LHRH analog.

Off-label use in the therapy of locally advanced Prostate cancer including those at a high risk of recurrence.

• 150 mg orally once every day as monotherapy
• If a dose is missed, take the next dose at the next scheduled time. Do not double the next dose.

Use in Children:

Not applicable

Pregnancy Risk Factor X

• It is not suggested for women.
• Anti-androgens can adversely impact fetal development.
• It can also impact male fertility.
• Effective contraception should be used by male and female partners of reproductive age to prevent pregnancy.

Use during breastfeeding:

• It is contraindicated for women, especially during breastfeeding.

Bicalutamide dose in Renal Disease:

• Adjustment in the dose is not required.

Bicalutamide dose in Liver Disease:

• Hepatic impairment at baseline:

  • Adjustment in the dose is not required.
  • Patients with moderate to severe hepatic impairment should use the drug with caution.

• Hepatic impairment during treatment:

  • Discontinue immediately if the ALT is more than twice the upper limits of normal or the patient develops jaundice.

Adverse reaction percentages are reported as part of a combination regimen with an LHRH analog unless otherwise noted.

Common Side Effects of Bicalutamide (Casodex):

• Hematologic & Oncologic:

  • Anemia

• Cardiovascular:

  • Peripheral Edema

• Endocrine & Metabolic:

  • Hot Flash
  • Gynecomastia

• Central Nervous System:

  • Pain
•  

• Gastrointestinal:

  • Nausea
  • Diarrhea
  • Constipation
  • Abdominal Pain

• Genitourinary:

  • Pelvic Pain
  • Hematuria
  • Mastalgia
  • Nocturia

• Infection:

  • Infection

• Respiratory:

  • Dyspnea

• Neuromuscular & Skeletal:

  • Back Pain
  • Weakness

Less Common Side Effects of Bicalutamide:

• Hepatic:

  • Increased Liver Enzyme
  • Increased Serum Alkaline Phosphatase

• Cardiovascular:

  • Myocardial Infarction
  • Syncope
  • Chest Pain
  • Cardiac Arrest
  • Cardiac Failure
  • Hypertension
  • Angina Pectoris
  • Coronary Artery Disease
  • Edema

• Hematologic & Oncologic:

  • Gastrointestinal Carcinoma
  • Rectal Hemorrhage
  • Skin Carcinoma

• Central Nervous System:

  • Dizziness
  • Paresthesia
  • Myasthenia
  • Anxiety
  • Headache
  • Insomnia
  • Chills
  • Confusion
  • Nervousness
  • Neuropathy
  • Drowsiness
  • Hypertonia
  • Depression

• Dermatologic:

  • Skin Rash
  • Pruritus
  • Xeroderma
  • Diaphoresis
  • Alopecia

• Endocrine & Metabolic:

  • Weight Loss
  • Decreased Libido
  • Dehydration
  • Hyperglycemia
  • Weight Gain
  • Gout
  • Hypercholesterolemia

• Gastrointestinal:

  • Flatulence
  • Vomiting
  • Dyspepsia
  • Anorexia
  • Dysphagia
  • Periodontal Abscess
  • Xerostomia
  • Hernia
  • Melena

• Genitourinary:

  • Urinary Urgency
  • Urinary Incontinence
  • Urinary Tract Infection
  • Urinary Retention
  • Dysuria
  • Impotence
  • Difficulty In Micturition

• Infection:

  • Herpes Zoster
  • Sepsis

• Neuromuscular & Skeletal:

  • Ostealgia
  • Arthritis
  • Neck Pain
  • Pathological Fracture
  • Leg Cramps
  • Myalgia

• Ophthalmic:

  • Cataract

• Renal:

  • Polyuria
  • Increased Serum Creatinine
  • Hydronephrosis
  • Increased Blood Urea Nitrogen

• Miscellaneous:

  • Cyst
  • Fever

• Respiratory:

  • Pneumonia
  • Rhinitis
  • Cough
  • Pharyngitis
  • Asthma
  • Epistaxis
  • Flu-Like Symptoms
  • Bronchitis
  • Sinusitis

Contraindications to Bicalutamide:

• Use in women
• Pregnancy
• Allergic reactions to bicalutamide and any component of this formulation
• Children

Warnings and Precautions

• Gynecomastia

  • Higher doses can cause breast pain and gynecomastia.

• Hematologic:

  • It is important to monitor CBC regularly as anemia could result from testosterone suppression.

• Hypersensitivity

  • Rarely, urticaria or Angioneurotic edema can occur.

• Hepatotoxicity:

  • Hepatotoxicity can occur in the first three to four months of therapy. It may lead to serious complications that could require discontinuation of therapy.
  • Patients with moderately severe or mild liver disease should be cautious when taking the drug.
  • It is important to monitor the patient for signs and symptoms of hepatotoxicity.
  • It is important to monitor the liver functions regularly and stop treatment if ALT exceeds twice the normal limit.

• Interstitial lung disease:

  • It is important to monitor patients for any worsening respiratory symptoms such as cough, fever, or shortness of breath. Interstitial lung disease has been reported in some cases.

• Cardiovascular disease

  • Monitor ECG, Echocardiogram, electrolytes, and ECG periodically as androgen deprivation therapy can increase cardiovascular disease risk.

• Reduced bone mineral density

  • It can lead to osteopenia or osteoporosis and increase the risk of bone fractures.

• Diabetes:

  • Patients with diabetes may experience a decrease in glucose tolerance or loss of glycemic control.

Bicalutamide: Drug Interaction

Periodically Monitor:

• CBC
• ECG
• echocardiogram
• prostate-specific antigen (PSA)
• Serum testosterone
• luteinizing hormone
• Liver function tests (at baseline and regularly in the first four months)
• Blood glucose in patients with diabetes.
• Monitor INR in patients on warfarin.

How to take Bicalutamide (Casodex)?

• It is taken orally at the same time each day (either in the morning or in the evening). It may be administered with or without food.
• It should be started concomitantly with an LHRH ( Luteinizing hormone-releasing hormone) analog for the treatment of metastasis.

Mechanism of action of Bicalutamide (Casodex):

• It prevents the growth of prostate cancerous cells with testosterone by competitively inhibiting testosterone and dihydrotestosterone binding to the androgen receptors.

International brand names of Bicalutamide:

• ACH-Bicalutamide
• ACT Bicalutamide
• APO-Bicalutamide
• Casodex
• DOM-Bicalutamide
• JAMP-Bicalutamide
• MYLAN-Bicalutamide
• PHL-Bicalutamide
• PMS-Bicalutamide
• PRO-Bicalutamide-50
• RAN-Bicalutamide
• SANDOZ Bicalutamide
• TEVA-Bicalutamide
• VAN-Bicalutamide
• Androdex
• Areclok
• Bicadex
• Bical
• Bicalan
• Bicalox
• Bicalude
• Bicapros
• Bicatero
• Bicatero 50
• Bicloc
• Bidrostat
• Bikalen
• Biprosta
• Bosconar
• Bypro
• Calumid
• Calutex
• Calutide
• Calutide-50
• Calutol
• Cosamide
• Diproca
• Gepeprostin
• Lutam
• Lutamidal
• Procalut
• Talum
• Tosadex
• Vicalud
• Yonistib
• Zolacos CP

Bicalutamide Brand Names in Pakistan: