Calmac 50/150 Tablets

Generic Name- Bicalutamide

Drug Class- Antineoplastic agent
Bicalutamide is a competitive androgen receptor antagonist indicated in several stages of prostate cancer and represents an alternative therapeutic strategy to castration. It acts by blocking the activation of androgen-regulated prostate cell growth and function, leading to cell apoptosis and inhibition of prostate cancer growth

Dosage and Administration

  • Recommended dose in combination with an LHRH analog: one 50 mg tablet once daily (morning or evening)

Dosage Forms and Strengths

  • Supplied as tablets for oral use
  • Available in 50 mg and 150mg strength


Calmac 50/150 (Bicalutamide) is an orally active chemotherapy drug, available in tablet form.

Indications & Usage

  • Bicalutamide is indicated for treatment of Stage D2 metastatic carcinoma of the prostate, in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog

Limitations of Use

  • Bicalutamide (150 mg) is not approved for use alone or with other treatments for metastatic carcinoma but can be used for locally advanced non-metastatic prostate cancer

Clinical Efficacy

  • Provides survival benefits along with important advantages with respect to the maintenance of physical capacity and sexual interest in men with previously untreated, locally-advanced disease
  • Significantly reduces the risk of objective disease progression in patients with localized or locally-advanced prostate cancer
  • Shows efficacy and good tolerability when combined with a GnRH agonist in patients with advanced prostate cancer who are suitable to receive MAB regimens

Safety Information

Adverse Reactions

  • The most common adverse events that occurred in more than 10% of patients receiving bicalutamide in combination with LHRH-A are hot flashes, nausea, constipation, infection, pain (including general, back, pelvic and abdominal), asthenia, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia


  • It is contraindicated in women, pregnancy and patients with a known hypersensitivity to bicalutamide

Special Precautions

  • Monitor serum transaminase levels before starting treatment with bicalutamide, at regular intervals for the first four months of treatment and periodically thereafter for symptoms or signs suggestive of hepatic dysfunction
  • Caution should be used while using bicalutamide in patients with hepatic impairment
  • Determine the prothrombin time (PT) and international normalized ratio (INR), and adjust the anticoagulant dose in patients receiving coumarin anticoagulant combined with bicalutamide
  • Bicalutamide can cause gynecomastia and breast pain during treatment, when used as a single agent
  • Blood glucose levels should be monitored in patients receiving bicalutamide in combination with LHRH agonists, as LHRH agonists have been shown to cause a reduction in glucose tolerance in males
  • Recommend monitoring of prostate specific antigen (PSA) levels and evaluate for clinical progression in cases with increased PSA levels
  • Advise males with female partners of reproductive potential to use effective contraception
  • Evaluate dosing in pediatric patients carefully as efficacy has not been demonstrated for the treatment of familial male-limited precocious puberty