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