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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

Category

Product Description

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

Indications and 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

Dosage and Administration

•Dosage Regimen for Metastatic Prostate Carcinoma

Bicalutamide plus luteinising hormone-releasing hormone (LHRH) analogue therapy

Bicalutamide One 50 mg tablet once daily (morning or evening)
Followed by LHRH analogue with
Goserelin Goserelin 3.6 mg every 28 days
Leuprolide 7.5 mg every 28 days

• 150 mg dose recommended in advanced non-metastatic prostate cancer as immediate therapy either as an adjuvant to active treatment or as monotherapy as an alternative to surgical or medical castration

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

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.

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

Bicalutamide 50 / 150 mg Tablet Manufacturer | ADMAC Oncology