Bical 50-MG Tablet

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

Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

The recommended dose for Bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food.

Pediatric Use: The safety and effectiveness of Bicalutamide in pediatric patients have not been established.

Hepatic Impairment: Bicalutamide is extensively metabolized by the liver. It should be used with caution in patients with moderate-to-severe hepatic impairment.

• R-Bical is an inhibitor of CYP 3A4; therefore, caution should be used when Bical is co-administered with CYP 3A4 substrates
• PT/INR should be closely monitored in patients already receiving coumarin anticoagulants who are started on Bical

Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Bicalutamide has no indication for women, and should not be used in this population.

Adverse reactions that occurred in more than 10% of patients receiving Bical plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia.

Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of Bicalutamide in pregnant women.

• Hemorrhage with concomitant use of Coumarin Anticoagulant. Closely monitor the Prothrombin Time (PT) and International Normalized Ratio (INR), and adjust the anticoagulant dose as needed
• Gynecomastia and breast pain have been reported during treatment with Bical 150 mg when used as a single agent as it cause a reduction in glucose tolerance in males
• Consideration should be given to monitoring blood glucose in patients receiving Bical in combination with LHRH agonists
• Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases

Pediatric Use: The safety and effectiveness of Bical in pediatric patients have not been established.

Hepatic Impairment: Periodic liver function tests should be considered for hepatic-impaired patients on long-term therapy.

Renal Impairment: Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total Bical or the active R-enantiomer.

Long-term clinical trials have been conducted with dosages up to 200 mg of Bical daily and these dosages have been well tolerated. A single dose of Bical that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic.

Hormonal Chemotherapy

Store at temperature not exceeding 30°C in a dry place. Protect from light and moisture.