Enzalutamide Capsules IP 40mg/80mg for oral use.
INDICATIONS AND USAGE: Enzalutamide is indicated for the treatment of adults with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.
DOSAGE FORM & STRENGTH: Enzalutamide Soft Gelatin Capsules IP 40mg/80mg.
DOSAGE AND ADMINISTRATION: The recommended dose is 160 mg enzalutamide (Four 40mg capsules/ Two 80mg capsules) as a single oral daily dose. Enzalutamide capsules can be taken with or without food. The capsules should be swallowed whole with water and it should not be chewed, dissolved or opened. Medical castration with a Luteinizing Hormone Releasing Hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.
CONTRAINIDCATIONS: Patients with hypersensitivity to active substance or any component of the Enzalutamide formulation and pregnancy.
WARNINGS AND PRECAUTIONS: Use cautiously in patients with a history of seizures or other predisposing factors such as underlying brain injury, stroke, primary brain tumours or brain metastases, alcoholism or concomitant seizure provoking medications. Discontinuation of enzalutamide is recommended in patients who develop posterior reversible encephalopathy syndrome (PRES). In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval clinicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Enzalutamide therapy. The safety and efficacy of concomitant use of enzalutamide with cytotoxic chemotherapy has not been established. However, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded. Caution is advised while treating patients with severe renal impairment (CrCL < 30 mL/min) or end-stage renal disease. An increased drug half-life has been observed in patients with severe hepatic impairment, possibly related to increased tissue distribution.
USE IN SPECIFIC POPULATIONS: Enzalutamide capsules are not for use in pregnant, lactating women and paediatric population.
ADVERSE REACTIONS: More common (≥10%) adverse reactions are asthenia/fatigue, back pain, arthralgia, musculoskeletal pain, decreased appetite, constipation, diarrhoea, headache, hot flush, upper respiratory tract infection, peripheral oedema, dyspnoea, decreased weight, hypertension and dizziness/vertigo.
STORAGE: Store below 30°C. Protect from light and moisture. Please refer to the full prescribing information before prescribing OBNYX.