Alecndr 150 112 Capsules-Size 1 Alectinib Capsule Indar Pharmaceutical

Product Name: Alectinib (Alecensa)

Specification: 150 mg × 112 capsules/box

Manufacturer: Indar Pharmaceutical Pvt. Ltd.

Targets: ALK, RET

Alectinib (Alecensa) is a kinase inhibitor indicated for: patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following treatment with crizotinib, or who are intolerant to crizotinib. The FDA granted accelerated approval for ALECENSA for the treatment of the aforementioned indication based on tumor response rate and duration of response data from clinical trials. Continued approval for Alectinib (Alecensa) for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Treatment: Indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer.

Reference Dosage and Administration: The recommended dose is 600 mg (four 150 mg capsules), administered orally, twice daily (for a total daily dose of 1200 mg).

Precautions: Hepatotoxicity: Perform liver function laboratory tests every 2 weeks during the first 2 months of treatment, and periodically thereafter. If severe elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), or elevations in bilirubin occur, withhold the drug, then reduce the dose, or permanently discontinue treatment. Interstitial Lung Disease (ILD)/Pneumonitis: In clinical trials, ILD/pneumonitis occurred in 0.4% of patients. If diagnosed, immediately withhold the drug. If no other potential causes are identified, permanently discontinue Alectinib (Alecensa). Bradycardia: Periodically monitor heart rate and blood pressure. If symptoms occur, withhold the drug, then reduce the dose, or permanently discontinue treatment. Severe Myalgia/Elevated Creatine Phosphokinase (CPK): In clinical trials, severe myalgia occurred in 1.2% of patients, and CPK elevations occurred in 4.6% of patients. During the first month of treatment, and in patients experiencing unexplained muscle pain, tenderness, or weakness, CPK levels should be monitored every two weeks. If CPK levels are significantly elevated, administration should be temporarily suspended, followed by resumption of the drug or a dose reduction. Embryo-Fetal Toxicity: Alectinib may cause harm to the fetus. Women of reproductive potential should be advised of the potential risk to the fetus and should use effective contraception.

Adverse Reactions: The most common adverse drug reactions (≥20%) include constipation (36%), edema (34%; including peripheral edema, generalized edema, eyelid edema, and periorbital edema), myalgia (31%; including myalgia and musculoskeletal pain), nausea (22%), increased bilirubin (21%; including increased blood bilirubin, hyperbilirubinemia, and increased conjugated bilirubin), anemia (20%; including anemia and decreased hemoglobin), and rash (20%; including rash, maculopapular rash, acneiform dermatitis, erythema, generalized rash, papular rash, pruritic rash, and macular rash).

Product Specifications

Product Name: Alectinib 150mg * 112 Capsules/Box (Alecndr 150) | Alectinib Capsule | Indar Pharmaceutical

Common Name: Alectinib

Composition: Alectinib

Dosage Form: Capsule

Specification: 150mg * 112 Capsules/Box

Manufacturer: Indar Pharmaceutical Pvt. Ltd.

Indications: Indicated for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant to crizotinib. ALECENSA was granted accelerated approval by the FDA for this indication based on tumor response rate and duration of response data from clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Dosage and Administration: The recommended dose is 600 mg (four 150 mg capsules), administered orally twice daily (total daily dose: 1200 mg).