Alecnib Capsule Everest

Product Name: Alectinib

Specification: 150 mg × 56 capsules/box

Manufacturer: Everest Pharmaceutical

Targets: ALK, RET

Alectinib is a kinase inhibitor 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. The FDA granted accelerated approval to ALECENSA 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.

Treatment: Indicated for the treatment of patients with 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) taken orally, twice daily (total daily dose of 1200 mg).

Precautions: Hepatotoxicity: Perform liver function 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 elevated bilirubin levels occur, withhold the dose, then reduce the dose, or permanently discontinue the drug. 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. Bradycardia: Monitor heart rate and blood pressure regularly. If symptoms occur, withhold the dose, then reduce the dose, or permanently discontinue the drug. Severe Myalgia/Elevated Creatine Phosphokinase (CPK): In clinical trials, severe myalgia occurred in 1.2% of patients, and elevated CPK levels occurred in 4.6% of patients. During the first month of treatment, and for patients who develop unexplained muscle pain, tenderness, or weakness, CPK levels should be monitored every two weeks. If CPK levels are significantly elevated, administration of the drug should be temporarily suspended, followed by resumption of treatment 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 x 56 Capsules/Box | Alecnib (Alectinib) 150mg Capsule | Everest Therapeutics

Common Name: Alectinib

Active Ingredient: Alectinib

Dosage Form: Capsule

Specification: 150mg x 56 Capsules/Box

Manufacturer: Everest Therapeutics

Indications: Alectinib (ALECENSA) is a kinase inhibitor 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).