Alecensa 150mg Alectinib

Alecensa is indicated for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as determined by an FDA-approved test. It is indicated as adjuvant treatment following tumor resection in patients with ALK-positive NSCLC and as treatment for patients with metastatic ALK-positive NSCLC. Alecensa is a targeted anticancer medicine that inhibits ALK signaling, helping slow or stop the growth of cancer cells with ALK alterations.

The US prescribing information does not list any formal contraindications. Alecensa should not be used in patients with known severe hypersensitivity to alectinib or any component of the formulation. Patients with significant liver disease, severe kidney impairment, or a history of serious medication-related adverse reactions require careful medical evaluation.

Common adverse reactions include fatigue, constipation, muscle pain, swelling, rash, nausea, and elevated liver enzymes. Other clinically significant adverse reactions include anemia, increased bilirubin, elevated creatine phosphokinase, bradycardia, photosensitivity, and visual disturbances. Serious adverse reactions may include hepatotoxicity, interstitial lung disease or pneumonitis, severe muscle injury including rhabdomyolysis, hemolytic anemia, and severe renal impairment.

Monitor liver function before treatment and regularly during therapy, particularly during the first months. Monitor heart rate and blood pressure because symptomatic bradycardia may occur. Assess creatine phosphokinase levels in patients with unexplained muscle pain, tenderness, or weakness. Monitor renal function and complete blood counts as clinically indicated. Alecensa may cause photosensitivity; patients should limit direct sunlight exposure and use protective clothing and broad-spectrum sunscreen during treatment and for at least seven days after the final dose. Evaluate new or worsening respiratory symptoms promptly for possible interstitial lung disease or pneumonitis. Pregnancy should be avoided during treatment because alectinib may cause fetal harm. Effective contraception is recommended during treatment and for the period specified in the official prescribing information.

The recommended adult dosage is 600 mg orally twice daily, for a total daily dose of 1,200 mg. Each dose should be taken with food. Treatment is continued until disease progression or unacceptable toxicity, according to the treatment setting and prescribing information. For patients who cannot tolerate the recommended dose, dose reductions may be made to 450 mg twice daily and then 300 mg twice daily. If the 300 mg twice-daily dose is not tolerated, treatment discontinuation may be necessary. Capsules should be swallowed whole and should not be opened, crushed, or dissolved. Dosage adjustments may be required for adverse reactions or significant organ impairment. Treatment must be prescribed and monitored by an oncologist.

Alectinib and its active metabolite may interact with medications that affect CYP3A enzymes. Strong CYP3A inhibitors may increase exposure to alectinib and its active metabolite, while strong CYP3A inducers may reduce exposure. Alectinib may increase the concentrations of certain P-glycoprotein and breast cancer resistance protein substrates, potentially increasing their adverse effects. Use caution with medications that slow the heart rate because bradycardia may be exacerbated. Patients should inform their healthcare provider about all prescription medicines, over-the-counter products, vitamins, and herbal supplements before starting treatment.

DailyMed, US National Library of Medicine; US Food and Drug Administration (FDA); Genentech, Inc., official Alecensa prescribing information; European Medicines Agency (EMA), Alecensa product information.