Alecensa 150mg Capsule

Alectinib Hydrochloride is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Alectinib Hydrochloride is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. Treatment of Metastatic ALK-Positive NSCLC Alectinib Hydrochloride is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. In case of severe ALT, AST, or bilirubin elevations, withhold, then reduce dose, or permanently discontinue Alectinib Hydrochloride. Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold Alectinib Hydrochloride in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified. Renal Impairment: Withhold Alectinib Hydrochloride for severe renal impairment, then resume Alectinib Hydrochloride at reduced dose upon recovery or permanently discontinue. Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold Alectinib Hydrochloride then reduce dose, or permanently discontinue. Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK every 2 weeks during the first month of treatment and in patients reporting unexplained muscle pain, tenderness, or weakness. In case of severe CPK elevations, withhold, then resume or reduce dose. Hemolytic Anemia: If hemolytic anemia is suspected, withhold Alectinib Hydrochloride. If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue. Severe Hypertriglyceridemia Leading to Pancreatitis: Monitor serum triglycerides before initiation and periodically during treatment. In patients with hypertriglyceridemia, monitor for signs and symptoms of acute pancreatitis. Withhold or permanently discontinue Alectinib Hydrochloride based on severity. Embryo-Fetal Toxicity: Alectinib Hydrochloride can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Hepatotoxicity Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with Alectinib Hydrochloride. In the pooled safety population of patients who received Alectinib Hydrochloride, hepatotoxicity occurred in 41% of patients and the incidence of Grade ≥ 3 hepatotoxicity was 8%. In the ALINA study, hepatotoxicity occurred in 61% of patients treated with Alectinib Hydrochloride and the incidence of Grade ≥ 3 hepatotoxicity was 4.7%. The majority (72% of 136 patients) of elevated transaminases occurred during the first 3 months of treatment. Treatment discontinuation due to hepatotoxicity occurred in 3.6% of patients who received Alectinib Hydrochloride in the pooled safety population and 1.6% of patients treated in the ALINA study. In the pooled safety population, concurrent elevations in ALT or AST greater than or equal to 3 times the ULN and total bilirubin greater than or equal to 2 times the ULN, with normal alkaline phosphatase, occurred in less than 1% of patients treated with Alectinib Hydrochloride. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in greater detail in other sections of the label: Hepatotoxicity Interstitial Lung Disease (ILD)/Pneumonitis Renal Impairment Bradycardia Severe Myalgia and Creatine Phosphokinase (CPK) Elevation Hemolytic Anemia Hypertriglyceridemia Leading to Pancreatitis Embryo-Fetal Toxicity The most common adverse reactions (incidence ≥20%) were hepatotoxicity, constipation, fatigue, myalgia, edema, rash and cough.. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to Alectinib Hydrochloride as a single agent at 600 mg orally twice daily in 533 patients in Studies NP28761, NP28673, ALEX and ALINA. Among 533 patients who received Alectinib Hydrochloride, 75% were exposed for 6 months or longer and 64% were exposed for greater than one year. In this pooled safety population, the most common (≥ 20%) adverse reactions were hepatotoxicity (41%), constipation (39%), fatigue (36%), myalgia (31%), edema (29%), rash (23%) and cough (21%). The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were increased CPK (6%), decreased hemoglobin (4.4%), increased ALT (4.2%), increased bilirubin (4.0%) and increased AST (3.4%). Adjuvant Treatment of Resected ALK-Positive NSCLC The safety of Alectinib Hydrochloride was evaluated in ALINA, a multi-center, open-label, randomized trial for the adjuvant treatment of patients with resected ALK-positive NSCLC. At the time of DFS analysis, the median duration of exposure was 23.9 months for Alectinib Hydrochloride and 2.1 months for platinum-based chemotherapy. Serious adverse reactions occurred in 13% of patients treated with Alectinib Hydrochloride; the most frequent serious adverse reactions (≥ 1%) were pneumonia (3.9%), appendicitis (3.1%), and acute myocardial infarction (1.6%). Permanent discontinuation of Alectinib Hydrochloride due to an adverse event occurred in 5% of patients; the most frequent adverse reactions (≥ 1%) that led to treatment discontinuation were pneumonitis and hepatotoxicity. Dosage interruptions of Alectinib Hydrochloride due to an adverse reaction occurred in 27% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included hepatotoxicity, increased blood CPK, COVID-19, myalgia, abdominal pain, and pneumonia. Dose reductions of Alectinib Hydrochloride due to an adverse reaction occurred in 26% of patients. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.