Alecensa
(Alectinib Hydrochloride)Dosage & Administration
600 mg orally twice daily. Administer ALECENSA with food. (
| Indication | Recommended Dosage of ALECENSA | Duration |
|---|---|---|
| Adjuvant treatment of resected NSCLC | 600 mg orally twice daily with food [see Clinical Pharmacology (12.3)] | For a total of 2 years or until disease recurrence or unacceptable toxicity |
| Metastatic NSCLC | Until disease progression or unacceptable toxicity | |
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Alecensa Prescribing Information
Indications and Usage (ALECENSA 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 [see Dosage & Administration (2.1)]. | 04/2024 | |||||||||||
Dosage and Administration (Select patients with resectable tumors for the adjuvant treatment of NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue [see Indications and Usage (1.1)and Clinical Studies (14.1)]. Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens [see Indications and Usage (1.2)and Clinical Studies (14.2)] . If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if feasible.Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/CompanionDiagnostics. The recommended dosage information for ALECENSA is provided in Table 1.
The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)]. | 04/2024 | |||||||||||
Warnings and Precautions (
Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1)] of patients who received ALECENSA, 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 ALECENSA 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 ALECENSA 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 ALECENSA. Three patients with Grades 3–4 AST/ALT elevations had drug-induced liver injury (documented by liver biopsy in two cases). Monitor liver function tests including ALT, AST, and total bilirubin 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. Based on the severity of the adverse drug reaction, withhold ALECENSA and resume at a reduced dose or permanently discontinue ALECENSA as described in Table 3 [see Dosage and Administration (2.4)]. ILD/pneumonitis occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1)] , ILD/pneumonitis occurred in 1.3% of patients treated with ALECENSA with 0.4% of patients experiencing Grade 3 ILD/pneumonitis.Five patients (0.9%) in the pooled safety population discontinued ALECENSA due to ILD/pneumonitis. The median time-to-onset of Grade 3 or higher ILD/pneumonitis was 2.1 months (range: 0.6 months to 3.6 months). Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold ALECENSA treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified [see Dosage and Administration (2.4)and Adverse Reactions (6)] .Renal impairment, including fatal cases, occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1)] , renal impairment occurred in 12% of patients treated with ALECENSA, including Grade ≥ 3 in 1.7% of patients, of which 0.4% were fatal events. The median time to Grade ≥ 3 renal impairment was 3.7 months (range 0.5 to 31.8 months). Dosage modifications for renal impairment were required in 2.4% of patients.Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold ALECENSA for Grade 3 renal toxicity until recovery to less than or equal to 1.5 times ULN, then resume at reduced dose [see Dosage and Administration (2.4)] .Symptomatic bradycardia occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1)] , bradycardia occurred in 11% of patients treated with ALECENSA. Twenty percent of 521 patients treated with ALECENSA, for whom serial electrocardiograms (ECGs) were available, had post-dose heart rates of less than 50 beats per minute (bpm).Monitor heart rate and blood pressure regularly. For asymptomatic bradycardia dose modification is not required. For symptomatic bradycardia that is not life-threatening, withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate ≥ 60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If bradycardia is attributable to a concomitant medication, resume ALECENSA at a reduced dose (see Table 2) upon recovery to asymptomatic bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in cases of life-threatening bradycardia if no contributing concomitant medication is identified [see Dosage and Administration (2.4)] . Permanently discontinue ALECENSA for recurrence of life-threatening bradycardia.Severe myalgia and creatine phosphokinase (CPK) elevation occurred in patients treated with ALECENSA. In the pooled safety population [see Adverse Reactions (6.1)] , myalgia (including muscle- and musculoskeletal-related reactions) occurred in 31% of patients treated with ALECENSA, including Grade ≥ 3 in 0.8% of patients. Dosage modifications for myalgia events were required in 2.1% of patients.In the pooled safety population, of the 491 patients with CPK laboratory data available, elevated CPK occurred in 56% of patients treated with ALECENSA, including 6% Grade ≥ 3. The median time to Grade ≥ 3 CPK elevation was 15 days (interquartile range - 15 –337 days). Dosage modifications for elevation of CPK occurred in 5% of patients. In the ALINA study, elevated CPK occurred in 77% of 128 patients with CPK laboratory data, including 6% Grade ≥ 3 elevations. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold ALECENSA, then resume or reduce dose [see Dosage and Administration (2.4)]. Hemolytic anemia occurred in patients treated with ALECENSA. Hemolytic anemia was initially reported with ALECENSA in the postmarketing setting, including cases associated with a negative direct antiglobulin test (DAT) result. Assessments for the determination of hemolytic anemia were subsequently collected in the ALINA study, where hemolytic anemia was observed in 3.1% of patients treated with ALECENSA. If hemolytic anemia is suspected, withhold ALECENSA and initiate appropriate laboratory testing. If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue ALECENSA [see Dosage and Administration (2.4)]. Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to pregnant women. Oral administration of alectinib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans with alectinib 600 mg twice daily. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 5 weeks following the last dose [see Use in Specific Populations (8.1and 8.3)and Clinical Pharmacology (12.1)] . | 04/2024 | |||||||||||
ALECENSA 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. ()
1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC)ALECENSA 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[see Dosage & Administration (2.1)]. - treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ()
1.2 Treatment of Metastatic ALK-Positive NSCLCALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test
[see Dosage & Administration (2.1)].
600 mg orally twice daily. Administer ALECENSA with food. (
| Indication | Recommended Dosage of ALECENSA | Duration |
|---|---|---|
| Adjuvant treatment of resected NSCLC | 600 mg orally twice daily with food [see Clinical Pharmacology (12.3)] | For a total of 2 years or until disease recurrence or unacceptable toxicity |
| Metastatic NSCLC | Until disease progression or unacceptable toxicity | |
| ||
150 mg hard capsules, white, with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body.
Lactation: Do not breastfeed. (
There are no data on the presence of alectinib or its metabolites in human milk, the effects of alectinib on the breastfed child, or its effects on milk production. Because of the potential for serious adverse reactions in breastfed children from alectinib, advise a lactating woman not to breastfeed during treatment with ALECENSA and for 1 week after the last dose.
None.