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Serious side effects have been reported with alectinib including the following:
Liver problems. Alectinib may cause a decline in liver function. Your doctor will order labs to check your liver function at least every 2 weeks for the first 2 months of treatment, and then as needed. Tell your healthcare provider if you have any of these signs of symptoms of liver damage:
- loss of appetite or start losing weight (anorexia)
- feel tired
- yellowing of your skin or the whites of your eyes
- dark urine or light colored stools
- itchy skin
- nausea or vomiting
- pain on the right side of your stomach area
- bleeding or bruising more easily than normal
Lung Problems. Tell your doctor immediately if you have any of the following symptoms:
- new or worsening cough
- trouble breathing
- shortness of breath
Slow heartbeat (Bradycardia). Alectinib can cause a slow heartbeat. Your doctor will monitor your heart rate and blood pressure while you are being treated with alectinib. Alert your doctor immediately if you feel dizzy, lightheaded, or faint. Make sure you tell your doctor about any medications you take for your heart or blood pressure.
Muscle pain, tenderness, and weakness. Alectinib may cause muscle problems that are potentially severe. Your doctor will perform labs to monitor CPK (an enzyme that may indicate muscle damage if high) at least every 2 weeks for the first month and then as needed during treatment with alectinib. Tell your doctor if you experience muscle pain, tenderness, or weakness.
Harm to your unborn baby. Alectinib can cause harm to an unborn baby if given to a pregnant woman. Females who are able to become pregnant should use an effective method of birth control while taking alectinib and for one week after completing treatment.
Avoid being in sunlight during treatment with alectinib and for 7 days after you complete treatment with alectinib. You may sunburn more easily while taking alectinib. Make sure to use sunscreen and lip balm with at least SPF 50 to prevent severe sunburns when you are outdoors.
Do not take alectinib if you are allergic to alectinib or to any of its ingredients.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What should I avoid while taking alectinib?
Avoid exposure to sunlight or tanning beds during treatment and for at least 7 days after your last dose of alectinib. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen and lip balm (SPF 50 or higher) when you are outdoors.
What other drugs will affect alectinib?
Other drugs may interact with alectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
- Antineoplastic Agent, Anaplastic Lymphoma Kinase Inhibitor
- Antineoplastic Agent, Tyrosine Kinase Inhibitor
Refer to adult dosing.
Concerns related to adverse effects:
• Bradycardia: Symptomatic bradycardia may occur; heart rate <50 beats per minute has been reported in ~20% of patients treated with alectinib. Monitor heart rate and blood pressure regularly. If symptomatic bradycardia (non-life-threatening) occurs, withhold treatment until recovery to asymptomatic bradycardia or to a heart rate of ≥60 beats per minute, evaluate concurrent medications, and potentially reduce alectinib dose. Permanently discontinue for life-threatening bradycardia due to alectinib if no contributing concomitant medication is identified and for recurrent bradycardia. If life-threatening bradycardia occurs and concurrent medications associated with bradycardia can be discontinued or dose adjusted, restart alectinib at a reduced dose (with frequent monitoring).
• Hepatotoxicity: Liver function test abnormalities have been reported, including elevations of AST/ALT >5 times ULN and bilirubin >3 times ULN; most abnormalities occurred during the first 3 months of therapy. Concurrent ALT/AST elevations ≥3 times ULN and total bilirubin ≥2 times ULN with normal alkaline phosphatase occurred rarely. Liver biopsy demonstrated drug induced liver injury in some patients with grade 3 to 4 AST or ALT elevations. Monitor liver function tests (ALT, AST, and total bilirubin) every 2 weeks during the first 3 months of therapy and then once a month and as clinically necessary; monitor more frequently in patients who develop transaminase and bilirubin elevations. May require therapy interruption, dose reduction, or permanent discontinuation.
• Myalgia: Myalgia or musculoskeletal pain occurred in over one-quarter of patients treated with alectinib (including grade 3 toxicity). Elevations of creatine phosphokinase (CPK) were reported in close to half of patients in clinical trials. The median time to grade 3 CPK elevations was 14 days. Monitor; advise patients to report unexplained muscle pain, tenderness, or weakness. Assess CPK every 2 weeks for the first month of therapy and then as clinically necessary. May require therapy interruption and/or dose reduction.
• Photosensitivity: Photosensitivity occurred in some patients. Patients should avoid sun exposure (during treatment and for 7 days after the final dose) and use a broad spectrum sunscreen and lip balm (SPF ≥50).
• Pulmonary toxicity: Severe interstitial lung disease (ILD) has been reported rarely. Monitor for ILD/pneumonitis; evaluate promptly in patients who present with worsening of respiratory symptoms or who have signs/symptoms suggestive of ILD/pneumonitis (eg, cough, dyspnea, fever). Immediately interrupt therapy for confirmed ILD/pneumonitis; permanently discontinue if alectinib is determined to be the causative factor.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Anaplastic lymphoma kinase testing: Approved for use only in patients with metastatic non-small cell lung cancer (NSCLC) who test positive for the abnormal anaplastic lymphoma kinase (ALK) gene.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience constipation, nausea, vomiting, headache, diarrhea, back pain, or weight gain. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting), severe loss of strength and energy, bradycardia, dizziness, passing out, muscle pain, muscle weakness, edema, or vision changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
Dosing & Uses
Dosage Forms & Strengths
Non-small Cell Lung Cancer
Indicated for anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib
600 mg PO BID until disease progression or unacceptable toxicity
Dose reduction schedule
- Starting dose: 600 mg PO BID
- First dose reduction: 450 mg PO BID
- Second dose reduction: 300 mg PO BID
- Discontinue if patients are unable to tolerate 300 mg PO BID
- Mild-to-moderate: No dose adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Not studied
- Mild (TB ≤ULN and AST >ULN or TB >1-1.5 x ULN and any AST): No dose adjustment required
- Moderate-to-severe: Not studied
- ALT or AST elevation >5 x ULN with total bilirubin (TB) ≤2 x ULN: Temporarily withhold until recovery to baseline or to ≤3 times ULN, then resume at reduced dose
- ALT or AST elevation >3 x ULN with TB elevation >2 x ULN in absence of cholestasis or hemolysis: Permanently discontinue
- TB elevation >3 x ULN: Temporarily withhold until recovery to baseline or to ≤1.5 x ULN, then resume at reduced dose
Interstitial lung disease (ILD)/pneumonitis
- Any grade treatment-related ILD/pneumonitis: Permanently discontinue
- Symptomatic bradycardia
- Withhold until recovery to asymptomatic bradycardia or to a heart rate ≥60 bpm
- If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume alectinib at previous dose upon recovery to asymptomatic bradycardia or to a heart rate ≥60 bpm
- If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume alectinib at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate ≥60 bpm
- Life-threatening bradycardia or urgent intervention indicated
- Permanently discontinue if no contributing concomitant medication is identified
- If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume alectinib at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate ≥60 bpm, with frequent monitoring as clinically indicated
- Permanently discontinue in case of recurrence
- CPK >5 x ULN: Temporarily withhold until recovery to baseline or to ≤2.5 x ULN, then resume at same dose
- CPK >10 x ULN or second occurrence of >5 x ULN: Temporarily withhold until recovery to baseline or to ≤2.5 x ULN, then resume at reduced dose
Indication is approved under accelerated approval based on tumor response rate and duration of response
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
Safety and efficacy not established
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Highlights for alectinib
Alectinib is used to treat metastatic non-small cell lung cancer. Metastatic means the cancer has spread to other parts of your body. This drug is given to people who cannot tolerate another cancer drug called crizotinib or whose cancer got worse during treatment with crizotinib.
This drug comes as a capsule that you take by mouth.
This drug is available as the brand-name drug Alecensa. It isn’t available as a generic drug.IMPORTANT INFORMATION
Liver problems See Details
Lung problems See Details
Low heart rate See Details
Muscle pain, tenderness, and weakness See Details
What is alectinib?
This drug is a prescription drug. It’s available as an oral capsule.
This drug is available as the brand-name drug Alecensa. It isn’t available as a generic drug.
This drug may be used as part of a combination therapy. This means you may need to take it with other medications.
Why it's used
Alectinib is used to treat non-small cell lung cancer. This drug is used when the cancer is metastatic (has spread to other parts of your body). It’s given to people who cannot tolerate the cancer drug crizotinib or whose cancer got worse during treatment with crizotinib.
How it works
Alectinib belongs to a class of anticancer drugs called tyrosine kinase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Alectinib works in your body by targeting certain proteins in the cancer cells. It works by stopping the cancer from growing and spreading.