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The following safety information outlines important risks and precautions related to the use of Alecensa (alectinib). It is crucial to carefully read and understand these warnings, and consult your healthcare provider if you have any questions or concerns.

• Liver Health Concerns: Alecensa may increase the risk of liver issues, such as irritation or swelling. Regular liver function tests are necessary—every two weeks for the first three months, then monthly thereafter. Alert your healthcare team if you notice symptoms like fatigue, decreased appetite, yellowing of the skin or eyes, dark urine, itching, or nausea.

• Muscle Health Monitoring: This medication can lead to muscle pain. Report any unexplained muscle discomfort or weakness to your oncologist. Regular tests to check creatine phosphokinase (CPK) levels will help monitor muscle health, especially in the initial month of treatment.

• Heart Rate Considerations: Alecensa may cause a slow heart rate, resulting in dizziness or faintness. Regular monitoring of heart rate and blood pressure is advised. Inform your doctor about any blood pressure medications you are taking, as these can also impact heart rate. Temporary discontinuation of Alecensa might be necessary if heart rate issues persist.

• Kidney Function Risks: Kidney problems can occur early in treatment or after prolonged use. Notify your care team immediately if you experience symptoms such as nausea, muscle cramps, changes in urine, or swelling in extremities. Dose adjustments or discontinuation may be required.

• Lung Issues: Though rare, some individuals may develop interstitial lung disease or pneumonitis, usually within two to four months of treatment. If you experience breathing difficulties, a cough, or fever, contact your oncologist promptly.

• Red Blood Cell Concerns: Alecensa may increase the risk of hemolytic anemia, a condition where red blood cells are destroyed faster than they are produced. Report symptoms like fatigue, weakness, dizziness, or trouble breathing to your healthcare team.

• Pregnancy Risks: Alecensa has not been adequately studied in pregnant humans but may harm an unborn baby based on animal studies. Women who can become pregnant should use effective contraception during treatment and for one week after the final dose.

These guidelines ensure safe use of Alecensa and help manage any potential side effects effectively.

When taking this medication, some common side effects may include tiredness, constipation, nausea, vomiting, diarrhea, swelling in the ankles, feet, or hands, back pain, headache, weight gain, and vision changes such as blurred or decreased vision. These effects are typically mild and may resolve on their own, but if they persist or worsen, it is advisable to consult your healthcare provider.

In some instances, users might experience elevated creatine phosphokinase, liver enzymes, or creatinine levels, as well as reduced red blood cell count. Additional common effects can include muscle aches, increased uric acid and blood sugar levels, low blood calcium, and changes in sodium or potassium levels. A rash, cough, or change in taste may also occur.

There are more serious side effects that, although rare, demand immediate medical attention. These include symptoms of severe lung problems such as difficulty breathing, cough, or fever, as well as liver issues marked by extreme tiredness, persistent nausea, vomiting, yellowing of the eyes or skin, stomach pain, and dark urine. Other serious concerns could be very slow heart rate, leading to dizziness, confusion, or chest pain, and signs of kidney problems like changes in urine output or color.

A serious allergic reaction to this medication is rare but requires urgent care if symptoms such as rash, severe dizziness, or difficulty breathing occur. Always contact your healthcare provider if you notice any unusual effects, especially if they are not listed here.