What is the most important information I should know about alectinib?
Alectinib can cause serious or life-threatening side effects.
Call your doctor right away if you have: heart problems --severe dizziness, very slow heartbeats; lung problems --fever, chest pain, cough, trouble breathing; kidney problems --a change in your urine color, little or no urination, swelling in your lower legs; or liver problems --upper stomach pain, dark urine, loss of appetite, yellowing of the skin or eyes.
What is alectinib?
Alectinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Alectinib is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body.
Alectinib is used only if your cancer has a specific genetic marker (an abnormal "ALK" gene). Your doctor will test you for this gene.
Alectinib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking alectinib?
You should not use alectinib if you are allergic to it.
Tell your doctor if you have ever had:
- lung or breathing problems other than lung cancer;
- liver disease; or
- slow heartbeats.
Alectinib can harm an unborn baby or cause birth defects if the mother or the father is taking this medicine.
- If you are a woman, do not use alectinib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 week after your last dose.
- If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
- Tell your doctor right away if a pregnancy occurs while either the mother or the father is using alectinib.
It is not known whether alectinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using alectinib and for at least 1 week after your last dose.
How should I take alectinib?
Your doctor will perform a blood test to make sure alectinib is the right treatment for your condition.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Alectinib works best if you take it with food.
Swallow the capsule whole and do not crush, chew, dissolve, or open it.
If you vomit shortly after taking alectinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking alectinib?
Alectinib could make you sunburn more easily. Avoid sunlight or tanning beds during treatment and for at least 7 days after your last dose of alectinib. Wear protective clothing and use sunscreen (SPF 50 or higher) when you are outdoors.
What are the possible side effects of alectinib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a very slow heart rate;
- a light-headed feeling, like you might pass out;
- unexplained muscle pain, tenderness, or weakness;
- lung problems --sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;
- low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
- kidney problems --a change in your urine color, little or no urination, swelling in your feet or ankles; or
- liver problems --stomach pain (upper right side), loss of appetite, easy bruising or bleeding, feeling tired, dark urine, jaundice (yellowing of the skin or eyes).
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- swelling in your face, eyelids, hands, or lower legs;
- tired feeling; or
- muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect alectinib?
Other drugs may affect alectinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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