Pronunciation:

al-EK-ti-nib

Brand Names:

• Alecensa

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Alectinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients whose tumors have an abnormal anaplastic lymphoma kinase (ALK) gene. Your doctor will perform a test to check for the ALK gene before you use this medicine.

Alectinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of alectinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alectinib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heart beat) or
• Kidney disease, severe or end-stage or
• Liver disease, moderate to severe or
• Lung or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not open, crush, or chew it. You may take this medicine with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For lung cancer:
    • Adults—At first, 600 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking this medicine, do not take an extra dose. Take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use effective birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 3 months after the last dose. If you think a pregnancy has occurred with this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to those for lung cancer. Check with your doctor right away if you have a new or worsening cough, fever, or trouble breathing.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Bradycardia (slow heartbeat) may occur while you are using this medicine. Tell your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, or a slow or uneven heartbeat.

Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness after taking this medicine. These may be symptoms of a serious muscle problem.

This medicine may cause hemolytic anemia. Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds during treatment with this medicine and for at least 7 days after the last dose.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloody urine

chest pain or discomfort

cough

decreased frequency or amount of urine

difficulty with moving

increased blood pressure

increased thirst

joint pain or swelling

loss of appetite

lower back or side pain

lightheadedness, dizziness, or fainting

muscle aching or cramping

muscle pains or stiffness

nausea

slow or irregular heartbeat

swelling of the face, fingers, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

Less common

Clay-colored stools

dark urine

decreased appetite

fever

headache

itching or skin rash

stomach pain or tenderness

yellow eyes or skin

Rare

Difficulty breathing

Incidence not known

Back, leg, or stomach pains

bleeding gums

chills

general body swelling

nosebleeds

pale skin

sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

difficulty having a bowel movement

double vision

lack or loss of strength

rapid weight gain

rash with flat lesions or small raised lesions on the skin

seeing double

seeing floating dark spots or material before the eyes

swelling around the eyes

tingling of the hands or feet

unusual weight gain or loss

vision changes

Less common

Change in taste

loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.