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Alectinib (Oral route)

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 who have an abnormal anaplastic lymphoma kinase (ALK) gene. It is used in patients who have already received other medicines that did not work well. Alectinib interferes with the growth of cancer cells which are then destroyed by the body. It is an antineoplastic agent (cancer medicine).

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

Although appropriate studies on the relationship of age to the effects of alectinib have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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
  • Breathing problems or
  • Interstitial lung disease, history of or
  • Liver disease or
  • Lung disease, history of or
  • Myalgia (muscle pain) or
  • Pneumonitis (lung inflammation), 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.

Take this medicine with food.

Swallow the capsule whole. Do not open, crush, or chew it.

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) two 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 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. Women should use effective birth control during treatment and for at least 1 week after the last dose. Men with sexual partners should use effective 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, shortness of breath, or trouble breathing.

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 make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds.

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
Chest pain or discomfort
cough
difficulty with moving
joint pain
lightheadedness, dizziness, or fainting
muscle aching or cramping
muscle pains or stiffness
shortness of breath
slow or irregular heartbeat
swollen joints
unusual tiredness
Less common
Abdominal pain or tenderness
clay colored stools
dark urine
decreased appetite
fever
headache
itching or skin rash
loss of appetite
nausea and vomiting
swelling of the feet or lower legs
yellow eyes or skin
Rare
Difficult breathing
fever

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 (stool)
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

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.


Last Updated: 9/15/2016
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