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alectinib (Oral route)

al-EK-ti-nib

Commonly used brand name(s)

In the U.S.

  • Alecensa

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For alectinib

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).

alectinib is available only with your doctor's prescription.

Before Using alectinib

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 alectinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alectinib 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.

Pediatric

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.

Geriatric

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

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.

Interactions with 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 alectinib, 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 alectinib with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using alectinib 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.

  • Adenovirus Vaccine
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 alectinib. 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 alectinib

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

Take alectinib 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.

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

Take alectinib with food.

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

Dosing

The dose of alectinib 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 alectinib. 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 alectinib, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking alectinib, 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 alectinib

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

Using alectinib 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 alectinib, 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.

alectinib 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 alectinib. 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 alectinib. These may be symptoms of a serious muscle problem.

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

alectinib Side Effects

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.

See also: Side effects (in more detail)

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