Alecensa

Alecensa 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 medications 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 medication).

This medication is only available with your doctor’s prescription.

This medication is available in the following forms:

• Capsule

As with all medicines, the risks of using Alecensa must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies - Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric - No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
• Geriatric - No appropriate studies have been performed on the relationship of age to the effects of this medication in the elderly. However, no elderly-specific problems have been documented to date.
• Breastfeeding - There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions - Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.
• Other Interactions - Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems - Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

  • Bradycardia (slow heart beat)

  • Breathing problems

  • Interstitial lung disease

  • Liver disease

  • Lung disease

  • Myalgia (muscle pain)

  • Pneumonitis (lung inflammation) - Use with caution. May make these conditions worse.

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

Only take this medication as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that you read this information. Ask your doctor if you have any questions.

Take this medication with food. Swallow the capsule whole. Do not open, crush or chew it.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

• Adults - Start with 600mg twice 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 medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

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

Storage

Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

It is very important that your doctor checks in with you often while you are receiving Alecensa to make sure that it is working properly.

Using this medication 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 medication, inform your doctor immediately.

Inform your doctor immediately if you have

• Pain or tenderness in the upper stomach,
• Pale stool
• Dark urine
• Loss of appetite
• Nausea
• Vomiting
• Yellow skin or eyes (jaundice)

These may be symptoms of a serious liver problem.

This medication may cause pneumonitis (swelling of the lungs) or interstitial lung disease. These are life-threatening conditions and require immediate medical care.

The symptoms may be similar to those of lung cancer.

Inform your doctor immediately if you have

• a new or worsening cough,
• fever,
• shortness of breath,
• trouble breathing.

Bradycardia (slow heartbeat) may occur while you are using this medication.

Inform your doctor immediately if you have

• chest pain or discomfort,
• lightheadedness,
• dizziness or fainting,
• a slow or uneven heartbeat.

Inform your doctor immediately if you have

• unexplained muscle pain,
• tenderness or weakness after taking this medication.

These may be symptoms of a serious muscle problem.

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

Alecensa may produce unwanted affects along with the intended 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 you experience any of the following side-effects:

More Common

• Chest pain or discomfort
• Cough
• Difficulty moving
• Joint pain
• Lightheadedness, dizziness, or fainting
• Muscle aching or cramping
• Muscle pains or stiffness
• Shortness of breath
• Slow or irregular heartbeat (bradycardia, arrhythmias)
• Swollen joints
• Unusual fatigue

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 (jaundice)

Rare

• Difficulty breathing
• Fever

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment.

Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

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
• Rash with flat lesions or small raised lesions on the skin
• 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

Some patients may experience other side effects that are not listed.

Check with your doctor if you notice any other side effects.

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