Alecensaro

The usual adult dose of alectinib is 600 mg (four 150 mg capsules) taken by mouth, twice a day, with food. This provides a daily total of 1,200 mg of alectinib.

Swallow the capsules whole with some liquid. Do not open or dissolve the capsules to take them.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. **If your doctor has recommended a dose different from the ones listed here, **do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you vomit after taking a dose, take your next dose at the regularly scheduled time. Do not replace the vomited dose.

Store this medication at room temperature in its original package, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each hard, white capsule, with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body, contains 150 mg alectinib (equivalent to 161.3 mg alectinib hydrochloride). *Nonmedicinal ingredients: *carboxymethylcellulose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate; capsule shell: carnauba wax, carrageenan, corn starch, hypromellose, potassium chloride, titanium dioxide, and trace of printing ink.

Do not take this medication if you are allergic to alectinib or any ingredients of the medication.

**Many medications can cause side effects. **A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation

• diarrhea

• dizziness

• dry skin

• fatigue

• fluid buildup in arms, legs, ankles

• hair loss

• headache

• increased sensitivity to the sun

• inflammation or soreness in the mouth

• itching

• metallic taste in the mouth

• muscle and joint aches or pain

• nausea

• rash

• vomiting

• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• numbness or tingling in hands and feet

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)

• slowed heartbeat (e.g., dizziness, lightheadedness, fainting)

• vision changes (e.g., blurred vision, loss of sight, black dots or white spots in vision, seeing double)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of lung problems (e.g., worsening or new difficulty breathing, shortness of breath, cough with or without mucus, fever)

• signs of tear in the stomach or intestines (e.g., severe stomach pain, fever, chills, changes in bowel habits)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Drowsiness/reduced alertness: Alectinib may cause drowsiness, dizziness, or vision changes, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Heart disease: Alectinib can cause very low heart rate. If you have heart conditions with low heart rate such as certain types of arrhythmias, congestive heart failure, sick sinus syndrome or certain types of heart block, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience signs of slow heartbeat, such as dizziness, lightheadedness, and fainting, let your doctor know as soon as possible.

**Gastrointestinal perforation: **Rarely, people taking alectinib experience a gastrointestinal perforation. This is a condition where a hole forms through the walls of the digestive tract and is a medical emergency. If you have risk factors for this type of complication, such as a history of diverticulitis, cancer that has spread to the digestive tract or are taking other medications that may cause gastrointestinal perforation, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Grapefruit juice: Grapefruit juice, grapefruit, starfruit, pomegranate and Seville oranges can interfere with how this medication is broken down and removed from the body. Consuming any of these products while taking alectinib may cause the medication to build up in the body, causing severe side effects. For this reason, it is advisable to avoid these fruits and their juices while taking this medication.

**Kidney function: **Alectinib may cause decreased kidney function. If you experience signs of kidney problems, such as a change in the amount or colour of urine, increased urination at night, blood in the urine, or swelling in the feet or legs, contact your doctor.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Alectinib may also cause harm to the liver. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Rarely, some people taking alectinib have experienced lung inflammation (interstitial lung disease), causing difficulty breathing. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking alectinib, contact your doctor immediately.

Muscle effects: Muscle damage has been associated with the use of alectinib. Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 50 or higher. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Women of childbearing age who are taking alectinib and women whose partners are taking alectinib should use an effective method of birth control, such as condoms, during treatment and for at least 3 months after stopping the medication. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if alectinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 75 are more likely to experience severe side effects of taking alectinib.

There may be an interaction between alectinib and any of the following:

• alpha-agonists (e.g., clonidine, methyldopa)

• amiodarone

• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)

• ceritinib

• dabigatran

• digoxin

• diltiazem

• donepezil

• dronedarone

• fentanyl

• fingolimod

• flecainide

• galantamine

• grapefruit juice

• guanfacine

• lacosamide

• lanreotide

• methotrexate

• octreotide

• ozanimod

• pasireotide

• propafenone

• rivastigmine

• siponimod

• tizanidine

• tofacitinib

• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Alecensaro