Alunbrig

The recommended starting dose of brigatinib is 90 mg taken by mouth once daily for 7 days. Depending on how well the medication is tolerated, your doctor may increase your dose to 180 mg daily after the first week.

Brigatinib may be taken with food or on an empty stomach. Swallow the tablet whole with water; do not crush or chew the tablet.

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 vomit after taking the medication, do not take another dose until the next scheduled dose time. 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.

Store this medication at room temperature, 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 film-coated tablet contains 30 mg, 90 mg, or 180 mg of brigatinib. Nonmedicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, silica colloidal hydrophobic, sodium starch glycolate (type A); tablet coating: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Initiation Pack

Each package contains 7 film-coated tablets containing 90 mg of brigatinib and 21 film-coated tablets containing 180 mg of brigatinib. Nonmedicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, silica colloidal hydrophobic, sodium starch glycolate (type A); tablet coating: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not take this medication if you are allergic to brigatinib 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.

• acne

• changed sense of taste

• constipation

• decreased appetite

• diarrhea

• dizziness

• dry mouth

• dry skin

• fatigue

• headache

• heartburn

• itchy skin

• mouth sores, inflammation

• muscle spasms

• muscle/bone stiffness

• nausea

• pain (joint, muscle, chest, back, arms, legs)

• rash

• skin sensitivity to the sun

• tiredness

• trouble sleeping

• vomiting

• weakness

• 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:

• abdominal pain

• change in voice quality

• cough

• difficulty speaking

• fever

• increased frequency of infections

• loss or change in vision

• numbness and tingling in the hands and feet

• shortness of breath

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

• 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)

• swelling caused by fluid build-up

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

• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

• symptoms of lung infection or inflammation (e.g., difficulty breathing, cough, or fever)

• symptoms of severely increased blood pressure (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)

• symptoms of slow heartbeat (bradycardia; e.g., chest pain or discomfort, changes in heartbeat, dizziness, light-headedness, fainting)

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

• symptoms of serious lung problems (e.g., new or worsening trouble breathing, chest pain, shortness of breath, cough with or without mucous, or fever)

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.

Birth control: Effective birth control should be practiced while using this medication as this medication may harm the baby if used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. People of childbearing age who are taking brigatinib should use an effective method of birth control such as condoms during treatment and for at least 4 months after stopping the medication.

People taking this medication who have partners of childbearing age should use condoms during treatment and for at least 3 months afterwards.

Blood sugar: Brigatinib may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, 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.

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

Eye problems: People taking brigatinib may experience eye problems and vision changes. If you experience changes to your vision such as cloudiness, blurred vision or vision loss, contact your doctor immediately.

**Galactose intolerance/glucose malabsorption: ** Brigatinib is prepared with lactose. If you have lactose or galactose intolerance, you should not take this medication.

Heart problems: This medication can decrease heart rate and increase blood pressure, both of which may contribute to heart failure or worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or arrhythmia, or you are taking certain medications used to treat irregular heart rhythms (e.g., procainamide, amiodarone, sotalol), 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 a heart rate of less than 60 beats per minute, or frequently feel faint or dizzy, contact your doctor.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have kidney 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.

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.

Lung inflammation: Lung inflammation (interstitial lung disease) causing difficulty breathing has occurred rarely in some people taking this medication. 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 brigatinib, contact your doctor immediately.

Muscle effects: Muscle damage has been associated with the use of brigatinib. 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 greater. 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. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if brigatinib passes into breast milk. If you are breast-feeding and 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: There is limited information about the safety and effectiveness of this medication when used by seniors. People over 65 years of age appear to be more likely to experience side effects related to breathing.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other 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.

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/Alunbrig