Pronunciation:

bri-GA-ti-nib

Brand Names:

• Alunbrig

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Brigatinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal anaplastic lymphoma kinase (ALK) gene. It is used in patients who have already received crizotinib, but their condition got worse or the medicine has stopped working. Brigatinib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

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 brigatinib in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brigatinib in the elderly.

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.

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. When you are taking this medicine, 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 this medicine 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.

• Abametapir
• Apalutamide
• Aprepitant
• Asciminib
• Atazanavir
• Avacopan
• Berotralstat
• Boceprevir
• Bosentan
• Carbamazepine
• Ceritinib
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Daridorexant
• Diltiazem
• Dronedarone
• Efavirenz
• Enasidenib
• Enzalutamide
• Erythromycin
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Lanreotide
• Letermovir
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Mobocertinib
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nirogacestat
• Octreotide
• Omaveloxolone
• Palbociclib
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Repotrectinib
• Ribociclib
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Selpercatinib
• Sotorasib
• St John's Wort
• Taurursodiol
• Telaprevir
• Telithromycin
• Tocilizumab
• Tucatinib
• Verapamil
• Vonoprazan
• Voriconazole

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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 heartbeat) or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Lung disease or breathing problems (eg, interstitial lung disease, pneumonitis), history of—Use with caution. May cause side effects to become worse.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

Do not take grapefruit products while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.

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 (tablets):
  • For non-small cell lung cancer:
    • Adults—At first, 90 milligrams (mg) once a day for the first 7 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 180 mg once a day.
    • 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 your medicine, call your doctor or pharmacist for instructions.

If you vomit after taking a dose, take the 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 and urine 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use effective birth control (eg, condoms, spermicide) along with their pills during treatment with this medicine and for at least 4 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you or your partner becomes pregnant while using the medicine, tell your doctor right away.

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 the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat.

Check with your doctor right away if you have any changes to your eyes, such as eye pain or redness, or vision changes while you are using this medicine. Your doctor may want your eyes be checked by an eye doctor (ophthalmologist).

This medicine may cause muscle damage. Check with your doctor right away if you have muscle pain, tenderness, and weakness.

Check with your doctor right away if you have loss of appetite, nausea, or pains in the stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

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 increase your blood sugar levels. Check with your doctor right away if you have confusion, nausea or vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.

This medicine may cause an increased sensitivity of the skin to sunlight (photosensitivity). Check with your doctor right away if you have itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Limit your time in the sun during treatment and for at least 5 days after the last dose. Use sunscreen or sunblock lotions with a sun protection factor (SPF) on a regular basis when you are outdoors. Wear protective clothing and hats and avoid sunlamps and tanning beds.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Back pain

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or tightness

chills

clay colored stools

confusion

cough

dark urine

decreased appetite

difficulty in moving

dizziness

dry mouth

fever

flushed, dry skin

fruit-like breath odor

headache

hoarseness

increased hunger

increased thirst

increased urination

itching, skin rash

joint pain

loss of appetite

lower back or side pain

muscle pain, tenderness, or weakness

nausea

nervousness

pain in the arms or legs

painful or difficult urination

pale skin

pounding in the ears

skin rash or itching

slow or fast heartbeat

sneezing

sore throat

stomach pain or tenderness

sweating

swelling of the feet or lower legs

swollen joints

thickening of bronchial secretions

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Less common

Anxiety

general feeling of discomfort or illness

increased sensitivity of the skin to sunlight

redness or other discoloration of the skin

severe sunburn

thickening of bronchial secretions

Rare

Fast heartbeat

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

Diarrhea

difficulty having a bowel movement

ear congestion

loss of voice

stuffy or runny nose

swelling or inflammation of the mouth

trouble sleeping

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Less common

Change in taste

loss of taste

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.