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brigatinib (Oral route)

bri-GA-ti-nib

Commonly used brand name(s)

In the U.S.

  • Alunbrig

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For brigatinib

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.

brigatinib is available only with your doctor's prescription.

Before Using brigatinib

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 brigatinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to brigatinib 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 brigatinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

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.

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 brigatinib, 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 brigatinib 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.

  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Enzalutamide
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Lumacaftor
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Phenytoin
  • Posaconazole
  • Rifampin
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Voriconazole

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

Using brigatinib 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 brigatinib, 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 brigatinib. 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.

Proper Use of brigatinib

Take brigatinib 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.

brigatinib should come with a patient information insert. 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 brigatinib with or without food.

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

Dosing

The dose of brigatinib 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 brigatinib. 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 if needed. 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 brigatinib, 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.

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 brigatinib

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

Using brigatinib 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. Female patients should use effective birth control during treatment 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.

brigatinib 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 brigatinib. Your doctor may want you to have your eyes checked by an eye doctor.

brigatinib 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 stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

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

If you plan to have children, talk with your doctor before using brigatinib. Some men and women using brigatinib 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 (eg, St. John's wort) or vitamin supplements.

brigatinib 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
  • Abdominal or stomach pain or tenderness
  • back pain
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or tightness
  • chills
  • confusion
  • cough
  • decreased appetite
  • difficulty in moving
  • dizziness
  • fever
  • flushed, dry skin
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain
  • loss of appetite
  • muscle pain, tenderness, or weakness
  • nausea and vomiting
  • nervousness
  • pain in the arms or legs
  • pounding in the ears
  • skin rash or itching
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • swollen joints
  • thickening of bronchial secretions
  • trouble breathing
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet

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
  • Blurred vision or changes in vision
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement (stool)
  • trouble sleeping

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.

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