ALUNBRIG

Generic Name/API: brigatinib

Manufacturer: Takeda Pharmaceuticals America

Dosage Forms & Strength & Pack Size:
Tablets: 180 mg, 90 mg, or 30 mg.
Tablets: 180 mg, 90 mg, or 30 mg.

Bottle of 23 tablets NDC 63020-180-23
Bottle of 30 tablets NDC 63020-180-30

Bottle of 7 tablets NDC 63020-090-07
Bottle of 30 tablets NDC 63020-090-30

Bottle of 30 tablets NDC 63020-113-30
90 mg / 7 count tablets (NDC 63020-090-07) and 180 mg / 23 count tablets (NDC 63020-180-23) are also available in a single carton as a one-month initiation pack:
One carton containing one bottle of 90 mg tablets (7 count) and one bottle of 180 mg tablets (23 count) NDC 63020-198-30

Storage:
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between
15°C to 30°C (59°F to 86°F) (see USP).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
What is ALUNBRIG?
ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):

that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and
that has spread to other parts of your body
It is not known if ALUNBRIG is safe and effective in children.

IMPORTANT SAFETY INFORMATION
ALUNBRIG can cause serious side effects, including:
Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms. including:
trouble breathing or shortness of breath
chest pain
cough with or without mucus
fever

High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.

Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.

Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
double vision
seeing flashes of light
blurry vision
light hurting your eyes
new or increased floaters

Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.

Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:
yellowing of your skin or the white part of your eyes
dark or brown (tea color) urine
nausea or vomiting
pain on the right side of your stomach area
bleed or bruise more easily than normal
itchy skin
decreased appetite
feeling tired

High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including:
feeling very thirsty
needing to urinate more than usual
feeling very hungry
feeling sick to your stomach
feeling weak or tired
feeling confused
The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing.

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ALUNBRIG. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What should I avoid while taking ALUNBRIG?
Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.
Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.
Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have liver problems, have diabetes mellitus or glucose intolerance, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.
Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
Males who have female partners who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.
It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

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