Brigatinib

What is Brigatinib?

• Brigatinib (Alunbrig) is a kinase inhibitor used to treat non-small cell lung cancer that has spread to other parts of the body and is anaplastic lymphoma kinase (ALK) positive.

Brigatinib

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Brigatinib structure

What are the uses of this medicine?

Brigatinib (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 used in patients whose cancer has gotten worse during treatment with or who cannot take crizotinib (a type of anticancer drug).

How does this medicine work?

• Brigatinib (bri ga' ti nib) is a small molecule tyrosine kinase receptor inhibitor with potent activity against anaplastic lymphoma kinase (ALK) that is rearranged and mutated in some cancers including approximately 5% of non-small cell lung cancer (NSCLC).
• The mutated, rearranged ALK promotes unregulated cell growth and proliferation.
• Brigatinib has been found to inhibit mutated ALK in cell culture and in several clinical trials was found to induce objective responses in a proportion of patients with refractory, advanced NSCLC that are ALK-positive.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG.
• Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inducers. If coadministration of a moderate CYP3A inducer is unavoidable, increase the dose of ALUNBRIG.

Is this medicine FDA approved?

• Brigatinib was approved for use in the United States in 2017 in patients with ALK-positive, metastatic NSCLC who have progressed despite therapy with first generation ALK inhibitors (such as crizotinib).

How should this medicine be used?

• Select patients for the treatment of metastatic NSCLC with ALUNBRIG based on the presence of ALK positivity in tumor specimens.

Recommended dosage:

• 90 mg orally once daily for the first 7 days; then increase the dose to 180 mg orally once daily.

Administration:

• Your healthcare provider will start you on a low dose (90 mg) of ALUNBRIG for the first 7 days of treatment. If you tolerate this dose of ALUNBRIG well, your healthcare provider may increase your dose after the first 7 days of treatment.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ALUNBRIG if you develop side effects.
• Take ALUNBRIG 1 time each day.
• Take ALUNBRIG with or without food.
• Swallow ALUNBRIG tablets whole. Do not crush or chew tablets.
• If you miss a dose of ALUNBRIG, do not take the missed dose. Take your next dose at your regular time.
• If you vomit after taking a dose of ALUNBRIG, do not take an extra dose. Take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 180 mg, 90 mg, or 30 mg.

This medicine is available in fallowing brand namesː

• ALUNBRIG

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• fatigue
• nausea
• rash
• cough
• muscle pain
• headache
• high blood pressure
• vomiting
• difficulty breathing

ALUNBRIG may cause fertility problems in males.

ALUNBRIG may cause serious side effects, including:

• Lung problems
• hypertension
• bradycardia
• Vision problems
• myalgia
• pancreatitis
• hepatotoxicity
• hyperglycemia

What special precautions should I follow?

• Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold ALUNBRIG for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG.
• Hypertension was reported in patients receiving ALUNBRIG. Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold ALUNBRIG, then dose reduce or permanently discontinue.
• Heart rates less than 50 beats per minute (bpm) occurred in 8.1% of patients receiving ALUNBRIG. Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue.
• Grade 1 or 2 adverse reactions leading to visual disturbance including blurred vision, photophobia, photopsia, and reduced visual acuity were reported in patients receiving ALUNBRIG. Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic evaluation, then dose reduce or permanently discontinue ALUNBRIG.
• Creatine phosphokinase (CPK) elevation occurred in patients who received ALUNBRIG. Monitor CPK levels regularly during treatment. Based on the severity and with muscle pain or weakness, withhold ALUNBRIG, then resume or reduce dose.
• Pancreatic enzymes elevation may occur. Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose.
• Hepatotoxicity may occur. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin levels regularly during treatment. Based on severity, withhold dose, then resume at lower level.
• Patients who received ALUNBRIG experienced new or worsening hyperglycemia. Assess fasting serum glucose prior to starting ALUNBRIG and regularly during treatment. If not adequately controlled with optimal medical management, withhold ALUNBRIG, then consider dose reduction or permanently discontinue, based on severity.
• Photosensitivity occurred in patients who received ALUNBRIG. Advise patients to limit sun exposure. Based on severity withhold ALUNBRIG, then resume at the same dose, reduce the dose, or permanently discontinue.
• Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: brigatinib
• Inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, and hydrophobic colloidal silica. The tablet coating consists of talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.

Who manufactures and distributes this medicine?

• Distributed by: Takeda Pharmaceuticals America, Inc., Lexington, MA 02421
• ALUNBRIG® is a registered trademark of ARIAD Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store ALUNBRIG at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Brigatinib
• FDA Brigatinib

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