Alunbrig

Generic name: brigatinib

Drug class: Multikinase inhibitors

Dosage form: Tablets (30 mg, 90 mg, and 180 mg)

Route of administration: Oral

Dose:

• Initial dose: 90 mg orally once daily for the first 7 days
• Maintenance dose: If the initial dose is tolerated, increase to 180 mg orally once daily
• Duration of therapy: Continue until disease progression or unacceptable toxicity

Mechanism of action: Brigatinib is an anaplastic lymphoma kinase (ALK) inhibitor that blocks the activity of the ALK protein, which is involved in the growth and spread of cancer cells. By inhibiting ALK, brigatinib reduces the proliferation of ALK-positive cancer cells, thereby slowing tumor growth and metastasis.

Drug usage cases:

• Treatment of adults with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
• First-line treatment for ALK-positive NSCLC in patients who have not been previously treated with an ALK inhibitor

Drug contraindications:

• Hypersensitivity to brigatinib or any of its components

Side effects:

• Lung problems: Severe or life-threatening inflammation of the lungs (interstitial lung disease/pneumonitis) may occur, especially within the first week of treatment. Symptoms include difficulty breathing, cough, chest pain, and fever.
• High blood pressure (hypertension): May cause headaches, dizziness, blurred vision, chest pain, or shortness of breath.
• Slow heart rate (bradycardia): May lead to dizziness, lightheadedness, or fainting.
• Vision problems: Including double vision, flashes of light, blurred vision, light sensitivity, or new or increased floaters.
• Muscle pain, tenderness, and weakness (myalgia): Elevated creatine phosphokinase (CPK) levels may indicate muscle damage.
• High blood sugar (hyperglycemia): Symptoms may include increased thirst, frequent urination, hunger, nausea, weakness, or confusion.
• Common side effects: Diarrhea, fatigue, nausea, rash, cough, headache, vomiting, and difficulty breathing.

Warnings:

• Monitor for signs of interstitial lung disease/pneumonitis, especially during the first week of treatment.
• Regularly check blood pressure and heart rate during treatment.
• Assess vision regularly; discontinue if severe vision problems occur.
• Monitor CPK levels to detect muscle damage; discontinue if significant increases are observed.
• Monitor blood sugar levels; initiate or adjust anti-hyperglycemic medications as needed.
• Use effective contraception during treatment and for at least 4 months after the final dose for females, and for at least 3 months after the final dose for males with female partners of reproductive potential.
• Advise patients not to breastfeed during treatment and for at least 1 week after the final dose.

Use during pregnancy or breastfeeding: Brigatinib can cause fetal harm when administered to pregnant women. There are no clinical data on the use of brigatinib in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with brigatinib and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of brigatinib. It is not known whether brigatinib is excreted in human milk; however, due to the potential for serious adverse reactions in nursing infants, advise patients not to breastfeed during treatment and for at least 1 week after the final dose.