Brigatinib (Brigatinib) Instructions, Indications, Usage and Dosage, Side Effects

Indications: Alunbrig (brigatinib) is a kinase inhibitor. Brigatinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval. Brigatinib is specifically indicated for the first-line treatment of adult patients with ALK+ metastatic NSCLC as detected by a U.S. FDA-approved test.

Mechanism of Action: Brigatinib is a kinase inhibitor with in vitro activity at clinically achievable concentrations against multiple kinases, including ALK, ROS1, insulin-like growth factor 1 receptor (IGF-1R), and FLT-3, as well as EGFR deletions and point mutations. Brigatinib inhibits ALK autophosphorylation and ALK-mediated phosphorylation of downstream signaling proteins STAT3, AKT, ERK1/2, and S6 in both in vitro and in vivo assays. Brigatinib also inhibited in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and showed dose-dependent inhibition of mouse EML4-ALK-positive NSCLC xenograft growth.

Dosage and Administration: Brigatinib is available as an oral tablet. The recommended dosing regimen is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated within the first 7 days, increase dose to 180 mg orally once daily. Administer brigatinib until disease progression or unacceptable toxicity. If brigatinib is interrupted for reasons other than adverse effects for 14 days or more, resume treatment at a dose of 90 mg once daily for 7 days and then increase to the previously tolerated dose. Brigatinib can be taken with food or alone. Instruct the patient to swallow the tablet whole. Do not crush or chew tablets. If you miss a dose of brigatinib or if you experience vomiting after taking the dose, do not take an additional dose and take the next dose at the scheduled time.

Side Effects: If the patient shows signs of allergic reaction while taking brigatinib:Hives; difficulty breathing; swelling of the face, lips, tongue, or throat, get emergency medical help.

Brigatinib may cause serious side effects. Contact your doctor immediately if you have: Lung problems - cough, trouble breathing, chest pain, fever Vision problems - blurred vision, double vision, increased sensitivity to light, seeing flashes of light or "floaters" in your vision High blood pressure - severe headache, in your neck or ears pounding, dizziness; high blood sugar - increased thirst, increased urination, hunger, nausea, fruity bad breath, weakness, confusion; heart problems - heartbeat so slow you feel like you might pass out; muscle problems - unexplained muscle pain or weakness; or pancreatitis - upper abdominal pain (worse while eating, may spread to the back), nausea, weight loss.

If you have certain side effects, your cancer treatment may be delayed or permanently stopped.

Common side effects of brigatinib may include: nausea, vomiting, diarrhea; increased blood pressure; difficulty breathing; cough; rash; muscle pain; headache; or feeling tired. This is not a complete list of side effects and other side effects may occur.

Storage: Store at room temperature, away from moisture and heat.