Alunib 30mg Tablet

Uses of Alunib 30mg Tablet

Non-Small Cell Lung Cancer

Common Side Effects of Alunib 30mg Tablet

Diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting, and difficulty breathing.

How does Alunib 30mg Tablet work?

It acts by inhibiting ALK phosphorylation and the activation of downstream signaling proteins.

Quick Suggestions:

• Swallow the tablets whole; do not chew or crush them.
• If you vomit after taking brigatinib, do not take another dose. Continue your regular dosing schedule.
• Your doctor may start you on a low dose of brigatinib and increase your dose once after 7 days of treatment.

Indication of Alunib 30mg Tablet

Non-small cell Lung Cancer (NSCLC) is indicated for anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC in patients who have progressed on or are intolerant to crizotinib.

Pharmacology

Tyrosine Kinase Inhibitor (TKI):

• Brigatinib is a tyrosine kinase inhibitor.
• It exhibits in vitro activity at clinically achievable concentrations against multiple kinases, including ALK, ROS1, IGF-1R, FLT-3, EGFR deletion, and point mutations.

Inhibition of ALK Signaling:

• Brigatinib inhibits the autophosphorylation of ALK (anaplastic lymphoma kinase).
• It also inhibits ALK-mediated phosphorylation of downstream signaling proteins such as STAT3, AKT, ERK1/2, and S6.

Antitumor Activity:

• Exhibits in vivo antitumor activity against mutant forms of EML4-ALK, including G1202R and L1196M mutants.
• Particularly effective in NSCLC tumors in patients who have progressed on crizotinib.

Reduction of Tumor Burden:

• Demonstrated efficacy in reducing tumor burden in mice implanted intracranially with an ALK-driven tumor cell line.

Prolonged Survival:

• Prolonged survival was observed in mice subjected to intracranial implantation of an ALK-driven tumor cell line.

Dosage & Administration of Alunib 30mg Tablet

The adult dosing information for Brigatinib (ALUNBRIG) in the treatment of non-small cell lung cancer (NSCLC) is as follows:

Non-Small Cell Lung Cancer:

• Indicated for anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC in patients who have progressed on or are intolerant to crizotinib.
• Initial dose: 90 mg orally once daily for the first 7 days.
• If 90 mg/day is tolerated during the first 7 days, increase the dose to 180 mg orally once daily.
• Continue treatment until disease progression or unacceptable toxicity.

Hepatic Impairment:

• Mild or moderate (Child-Pugh A or B): No dose adjustment is required.
• Severe (Child-Pugh C): Reduce the once-daily dose by approximately 40% (e.g., from 180 mg to 120 mg, 120 mg to 90 mg, or 90 mg to 60 mg).

Renal Impairment:

• Mild or moderate (CrCl 30-89 mL/min): No dose adjustment is required.
• Severe (CrCl 15-29 mL/min): Reduce brigatinib dose by approximately 50% (e.g., from 180 mg to 90 mg, or 90 mg to 60 mg).

Interaction

• Avoid eating grapefruit or drinking grapefruit juice during treatment.

Before Taking Brigatinib, Inform Your Healthcare Provider If You Have:

• Lung or breathing problems, high blood pressure, a slow heartbeat, vision problems, pancreatitis, liver problems, diabetes, kidney problems, pregnancy, breastfeeding, or planning to become pregnant.

Inform your healthcare provider about all medicines, including prescription, over-the-counter, vitamins, or herbal supplements.

Contraindications:

Hypersensitivity

Pregnancy & Lactation

• Brigatinib can harm the unborn baby. Pregnancy should be discussed with your healthcare provider.
• Effective birth control is recommended during treatment and for a specified duration afterward.
• Breastfeeding is not advised during Brigatinib treatment and for one week after the final dose.

Precautions & Warnings

Lung Problems:

• Brigatinib may cause severe or life-threatening lung inflammation.
• Symptoms include trouble breathing, chest pain, cough with or without mucus, and fever.
• Promptly report any new or worsening respiratory symptoms.

High Blood Pressure (Hypertension):

• Brigatinib may lead to high blood pressure.
• Regular blood pressure checks are necessary during treatment.
• Notify your healthcare provider if you experience headaches, dizziness, blurred vision, chest pain, or shortness of breath.

Slow Heart Rate (Bradycardia):

• Brigatinib can cause severe bradycardia (very slow heartbeats).
• Regular heart rate monitoring is essential during treatment.
• Inform your healthcare provider if you feel dizzy, lightheaded, or faint.

Vision Problems:

• Brigatinib may result in vision problems.
• Seek medical attention if you notice double vision, flashes of light, blurry vision, or any vision changes.

Muscle Pain, Tenderness, and Weakness (Myalgia):

• Brigatinib may elevate creatine phosphokinase (CPK), indicating muscle damage.
• Notify your healthcare provider if you experience unexplained muscle pain, tenderness, or weakness.

Inflammation of the Pancreas (Pancreatitis):

• Brigatinib may increase pancreatic enzymes, signifying pancreatitis.
• Report new or worsening signs of pancreatitis, such as upper abdominal pain, weight loss, or nausea.

Liver Problems (Hepatotoxicity):

• Brigatinib may elevate bilirubin and liver enzymes, indicating liver problems.
• Notify your healthcare provider if you experience yellowing of the skin or eyes, dark urine, abdominal pain, or unusual bleeding or bruising.

High Blood Sugar (Hyperglycemia):

• Brigatinib may increase blood sugar levels.
• Inform your healthcare provider if you experience symptoms such as excessive thirst, increased urination, hunger, nausea, weakness, or confusion.

Sun Exposure:

• Limit time in the sun during treatment and for at least 5 days after the final dose.
• Use protective measures like hats, clothing, and broad-spectrum sunscreen.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.