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.