ROZLYTREK 100MG /200MG CAPSULE (ENTRECTINIB)

Rozlytrek® (Entrectinib) is an oral targeted therapy approved for treating specific cancers driven by genetic mutations. Here’s a comprehensive overview:

🧬 Introduction

• Generic Name: Entrectinib

• Brand Name: Rozlytrek

• Manufacturer: Genentech, Inc. 

• Formulation: Hard capsules

• Available Strengths: 100 mg and 200 mg

            Rozlytrek is a selective tyrosine kinase inhibitor designed to target tumors with specific gene fusions, notably ROS1 and NTRK.

📋 Approved Indications

        Rozlytrek is indicated for:

1. ROS1-Positive Non-Small Cell Lung Cancer (NSCLC):

   • For adult patients with metastatic NSCLC whose tumors are ROS1-positive.

2. NTRK Gene Fusion-Positive Solid Tumors:

   • For adult and pediatric patients (12 years and older) with solid tumors that:

     • Have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation.

     • Are metastatic or where surgical resection is likely to result in severe morbidity.

     • Have progressed following treatment or have no satisfactory alternative therapy.

                    These approvals are based on clinical trials demonstrating the efficacy of Rozlytrek in targeting these specific genetic alterations.

💊 Dosage & Administration

• Adults (ROS1-Positive NSCLC and NTRK Fusion-Positive Solid Tumors):

  • 600 mg orally once daily, with or without food.

• Pediatric Patients (12 years and older) with NTRK Fusion-Positive Solid Tumors:

  • Dosing is based on body surface area (BSA):

    • BSA ≥1.51 m²: 600 mg once daily.

    • BSA 1.11–1.50 m²: 500 mg once daily.

    • BSA 0.91–1.10 m²: 400 mg once daily.

                    Continue treatment until disease progression or unacceptable toxicity.

⚠️ Side Effects

          Common Side Effects:

• Fatigue

• Constipation

• Dysgeusia (altered taste)

• Edema (swelling)

• Dizziness

• Diarrhea

• Nausea

• Dysesthesia (abnormal sensation)

• Dyspnea (shortness of breath)

• Anemia

• Weight gain

• Increased blood creatinine

• Cognitive disorders (e.g., confusion, memory issues)

• Vomiting

• Cough

• Fever

          Side Effects:

• Congestive heart failure (CHF)

• Central nervous system effects (e.g., cognitive impairment, mood changes)

• Vision disorders

• Hepatotoxicity (liver injury)

• Hyperuricemia (elevated uric acid levels)

             Patients should be monitored regularly for these adverse effects.

⚠️ Warnings & Precautions

• Congestive Heart Failure (CHF):

  • Assess left ventricular ejection fraction (LVEF) before initiating treatment. Monitor patients for signs and symptoms of CHF during treatment.

• Central Nervous System (CNS) Effects:

  • Monitor for cognitive changes, mood alterations, and other CNS effects. Adjust dosage or discontinue if severe symptoms occur.

• Hepatotoxicity:

  • Monitor liver function tests prior to and during treatment. Interrupt, reduce, or discontinue dosage based on severity.

• Hyperuricemia:

  • Monitor serum uric acid levels and manage with urate-lowering medications if necessary.

• Embryo-Fetal Toxicity:

  • Rozlytrek can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for at least 5 weeks after the final dose.

• Drug Interactions:

  • Avoid concomitant use with strong CYP3A4 inhibitors or inducers. Monitor for adverse reactions when used with other medications.

✅ Conclusion

                Rozlytrek (Entrectinib) offers a targeted treatment option for patients with ROS1-positive NSCLC and NTRK fusion-positive solid tumors. Its approval and availability in India                            provide hope for improved management of these challenging conditions. Patients should consult with healthcare professionals to determine suitability and to initiate appropriate                      monitoring protocols during therapy.