AUGTYRO 40 MG CAPSULE (REPOTRECTINIB)

🧬 Introduction

• Brand Name: Augtyro

• Generic Name: Repotrectinib

• Drug Class: Next-generation Tyrosine Kinase Inhibitor (TKI) targeting ROS1 and NTRK fusions

• Indications:

  • Adults with ROS1-positive locally advanced or metastatic non‑small cell lung cancer 

  • Adults and pediatric patients  with NTRK fusion-positive solid tumors that are metastatic or unresectable, particularly after prior therapies

💊 Salt & Formulation

• Active Ingredient: Repotrectinib

• Dosage Form: Oral capsules

• Strength: 40 mg each

📋 Dosage & Administration

• Starting Dose: 160 mg once daily for 14 days

• Maintenance Dose: 160 mg twice daily thereafter, continued until disease progression or unacceptable toxicity

• Administration: With or without food; swallow capsules whole—do not crush, chew, or open

• Missed Doses or Vomiting: Skip and resume at next scheduled time; do not double

⚠️ Side Effects

     Common Effects

• Elevated liver enzymes , fatigue, GI upset

• Hyperuricemia

• Bone fractures , including ribs, feet, spine, ankle

• Peripheral neuropathy, dizziness, edema, respiratory or neurological symptoms

     Serious Risks

• Hepatotoxicity

• Interstitial Lung Disease (ILD) / Pneumonitis: Any grade requires withholding; confirmed cases mandate permanent cessation

• Central Nervous System Effects: Withhold for intolerable Grade 2 or higher; resume at reduced dose once resolved

• Creatine phosphokinase (CPK) elevation

• Hyperuricemia: Regular monitoring, withhold and consider urate-lowering therapy as needed

⚠️ Warnings & Precautions

• Liver & Renal Function: Assess prior to and during treatment

• Uric Acid: Baseline check and ongoing monitoring; manage hyperuricemia appropriately

• Bone Health: Investigate new pain or mobility changes promptly

• Contraception:

  • Women: Effective, non-hormonal methods during treatment and for 2 months afterward

  • Men: Use contraception during treatment and for 4 months afterward

• Avoid concomitant strong/moderate CYP3A inhibitors or inducers—stop such drugs 3–5 half-lives before starting Augtyro

• Grapefruit should be avoided

• Pregnancy/Breastfeeding: Contraindicated; do not breastfeed for 10 days post-treatment

✅ Conclusion

Augtyro (repotrectinib) is a potent, next-generation TKI targeting ROS1 and NTRK fusion-positive cancers in adults and youths aged ≥12. Its distinctive delayed-dose escalation strategy helps mitigate early pulmonary risks. While highly effective in targeted populations, it demands close monitoring for liver, lung, bone, and metabolic adverse effects. Avoid drug interactions, ensure contraception, and provide patient education on fracture and liver symptoms early.