Ibtrozi (Taletrectinib)

Ibtrozi (taletrectinib) is a kinase inhibitor used for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Recommended Dosage:
The recommended dosage of Taletrectinib is 600 mg administered orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking the dosage) until there is evidence of disease progression or unacceptable toxicity. Take Taletrectinib at approximately the same time each day. Swallow the capsules whole. Do not chew, open, crush, or dissolve the capsule before swallowing.

If any scheduled dose is missed, take the very next dose at its scheduled time on the following day. Avoid food or drink containing grapefruit during treatment with Taletrectinib.

• Monitor liver tests before and during treatment, interrupt Taletrectinib in case AST or ALT increase above 3 times normal with signs and symptoms, or 5 times without. Resume at a reduced dose when values fall. Do not use this drug in serious liver disease because of the life-threatening potential risk of hepatotoxicity overall.
• Patients should report new or worsening cough, fever, or shortness of breath promptly. In case interstitial lung disease or pneumonitis occurs, withhold this treatment and perform necessary imaging. Resume at a lower dose only after confirmed improvement and resolution of signs. Stop permanently for serious cases.
• Obtain ECGs before and during treatment to monitor QTc intervals. Do not use Taletrectinib in those with congenital long QT syndrome or those taking other QT-prolonging medicines. Correct electrolyte imbalances, such as low potassium or magnesium, before starting treatment. Interrupt this treatment for QTc >500 ms until resolution.
• Check serum uric acid levels before starting to take treatment with this drug and periodically thereafter. Start urate-lowering therapy for asymptomatic hyperuricemia in case levels exceed 8 mg/dL. Monitor for gout attacks. Reduce or interrupt the dose if serious hyperuricemia occurs. Maintain adequate hydration to help prevent uric acid accumulation.
• Patients should report weakness, muscle pain, or cramps promptly during treatment. Check creatine phosphokinase levels regularly. Interrupt treatment for serious myalgia with marked CPK elevations above 5 times normal. Resume at a reduced dose when symptoms resolve and CPK normalizes.
• Assess fracture risk before starting this treatment, especially in those with osteoporosis or bone metastases. Consider weight-bearing exercise, calcium, and vitamin D supplementation. Monitor for new bone pain or fractures during treatment. Stop using treatment and refer to orthopedics for serious or multiple skeletal fractures that require intervention.
• Women of childbearing potential should use appropriate contraception during this treatment and for at least 3 months after the final dose. Discuss potential risks to a fetus. If pregnancy occurs, discontinue medicine immediately and monitor the mother and baby closely for adverse outcomes and developmental effects.
• Because this drug may pass into human breast milk and harm the nursing infant, women should not breastfeed during treatment and for at least 30 days after the final dose. Discuss alternative feeding options. If urgent, monitor the infant for potential toxicity and consult pediatrics before resuming breastfeeding.