FOTIVDA 0.89MG /1.34MG CAPSULE (TIVOZANIB)

🔬 Introduction

Fotivda is a prescription medicine used to treat adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and                has come back or did not respond to treatment. It is not known if this medicine is safe and effective in children

• Generic Name: Tivozanib

• Brand Name: FOTIVDA

• Drug Class: VEGF receptor tyrosine kinase inhibitor, which works by blocking angiogenesis (new blood vessel formation in tumors)

• Indication: Treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) after at least two prior systemic therapies

💊 Dose & Administration

• Route: Oral capsules

• Dosage: Taken once daily, typically as 1 capsule (0.89 mg or 1.34 mg base equivalent) depending on approved strength

• Treatment Duration: Continue until disease progression or unacceptable toxicity

• Special Instructions:

  • Avoid other VEGF inhibitors concurrently

  • Withhold ≥24 days before elective surgery and resume ≥2 weeks afterward due to impaired wound healing

⚠️ Common Side Effects

        (occurring in ≥20% of patients)

• Fatigue

• Hypertension (high blood pressure; ~45–48%)

• Diarrhea

• Decreased appetite

• Nausea

• Dysphonia (voice changes/hoarseness)

• Hypothyroidism

• Cough

• Stomatitis (mouth sores)

⚠️ Serious Side Effects & Risks

• Hypertension/Hematologic Events

  • Severe or crisis-level hypertension may occur—monitor BP at 2 weeks and monthly; treat and adjust dose accordingly

• Cardiac Events: Including heart failure, heart attack, or blood clots

• Bleeding: Increased risk of hemorrhage—monitor for bleeding signs

• Proteinuria: May lead to kidney impairment—check urine protein levels

• Thyroid Abnormalities: Low thyroid hormone common—monitor TSH/T4 levels

• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Monitor for headache, vision change, seizures

• Gastrointestinal Perforation or Fistula: Rare but potentially fatal—permanent discontinuation indicated

⚠️ Other Side Effects

• Electrolyte abnormalities: Hyponatremia, hypophosphatemia

• Increased lipase (pancreatic enzyme), hoarseness, mouth sores, coughing, weakness

• Infertility risk for both males and females—discuss family planning before starting therapy

⚠️ Precautions & Monitoring

• Blood Pressure: Monitor regularly; initiate antihypertensive therapy if needed, interrupt/adjust FOTIVDA for persistent Grade ≥3 hypertension

• Cardiovascular Monitoring: Watch for signs of heart failure or ischemia

• Urinalysis: Assess urine protein to detect early renal injury

• Thyroid Function: Baseline and periodic TFTs (TSH, T4)

• Neurologic Assessment: Monitor for focal deficits or neuro symptoms suggesting RPLS

• Pre-Surgery: Discontinue ≥24 days before major surgery; resume ≥2 weeks after healing confirmed

• Pregnancy: Teratogenic in animals—avoid during pregnancy; use contraception

✅ Conclusion

FOTIVDA is a valuable oral VEGFR-TKI for heavily pre-treated advanced RCC. While it offers improved disease control, it demands intensive monitoring for hypertension, heart, kidney, thyroid, neurologic, and bleeding risks. Patients should be closely managed by oncology teams well-versed in supportive care strategies and dose adjustments.