Fotivda

About Tivozanib

• Fotivda (Tivozanib) contains the active ingredient tivozanib and received FDA approval on July 6, 2023, for treating adults with advanced renal cell carcinoma (RCC) who have relapsed or refractory disease. 
• Tivozanib, is an oral VEGF receptor tyrosine kinase inhibitor. It works by inhibiting blood vessel growth that supplies nutrients and oxygen to the tumor, thereby slowing or halting cancer cell growth. 
• This mechanism suggests promising results in managing relapsed or refractory advanced RCC, indicating a favorable success rate in treating this type of kidney cancer.

Strength: 

• Fotivda capsules of 1.34 mg and 0.89 mg

Recommended Dosage:

Fotivda capsules are designed to be taken orally and can be consumed with or without food. However, it is advisable to consult your healthcare provider for more detailed information regarding dosage instructions tailored to your specific medical condition. 

They can provide personalized guidance based on factors such as your overall health, medical history, and any other medications you may be taking. Always follow your doctor’s recommendations carefully to ensure the safe and effective use of the drug.

• The recommended dose of 1.34 mg of Fotivda is to be taken once daily, with or without food, for 21 days followed by 7 days of treatment, constituting a 28-day cycle, until disease progression or unacceptable toxicity. 
• Dose interruptions and/or reductions may be necessary to manage adverse reactions effectively. In patients with moderate hepatic impairment, the dose should be reduced to 0.89 mg for 21 days on treatment followed by 7 days off treatment.

Important:

Before starting the treatment, it’s crucial to discuss any existing medications, medical conditions, pregnancy status, or plans for breastfeeding with your healthcare provider. This information enables your doctor to assess potential drug interactions and tailor the treatment plan to your individual needs, prioritizing your safety and well-being. For further clarification and guidance, consult your doctor for personalized information and advice.

Warnings & Precautions

• Avoid using strong CYP3A inducers concomitantly. 
• Before initiating Fotivda treatment, it’s crucial to control blood pressure. Monitor patients for hypertension and manage it as necessary. If hypertension persists despite anti-hypertensive medications, consider reducing the Fotivda dose. 
• Throughout treatment, closely monitor for signs or symptoms of cardiac failure, cardiac ischemia, arterial thromboembolic events, and venous thromboembolic events, especially in patients at increased risk. 
• Permanently discontinue the medicine for severe arterial or venous thromboembolic events. 
• Monitor patients at risk of or with a history of bleeding for hemorrhagic events. Proteinuria should be monitored throughout treatment, and for moderate to severe cases, consider dose reduction or temporary interruption. 
• Monitor thyroid function before and during the treatment. Withhold Fotivda before elective surgery for at least 24 days and 2 weeks following major surgery and adequate wound healing. 
• Discontinue the drug if signs or symptoms of reversible posterior leukoencephalopathy syndrome occur. 
• Advise patients of potential embryo-fetal toxicity and the need for effective contraception. 
• Additionally, caution patients allergic to tartrazine, present in the 0.89 mg Fotivda capsule, of possible allergic reactions.

Common Fotivda Side Effects:

•  Fatigue
•  Hypertension
•  Diarrhea
•  Decreased appetite
•  Nausea
•  Dysphonia
•  Hypothyroidism
•  Cough
•  Stomatitis

Laboratory abnormalities of Grade 3 or 4, occurring in ≥5% of cases, included:

•  Decreased sodium
•  Increased lipase
•  Decreased phosphate

Use in Specific Population

• Fotivda has the potential to cause fetal harm in pregnant women based on animal studies and its mechanism of action. 
• There is insufficient data on the presence of tivozanib in human milk, its effects on breastfed infants, or milk production. Therefore, lactating women are advised not to breastfeed during the treatment and for one month after the last dose. 
• Prior to initiating treatment, verify the pregnancy status of females of reproductive potential and advise them to use effective contraception throughout treatment and for one month after discontinuation. 
• Male patients with female partners of reproductive potential should also use effective contraception during and for one month after the treatment. Animal studies suggest that this medicine may impair fertility in both females and males of reproductive potential. 
• The safety and efficacy of Fotivda in pediatric patients have not been established. No dosage adjustment is necessary for patients with mild to severe renal impairment, but the recommended dosage for those with end-stage renal disease has not been determined. 
• Similarly, the recommended dosage for patients with severe hepatic impairment has not been established. Excessive intake of Fotivda can lead to severe hypertension and hypertensive crisis, which may be fatal.

Storage and Handling

• Store Fotivda at 20ºC to 25ºC (68ºF to 77ºF), with excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
• Keep the medicine protected from moisture.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.