Fotivda 1.34mg Capsules

Tivozanib is an oral, potent, and selective tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. By inhibiting these receptors, tivozanib blocks VEGF-mediated signaling pathways, which are crucial for angiogenesis (formation of new blood vessels) and tumor growth. This leads to inhibition of tumor angiogenesis, tumor growth, and metastasis.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Thyroid Problems: Weight changes, nervousness, excitability, restlessness, weakness, hair loss, depression, eye or neck swelling, difficulty concentrating, heat or cold intolerance, menstrual changes, shakiness, or sweating.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe stomach upset or vomiting.
Skin Reactions: Redness or irritation on the palms of the hands or soles of the feet.
Posterior Reversible Encephalopathy Syndrome (PRES): A rare but potentially life-threatening brain condition. Seek immediate medical attention if you experience confusion, decreased alertness, vision changes, loss of vision, seizures, or severe headache.
Blood Clots: Chest, arm, back, neck, or jaw pain or pressure, coughing up blood, numbness or weakness on one side of the body, speech or thinking difficulties, balance problems, vision changes, shortness of breath, or swelling, warmth, or pain in the leg or arm.
Heart Failure: Shortness of breath, sudden weight gain, swelling in the arms or legs, or bulging neck veins.
Gastrointestinal Perforation or Fistula: Severe stomach pain or swelling, black, tarry, or bloody stools, or high fever.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not resolve on their own:

Fatigue or weakness
Diarrhea, stomach upset, or vomiting
Decreased appetite
Cough
Mouth irritation or sores
Voice changes
Back pain
* Weight loss

This is not an exhaustive list of potential side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as high blood pressure or thyroid problems.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial because some medications, including those used to treat HIV, infections, seizures, and other conditions, should not be taken with this drug.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication or for 1 month after your last dose.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, health problems, and allergies. This will help determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as there may be ways to minimize these effects.

Regular blood tests and other laboratory evaluations should be performed as directed by your doctor to monitor your condition. Be aware that this medication can cause high blood pressure, so it is crucial to have your blood pressure checked as advised by your doctor.

If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. Additionally, this medication may increase your risk of bleeding, so it is essential to be cautious and avoid injuries. To minimize bleeding risks, use a soft toothbrush and an electric razor. Although rare, some bleeding problems can be life-threatening.

This medication may also affect wound healing, so if you require surgery, your doctor may instruct you to stop taking it before the procedure. You can resume taking the medication after surgery as directed by your doctor. If you notice any issues with wound healing or experience other wound-related problems, contact your doctor immediately.

If you are allergic to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some formulations of this medication may contain this ingredient.

It is also important to note that this medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, consult your doctor before starting this medication.

Due to the potential risk of harm to an unborn baby, a pregnancy test will be performed before initiating treatment to confirm that you are not pregnant. If you may become pregnant, use effective birth control while taking this medication and for one month after your last dose. If you become pregnant, notify your doctor immediately.

Similarly, if your partner may become pregnant, use birth control while taking this medication and for one month after your last dose. If your partner becomes pregnant, contact the doctor right away.

• Strong CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease tivozanib exposure, reducing efficacy. Avoid coadministration.
• Strong P-gp Inducers (e.g., rifampin, St. John's Wort): May decrease tivozanib exposure. Avoid coadministration.

• Moderate CYP3A4 Inducers (e.g., efavirenz, bosentan): May decrease tivozanib exposure. Consider alternatives.
• Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase tivozanib exposure. Use with caution, monitor for increased adverse reactions.
• Strong P-gp Inhibitors (e.g., cyclosporine, verapamil, amiodarone, quinidine): May increase tivozanib exposure. Use with caution, monitor for increased adverse reactions.

• Moderate P-gp Inhibitors: May slightly increase tivozanib exposure. Monitor.
• Weak CYP3A4 Inhibitors/Inducers: Unlikely to cause clinically significant interactions.

• Headache
• Dizziness
• Blurred vision
• Nosebleeds
• Fatigue
• Diarrhea
• Nausea
• Decreased appetite
• Dysphonia (hoarseness)
• Palmar-plantar erythrodysesthesia (hand-foot syndrome)
• Changes in voice
• Swelling (edema)
• Shortness of breath
• Chest pain
• Signs of bleeding (e.g., unusual bruising, black/tarry stools, red urine)
• Signs of arterial thrombotic events (e.g., sudden numbness/weakness, vision changes, severe headache)

Fotivda can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, tivozanib is expected to cause adverse developmental effects. Advise pregnant women of the potential risk to the fetus.

It is not known whether tivozanib or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Fotivda and for 28 days after the last dose.

The safety and effectiveness of Fotivda in pediatric patients have not been established.

No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients. No dose adjustment is required based on age.

• Tivozanib has a very long half-life (approx. 4.5 days), meaning it takes a long time to reach steady state and to be eliminated from the body. This contributes to its unique dosing schedule (21 days on, 7 days off).
• Hypertension is a very common and potentially severe side effect. Aggressive blood pressure management is critical, often requiring multiple antihypertensive agents.
• Thyroid dysfunction, particularly hypothyroidism, is common. Patients should be monitored and treated with thyroid replacement therapy as needed.
• Patients should be educated on the signs and symptoms of hypertension, hemorrhage, and arterial thrombotic events, and instructed to seek immediate medical attention if these occur.
• Hand-foot syndrome (palmar-plantar erythrodysesthesia) can occur; advise patients on moisturizers and comfortable footwear.

• Other VEGFR TKIs for RCC: Axitinib (Inlyta), Cabozantinib (Cabometyx), Lenvatinib (Lenvima), Pazopanib (Votrient), Sorafenib (Nexavar), Sunitinib (Sutent).
• Immunotherapy agents for RCC: Nivolumab (Opdivo), Pembrolizumab (Keytruda), Ipilimumab (Yervoy).
• mTOR inhibitors for RCC: Everolimus (Afinitor), Temsirolimus (Torisel).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.