The oral anti-cancer drug tivozanib, which is sold under the trade name Fotivda, is mainly used to treat renal cell carcinoma (RCC), a subtype of kidney cancer. Patients with relapsed or refractory advanced RCC who have had at least two previous systemic treatments are specifically eligible for Fotivda. Tyrosine kinase inhibitors (TKIs) are a class of medications that work by inhibiting particular proteins that support the proliferation of cancer cells and angiogenesis (the creation of new blood vessels).

Active Ingredient and Strength:

1.34 mg of Tivozanib hydrochloride, or 1.0 mg of Tivozanib free base, are contained in each Fotivda capsule. In accordance with a recommended dosage schedule, the capsule is normally taken orally once daily.

Mechanism of Action:

Tivozanib is a powerful, long-acting, and specific inhibitor of the tyrosine kinase of the vascular endothelial growth factor receptor (VEGFR). It functions by focusing on and blocking VEGFR-1, VEGFR-2, and VEGFR-3, which are important receptors in the angiogenesis process that cancers depend on for growth and metastasis. Tivozanib prevents tumor development and proliferation by blocking these receptors, which limits the blood flow to cancer cells.

Indications and Usage:

Adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have had two or more systemic treatments in the past can use fotivda, according to FDA approval. It is frequently administered when immune checkpoint inhibitors or other TKIs have failed to control the malignancy.

Dosage and Administration:

The recommended dose of Fotivda is 1.34 mg orally once daily for 21 consecutive days, followed by a 7-day rest period, in 28-day treatment cycles. This cycle may be repeated as long as the patient is benefitting and tolerating the treatment. Capsules should be swallowed whole with water and taken with or without food.

Pharmacokinetics:

Tivozanib 1.34 mg (Fotivda) has advantageous pharmacokinetic characteristics, such as:

Its long half-life (around 4.5 days) permits once-daily dosage.

high VEGF receptor selectivity in contrast to other TKIs.

little off-target effects, which helps many patients have a more desirable side effect profile.

Side Effects and Warnings:

Tivozanib may have adverse effects, just like any other cancer medication. The following negative consequences are most frequently reported:

Elevated blood pressure, or hypertension

Weariness

Having diarrhea

Diminished appetite

Feeling queasy

Voice hoarseness, or dysphonia

Palmar-plantar erythrodysesthesia, often known as hand-foot condition

Serious adverse effects could consist of:

Hypertensive crisis or severe hypertension

Events involving arterial thromboembolism

Events involving hemorrhage

Fistula formation and intestinal perforation

Syndrome of Reversible Posterior Leukoencephalopathy (RPLS)

Throughout the course of treatment, patients should be regularly checked for possible problems, including blood pressure and liver function. Depending on tolerance and test findings, dosage changes can be required.

Contraindications and Precautions:

Fotivda is not recommended in the following cases:

Pregnancy: When given to expectant mothers, tivozanib may harm the fetus. Effective contraception is recommended during treatment and for at least one month after the last dose.

Hepatic Impairment: Caution is advised in patients with moderate to severe hepatic impairment due to altered metabolism and drug accumulation.

Recent Surgery or Wound Healing Issues: As Tivozanib may interfere with healing, it should be withheld prior to major surgery and resumed only after adequate recovery.

Drug Interactions:

The primary enzyme in charge of tivozanib metabolism is CYP3A4. Its efficacy and safety may change if it is taken concurrently with potent CYP3A4 inducers (like rifampin or carbamazepine) or inhibitors (like ketoconazole or clarithromycin). Before starting therapy, a thorough examination of the patient’s current medication schedule is advised.

Clinical Efficacy:

In patients with advanced RCC who had previously received treatment, Tivozanib showed a statistically significant improvement in progression-free survival (PFS) when compared to sorafenib, another TKI, in the pivotal TIVO-3 trial. Tivozanib has proven to be a useful therapy choice for individuals with RCC who have received a lot of prior treatment because it was also linked to a more manageable adverse effect profile.

Handling and Storage:

The recommended storage temperature for Fotivda capsules is room temperature (20°C to 25°C / 68°F to 77°F), away from light and moisture. Do not use the drug after its expiration date and keep it out of children’s reach.

Conclusion:

Patients with advanced kidney cancer who have tried every other treatment option can benefit from the highly focused drug tivozanib 1.34 mg (Fotivda). For eligible patients with recurrent or refractory RCC, Fotivda remains a mainstay due to its once-daily dosage, strong selectivity for VEGF receptors, and controllable toxicity profile. To maximize therapeutic benefit, as with all oncology treatments, thorough patient selection, monitoring, and side effect control are crucial.

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1. What is the purpose of Tivozanib (Fotivda)?
Tivozanib is used to treat adult patients with advanced renal cell carcinoma (RCC), a kind of kidney cancer, that has relapsed or is refractory. This is especially true for individuals who have had two or more systemic therapies in the past.

2. How does Tivozanib work?
Tivozanib is a tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. These receptors play a key role in the development of blood vessels that supply tumors, and blocking them can slow or stop tumor growth.

3. What is the usual dosage of Tivozanib?
The standard dosage is 1.34 mg orally once daily for 21 consecutive days, followed by a 7-day rest period, making up a 28-day cycle. Until the condition worsens or there is intolerable toxicity, treatment is continued.

4. Is it necessary to take Tivozanib with food?
Tivozanib can be taken with or without food, however in order to maintain stable blood levels, it should be taken at the same time every day.

5. Is it safe to use Tivozanib while pregnant or nursing?
Tivozanib is not advised during pregnancy since it may harm the fetus. Effective contraception should be used by women who are of childbearing age. Breastfeeding during therapy and for at least one month following the last dosage is also discouraged.