Instructions for Tisotumab vedotin-tftv

1. Name: Vedotin-tisotumab, tisotumab vedotin-tftv, tisotumab, Tivdak

2. Indications: Vetin-Tisotumab vedotin-tftv is suitable for the treatment of adult patients with recurrent or metastatic cervical cancer who have disease progression during or after chemotherapy.

3. Usage and dosage:

1. Before use: Follow the prescription information recommendations to reduce the risk of adverse eye reactions.

(1) Ophthalmic examination: Perform an ophthalmic examination, including visual acuity and slit lamp examination at baseline, prior to each dose, as clinically indicated.

(2) Topical Corticosteroid Eye Drops: The initial prescription and all updates of any corticosteroid medication should be made only after examination with a slit lamp. Place the first drop in each eye before each infusion. Instruct patients to continue using prescribed eye drops in each eye for 72 hours after each infusion.

(3) Topical Ocular Vasoconstrictor Drops: Administer in each eye immediately before each infusion.

(4) Ice packs: Use a cooling eye patch during infusion of vitin-tisolutumab.

(5) Topical lubricating eye drops: Instruct patients to use during treatment and within 30 days after the last dose of Vistin-tisolutumab

(6) Contact Lenses: Patients are advised to avoid wearing contact lenses unless their ophthalmologist recommends wearing them throughout treatment.

2. Recommended dose: The recommended dose of Vietin-tisotuzumab is 2 mg/kg. The maximum dose for patients ≥100kg is 200mg. Intravenous infusion for 30 minutes every 3 weeks until disease progression or unacceptable toxicity occurs.

3. Dosage adjustment: If the patient experiences adverse reactions and other uncomfortable symptoms after use, the drug dosage should be adjusted under the guidance of a doctor. Vitin-TisotuzumabThe first dose was reduced to 1.3mg/kg, and the second dose was reduced to 0.9mg/kg; patients who could not tolerate 0.9mg/kg were permanently discontinued.

4. Adverse reactions:

In clinical studies of Vitin-tisotuzumab, the most common (≥25%) adverse reactions (including laboratory abnormalities) included hemoglobinemia, fatigue, lymphopenia, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, leukopenia Hypotension, increased creatinine, dry eye, increased prothrombin international normalized ratio, prolonged activated partial thromboplastin time, diarrhea and rash; the most common (≥3%) serious adverse reactions are intestinal obstruction, bleeding, pneumonia, peripheral neuropathy, sepsis, constipation and pyrexia; fatal adverse reactions include septic shock, pneumonia, sudden death and multisystem organ failure.

5. Storage:

Vitin-Tisotuzumab will be refrigerated in the original carton at 2°C to 8°C (36°F to 46°F) to protect from light; do not freeze; do not shake.

6. Special groups:

1. Women: Based on the mechanism of action and findings in animals, Vietin-tisotumab can cause fetal damage when administered to pregnant women. Therefore, it is recommended that lactating women use Vietin-tisotumab during treatment and after the last dose pan>Do not breastfeed for 3 weeks; advise females of reproductive potential to use effective contraception during treatment with Vitin-Tisotuzumab and for 2 months after the last dose.

2. Men: According to the results of animal studies, Vietin-tisotumab may impair male fertility. Therefore, male patients with female partners of reproductive potential are recommended to use effective contraceptive measures during treatment with Vitin-tisotumab and within 4 months after the last dose.

3. Liver function impairment: Avoid use in patients with moderate or severe liver function impairment (total bilirubin >1.5×ULN).

7. Mechanism of action:

Vitin-Tisotuzumab is a tissue factor (TF)-directed antibody drug conjugate (ADC) that is human IgG1 directed against cell surface TF. TF is the main initiator of the extrinsic coagulation cascade. The small molecule MMAE is a microtubule-disrupting agent that is attached to the antibody via a protease-cleavable linker. Non-clinical data suggest that the anticancer activity of Vitin-Tesotuzumab is due to binding of ADC to TF-expressing cancer cells, subsequent internalization of the ADC-TF complex, and release of MMAE through proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro,Vitin-Tisotuzumab also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

Vitin-TisotumabThe original drug has not yet been marketed in China, so it cannot be included in medical insurance. The original drugs marketed overseas are very expensive. The price of each box of 40 mg/vial may be around RMB 90,000 (the price may fluctuate due to the exchange rate). Currently, there is no generic version of Vitin-Tisotuzumab on the market. For more drug information and specific prices, please consult the medical consultant of the drug.