What are the precautions for Tisotumab vedotin-tftv?

In Vitin-Tisotumab In clinical studies of vedotin-tftv) , warnings and precautions such as ocular adverse reactions, peripheral neuropathy, hemorrhage, pneumonia, severe skin adverse reactions, embryo-fetal toxicity, etc. have occurred. According to the severity of the disease, the administration needs to be suspended, and then the dose should be reduced or permanently discontinued. Vedotin-tisotumab.

1. Ocular adverse reactions: In clinical trials, the most common ocular adverse reactions are conjunctival adverse reactions, dry eye, corneal adverse reactions and blepharitis. One patient developed a perforated ulcerative keratitis requiring corneal transplantation. Cases of symblepharon have been reported in patients with other tumor types treated with Vitin-Tisotuzumab at recommended doses, with a median time to first ocular adverse reaction of 1.2 months.

Refer patients to an ophthalmologist for ophthalmic examination, including visual acuity and slit lamp examination, at baseline examination, prior to each dose, and as clinically indicated. Adhere to preoperative medication and necessary eye care to reduce the risk of adverse ocular reactions. For any new or worsening ocular signs and symptoms, refer the patient immediately to a specialist

2. Peripheral neuropathy: including peripheral neuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, motor neuropathy, myasthenia and demyelinating peripheral polyneuropathy. A patient with another tumor type developed Guillain-Barre syndrome after treatment with Vistin-tisotuzumab at the recommended dose. The median time to onset of peripheral neuropathy was 2.4 months. Monitor patients for signs and symptoms of neuropathy, such as paresthesias, tingling or burning sensations, neuropathic pain, muscle weakness, or paresthesia.

3. Bleeding: The most common adverse reactions of all levels of bleeding are epistaxis, hematuria and vaginal bleeding. The median time to bleeding onset is 0.3 months. Monitor patients for signs and symptoms of bleeding and permanently discontinue Vitin-Tisotuzumab in patients who develop pulmonary or central nervous system bleeding. For grade 2 or higher bleeding at any other site, treatment should be withheld until the bleeding subsides, the hemoglobin is stable, there are no bleeding factors that may increase the risk of continued treatment, and there are no anatomic or pathological conditions that may increase the risk of recurrence of bleeding.

4. Pneumonitis: Patients treated with antibody-drug conjugates containing vedotin (including vetin-tisotumab) may develop severe, life-threatening or fatal pneumonia. Of cervical cancer patients treated with Vitin-tisotuzumab in clinical trials, Pneumonitis occurred in 2 patients (1.3%), including 1 patient who died. Monitor patients for the development of pulmonary symptoms of pneumonia. On radiologic examination, symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates. Infectious, neoplastic, and other causes of such symptoms should be ruled out by appropriate investigations.

5. Serious skin adverse reactions: Monitor patients for signs or symptoms of serious skin adverse reactions, including target lesions, worsening skin reactions, skin blistering or peeling, pain in the mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes. If signs or symptoms of a serious adverse cutaneous reaction occur, Vietin-tisotuzumab should be discontinued until the cause of the reaction is determined.

6. Embryo-Fetal Toxicity: Based on the mechanism of action and findings in animals, when Vitin-Tisotuzumab is administered to pregnant women, it can cause fetal damage. Administration of the small molecule component of MMAE tiv dak to rats resulted in adverse developmental outcomes, including embryo-fetal death and structural abnormalities, at exposures below clinically occurring levels at recommended doses. Advise females of reproductive potential to use effective contraception during treatment with Vitin-Tisotuzumab and for 2 months after the last dose. It is recommended that male patients with a female partner of reproductive potential use effective contraception during treatment with Vistin-Tisotuzumab and for 4 months after the last dose.

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.