Référentiel des médicaments
Tisotumab vedotin
Tisotumab vedotin is a medicine in the class oncology. It is used for cervical cancer.
- Classe médicamenteuse: Oncology
- Indications: cervical cancer
Dernière mise à jour Sources: US FDA label
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L'essentiel
- Classe médicamenteuse
- Oncology
- Code ATC
- L01FX23
- Formes courantes
- injection
- Dosages courants
- 40 mg/4 ml
- Interactions connues
- 7 (Modérée: 7)
- Noms commerciaux
- 2
- Pays et marchés
- 2
Indications
Mécanisme d'action
Tissue factor-directed antibody drug conjugate. The ADC binds TF-expressing cancer cells and is internalized. MMAE is then released by proteolytic cleavage, disrupting the microtubule network and causing cell cycle arrest and apoptotic cell death.
Posologie adulte habituelle (résumé de la notice)
Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy: 2 mg/kg (maximum 200 mg for patients ≥100 kg) IV infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity
Grossesse et allaitement
- Grossesse
- Unsafe Can cause fetal harm: no human data; its MMAE payload caused fetal deaths and malformations in rats below human exposure. Check pregnancy status before starting; contraception during and for 2 months after the last dose (men with female partners: 4 months).
- Allaitement
- Unsafe No human milk data. The antibody is large and poorly absorbed, but the small MMAE payload might reach the infant. Do not breastfeed during treatment and for 3 weeks after the last dose.
Effets indésirables signalés
- Hemoglobin decreased
- Peripheral neuropathy
- Conjunctival adverse reactions
- Nausea
- Fatigue
- Aspartate aminotransferase increased
Mises en garde encadrées
- Ocular toxicity: can cause severe ocular toxicities, including changes in vision, severe vision loss and corneal ulceration. Conduct an ophthalmic exam (symptoms, visual acuity, slit lamp exam) before starting, before every cycle for the first nine cycles, and as clinically indicated. Adhere to required premedication and eye care. Withhold until improvement, then resume, reduce the dose, or permanently discontinue based on severity.
Précautions particulières
- Severe ocular adverse reactions (conjunctivitis, keratopathy, dry eye) occurred in 55% of patients; eye exams and eye care are required.
- Peripheral neuropathy occurred in 39% of patients; monitor and withhold, reduce or discontinue based on severity.
- Hemorrhage occurred in 51% of patients; permanently discontinue for pulmonary or CNS hemorrhage.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (7)
- Chloramphenicol + Tisotumab vedotin Moderate
- Clarithromycin + Tisotumab vedotin Moderate
- Itraconazole + Tisotumab vedotin Moderate
- Ketoconazole + Tisotumab vedotin Moderate
- Mifepristone + Tisotumab vedotin Moderate
- Posaconazole + Tisotumab vedotin Moderate
- Tisotumab vedotin + Voriconazole Moderate
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- IV preparation and dilution
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Questions fréquentes
What is Tisotumab vedotin used for?
Tisotumab vedotin is a medicine in the class oncology. It is used for Cervical cancer.
What side effects have been reported with Tisotumab vedotin?
Hemoglobin decreased, Peripheral neuropathy, Conjunctival adverse reactions, Nausea, Fatigue, Aspartate aminotransferase increased. Serious warning: Ocular toxicity: can cause severe ocular toxicities, including changes in vision, severe vision loss and corneal ulceration.
Can Tisotumab vedotin be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. Can cause fetal harm: no human data; its MMAE payload caused fetal deaths and malformations in rats below human exposure. Check pregnancy status before starting; contraception during and for 2 months after the last dose (men with female partners: 4 months). Breastfeeding: Unsafe. No human milk data. The antibody is large and poorly absorbed, but the small MMAE payload might reach the infant. Do not breastfeed during treatment and for 3 weeks after the last dose.
What does Tisotumab vedotin interact with?
MediHelp lists 7 known interactions for Tisotumab vedotin. Moderate: 7. The most serious include Chloramphenicol, Clarithromycin, Itraconazole.
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