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Tisotumab vedotin

Tisotumab vedotin is a medicine in the class oncology. It is used for cervical cancer.

Ultimo aggiornamento Fonti: US FDA label

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In breve

Classe del farmaco
Oncology
Codice ATC
L01FX23
Forme farmaceutiche comuni
iniezione
Dosaggi comuni
40 mg/4 ml
Interazioni note
7 (Moderata: 7)
Nomi commerciali
2
Paesi e mercati
2

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Per cosa si usa

Come agisce

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.

Dose abituale nell'adulto (sintesi del foglio illustrativo)

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

Sintesi del foglio illustrativo limitata alla prima riga di posologia; le sezioni complete sulla posologia sono nell'app.

Gravidanza e allattamento

Gravidanza
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).
Allattamento
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.

Effetti indesiderati segnalati

  • Hemoglobin decreased
  • Peripheral neuropathy
  • Conjunctival adverse reactions
  • Nausea
  • Fatigue
  • Aspartate aminotransferase increased

Avvertenze in evidenza

  • 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.

Chi deve prestare attenzione

  • 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.

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Interazioni principali (7)

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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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Domande frequenti

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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