Active Ingredient: Tisotumab vedotin
Tisotumab vedotin as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 2 milligrams tisotumab vedotin per kilogram of body weight, once every 3 weeks.
The recommended dose of tisotumab vedotin is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) every 3 weeks until disease progression or unacceptable toxicity.
The recommended tisotumab vedotin dose reduction schedule is provided in Table 1. Tisotumab vedotin should be permanently discontinued in patients who cannot tolerate 0.9 mg/kg.
Table 1. Dose reduction schedule:
| Dose level | |
|---|---|
| Starting dose | 2 mg/kg (up to maximum of 200 mg) |
| First dose reduction | 1.3 mg/kg (up to maximum of 130 mg) |
| Second dose reduction | 0.9 mg/kg (up to maximum of 90 mg) |
If a planned dose of tisotumab vedotin is missed, it should be administered as soon as possible. The scheduling of administration should be adjusted to maintain the appropriate interval between doses.
Patients should adhere to the following recommendations to reduce the risk of ocular adverse reactions.
Prior to each infusion, the treating healthcare provider should inspect the patient’s eyes, including control of normal eye movement, and ask about any ocular signs or symptoms. The patient should be referred to an eye care professional for any ocular signs or symptoms.
Patients should be instructed to administer 1 drop in each eye 3 times daily starting 1 day prior to each infusion and to continue to administer as prescribed for 3 days after each infusion.
Drops should be administered in each eye immediately prior to each infusion.
Following administration of eye drops, cooling eye pads should be applied prior to the start of the infusion and used during and for 30 minutes after the infusion.
Patients should be instructed to administer lubricating eye drops multiple times every day throughout treatment and for 30 days after the last dose of tisotumab vedotin.
Patients should be advised to avoid wearing contact lenses for the entire duration of therapy unless advised by their eye care professional.
Tisotumab vedotin is for intravenous use. The recommended dose must be administered by intravenous infusion over 30 minutes. Tisotumab vedotin must not be administered as an intravenous push or bolus injection.
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