Tevimbra Dosage/Direction for Use

Tevimbra treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Posology: The recommended dose of Tevimbra is 200 mg administered by intravenous infusion once every 3 weeks.
Duration of treatment: Patients should be treated with Tevimbra until disease progression or unacceptable toxicity.
Dose delay or discontinuation (see also Precautions): No dose reductions of Tevimbra as monotherapy are recommended. Tevimbra should be withheld or discontinued as described in Table 2. (See Table 2.)
Detailed guidelines for the management of immune-related adverse reactions are described in Precautions.

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Special populations: Paediatric population: The safety and efficacy of Tevimbra in patients aged below 18 years have not been established. No data are available.
Elderly: No dose adjustment is needed for patients aged ≥65 years (see Adverse Reactions).
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to make dosing recommendations for this population (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is needed for patients with mild or moderate hepatic impairment. Data from patients with severe hepatic impairment are too limited to make dosing recommendations for this population (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Tevimbra is for intravenous use only. It is to be administered as an infusion and must not be administered as an intravenous push or single bolus injection. For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
The first infusion should be administered over a period of 60 minutes. If this is well tolerated, the subsequent infusions may be administered over a period of 30 minutes. The infusion should be given via an intravenous line containing a sterile, non-pyrogenic, low-protein-binding 0.2 or 0.22 micron in-line or add-on filter.
Other medicinal products must not be mixed or co-administered through the same infusion line.