Tevimbra Dosage/Direction for Use

Tevimbra treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
PD-L1 testing: If specified in the indication, patient selection for treatment with Tevimbra based on the tumour expression of PD-L1 should be assessed by a CE-marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used (see Indications/Uses, Precautions, and Pharmacology: Pharmacodynamics under Actions).
Posology: Tevimbra monotherapy: The recommended dose of Tevimbra is 200 mg administered by intravenous infusion once every 3 weeks.
Tevimbra combination therapy: The recommended dose of Tevimbra is 200 mg administered by intravenous infusion once every 3 weeks, in combination with chemotherapy.
When Tevimbra and chemotherapy are administered on the same day, Tevimbra should be administered before chemotherapy. The Summary of Product Characteristics (SmPC) for the chemotherapy product should be referred to for dosing as well as for recommendations on corticosteroid use as pre-medication for the prevention of chemotherapy-related adverse reactions.
Duration of treatment: Patients should be treated with Tevimbra until disease progression or unacceptable toxicity (see Pharmacology: Pharmacodynamics under Actions).
Dose delay or discontinuation (see also Precautions): Dose reductions of Tevimbra as monotherapy or in combination therapy are not recommended. Tevimbra should be withheld or discontinued based on safety and tolerability as described in Table 8. (See Table 8.)
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.