TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML [SIN17089P]

Product Info

TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML

[SIN17089P]

4.1 Therapeutic indications

Non-small cell lung cancer (NSCLC)

TEVIMBRA in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:

• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or

• metastatic NSCLC.

TEVIMBRA in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:

• locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or

• metastatic NSCLC.

TEVIMBRA as monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy.

Esophageal squamous cell carcinoma (ESCC)

TEVIMBRA as monotherapy is indicated for the treatment of patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy.

4.2 Posology and method of administration

Tevimbra treatment must be initiated and supervised by physicians experienced in the treatment of cancer.

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 Package Leaflet 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.

Dose delay or discontinuation (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
No dose reductions of Tevimbra as monotherapy or in combination therapy are recommended.
Tevimbra should be withheld or discontinued as described in Table 1.

Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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 section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.