JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML [SIN16623P]

Product Info

JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML

[SIN16623P]

Indications

Endometrial cancer

JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.

JEMPERLI is indicated as monotherapy for the treatment of adult patients with recurrent or advanced dMMR/MSI-H endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

Dosage and Administration

Pharmaceutical Form

Concentrate for solution for infusion.

Posology

JEMPERLI in combination with carboplatin and paclitaxel

When JEMPERLI is administered in combination with carboplatin and paclitaxel, refer to the full Prescribing Information for the combination products (see also Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The recommended dose as combination therapy is 500 mg dostarlimab administered as an intravenous infusion over 30 minutes every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for all cycles thereafter.

The dosage regimen in combination with carboplatin and paclitaxel is presented in Table 1.

Administration of JEMPERLI should continue according to the recommended dose and schedule until disease progression or unacceptable toxicity, or for a duration of up to 3 years (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

JEMPERLI monotherapy

The recommended dose as monotherapy is 500 mg dostarlimab administered as an intravenous infusion over 30 minutes every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter.

The dosage regimen as monotherapy is presented in Table 2.

Administration of JEMPERLI should continue according to the recommended dose and schedule until disease progression or unacceptable toxicity.

Dose modifications
Dose reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Recommended modifications to manage adverse reactions are provided in Table 3.

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

Method of Administration

JEMPERLI is for intravenous infusion only. JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes.

JEMPERLI must not be administered as an intravenous push or bolus injection.

For instructions on dilution of the medicinal product before administration, see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Children

The safety and efficacy of JEMPERLI in children and adolescents aged under 18 years have not been established. No data are available.

Elderly

No dose adjustment is recommended for patients who are 65 years of age or over. There are limited clinical data with JEMPERLI in patients 75 years of age or over.

Renal impairment

No dose adjustment is recommended for patients with mild or moderate renal impairment. There are limited data in patients with severe renal impairment or end-stage renal disease undergoing dialysis (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is recommended for patients with mild hepatic impairment. There are limited data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).