Jemperli Dosage/Direction for Use

Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
The identification of dMMR/MSI-H tumour status should be determined using a validated testing method such as IHC, PCR or NGS* (see Pharmacology: Pharmacodynamics under Actions for information on assays used in the studies).
*IHC=immunohistochemistry; PCR=polymerase chain reaction; NGS=next-generation sequencing.
Posology: The recommended dose as monotherapy is 500 mg dostarlimab every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter.
The dosage regimen is presented in Table 2. (See Table 2.)

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Administration of dostarlimab should continue according to the recommended schedule until disease progression or unacceptable toxicity (see Pharmacology: Pharmacodynamics under Actions).
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. (See Table 3.)
Detailed guidelines for the management of immune-related adverse reactions and infusion-related reactions are described in Precautions.

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Patient Card: All prescribers of JEMPERLI should inform patients about the Patient Card, explaining what to do should they experience any symptom of immune-related adverse reactions. The physician will provide the Patient Card to each patient.
Special populations: Elderly: No dose adjustment is recommended for patients who are aged 65 years or over.
There are limited clinical data with dostarlimab in patients aged 75 years or over (see Pharmacology: Pharmacodynamics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of JEMPERLI in children and adolescents aged under 18 years have not been established. No data are available.
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 Special precautions for disposal and other handling under Cautions for Usage.