- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Concentrate for infusion of dostarlimab.
Carcinoma - endometrium
As monotherapy in adult patients for the treatment of recurrent or advanced endometrial cancer (EC) with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) that has progressed on or following prior treatment with a platinium-containing regimen.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
500mg every 3 weeks for 4 cycles followed by 1000mg every 6 weeks for all cycles thereafter as an intravenous infusion.
Treatment should continue until disease progression or unacceptable toxicity.
For intravenous infusion over 30 minutes.
Children under 18 years
Precautions and Warnings
History of progenitor cell transplantation
Patients over 75 years
Solid organ transplant recipients
End stage renal disease
Moderate hepatic impairment
Severe renal impairment
Administration of live vaccines is not recommended
Confirm dMMR/MSI-H tumour status prior to treatment
Consider use of corticosteroids if adverse reactions occur
Risk of serious transplant-related complications
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function before treatment and regularly during treatment
Monitor thyroid function prior to and periodically during treatment
Monitor for adrenal insufficiency during and after treatment
Monitor for signs and symptoms of colitis
Monitor for signs and symptoms of pneumonitis
Monitor patients for endocrinopathies
Advise patient to seek medical advice if joint aches or pain occur
Advise patient to seek medical advice if severe skin reaction occurs
Interrupt/reduce infusion rate by 50% if grade 2 infusion reaction occurs
Suspend treatment if grade 2 adrenal insufficiency occurs
Suspend treatment if grade 3 adverse reaction occurs
Discontinue if grade 3 or greater adverse reaction that recurs/persists
Discontinue if grade 3 or higher infusion reaction occurs
Discontinue if grade 4 skin reaction occurs
Discontinue permanently if grade 4 colitis occurs
Discontinue treatment if AST/ALT >5 times upper limit of normal
Discontinue treatment if grade 3 or greater nephritis occurs
Discontinue treatment if grade 3 or greater pneumonitis occurs
Discontinue treatment if total bilirubin >3 times upper limit of normal
Suspend treatment if AST/ALT is 3-5 times upper limit of normal
Suspend treatment if grade 2 hypophysitis occurs
Suspend treatment if grade 2 nephritis occurs
Suspend treatment if grade 2 or 3 colitis occurs
Suspend treatment if grade 2 pneumonitis occurs
Suspend treatment if grade 3 hyperthyroidism occurs
Suspend treatment if grade 3 hypothyroidism occurs
Suspend treatment if grade 3 or greater hyperglycaemia occurs
Suspend treatment if total bilirubin between 1.5 and 3 times ULN
Permanently discontinue treatment if grade 4 adverse reactions occur
Female: Contraception required during and for 4 months after treatment
Breastfeeding: Do not breastfeed during & for 4 months after treatment
Advise patient to seek medical advice if adverse reactions occur
Remind patient of importance of carrying Alert Card with them at all times
Upon improvement of immune related reactions to grade 1 or baseline the corticosteroid taper should be initiated and continued for at least 1 month.
To identify tumour status as dMMR/MSI-H a validated testing method such as immunohistochemistry (IHC), polymerase chain reaction (PCR) or next-generation sequencing (NGS) should be used.
Pregnancy and Lactation
Dostarlimab is contraindicated during pregnancy.
The manufacturer does not recommend using dostarlimab during pregnancy.
At the time of writing there is limited published information regarding the use of dostarlimab during pregnancy. Potential risks are unknown, however dostarlimab has the potential to cross the placenta.
Animal studies have shown an increased risk of foetal loss.
Dostarlimab is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using dostarlimab and for at least 4 months after the last dose of dostarlimab.
At the time of writing, it is unknown whether dostarlimab is excreted in breast milk. Dostarlimab is a large protein molecule (molecular weight of around 144,00 Da), therefore the expected amount found in milk is likely to be very low. A risk to neonate cannot be excluded.
Increase of liver transaminases
Interstitial lung disease
Toxic epidermal necrolysis
It is strongly recommend that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Summary of Products Characteristics: Jemperli 500 mg concentrate for solution for infusion. GlaxoSmithKline UK Limited. Revised June 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlmi.nih.gov/books/NBK501922/
Dostarlimab. Last revised: 17 May 2021
Last accessed: 18 February 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.