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JEMPERLI is a brand name for Dostarlimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: JEMPERLI is indicated in combination with platinum-containing chemotherapy for the treatment of adult patients with 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 mismatch repair deficient…
Verbatim from this product's MHRA label. Tap a section to expand.
Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. 1 for information on assays used in the studies). *IHC=immunohistochemistry; PCR=polymerase chain reaction; NGS=next-generation sequencing.
1). The recommended dose as combination therapy is 500 mg dostarlimab every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for all cycles thereafter. The dosage regimen in combination with chemotherapy is presented in Table 1.
Table 1. Dosage regimen for JEMPERLI in combination with chemotherapy 500 mg once every 3 weeks in combination with chemotherapya (1 Cycle = 3 weeks) 1000 mg once every 6 weeks until disease progression or unacceptable toxicity (1 Cycle = 6 weeks) Cycl e Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6 Cycle 7 Cycle 8 Cycle 9 Wee k 1 4 7 10 13 16 19 25 31 3 weeks between Cycle 6 and Cycle 7 a Administer dostarlimab prior to chemotherapy on the same day.
1). JEMPERLI monotherapy 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 as monotherapy is presented in Table 2. Table 2.
1). 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 section
Summary of the safety profile Dostarlimab is most commonly associated with immune-related adverse reactions. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of dostarlimab (see “Description of selected adverse reactions” below).
Dostarlimab in monotherapy The safety of dostarlimab has been evaluated in 605 patients with EC or other advanced solid tumours who received dostarlimab monotherapy in the GARNET study, including 153 patients with advanced or recurrent dMMR/MSI-H EC.
Patients received doses of 500 mg every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter. 2 %). 3 %) patients; most of them were immune-related events. 4). The safety profile for patients with dMMR/MSI-H EC in the GARNET study (N=153) was not different from that of the overall monotherapy population presented in Table 4.
Dostarlimab in combination with chemotherapy The safety of dostarlimab has been evaluated in 241 patients with primary advanced or recurrent EC who received dostarlimab in combination with paclitaxel and carboplatin in the RUBY study.
Patients received doses of 500 mg dostarlimab every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for all cycles thereafter. 0 %). 0 %) patients; most were immune-related events. 4). Tabulated list of adverse reactions Adverse reactions reported in clinical trials of dostarlimab as a monotherapy or in combination with chemotherapy are listed in Table 4 by system organ class and by frequency.
Unless otherwise stated, the frequencies of adverse reactions listed in the dostarlimab monotherapy column are based on all-cause adverse event frequency identified in 605 patients with advanced or recurrent solid tumours from the GARNET study exposed to dostarlimab monotherapy for a median duration of treatment of 24 weeks (range: 1 week to 229 weeks).
4. Table 3. Recommended dose modifications for JEMPERLI Immune-related adverse reactions Severity gradea Dose modification 2 or 3 Withhold dose. Colitis 4 Permanently discontinue. 5 and up to 3 × ULN Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.
Table 3. Recommended dose modifications for JEMPERLI Immune-related adverse reactions Severity gradea Dose modification Grade ≥ 3 with AST or ALT > 5 × ULN or total bilirubin > 3 × ULN Permanently discontinue (see exception below)e.
Type 1 diabetes mellitus (T1DM) 3 or 4 (hyperglycaemia) Withhold dose. Restart dosing in appropriately managed, clinically and metabolically stable patients. Hypophysitis or adrenal insufficiency 2, 3 or 4 Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.
Permanently discontinue for recurrence or worsening while on adequate hormonal therapy. Hypothyroidism or hyperthyroidism 3 or 4 Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1. 2 Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1.
If grade 2 recurs, permanently discontinue. Pneumonitis 3 or 4 Permanently discontinue. 2 Withhold dose. Nephritis 3 or 4 Permanently discontinue. Suspected Withhold dose for any grade. Restart dosing if not confirmed and when toxicity resolves to grade 0 or 1.
g. SJSf, TENg, DRESSh) Confirmed Permanently discontinue. Myocarditis 2, 3 or 4 Permanently discontinue. Table 3. Recommended dose modifications for JEMPERLI Immune-related adverse reactions Severity gradea Dose modification Severe neurological toxicities (myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, encephalitis, transverse myelitis) 2, 3 or 4 Permanently discontinue.
3 Withhold dose. Restart dosing when toxicity resolves to grade 0 or 1. Other immune-related adverse reactions (including but not limited to myositis, sarcoidosis, autoimmune haemolytic anaemia, pancreatitis, iridocyclitis, uveitis, diabetic ketoacidosis, arthralgia, solid organ transplant rejection, graft- versus-host disease) 4 Permanently discontinue.
1.
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6 weeks). For additional safety information when dostarlimab is administered in combination, refer to the respective Prescribing Information for the combination products. Adverse reactions known to occur with dostarlimab as monotherapy or combination therapy components given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical studies with combination therapy.
These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); and not known (cannot be estimated from the available data).
Table 4:
Adverse reactions in patients treated with dostarlimab System Organ Class Dostarlimab monotherapy Dostarlimab in combination therapy Blood and lymphatic system disorders Very common Anaemiaa Endocrine disorders Very common Hypothyroidism*b Common Hyperthyroidism*, adrenal insufficiency* Uncommon Thyroiditis*c, hypophysitisd Very common Hypothyroidisme Common Hyperthyroidism Uncommon Thyroiditis, adrenal insufficiency Metabolism and nutrition disorders Uncommon Type 1 diabetes mellitus, diabetic ketoacidosis Uncommon Type 1 diabetes mellitus Nervous system disorders Uncommon Encephalitis, myasthenia gravis Uncommon Myasthenic syndrome†, Guillain-Barré syndrome†f Eye disorders Uncommon Uveitisg Uncommon Uveitis Cardiac disorders Uncommon Myocarditis†h Respiratory, thoracic and mediastinal disorders Common Pneumonitis*i Common Pneumonitis Gastrointestinal disorders Very common Diarrhoea, nausea, vomiting Common Colitis*j, pancreatitisk, gastritis Uncommon Oesophagitis Common Colitis†l , pancreatitis Uncommon Immune mediated gastritis†, vasculitis gastrointestinal† Hepatobiliary disorders Common Hepatitis*m Skin and subcutaneous tissue disorders Very common Rash*n, pruritus Uncommon Stevens-Johnson syndrome† Very common Rasho, dry skin Musculoskeletal and connective tissue disorders Very common Arthralgia* Common Myalgia Uncommon Immune-mediated arthritis, polymyalgia Uncommon Immune-mediated arthritis, myositis† System Organ Class Dostarlimab monotherapy Dostarlimab in combination therapy rheumatica, immune- mediated myositis Renal and urinary disorders Uncommon Nephritis*p General disorders and administration site conditions Very common Pyrexia Common Chills Very common Pyrexia Uncommon Systemic inflammatory response syndrome† Investigations Very common Transaminases increasedq Very common Alanine aminotransferase increased, aspartate aminotransferase increased Injury, […]
Recurrence of immune-related adverse reactions after resolution to ≤ grade 1 (except for pneumonitis, see above) 3 or 4 Permanently discontinue. Other adverse reactions Severity gradea Dose modification 2 Withhold dose. If resolved within 1 hour of stopping, may be restarted at 50 % of the original infusion rate, or restart when symptoms resolve with pre-medication.
If grade 2 recurs with adequate premedication, permanently discontinue. Infusion-related reactions 3 or 4 Permanently discontinue. 0. b AST = aspartate aminotransferase c ALT = alanine aminotransferase d ULN = upper limit of normal e For patients with liver metastases who begin treatment with grade 2 increase of AST or ALT, if AST or ALT increases by ≥ 50 % relative to baseline and lasts for at least 1 week, then treatment should be discontinued f SJS = Stevens-Johnson syndrome g TEN = toxic epidermal necrolysis h DRESS = drug reaction with eosinophilia and systemic symptoms.
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. 1). Renal impairment No dose adjustment is recommended for patients with mild or moderate renal impairment. 2). Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment.
2). 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. 6. 1. 4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Immune-related adverse reactions Immune-related adverse reactions, which may be severe or fatal, can occur in patients treated with antibodies blocking the programmed cell death protein-1 / programmed death-ligand 1 (PD-1/PD-L1) pathway, including dostarlimab.
While immune-related adverse reactions usually occur during treatment with PD-1/PD-L1 blocking antibodies, symptoms can also manifest after discontinuation of treatment. Immune-related adverse reactions may occur in any organ or tissue and may affect more than one body system simultaneously.
Important immune-related adverse reactions listed in this section are not inclusive of all possible severe and fatal immune-related reactions. Early identification and management of immune-related adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.
Patients should be monitored for symptoms and […]