JEMPERLI- dostarlimab injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOSTARLIMAB (UNII: P0GVQ9A4S5) (DOSTARLIMAB - UNII:P0GVQ9A4S5)

Available from:

GlaxoSmithKline LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H) [see Dosage and Administration ( 2.1)]. JEMPERLI, as a single agent, is indicated for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration ( 2.1)]. JEMPERLI, as a single agent, is indicated for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1)]. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies ( 14.2)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on its mechanism of action, JEMPERLI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on the use of JEMPERLI in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data). Human IgG4 immunoglobulins (IgG4) are known to cross the placental barrier; therefore, dostarlimab-gxly has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Animal reproduction studies have not been conducted with JEMPERLI to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering JEMPERLI during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to dostarlimab-gxly may increase the risk of developing immune-mediated disorders or altering the normal immune response. Risk Summary There is no information regarding the presence of dostarlimab-gxly in human milk or its effects on the breastfed child or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to JEMPERLI are unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose of JEMPERLI. JEMPERLI can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating JEMPERLI [see Use in Specific Populations (8.1)]. Contraception Females: Advise females of reproductive potential to use effective contraception during treatment with JEMPERLI and for 4 months after the last dose. The safety and efficacy of JEMPERLI have not been established in pediatric patients. In Combination with Carboplatin and Paclitaxel Of the 241 patients treated with JEMPERLI in RUBY, 52.3% were younger than 65 years, 36.5% were aged 65 through 75 years, and 11.2% were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients. As a Single Agent Of the 605 patients treated with JEMPERLI in GARNET, 51.6% were younger than 65 years, 36.9% were aged 65 through 75 years, and 11.5% were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Product summary:

JEMPERLI (dostarlimab-gxly) injection is a clear to slightly opalescent, colorless to yellow solution supplied in a carton containing one 500 mg/10 mL (50 mg/mL), single-dose vial (NDC 0173-0898-03). Store vial refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze or shake.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

GlaxoSmithKline LLC
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MEDICATION GUIDE
JEMPERLI (jem-PER-lee)
(dostarlimab-gxly)
injection
What is the most important information I should know about JEMPERLI?
JEMPERLI is a medicine that may treat certain cancers by working with
your immune system.
JEMPERLI can cause your immune system to attack normal organs and
tissues in any area of your body
and can affect the way they work. These problems can sometimes become
severe or life-threatening and
can lead to death. You can have more than one of these problems at the
same time. These problems may
happen anytime during treatment or even after your treatment has
ended.
Call or see your healthcare provider right away if you develop any new
or worsening signs or symptoms,
including:
Lung problems.
•
cough
•
shortness of breath
•
chest pain
Intestinal problems.
•
diarrhea or more bowel movements than usual
•
stools that are black, tarry, sticky, or have blood or mucus
•
severe stomach-area (abdomen) pain or tenderness
Liver problems.
•
yellowing of your skin or the whites of your eyes
•
severe nausea or vomiting
•
pain on the right side of your stomach area (abdomen)
•
dark urine (tea colored)
•
bleeding or bruising more easily
than usual
Hormone gland problems.
•
headaches that will not go away or unusual headaches
•
eye sensitivity to light
•
eye problems
•
urinating more often than usual
•
hair loss
•
feeling cold
•
rapid heartbeat
•
increased sweating
•
extreme tiredness
•
weight gain or weight loss
•
feeling more hungry or thirsty than usual
•
constipation
•
your voice gets deeper
•
dizziness or fainting
•
changes in mood or behavior, such
as decreased sex drive, irritability,
or forgetfulness
Kidney problems.
•
change in the amount or color of your urine
•
blood in your urine
•
swelling in your ankles
•
loss of appetite
Skin problems.
•
rash
•
itching
•
skin blistering or peeling
•
swollen lymph nodes
•
painful sores or ulcers in your
mouth or in your nose, throat, or
genital area
•
f

Summary of Product characteristics

JEMPERLI- DOSTARLIMAB INJECTION
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JEMPERLI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JEMPERLI.
JEMPERLI (DOSTARLIMAB-GXLY) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Indications and Usage (1)
7/2023
Dosage and Administration (2.1, 2.2)
7/2023
Warnings and Precautions, Severe and Fatal Immune-Mediated Adverse
Reactions (5.1)
3/2024
INDICATIONS AND USAGE
JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody
indicated:
Endometrial Cancer (EC)
•
•
Mismatch Repair Deficient Recurrent or Advanced Solid Tumors
•
This indication is approved under accelerated approval based on tumor
response rate and durability of
response. Continued approval for this indication may be contingent
upon verification and description of
clinical benefit in a confirmatory trial(s). (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
in combination with carboplatin and paclitaxel, followed by JEMPERLI
as a single agent for the
treatment of adult patients with primary advanced or recurrent
endometrial cancer that is mismatch
repair deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high
(MSI-H). (1.1, 2.1)
as a single agent for the treatment of adult patients with dMMR
recurrent or advanced endometrial
cancer, as determined by an FDA-approved test, that has progressed on
or following prior treatment
with a platinum-containing regimen in any setting and are not
candidates for curative surgery or
radiation. (1.1, 2.1)
as a single agent for the treatment of adult patients with dMMR
recurrent or advanced solid tumors,
as determined by an FDA-approved test, that have progressed on or
following prior treatment and
who have no satisfactory alternative treatment