OPDUALAG- nivolumab and relatlimab-rmbw injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NIVOLUMAB (UNII: 31YO63LBSN) (NIVOLUMAB - UNII:31YO63LBSN), RELATLIMAB (UNII: AF75XOF6W3) (RELATLIMAB - UNII:AF75XOF6W3)

Available from:

E.R. Squibb & Sons, L.L.C.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. None.       Risk Summary Based on findings in animals and mechanism of action, OPDUALAG can cause fetal harm when administered to a pregnant woman. Administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see Data ). Human IgG4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. The effects of OPDUALAG are likely to be greater during the second and third trimesters of pregnancy. There are no available data on OPDUALAG in pregnant women to evaluate a drug-associated risk. Advise the patient 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 OPDUALAG injection for intravenous use contains nivolumab and relatlimab [see Description (11)] . Nivolumab: One function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. The effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on AUC). Nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. In surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. Relatlimab: There are no available animal data on relatlimab. The effects of a murine surrogate anti-LAG-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. When anti-LAG-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. Risk Summary There are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with OPDUALAG and for at least 5 months after the last dose [see Pharmacokinetics (12.3)] . OPDUALAG can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating OPDUALAG [see Use in Specific Populations (8.1)] . Contraception Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of OPDUALAG [see Clinical Pharmacology (12.3)] . The safety and effectiveness of OPDUALAG for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. Use of OPDUALAG for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. The pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). A recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)] . The safety and effectiveness of OPDUALAG have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. Of the 355 patients treated with OPDUALAG in RELATIVITY-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. No overall differences in safety or effectiveness were observed between elderly patients and younger patients.

Product summary:

OPDUALAG (nivolumab and relatlimab-rmbw) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for intravenous use supplied in a single-dose vial containing 240 mg of nivolumab and 80 mg of relatlimab per 20 mL (12 mg and 4 mg per mL) per carton (NDC 0003-7125-11). Store OPDUALAG refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

E.R. Squibb & Sons, L.L.C.
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MEDICATION GUIDE
MEDICATION GUIDE
OPDUALAG™ (op-DEW-uh-lag)
(nivolumab and relatlimab-rmbw)
injection
What is the most important information I should know about OPDUALAG?
OPDUALAG is a medicine that may treat a type of skin cancer called
melanoma by working with your
immune system. OPDUALAG 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
can lead to death. These problems may happen anytime during treatment
or even after your treatment has
ended. You may have more than one of these problems at the same time.
Call or see your healthcare provider right away if you develop any new
or worse signs of symptoms,
including:
Lung problems.
•
new or worsening cough
•
shortness of breath
•
chest pain
Intestinal problems.
•
diarrhea (loose stools) or more frequent bowel movements than usual
•
stool that are black, tarry, sticky, or have blood or mucus
•
severe stomach-area (abdominal) 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
normal
Hormone gland problems.
•
headaches that will not go away or unusual
•
urinating more often than usual
headaches
•
eye sensitivity to light
•
eye problems
•
rapid heartbeat
•
increased sweating
•
extreme tiredness
•
weight gain or weight loss
•
feeling more hungry or thirsty than usual
•
hair loss
•
feeling cold
•
constipation
•
your voice gets deeper
•
dizziness or fainting
•
changes in mood or behavior, such as
decreased sex drive, irritability, or
forgetfulness
Kidney problems.
•
decrease in your amount of urine
•
blood in your urine
•
swelling in your ankles
•
loss of appetite
Skin problems.
•
rash
•
itching
•
skin blistering or peeling
•
painful sore or ulcers in mouth or no

Summary of Product characteristics

OPDUALAG- NIVOLUMAB AND RELATLIMAB-RMBW INJECTION
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPDUALAG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPDUALAG.
OPDUALAG™ (NIVOLUMAB AND RELATLIMAB-RMBW) INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2022
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
3/2024
INDICATIONS AND USAGE
OPDUALAG is a combination of nivolumab, a programmed death receptor-1
(PD-1) blocking antibody, and
relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody,
indicated for the treatment of adult
and pediatric patients 12 years of age or older with unresectable or
metastatic melanoma. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are musculoskeletal pain,
fatigue, rash, pruritus, and
diarrhea. (6.1)
The most common laboratory abnormalities (≥20%) are decreased
hemoglobin, decreased lymphocytes,
increased AST, increased ALT, and decreased sodium. (6.1)
Adult patients and pediatric patients 12 years of age or older who
weigh at least 40 kg: 480 mg
nivolumab and 160 mg relatlimab intravenously every 4 weeks. (2)
Administer OPDUALAG as an intravenous infusion over 30 minutes. (2)
See full Prescribing Information for dosage modifications for adverse
reactions (2.2) and preparation
and administration instructions for the injection (2.3).
Injection: 240 mg of nivolumab and 80 mg of relatlimab per 20 mL (12
mg and 4 mg per mL) in a
single-dose vial. (3)
None. (4)
Immune-Mediated Adverse Reactions: (5.1)
o
o
o
Immune-mediated adverse reactions, which may be severe or fatal, can
occur in any organ
system or tissue, including the following: immune-mediated
pneumonitis, immune-mediated
colitis, immune-mediated hepatitis, immune-mediated endocrinopathies,
immune-mediated
dermatologic adverse reactions, immune-mediated