Opdualag Injection Dosage

Generic name: NIVOLUMAB 12mg in 1mL, RELATLIMAB 4mg in 1mL
Dosage form: injection
Drug class: Antineoplastic combinations

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

Recommended Dosage

The recommended dosage of OPDUALAG for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

The recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see Use in Specific Populations (8.4)].

Dosage Modifications

No dose reduction for OPDUALAG is recommended. In general, withhold OPDUALAG for severe (Grade 3) immune-mediated adverse reactions (IMARs). Permanently discontinue OPDUALAG for life-threatening (Grade 4) IMARs, recurrent severe (Grade 3) IMARs that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for adverse reactions that require management different from these general guidelines are summarized in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
* Based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0. a Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids. b Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved. ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
Adverse Reaction	Severity*	Dose Modification
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis	Grade 2	Withholda
	Grade 3 or 4	Permanently discontinue
Colitis	Grade 2 or 3	Withholda
	Grade 4	Permanently discontinue
Hepatitis	AST/ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN.	Withholda
	AST or ALT increases to more than 8 times ULN regardless of baseline. or Total bilirubin increases to more than 3 times ULN.	Permanently discontinue
Endocrinopathiesb	Grade 3 or 4	Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction	Grade 2 or 3 increased blood creatinine	Withholda
	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis	Grade 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withholda
	Grade 3 or 4	Permanently discontinue
Other Adverse Reactions
Infusion-Related Reactions [see Warnings and Precautions (5.2)]	Grade 1 or 2	Interrupt or slow the rate of infusion
	Grade 3 or 4	Permanently discontinue

Preparation and Administration

OPDUALAG is a fixed-dose combination of nivolumab and relatlimab.

Visually inspect the solution in the drug product vial for particulate matter and discoloration prior to administration. OPDUALAG is a clear to opalescent, colorless to slightly yellow solution. Discard the vial if the solution is cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white particles.

Preparation

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During preparation of the infusion solution, use aseptic technique to assure sterility, as the product does not contain a preservative.

•

OPDUALAG can be administered diluted or undiluted and administered at a final concentration as specified in Table 2 below.

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Withdraw the required volume of OPDUALAG and transfer into an intravenous container. OPDUALAG is compatible with di(2-ethylhexyl)phthalate (DEHP)-plasticized polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), and polyolefin (PO) intravenous bags.

•

If diluting OPDUALAG prior to administration:

-: Dilute OPDUALAG solution with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare an infusion meeting the final concentration and maximum infusion volume parameters as specified in Table 2 below.
-: Then mix the diluted solution by gentle inversion. Do not shake.

•

Discard partially used vials or empty vials following infusion preparation.

Table 2: Maximum Infusion Volumes and Concentration Ranges by Patient Group
* The concentration range in each group includes 12 mg/mL nivolumab and 4 mg/mL relatlimab as the upper limit, which represents a scenario in which the drug product is infused without dilution.
Patient Group	Maximum Infusion Volume (mL or mL/kg)	Concentration Range (mg/mL)*
Adult patients who weigh at least 40 kg and pediatric patients 12 years of age or older who weigh at least 40 kg	160 mL	Nivolumab: 3 mg/mL to 12 mg/mL Relatlimab: 1 mg/mL to 4 mg/mL
Adult patients who weigh less than 40 kg	4 mL/kg	Nivolumab: 3 mg/mL to 12 mg/mL Relatlimab: 1 mg/mL to 4 mg/mL

Storage of Prepared Solution

Store the prepared solution either:

•: at room temperature and room light for no more than 8 hours from the time of preparation to the end of the infusion. Discard the prepared solution if not used within 8 hours from the time of preparation;

-or-

: under refrigeration at 2°C to 8°C (36°F to 46°F) with protection from light for no more than 24 hours from the time of preparation, which includes the time allowed for equilibration of the infusion bag to room temperature and the duration of the infusion. Discard the prepared solution if not used within 24 hours from the time of preparation.

Do not freeze.

Administration

•: Administer the infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line polyethersulfone (PES), nylon, or polyvinylidene fluoride (PVDF) filter (pore size of 0.2 micrometer to 1.2 micrometer).
•: Flush the intravenous line at the end of the infusion.
•: Do not coadminister other drugs through the same intravenous line.