Opdualag

Generic Name: nivolumab and relatlimab-rmbw
Dosage Form: injection, for intravenous use

Medically reviewed by A Rash MD.  Last updated on Mar 22, 2022.

What is Opdualag?

Opdualag (Nivolumab and relatlimab-rmbw) are two IgG4 kappa monoclonal antibodies that come in a fixed-dose combination (mAbs). Nivolumab is a PD-1 blocking antibody that is expressed in a recombinant Chinese Hamster ovary cell line (CHO) and has an estimated molecular mass of 146 kDa.

OPDUALAG (nivolumab and relatlimab-rmbw) injection is a sterile, preservative-free, clear to
opalescent, colorless to a slightly yellow solution that may contain few translucent-to-white
particles. OPDUALAG is supplied as 240 mg of nivolumab and 80 mg of relatlimab in a 20 mL
single-dose vial for intravenous use. Each mL of OPDUALAG solution contains 12 mg of
nivolumab, 4 mg of relatlimab, and histidine (1.1 mg), L-histidine hydrochloride monohydrate
(2.7 mg), pentetic acid (0.008 mg), polysorbate 80 (0.5 mg), sucrose (85.6 mg), and Water for
Injection, USP. The pH is 5.8.

It is used to treat:

It is not known if this medicine is safe and effective when used:

Important information to know

Opdualag is a drug that works with your immune system to treat melanoma, a kind of skin cancer. Opdualag can make your immune system attack healthy organs and tissues in any part of your body, causing them to malfunction. These issues can sometimes become life-threatening or even fatal. These issues can arise at any time throughout your therapy or even after it has been completed. You could be dealing with more than one of these issues at the same time.

If you notice any new or worsening symptoms, call or contact your healthcare professional right away, including:

Lung problems.

Intestinal problems.

Liver problems.

Hormone gland problems.

Kidney problems.

Skin problems.

Heart problems.

Problems that can also happen in other organs. 

These aren’t the only signs and symptoms of immune system issues that OPDUALAG might cause. If you see any new or worsening signs or symptoms, call or contact your healthcare professional straight away.

Getting medical treatment right away may keep these problems from becoming more serious.

During your therapy with OPDUALAG, your healthcare professional will check for these issues. Your doctor may prescribe corticosteroid or hormone replacement therapy for you. If you encounter severe adverse effects, your healthcare professional may need to postpone or stop your treatment with OPDUALAG.

Before you receive Opdualag

 

Tell your healthcare practitioner if you have any of the following conditions before receiving treatment:

Females who are able to conceive include:

How will I receive OPDUALAG?

Dosage and administration

Recommended Dosage

Adult patients and pediatric patients 12 years of age and older who weigh at least 40 kg should receive 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

There is no recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg.

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

Adverse Reaction Severity Dose Modification
Immune-Mediated Adverse Reactions 
Pneumonitis Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 or 3 Withhold
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.

Withhold

Table 1: Recommended Dosage Modifications for Adverse Reactions

Adverse Reaction Severity Dose Modification
Immune-Mediated Adverse Reactions 
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
Endocrinopathies 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 Withhold
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 Withhold
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

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

Preparation and Administration

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

Prior to administration, visually inspect the solution in the drug product container for particle matter and discoloration. OPDUALAG is a colorless to slightly yellow solution that is transparent to opalescent.

If the solution is hazy, discolored, or includes particulate matter other than a few translucent-to-white particles, discard the bottle.

Preparation

− 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.

Table 2: Maximum Infusion Volumes and Concentration Ranges by Patient Group

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

* 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.

Storage of prepared solution

Store the prepared solution either:

-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

DOSAGE FORMS AND STRENGTHS

Injection: 240 mg nivolumab and 80 mg relatlimab per 20 mL (12 mg and 4 mg per mL) as a clear to opalescent, colorless to slightly yellow solution in a single-dose vial.

Opdualag side effects

Opdualag can cause serious side effects, including:

The most common side effects include:

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Additional information

Always check with your healthcare practitioner to make sure the information on this page pertains to your specific situation.

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