Nivolumab and Relatlimab-rmbw Monograph for Professionals - Drugs.com

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# Nivolumab and Relatlimab-rmbw

Brand name: Opdualag
Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on Mar 29, 2022. Written by ASHP.

## Introduction

The fixed combination of nivolumab and relatlimab-rmbw is an antineoplastic agent.

## Uses for Nivolumab and Relatlimab-rmbw

### Nivolumab and relatlimab-rmbw has the following uses:

Nivolumab and relatlimab-rmbw is a fixed-dose 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.

## Nivolumab and Relatlimab-rmbw Dosage and Administration

### General

Nivolumab and relatlimab-rmbw is available in the following dosage form(s) and strength(s):

- 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.

### Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

#### Pediatric Patients

##### Dosage and Administration

- Pediatric patients ≥12 years of age weighing ≥40 kg: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

- Administer nivolumab and relatlimab-rmbw as an intravenous infusion over 30 minutes.

- See manufacturer's labeling for dosage modifications for adverse reactions and preparation and administration instructions for the IV infusion.

#### Adults

##### Dosage and Administration

- Adult patients: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

- Administer nivolumab and relatlimab-rmbw as an intravenous infusion over 30 minutes.

- See manufacturer's labeling for dosage modifications for adverse reactions and preparation and administration instructions for the IV infusion.

Detailed Nivolumab / relatlimab dosage information

## Cautions for Nivolumab and Relatlimab-rmbw

### Contraindications

- None.

### Warnings/Precautions

#### Severe and Fatal Immune-mediated Adverse Reactions

The fixed-combination of nivolumab and relatlimab-rmbw potentially breaks peripheral tolerance and induces immune-mediated adverse reactions (IMARs).

IMARs, which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, they can also manifest after discontinuation.

Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity. In general, if nivolumab and relatlimab-rmbw requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg per day prednisone or equivalent) until improvement to grade 1 or less. Upon improvement to grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy.

Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

##### Immune-mediated Pneumonitis

Nivolumab and relatlimab-rmbw can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

Immune-mediated pneumonitis occurred in 3.7% (13/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (0.6%), and grade 2 (2.3%) adverse reactions. Pneumonitis led to permanent discontinuation of the fixed-combination drug in 0.8% and interruption of therapy in 1.4% of patients.

Systemic corticosteroids were required in 100% (13/13) of patients with pneumonitis. Pneumonitis resolved in 85% of the 13 patients. Of the 5 patients in whom nivolumab and relatlimab-rmbw was withheld for pneumonitis, 5 reinitiated the fixed-combination drug after symptom improvement; of these, none had recurrence of pneumonitis.

##### Immune-mediated Colitis

Nivolumab and relatlimab-rmbw can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

Immune-mediated diarrhea or colitis occurred in 7% (24/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (1.1%) and grade 2 (4.5%) adverse reactions. Colitis led to permanent discontinuation of the fixed-combination drug in 2% and interruption of therapy in 2.8% of patients.

Systemic corticosteroids were required in 100% (24/24) of patients with diarrhea or colitis. Colitis resolved in 83% of the 24 patients. Of the 10 patients in whom nivolumab and relatlimab-rmbw was withheld for colitis, 9 reinitiated the fixed-combination drug after symptom improvement; of these, 67% had recurrence of colitis.

##### Immune-mediated Hepatitis

Nivolumab and relatlimab-rmbw can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.

Immune-mediated hepatitis occurred in 6% (20/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 4 (0.6%), grade 3 (3.4%), and grade 2 (1.4%) adverse reactions. Hepatitis led to permanent discontinuation of the fixed-combination drug in 1.7% and interruption of therapy in 2.3% of patients.

Systemic corticosteroids were required in 100% (20/20) of patients with hepatitis. Hepatitis resolved in 70% of the 20 patients. Of the 8 patients in whom nivolumab and relatlimab-rmbw was withheld for hepatitis, 6 reinitiated nivolumab and relatlimab-rmbw after symptom improvement; of these, 50% had recurrence of hepatitis.

##### Immune-mediated Endocrinopathies

Nivolumab and relatlimab-rmbw can cause primary or secondary adrenal insufficiency. For grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold nivolumab and relatlimab-rmbw depending on severity.

Adrenal insufficiency occurred in 4.2% (15/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (1.4%) and grade 2 (2.5%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of the fixed-combination drug in 1.1% and interruption of therapy in 0.8% of patients.

Approximately 87% (13/15) of patients with adrenal insufficiency received hormone replacement therapy. Systemic corticosteroids were required in 87% (13/15) of patients with adrenal insufficiency. Adrenal insufficiency resolved in 33% of the 15 patients. Of the 3 patients in whom nivolumab and relatlimab-rmbw was withheld for adrenal insufficiency, all 3 reinitiated the fixed-combination drug after symptom improvement.

Nivolumab and relatlimab-rmbw can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity.

Hypophysitis occurred in 2.5% (9/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (0.3%) and grade 2 (1.4%) adverse reactions. Hypophysitis led to permanent discontinuation of the fixed-combination drug in 0.3% and interruption of therapy in 0.6% of patients.

All (9/9) of patients with hypophysitis received hormone replacement therapy. Systemic corticosteroids were required in 100% (9/9) of patients with hypophysitis. Hypophysitis resolved in 22% of the 9 patients. Of the 2 patients in whom nivolumab and relatlimab-rmbw was withheld for hypophysitis, none reinitiated the drug after symptom improvement.

Nivolumab and relatlimab-rmbw can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management as clinically indicated. Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity.

Thyroiditis occurred in 2.8% (10/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 2 (1.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of the fixed-combination drug. Thyroiditis led to interruption of therapy in 0.3% of patients.

Systemic corticosteroids were required in 20% (2/10) of patients with thyroiditis. Thyroiditis resolved in 90% of the 10 patients. For the 1 patient in whom nivolumab and relatlimab-rmbw was withheld for thyroiditis, the fixed-combination drug was reinitiated after symptom improvement without recurrence of thyroiditis.

Hyperthyroidism occurred in 6% (22/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 2 (1.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of nivolumab and relatlimab-rmbw. Hyperthyroidism led to interruption of therapy in 0.3% of patients.

Systemic corticosteroids were required in 23% (5/22) of patients. Hyperthyroidism resolved in 82% of the 22 patients. For the 1 patient in whom nivolumab and relatlimab-rmbw was withheld for hyperthyroidism, the fixed-combination drug was reinitiated after symptom improvement without recurrence of hyperthyroidism.

Hypothyroidism occurred in 17% (59/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 2 (11%) adverse reactions. Hypothyroidism led to the permanent discontinuation of nivolumab and relatlimab-rmbw in 0.3% and therapy interruption in 2.5% of patients.

None of the patients with hypothyroidism required systemic corticosteroids. Hypothyroidism resolved in 12% of the 59 patients. Of the 9 patients in whom nivolumab and relatlimab-rmbw was withheld for hypothyroidism, 6 reinitiated the fixed-combination drug after symptom improvement; of these, 33% had recurrence of hypothyroidism.

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity. Diabetes occurred in 0.3% (1/355) of patients receiving nivolumab and relatlimab-rmbw, a grade 3 (0.3%) adverse reaction, and no cases of diabetic ketoacidosis. Diabetes did not lead to the permanent discontinuation or withholding of nivolumab and relatlimab-rmbw in any patient.

##### Immune-mediated Nephritis with Renal Dysfunction

Nivolumab and relatlimab-rmbw can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear alternate etiology. Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity.

Immune-mediated nephritis and renal dysfunction occurred in 2% (7/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (1.1%) and grade 2 (0.8%) adverse reactions. Immune-mediated nephritis and renal dysfunction led to permanent discontinuation of the fixed-combination drug in 0.8% and interruption of therapy in 0.6% of patients.

Systemic corticosteroids were required in 100% (7/7) of patients with nephritis and renal dysfunction. Nephritis and renal dysfunction resolved in 71% of the 7 patients. Of the 2 patients in whom nivolumab and relatlimab-rmbw was withheld for nephritis or renal dysfunction, 1 reinitiated the fixed-combination drug after symptom improvement without recurrence of nephritis or renal dysfunction.

##### Immune-mediated Dermatologic Adverse Reactions

Nivolumab and relatlimab-rmbw can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue nivolumab and relatlimab-rmbw depending on severity.

Immune-mediated rash occurred in 9% (33/355) of patients receiving nivolumab and relatlimab-rmbw, including grade 3 (0.6%) and grade 2 (3.4%) adverse reactions. Immune-mediated rash did not lead to permanent discontinuation of the fixed-combination drug. Immune-mediated rash led to interruption of therapy in 1.4% of patients.

Systemic corticosteroids were required in 88% (29/33) of patients with immune-mediated rash. Rash resolved in 70% of the 33 patients. Of the 5 patients in whom nivolumab and relatlimab-rmbw was withheld for immune-mediated rash, 4 reinitiated the drug after symptom improvement; of these, 25% had recurrence of immune-mediated rash.

##### Immune-mediated Myocarditis

Nivolumab and relatlimab-rmbw can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology. The diagnosis of immune-mediated myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. If clinically confirmed, permanently discontinue nivolumab and relatlimab-rmbw for grade 2-4 myocarditis.

Myocarditis occurred in 1.7% (6/355) of patients receiving nivolumab and relatlimab-rmbw, including Grade 3 (0.6%), and Grade 2 (1.1%) adverse reactions. Myocarditis led to permanent discontinuation of nivolumab and relatlimab-rmbw in 1.7% of patients.

Systemic corticosteroids were required in 100% (6/6) of patients with myocarditis. Myocarditis resolved in 100% of the 6 patients.

##### Other Immune-mediated Adverse Reactions

The following clinically significant IMARs occurred at an incidence of <1% (unless otherwise noted) in patients who received nivolumab and relatlimab-rmbw or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

Cardiac/Vascular: Pericarditis, vasculitis.

Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other IMARs, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica.

Endocrine: Hypoparathyroidism.

Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

#### Infusion-related Reactions

Nivolumab and relatlimab-rmbw can cause severe infusion-related reactions. Discontinue nivolumab and relatlimab-rmbw in patients with severe or life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions.

In patients who received nivolumab and relatlimab-rmbw as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23/355) of patients.

#### Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.

#### Fetal/Neonatal Morbidity and Mortality

Based on its mechanism of action and data from animal studies, nivolumab and relatlimab-rmbw can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with nivolumab and relatlimab-rmbw for at least 5 months after the last dose.

#### Specific Populations

##### Pregnancy

Based on findings in animals and mechanism of action, nivolumab and relatlimab-rmbw 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. 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 nivolumab and relatlimab-rmbw are likely to be greater during the second and third trimesters of pregnancy. There are no available data on nivolumab and relatlimab-rmbw 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.

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.

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.

##### Lactation

There are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breast-fed 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 breast-fed child, advise patients not to breast-feed during treatment with nivolumab and relatlimab-rmbw and for at least 5 months after the last dose.

##### Females and Males of Reproductive Potential

Nivolumab and relatlimab-rmbw can cause fetal harm when administered to a pregnant woman.

Verify the pregnancy status of females of reproductive potential prior to initiating nivolumab and relatlimab-rmbw.

Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of nivolumab and relatlimab-rmbw.

##### Pediatric Use

The safety and effectiveness of nivolumab and relatlimab-rmbw 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 nivolumab and relatlimab-rmbw 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.

The safety and effectiveness of nivolumab and relatlimab-rmbw 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.

##### Geriatric Use

Of the 355 patients treated with nivolumab and relatlimab-rmbw 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.

### Common Adverse Effects

The most common adverse reactions (≥20%) are musculoskeletal pain, fatigue, rash, pruritus, and diarrhea.

The most common laboratory abnormalities (≥20%) are decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium.

## Drug Interactions

### Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Nivolumab / relatlimab drug interactions (more detail)

## Actions

### Mechanism of Action

Relatlimab is a human IgG4 monoclonal antibody that binds to the LAG-3 receptor, blocks interaction with its ligands, including MHC II, and reduces LAG-3 pathway-mediated inhibition of the immune response. Antagonism of this pathway promotes T cell proliferation and cytokine secretion.

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human IgG4 monoclonal antibody that binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and reduces PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

The combination of nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) results in increased T-cell activation compared to the activity of either antibody alone. In murine syngeneic tumor models, LAG-3 blockade potentiates the anti-tumor activity of PD-1 blockage, inhibiting tumor growth and promoting tumor regression.

## Advice to Patients

- Advise the patient to read the FDA-approved patient labeling (Medication Guide).

- Inform patients of the risk of IMARs that may require corticosteroid treatment and withholding or discontinuation of nivolumab and relatlimab-rmbw, including:

- Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath.

- Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain.

- Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding.

- Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, adrenal insufficiency, thyroiditis, hypothyroidism, hyperthyroidism, and diabetes mellitus.

- Nephritis with renal dysfunction: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis, including decreased urine output, blood in urine, swelling in ankles, loss of appetite, and any other symptoms of renal dysfunction.

- Skin adverse reactions: Advise patients to contact their healthcare provider immediately for rash.

- Myocarditis: Advise patients to contact their healthcare provider immediately for signs or symptoms of new or worsening chest pain, palpitations, shortness of breath, fatigue, or swelling in ankles.

- Advise patients of the potential risk of infusion-related reactions.

- Advise patients of complications of allogeneic HSCT and potential risk of post-transplant complications.

- Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

- Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Advise females of reproductive potential of the potential risk to a fetus. Advise such females to use effective contraception during treatment with nivolumab and relatlimab-rmbw and for at least 5 months following the last dose. Advise women not to breast-feed during treatment with nivolumab and relatlimab-rmbw and for 5 months after the last dose.

- Importance of informing patients of other important precautionary information. (See Cautions.)

## Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

## Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Nivolumab and Relatlimab-rmbw
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | Injection, for IV infusion | 12 mg/1 mL nivolumab and 4 mg/1 mL relatlimab | Opdualag | E.R. Squibb & Sons L.L.C.

AHFS Drug Information. © Copyright 2023, Selected Revisions March 29, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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## More about nivolumab / relatlimab

- Check interactions
- Side effects
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- During pregnancy
- Drug class: antineoplastic combinations
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### Patient resources

- Drug Information
- Nivolumab/relatlimab-rmbw Intravenous (Advanced Reading)

### Professional resources

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Opdualag

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