Medical Editor: John P. Cunha, DO, FACOEP
What Is Opdualag?
Opdualag (nivolumab and relatlimab-rmbw) is a combination of a programmed death receptor-1 (PD-1) blocking antibody and 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.
What Are Side Effects of Opdualag?
Side effects of Opdualag include:
- musculoskeletal pain,
- decreased appetite,
- decreased hemoglobin,
- decreased lymphocytes,
- increased AST,
- increased ALT, and
- decreased sodium.
Dosage for Opdualag
The dose 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 intravenously every 4 weeks.
Opdualag In Children
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.
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 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.
What Drugs, Substances, or Supplements Interact with Opdualag?
Opdualag may interact with other medicines.
Tell your doctor all medications and supplements you use.
Opdualag During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Opdualag; it may harm a fetus. The pregnancy status of females of reproductive potential should be verified prior to initiating Opdualag. Females of reproductive potential are advised to use effective contraception during treatment and for at least 5 months following the last dose of Opdualag. Because nivolumab and relatlimab may pass into breast milk and because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with Opdualag and for at least 5 months after the last dose.
Our Opdualag (nivolumab and relatlimab-rmbw) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling.
- Severe and Fatal IMARs [see WARNINGS AND PRECAUTIONS]
- Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
- Complications of Allogeneic HSCT [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of OPDUALAG was evaluated in RELATIVITY-047, a randomized (1:1), double-blinded trial in 714 patients with previously untreated metastatic or unresectable melanoma [see Clinical Studies]. Patients received intravenous OPDUALAG (nivolumab 480 mg and relatlimab 160 mg) every 4 weeks (n=355) or nivolumab 480 mg by intravenous infusion every 4 weeks (n=359). Patients were treated with OPDUALAG or nivolumab until disease progression or unacceptable toxicity. The median duration of exposure was 6 months (range: 0 to 31 months) in OPDUALAG-treated patients and 5 months (range: 0 to 32 months) in nivolumab-treated patients.
Serious adverse reactions occurred in 36% of patients treated with OPDUALAG. The most frequent serious adverse reactions reported in ≥1% of patients treated with OPDUALAG were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%). Fatal adverse reaction occurred in 3 (0.8%) patients who were treated with OPDUALAG; these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis.
OPDUALAG was permanently discontinued due to adverse reactions in 18% of patients. Adverse reactions which resulted in permanent discontinuation of OPDUALAG in ≥1% of patients included myocarditis (1.7%) and pneumonitis (1.4%).
Dosage interruptions due to an adverse reaction occurred in 43% of patients who received OPDUALAG. Adverse reactions that required dosage interruption in ≥2% of patients who received OPDUALAG were diarrhea (3.9%), troponin increased (3.9%), AST increased (2.8%), troponin T increased (2.8%), ALT increased (2.3%), arthralgia (2.3%), hypothyroidism (2.3%), anemia (2%), fatigue (2%), pneumonitis (2%), and rash (2%).
The most common (≥20%) adverse reactions that occurred in patients treated with OPDUALAG were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%). The most common (≥20%) laboratory abnormalities that occurred in patients treated with OPDUALAG were decreased hemoglobin (37%), decreased lymphocytes (32%), increased AST (30%), increased ALT (26%), and decreased sodium (24%).
Tables 3 and 4 summarize both the adverse reactions and laboratory abnormalities, respectively, in RELATIVITY-047.
Table 3: Adverse Reactions in ≥15% of Patients - RELATIVITY-047
|All Grades (%)||Grades 3-4 (%)||All Grades (%)||Grades 3-4 (%)|
|Musculo skeletal and Co nnective Tissue|
|Skin and Subcutaneous Tissue|
|Metabolism and Nutrition Disorders|
|Decrea sed appetite||15||0.6||7||0.3|
|Respiratory, Thoracic and Mediastinal Disorders|
|Toxicity was graded per NCI CTCAE v5.
a Includes multiple terms.
Clinically relevant adverse reactions in <15% of patients who received OPDUALAG included vitiligo, adrenal insufficiency, myocarditis, and hepatitis.
Table 4: Laboratory Abnormalities (≥15%) That Worsened from Baselinea in Patients Who Received OPDUALAG in RELATIVITY-047
|Grades 1-4 (%)||Grades 3-4 (%)||Grades 1-4 (%)||Grades 3-4 (%)|
|Increased alkaline phosphatase||19||0.6||17||0.9|
|a Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: OPDUALAG group (range: 280 to 342 patients) and nivolumab group (range: 276 to 345 patients).|
No Information provided
Read the entire FDA prescribing information for Opdualag (Nivolumab and Relatlimab-rmbw Injection)
© Opdualag Patient Information is supplied by Cerner Multum, Inc. and Opdualag Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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