Nivolumab-Relatlimab

Nivolumab-Relatlimab is a combination medication used for the treatment of unresectable or metastatic melanoma.

• Nivolumab-Relatlimab is available under the following different brand names: Opdualag, Nivolumab-Relatlimab-rmbw

Common side effects of Nivolumab-Relatlimab include:

• musculoskeletal pain
• fatigue
• rash
• itching
• diarrhea
• nausea
• headache 
• decreased appetite
• cough
• hypothyroidism 
• decreased hemoglobin
• decreased lymphocytes
• increased AST
• increased ALT
• decreased sodium

Serious side effects of Nivolumab-Relatlimab include:

• fever,
• chills or shaking 
• dizziness
• trouble breathing 
• itching or rash
• lightheadedness
• fainting

Rare side effects of Nivolumab-Relatlimab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• (240 mg/80 mg)/20 mL

Melanoma

Adult dosage

• 480 mg Nivolumab/160 mg Relatlimab IV every 4 weeks
• Continue until disease progression or unacceptable toxicity occurs

Pediatric dosage

• Children aged younger than 12 years: Safety and efficacy not established
• Children aged 12 years and above and weighing more than 40 kg
  • 480 mg nivolumab/160 mg relatlimab IV every 4 weeks.
  • Continue until disease progression or unacceptable toxicity occurs.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Nivolumab-Relatlimab has no noted severe interactions with any other drugs
• Nivolumab-Relatlimab has no noted serious interactions with any other drugs
• Nivolumab-Relatlimab has no noted moderate interactions with any other drugs
• Nivolumab-Relatlimab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nivolumab-Relatlimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nivolumab-Relatlimab?”

Cautions

• Severe infusion-related reactions can occur; discontinue if severe or life-threatening infusion reactions occur
• Fatal or serious graft-versus-host disease can occur in patients who receive allogeneic hematopoietic stem cell transplantation before or after treatment with a PD-1/PD-L1 receptor blocking antibody; closely monitor for evidence of GVHD and intervene promptly; consider benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody after allogeneic HSCT
• May cause fetal harm when administered to pregnant women
• Immune-mediated adverse reactions
  • Immune-mediated adverse reactions (IMARs), which may be severe or fatal, can occur
• IMARs can manifest during treatment and after discontinuation
  • Closely monitor 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
  • If IMARs are suspected, initiate appropriate workup to exclude alternative etiologies, including infection; promptly institute medical management, including specialty consultation as appropriate
  • May cause immune-mediated pneumonitis; the incidence of pneumonitis is higher in patients who have received prior thoracic radiation and treated with other PD-1/PD-L1 blocking antibodies
  • Immune-mediated encephalitis can occur; withhold therapy in patients with new-onset moderate-to-severe neurologic signs or symptoms and evaluate to rule out infectious or other causes of moderate-to-severe neurologic deterioration
  • Other clinically significant and potentially fatal IMARs (e.g., myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, hepatitis, nephritis) can occur after discontinuation
• Immune-mediated endocrinopathies
  • Immune-mediated hypophysitis; monitor
  • Immune-mediated hypothyroidism and hyperthyroidism reported; monitor for changes in thyroid function and initiate thyroid hormone replacement as needed; administer hormone replacement therapy for hypothyroidism; initiate medical management for control of hyperthyroidism
  • Adrenal insufficiency may occur; monitor for signs and symptoms of adrenal insufficiency during and after treatment
  • May cause type 1 diabetes mellitus; monitor for hyperglycemia
• Hypothyroidism can follow hyperthyroidism
  • Thyroiditis may not lead to permanent discontinuation and may be reinitiated after symptoms improve without reoccurrence
  • Type 1 diabetes mellitus may present with diabetic ketoacidosis; initiate treatment with insulin as clinically indicated
  • Immune-mediated skin reactions
  • May cause immune-mediated rash, including SJS, and TEN; for symptoms or signs of SJS or TEN, withhold therapy and refer the patient for specialized care for assessment and treatment
• Immune-mediated colitis
  • Immune-mediated colitis is reported as requiring corticosteroids and no clear alternate etiology; a common symptom in the definition of colitis is reported to be diarrhea
  • Cytomegalovirus infection/reactivation is also reported in patients with corticosteroid-refractory immune-mediated colitis
  • For corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies

Pregnancy and Lactation

• Based on the mechanism of action, fetal harm may occur when administered to pregnant women.
• No data are available on use in pregnant women to evaluate drug-associated risks
• Advise patients of potential risks to the fetus
• Verify pregnancy status before initiating
• Human IgG4 is known to cross the placenta; therefore, nivolumab and relatlimab may transmit from the mother to the developing fetus; effects are likely to be greater during the second and third trimesters of pregnancy
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment with nivolumab and for at least 5 months following the last dose of therapy
• Lactation
  • There is no data on the presence of nivolumab and relatlimab in human milk, their effects on breastfed infants, or on milk production
  • Advise patients not to breastfeed during treatment and for at least 5 months after the last dose