Nivolumab / Relatlimab Dosage

Medically reviewed by Drugs.com. Last updated on Sep 26, 2022.

Applies to the following strengths: rmbw 240 mg-80 mg/20 mL

Usual Adult Dose for Malignant Melanoma

Recommended dose: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Use: For the treatment of patients with unresectable or metastatic melanoma

Usual Pediatric Dose for Malignant Melanoma

Recommended dose: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks in pediatric patients 12 years of age or older who weigh at least 40 kg

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Comments:

No dosage recommendation has been established for pediatric patients 12 years and older weighing less than 40 kg.

Use: For the treatment of patients with unresectable or metastatic melanoma

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

No dose reduction of this drug is recommended.

General Guidelines:

Withhold treatment for: Severe (Grade 3) immune-mediated adverse reactions (IMARs)
Permanently discontinue for: Life-threatening (Grade 4) IMARs, recurrent Grade 3 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 or initiating steroids.

Dosage modifications for adverse reactions that require management different from the general guidelines:

Pneumonitis:

Grade 2: Withhold [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].
Grade 3 or 4: Permanently discontinue

Colitis:

Grade 2 or 3: Withhold [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].
Grade 4: Permanently discontinue

Hepatitis:

AST/ALT increases more than 3 and up to 8 times the upper limit of normal (ULN) OR total bilirubin increases to more than 1.5 and up to 3 times ULN: Withhold [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].
AST/ALT increases 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.
Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.

Nephritis with Renal Dysfunction:

Grade 2 or 3 increased blood creatinine: Withhold [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].
Grade 4 increased blood creatinine: Permanently discontinue

Exfoliative Dermatologic Conditions - Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN):

Suspected TEN, SJS or DRESS: Withhold
Confirmed TEN, SJS, or DRESS: Permanently discontinue

Myocarditis:

Grade 2, 3 or 4: Permanently discontinue

Neurological Toxicities:

Grade 2: Withhold [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].
Grade 3 or 4: Permanently discontinue

Other Infusion-Related Reactions:

Grade 1 or 2: Interrupt or slow the rate of infusion
Grade 3 or 4: Permanently discontinue

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 12 years old or older patients who weigh less than 40 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice:

For IV use only.
Administer as an intravenous infusion over 30 minutes undiluted or after dilution with recommended diluents.
Inspect the solution visually for particulate matter or discoloration prior to administration.
Discard if cloudy, discolored, or if it contains extraneous or translucent to white particles.
Flush the IV line at the end of the infusion.
Do not co-administer with other drugs through the same IV line.

Storage requirements:

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 any prepared solution not used within 8 hours from the time of preparation.
Under refrigeration at 2C to 8C (36F to 46F) with protection from light for no more than 24 hours from the time of preparation (including 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 or shake.

Reconstitution/preparation techniques:

The manufacturer's product information should be consulted.
The intravenous line should contain a sterile, non-pyrogenic, low protein binding in-line polyethersulfone (PES), nylon, or polyvinylidene fluoride (PVDF) filter (pore size of 0.2 to 1.2 micrometer).
The maximum infusion volumes and concentration ranges are as follows:
Adult patients who weigh at least 40 kg (maximum infusion volume of 160 mL): Nivolumab: 3 to 12 mg/mL; Relatlimab:1 to 4 mg/mL
Adults who weigh less than 40 kg (maximum infusion volume of 4 mL/kg): Nivolumab: 3 to 12 mg/mL; Relatlimab:1 to 4 mg/mL

Monitoring:

For signs and symptoms that may be clinical manifestations of immune-mediated adverse reactions (IMARs)

Patient advice:

Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Contact your healthcare provider immediately if you have:
any new or worsening cough, chest pain, shortness of breath, palpitations, or fatigue
diarrhea or severe abdominal pain
jaundice, severe nausea or vomiting, pain on the right side of the abdomen, lethargy, easy bruising or bleeding
decreased urine output, blood in urine, swelling in ankles, loss of appetite
rash, itching, skin blistering or peeling
Women of reproductive potential should contact their healthcare provider if they become pregnant or suspect a pregnancy.
Women of reproductive potential should use effective contraception during treatment and for at least 5 months after the last dose.
Do not breastfeed during treatment and for 5 months after the last dose.