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Opdulag is suitable for the treatment of adults and children over 12 years old with unresectable or metastatic melanoma. It is recommended to be infused intravenously every 4 weeks. The specific medication should be followed the guidance of a doctor.
Common name : OPDUALAG
Trade name : OPDUALAG™
Dosage form :Intravenous injection
Applicable population :Treatment of adults and children aged 12 years and above with unresectable or metastatic melanoma.
Restrictions for : Indications need to be confirmed by an FDA-approved test.
Specifications : Each 20mL single dose vial contains 240mg nivolumab and 80mg relalimumab (12mg/mL and 4mg/mL).
Properties : Clear to slightly opalescent, colorless to light yellow solution, which may contain a small amount of translucent to white particles.
Active ingredient : Nivolumab (anti-PD-1 monoclonal antibody) and relalimumab (anti-LAG-3 monoclonal antibody).
Excipients : Histidine, L-histidine hydrochloride monohydrate, pentetic acid, polysorbate 80, sucrose and water for injection.
Adults and children ≥12 years old and weighing ≥40kg : 480mg nivolumab + 160mg relalimab, intravenously infused for 30 minutes every 4 weeks.
<40kg children : No recommended dose has been established.
Missed dose of : Make up for the dose as soon as possible. If it is close to the next dose time, skip it.
Diet : No special requirements.
Grade3 : Suspend dosing and consider restarting after recovery.
Grade4 or recurrent Grade3 : Permanent discontinuation.
Grade1-2 : Slow down or interrupt the infusion.
Grade3-4 : Permanent discontinuation.
Monitoring requirements : Check liver function, kidney function, thyroid function and electrocardiogram regularly before and during medication.
Infusion management : Use a 0.2-1.2μm filter, flush the pipeline after infusion, and do not infuse it with other drugs on the same line.
Storage conditions :
Unopened: Keep refrigerated at 2-8°C and away from light. Do not freeze or shake.
After preparation: use at room temperature for 8 hours or refrigerated for 24 hours.
Pregnant women: may cause fetal harm, so contraception is required until 5 months after the last dose.
Lactation : Avoid breastfeeding during treatment and within 5 months of stopping the drug.
Children : It is safe and effective in patients ≥12 years old and ≥40kg. There is insufficient data in smaller groups.
Hepatic/renal insufficiency : No adjustment is required for mild to moderate, and no data for severe.
Common (≥20%) : Musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), diarrhea (24%).
Severe but rare :
Immune-mediated pneumonia (3.7%), hepatitis (6%), myocarditis (1.7%).
Endocrine diseases (thyroid dysfunction 17%, adrenal insufficiency 4.2%).
There are no absolute contraindications, but it is prohibited for those who are allergic to the ingredients.
Immunosuppressant : May weaken the efficacy of the drug, avoid combined use.
Strong CYP3A4 inducer : Not studied, use with caution.
Manufacturer of : Bristol-Myers Squibb.
Storage : Store in original packaging at 2-8°C away from light and avoid shock.