All Names:
Indications:
Manufacturer:Bristol-Myers Squibb Company,USA
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Opdulag is suitable for the treatment of adult and pediatric patients aged 12 and above with unresectable or metastatic melanoma. It is recommended to administer it intravenously every 4 weeks, and specific medication should be taken according to the doctor's guidance.
1. Drug name and main ingredients
Common name: Opdulag
Product Name: OPDUALAG ™
Dosage form: Intravenous injection
2. Indications
Applicable population: Adult and pediatric patients aged 12 years and above with unresectable or metastatic melanoma.
Restriction: Indications must be confirmed through FDA approved testing.
3. Specifications and characteristics
Specification: Each 20mL single dose vial contains 240mg of nivolumab and 80mg of ranibizumab (12mg/mL and 4mg/mL).
Appearance: Clear to microemulsion light, colorless to light yellow solution, may contain a small amount of semi transparent to white particles.
4. Main components
Active ingredients: nivolumab (anti-PD-1 monoclonal antibody) and ranibizumab (anti-LAG-3 monoclonal antibody).
Accessories: Histidine, L-histidine hydrochloride monohydrate, pantothenic acid, polysorbate 80, sucrose, and injection water.
5. Usage and dosage
Conventional dosage:
Adults and children aged ≥ 12 years and weighing ≥ 40kg: 480mg nivolumab+160mg ranibizumab, intravenous infusion every 4 weeks for 30 minutes.
Children weighing less than 40kg: No recommended dosage has been established.
Missed administration: Make up for the infusion as soon as possible, and skip if it is close to the next administration time.
Diet: No special requirements.
6. Dose adjustment
Immune mediated adverse reactions (IMAR):
Grade 3: Suspend medication and consider restarting after recovery.
Grade 4 or recurrent Grade 3: permanent discontinuation of medication.
Infusion reaction:
Grade 1-2: Slow down infusion rate or interrupt.
Grade 3-4: Permanent discontinuation of medication.
7. Medication precautions
Monitoring requirements: Regularly check liver function, kidney function, thyroid function, and electrocardiogram before and during medication.
Infusion management: Use a 0.2-1.2 μ m filter, rinse the tubing after infusion, and prohibit simultaneous infusion with other drugs.
Storage conditions:
Unopened: Keep refrigerated at 2-8 ℃ and avoid light exposure. Do not freeze or shake.
After preparation: Use at room temperature for 8 hours or refrigerated for 24 hours.
8. Medication for special populations
Pregnant women: May cause harm to the fetus, contraception should be used until 5 months after the last dose.
Breastfeeding period: Avoid breastfeeding during treatment and within 5 months of discontinuing medication.
Children: Patients aged ≥ 12 and ≥ 40kg are safe and effective, but there is insufficient data for smaller groups.
Liver/kidney dysfunction: Mild to moderate without adjustment, severe without data available.
9. Adverse reactions
Common (≥ 20%): musculoskeletal pain (45%), fatigue (39%), rash (28%), itching (25%), diarrhea (24%).
Serious but rare:
Immune mediated pneumonia (3.7%), hepatitis (6%), and myocarditis (1.7%).
Endocrine disorders (17% thyroid dysfunction, 4.2% adrenal insufficiency).
10. Contraindications
There are no absolute contraindications, but it is contraindicated for those who are allergic to the ingredients.
11. Drug interactions
Immunosuppressants: May weaken the efficacy, avoid combination therapy.
CYP3A4 strong inducer: not studied, use with caution.
12. Production and Storage
Manufacturer: Bristol Myers Squibb.
Storage: Store in the original packaging at 2-8 ℃ away from light and avoid shaking.
Opdualaginformation