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