Opdyta nivolumab 40mg

[Indications and Usage]

1. Unresectable or metastatic melanoma

2. Metastatic squamous non-small cell lung cancer (NSCLC)

[Presentation and Specifications] Solution for Injection: 40 mg/4 mL (10 mg/mL)

[Dosage and Administration]

The recommended dosage of OPDIVO is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

How is OPDIVO administered?

(1) What dosage of OPDIVO is required?

When OPDIVO is administered alone, the recommended dosage is 240 mg every 2 weeks or 480 mg every 4 weeks, depending on the specific indication.

When OPDIVO is used alone for the adjuvant treatment of melanoma in adults following complete resection, the recommended dosage is 3 mg of nivolumab per kilogram of body weight every 2 weeks.

When OPDIVO is used in combination with ipilimumab for the treatment of skin cancer, the recommended dosage for the first 4 doses is 1 mg of nivolumab per kilogram of body weight (combination phase). Thereafter, the recommended dosage of OPDIVO is 240 mg every 2 weeks or 480 mg every 4 weeks (monotherapy phase).

When OPDIVO is used in combination with ipilimumab for the treatment of advanced renal cell carcinoma, the recommended dosage for the first 4 doses is 3 mg of nivolumab per kilogram of body weight (combination phase). Thereafter, the recommended dosage of OPDIVO is 240 mg every 2 weeks or 480 mg every 4 weeks (monotherapy phase).

Depending on the dosage required for your treatment, the appropriate amount of OPDIVO will be diluted with 9 mg/mL (0.9%) Sodium Chloride Injection or 50 mg/mL (5%) Dextrose Injection prior to administration. Multiple vials of OPDIVO may be required to obtain the necessary dosage.

(2) How is OPDIVO administered?

You will receive OPDIVO treatment in a hospital or clinic under the supervision of a physician.

Depending on the dosage you are prescribed, OPDIVO will be administered to you via intravenous infusion (drip) over a period of 30 or 60 minutes, either every 2 weeks or every 4 weeks. Your physician will continue to administer OPDIVO to you for as long as you continue to derive therapeutic benefit from the treatment, or until you are no longer able to tolerate the therapy. When OPDIVO is used in combination with ipilimumab, the first 4 doses (combination phase) are administered every 3 weeks; each infusion will take place over a period of 30 minutes or longer. Subsequently, doses will be administered every 2 or 3 weeks, with each infusion lasting 30 or 60 minutes or longer, depending on the specific dosage you receive (single-agent phase).

(3) If you miss a dose of OPDIVO:

If you miss an appointment, please ask your doctor when to schedule your next dose.

(4) If you stop using OPDIVO:

Stopping treatment may affect how the medication works. Do not stop using OPDIVO unless you have consulted with your doctor.

If you have any questions regarding your treatment or the use of this medication, please consult your doctor.

When OPDIVO is used in combination with ipilimumab, OPDIVO is administered first, followed by ipilimumab.

Please refer to the package insert for ipilimumab for information regarding the use of that medication. If you have questions about that medication, please consult your doctor.

Product Specifications

Product Name: Nivolumab (Opdyta) 40 mg — Bristol-Myers Squibb Original Research Drug

Common Name: Nivolumab

Active Ingredient: Nivolumab

Dosage Form: Solution for Injection

Specification: 40 mg/4 mL

Manufacturer: Bristol-Myers Squibb

Indications: Melanoma, Non-Small Cell Lung Cancer (NSCLC)

Dosage and Administration:The recommended dosage is 3 mg/kg administered via intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity occurs.