Opdyta nivolumab 100ml

[Dosage and Administration]

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

[Indications]

Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with:

(1) Unresectable or metastatic melanoma who have progressed following ipilimumab and, if *BRAF* V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

(2) Metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

[Adverse Reactions]

In patients with melanoma, the most common adverse reactions (≥20%) were:

(1) As a single agent: Rash.

(2) In combination with ipilimumab: Rash, pruritus, headache, vomiting, and colitis. In patients with metastatic non-small cell lung cancer, the most common adverse reactions (≥20%) were fatigue, musculoskeletal pain, decreased appetite, cough, and constipation.

[Precautions]

Immune-Mediated Adverse Reactions: Administer corticosteroids based on the severity of the reaction.

(1) Immune-mediated pneumonitis: Withhold for moderate pneumonitis; permanently discontinue for severe or life-threatening pneumonitis.

(2) Immune-mediated colitis: Withhold for moderate or severe colitis; permanently discontinue for life-threatening colitis.

(3) Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate hepatitis; permanently discontinue for severe or life-threatening elevations in transaminases or total bilirubin.

(4) Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate renal dysfunction; permanently discontinue for severe or life-threatening elevations in serum creatinine. (5) Immune-Mediated Hypothyroidism and Hyperthyroidism: Monitor for changes in thyroid function. Initiate thyroid hormone replacement therapy as needed.

(6) Embryo-Fetal Toxicity: May cause fetal harm. Advise patients of the potential risk to the fetus and the need to use effective contraception.

[Contraindications] None.

[Pharmacology and Toxicology] PD-1 ligands—PD-L1 and PD-L2—bind to the PD-1 receptor found on T cells, thereby inhibiting T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway may contribute to the suppression of active anti-tumor T-cell immune surveillance. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing the PD-1 pathway-mediated inhibition of immune responses, including anti-tumor immune responses. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. The combination of Nivolumab (anti-PD-1) and Ipilimumab (anti-CTLA-4) resulted in enhanced T-cell function that was greater than that of either antibody alone, and led to improved anti-tumor responses in metastatic melanoma; in murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 resulted in increased anti-tumor activity.

[Use in Specific Populations: Pregnancy and Lactation]

It is not known whether Nivolumab is excreted in human milk. Because many drugs—including antibodies—are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Opdivo, women are advised to discontinue breastfeeding during treatment with Opdivo.

[Overdosage] There is no information regarding overdosage with Opdivo.

[Storage] Store under refrigeration at 2°C to 8°C (36°F to 46°F). Do not store for more than 24 hours after preparation for infusion. **Specifications & Parameters**

**Product Name:** Nivolumab (Opdyta) 100ml — Bristol-Myers Squibb Original Research Drug

**Common Name:** Nivolumab

**Active Ingredient:** Nivolumab

**Dosage Form:** Solution for Injection

**Specification:** 100 mg/10 mL

**Manufacturer:** Bristol-Myers Squibb

**Indications:** Nivolumab is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with the following conditions:

⑴ Unresectable or metastatic melanoma who have progressed following ipilimumab and, if *BRAF* V600 mutation-positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

⑵ Metastatic squamous non-small cell lung cancer that has progressed on or after platinum-based chemotherapy.

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