Opdyta 100mg Injection, Nivolumab, Cancer Immunotherapy, ZarvyPharm
AntiCancer Drugs Liver Cancer Head/Neck Cancer Kidney Cancer Skin Cancer Lung Cancer +1

Opdyta 100mg, solution for injection - 10ml

★★★★★
★★★★★
5

(6)

Generic For OPDIVO
Active Ingredient NIVOLUMAB
Strength 40MG
Manufacturer BRISTOL MYERS SQUIBB INDIA PVT LTD
Opdyta 100mg Solution for Injection 10ml front box packaging
Opdyta 100mg Solution for Injection 10ml vial close-up
Opdyta 100mg Solution for Injection 10ml vial with outer carton
Opdyta 100mg Solution for Injection 10ml front box packaging
Opdyta 100mg Solution for Injection 10ml vial close-up
Opdyta 100mg Solution for Injection 10ml vial with outer carton
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Product Description

Opdyta 100mg, solution for injection is a high-concentration formulation of Nivolumab, a fully human IgG4 monoclonal antibody that targets PD-1, a key immune checkpoint receptor on T cells. By blocking PD-1 interaction with its ligands PD-L1 and PD-L2, Nivolumab reactivates immune surveillance against tumor cells. This 100mg preparation is commonly diluted and administered intravenously across a wide range of solid and hematologic malignancies either as monotherapy or in combination regimens, especially with Ipilimumab. It plays a central role in immuno-oncology protocols across multiple cancer types.

Indications & Uses

- AntiCancer Drugs > Lung Cancer (NSCLC, Mesothelioma) Nivolumab is a frontline immunotherapy in NSCLC, used both alone and in combination with chemotherapy or Ipilimumab. In malignant pleural mesothelioma, it is approved as part of a dual checkpoint blockade strategy. > Skin Cancer (Melanoma) Used in advanced and metastatic melanoma either as monotherapy or in synergy with Ipilimumab. Also indicated for adjuvant treatment after surgical resection to reduce recurrence. > Kidney Cancer (RCC) A core agent in first-line regimens for advanced RCC, especially in intermediate- and poor-risk groups. Often combined with Ipilimumab or Cabozantinib to enhance response rates. > Head and Neck Squamous Cell Carcinoma (HNSCC) Approved for recurrent/metastatic HNSCC after progression on platinum-based therapy. Improves overall survival compared to chemotherapy. > Liver Cancer (Hepatocellular Carcinoma) Indicated for patients with HCC who have received prior sorafenib treatment. Also used in combination with Ipilimumab for more durable responses. > Blood Cancer (Hodgkin Lymphoma) Nivolumab is approved for relapsed/refractory classical Hodgkin lymphoma, offering a non-chemotherapy alternative with high response rates. > Urothelial Carcinoma Utilized for advanced urothelial cancer post platinum-therapy failure. Provides long-term disease control in PD-L1 positive tumors. > Gastrointestinal Cancers (Esophageal, Gastric, GEJ, Colorectal) Used in multiple GI tract malignancies as either monotherapy or in combination with chemotherapy or Ipilimumab, particularly in PD-L1 positive or MSI-H/dMMR colorectal cancers.

Benefits & Effectiveness

Nivolumab blocks the PD-1 receptor on activated T cells, restoring T-cell function and allowing the immune system to recognize and destroy tumor cells. It acts by removing inhibitory signals in the tumor microenvironment, thereby enhancing immune-mediated antitumor activity. As a PD-1 checkpoint inhibitor, it has broad applicability across cancers with immune evasion mechanisms. When used with CTLA-4 inhibitors like Ipilimumab, the dual blockade produces a synergistic effect by activating different immune pathways.

Directions for Use

All doses are given intravenously over 30 minutes. Dose selection depends on weight, cancer type, and co-administered agents. - Melanoma (Unresectable, Adjuvant): • 240 mg q2w or 480 mg q4w • With Ipilimumab: Ipi 3 mg/kg + Nivo 1 mg/kg IV q3w × 4 doses, then Nivo monotherapy - NSCLC: • Monotherapy: 240 mg q2w or 480 mg q4w • Combo: Nivo 3 mg/kg q2w + Ipi 1 mg/kg q6w (up to 2 years) • Chemo Combo: Nivo 360 mg q3w + Ipi 1 mg/kg q6w + 2 cycles platinum chemo - RCC: • Monotherapy: 240 mg q2w or 480 mg q4w • Combo: Nivo 3 mg/kg + Ipi 1 mg/kg q3w × 4 doses, then Nivo monotherapy • With Cabozantinib: Nivo 240 mg q2w + Cabo 40 mg PO daily - Hodgkin’s Lymphoma: • 240 mg q2w or 480 mg q4w - HNSCC, Urothelial Carcinoma: • 240 mg q2w or 480 mg q4w - Hepatocellular Carcinoma: • Monotherapy: 240 mg q2w or 480 mg q4w • With Ipilimumab: Nivo 1 mg/kg + Ipi 3 mg/kg q3w × 4 doses, then Nivo alone - Esophageal, Gastric & GEJ Cancer: • Monotherapy: 240 mg q2w or 480 mg q4w (up to 1 year) • Chemo Combo: Nivo 240 mg q2w + fluoropyrimidine/platinum q2w OR Nivo 360 mg q3w + chemo - Colorectal Cancer: • Monotherapy (≥40kg): 240 mg q2w or 480 mg q4w • Combo: Nivo 3 mg/kg + Ipi 1 mg/kg q3w × 4 doses, then Nivo monotherapy - Pediatric CRC (≥12 yrs): • <40kg: 3 mg/kg q2w • ≥40kg: 240 mg q2w or 480 mg q4w • Combo: Nivo 3 mg/kg + Ipi 1 mg/kg q2w × 4 doses

Storage

Store under refrigeration between 2°C to 8°C. Do not freeze. Protect from light. Do not shake. Once opened or diluted, use immediately or within 24 hours if stored at 2–8°C.

Possible Side Effects

Common immune-related adverse events include colitis, pneumonitis, thyroid disorders, adrenal insufficiency, hepatitis, and nephritis. Other side effects may include fatigue, rash, nausea, pruritus, and infusion-related reactions. Routine monitoring of liver, renal, and thyroid function is recommended. Immune-related toxicities may require corticosteroid management and dose withholding or discontinuation.

FAQs

It is used to treat various cancers including lung, kidney, melanoma, liver, head and neck, bladder, gastrointestinal, and blood cancers.
Nivolumab can be used both as monotherapy or in combination with Ipilimumab or chemotherapy, depending on cancer type and treatment phase.
Many regimens continue until disease progression or unacceptable toxicity, sometimes up to 2 years.
Yes, it is approved for pediatric use in select indications like colorectal cancer in patients aged ≥12 years.
PD-L1 expression, MSI/dMMR status, or other tumor-specific biomarkers may be required to confirm eligibility for treatment.

Ratings & Reviews

Reviewed by 6 Users

5/5
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Product
J**s W**n Mar 08, 2023
★★★★★
★★★★★

Thanks Zarvy

The package came right on time.

Product
E**y R**s Feb 17, 2023
★★★★★
★★★★★

Delivered sooner than expected

My injection arrived earlier than planned, packed neatly and stored safely.

Product
O**a B**t Feb 15, 2023
★★★★★
★★★★★

Arrived in secure condition

The vial was carefully wrapped and reached me without any damage.

Product
S**a D**s Jan 27, 2023
★★★★★
★★★★★

Good stuff

Everything went smoothly.

Product
L**m J**n Dec 28, 2022
★★★★★
★★★★★

Customer service was quick

My inquiry was handled fast and politely by the support staff.

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