Opdivo SC

Produktresumé för våra godkända läkemedel på FASS: OPDIVO^® (nivolumab)

OPDIVO (nivolumab) over 3-5 minutes¹

Treatment with OPDIVO (nivolumab) can be given as subcutaneous injection (SC) over 3–5 minutes as alternative to Intravenous Infusion (IV) over 30 minutes.

OPDIVO SC is approved to use alone or in combination with other cancer medicines across multiple solid tumours in adults:

As monotherapy (adjuvant or metastatic)
As monotherapy maintenance following completion of OPDIVO + YERVOY (ipilimumab) combination therapy
In combination with chemotherapy or cabozantinib

See SmPC for specific indications approved for Opdivo SC

Subcutaneous administration may offer practical advantages compared to intravenous infusion:

What types of cancer is OPDIVO SC approved to treat?

OPDIVO SC is approved alone or in combination with other cancer medication for adults with the following cancers¹:

	MELANOMA	Adjuvant treatment of adults with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection As monotherapy or in combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression
	COLORECTAL CANCER	In combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: - first-line treatment of unresectable or metastatic colorectal cancer - treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy
	RENAL CELL CARCINOMA	In combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma In combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults.
	NON-SMALL CELL LUNG CANCER	In combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% As monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.
	HEPATOCELLULAR CARCINOMA	In combination with ipilimumab for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
	UROTHELIAL CARCINOMA	As monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma As monotherapy for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
	OESOPHAGEAL SQUAMOUS CELL CARCINOMA	In combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. As monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
	ADJUVANT TREATMENT OF OESOPHAGEAL OR GASTRO-OESOPHAGEAL JUNCTION CANCER	As monotherapy for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
	GASTRO, GASTRO-OESOPHAGEAL JUNCTION OR OESOPHAGEAL ADENOCARCINOMA	In combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
	SQUAMOUS CELL CANCER OF THE HEAD AND NECK	As monotherapy for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy

See SmPC for indication specific instructions and dosing.

Dosing of OPDIVO SC¹

The recommended dose of OPDIVO SC is either 600 mg every 2 weeks or 1200 mg every 4 weeks over 3–5 minutes.

OPDIVO SC
600 mg q2w*

Allow 1 vial to reach room temperature, then withdraw 5 mL of OPDIVO solution for injection into the syringe

OPDIVO SC
1200 mg q4w*

Allow 2 vials to reach room temperature, then withdraw 10 mL of OPDIVO solution for injection into the syringe

*See SmPC for indication specific dosing and how to prepare the syringe

Administration of OPDIVO SC¹

OPDIVO SC should be administered into the subcutaneous tissue of the abdomen (one of the four quadrants) or the thigh over 3-5 minutes.

Alternate injection sites for successive injections.

Hypodermic injection needle or with a subcutaneous administration set (“butterfly”) can be used for administration.

CheckMate-67T demonstrate consistent efficacy, non-inferior exposure, and comparable safety to IV nivolumab²

CheckMate 67T is a randomized, open label Phase 3 trial designed to evaluate the pharmacokinetics, efficacy, and safety of OPDIVO SC (nivolumab subcutaneous injection) compared with nivolumab IV (intravenous infusion) in patients with advanced or metastatic clear cell renal cell carcinoma.

A total of 495 patients who had received ≤2 prior systemic therapies were randomized to receive either OPDIVO SC or nivolumab IV. The minimum follow up was 8 months.

Co primary PK endpoints (noninferiority): Cavg,d28 (time averaged concentration over 28 days) and Cmin,ss (minimum concentration at steady state)

Secondary endpoint: Overall Response Rate (ORR) assessed by blinded independent central review (BICR), Progression free survival (PFS) and Safety outcomes

Key Findings from CheckMate 67T

OPDIVO SC met the predefined non inferiority criteria for both PK endpoints, demonstrating comparable systemic exposure to IV nivolumab.
ORR: 24% with OPDIVO SC vs 18% with IV nivolumab. This demonstrated similar efficacy, with a numerically higher response rate in the SC arm.
The safety profile of OPDIVO SC was comparable to IV nivolumab, with the most common adverse events including fatigue, musculoskeletal pain, pruritus, rash, and cough.

Link to full publication: Subcutaneous versus intravenous nivolumab for renal cell carcinoma - PubMed

1506-NOR-2600003/ Developed Feb 10 2026

Reference 1. OPDIVO SmPC. 2. Albiges et al. Annals of Oncology Vol 36, issue 1, Jan 2025 p99-107

Opdivo SC introduction video in Swedish

2.40 min. Produktresumé för våra godkända läkemedel på FASS: OPDIVO^® (nivolumab)

1506-NOR-2600005/ Developed March 03 2026