A form of Nivolumab that can be injected under the skin ( subcutaneous ) has gained approval from the Food and Drug Administration (FDA). The approval allows the injectable version to be used for most of the same patient groups as the original formulation, which is given as an infusion through a vein (intravenous or IV).

The injectable version of Nivolumab, also called Opdivo Qvantig, will make the treatment quicker and easier for patients to get. The injection takes less than 5 minutes, compared with about 30 minutes for the infusion.
The injection, which is usually given in the abdomen or thigh, doesn’t require a surgically implanted port, which is sometimes needed for intravenous Nivolumab.

The approval of subcutaneous Nivolumab is based on results from a clinical trial comparing both forms of Nivolumab in people with advanced kidney cancer. The trial showed that both forms of the drug had similar pharmacokinetics, meaning how the drug is absorbed, broken down, and excreted in the body. And subcutaneous Nivolumab was as safe and effective, in terms of objective response rates, as intravenous Nivolumab.

The recommended dosage depends on the specific indication and is either 600 mg Nivolumab and 10,000 units Hyaluronidase every 2 weeks; 900 mg Nivolumab and 15,000 units of Hyaluronidase every 3 weeks; or 1,200 mg Nivolumab and 20,000 units Hyaluronidase every 4 weeks until disease progression, unacceptable toxicity, or as indicated in the prescribing information. ( Xagena_2024 )

Source: FDA, 2024

XagenaMedicine_2024