TM Owner Bristol Myers Squibb
Nivolumab SC 600mg/5ml (also 300mg/2.5ml) Vial
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Indications & Clinical Uses
- Nivolumab SC (Opdivo Qvantig, nivolumab and hyaluronidase-nvhy) is the subcutaneous form of nivolumab, a PD-1 blocking antibody, combined with hyaluronidase.
- In the US it is approved for several cancers, including renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck cancer, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, and oesophageal and gastric cancers.
- It is not indicated in combination with ipilimumab for most indications.
- A healthcare professional injects it under the skin of the abdomen or thigh over 3 to 5 minutes, typically 600 mg every 2 weeks or 1,200 mg every 4 weeks.
- Use in children is limited to age 12 and over weighing at least 30 kg for specific cancers.
- The vial is 600 mg nivolumab with 10,000 units hyaluronidase in 5 mL (a 300 mg/2.5 mL vial also exists), not 10 mL.
- It has different dosing from IV Opdivo and must never be given intravenously.
Side Effects
- The most common side effects are muscle and bone pain, tiredness, itching, rash, underactive thyroid (hypothyroidism), diarrhoea, cough and abdominal pain.
- Injection site reactions occurred in about 8% of patients.
- As with other PD-1 blockers, immune-mediated reactions may be severe or even fatal and can affect any organ, including the lungs, bowel, liver, hormone glands, skin and kidneys.
- Report new cough, chest pain, severe diarrhoea, jaundice, rash or unusual tiredness straight away.
- The current US label has no boxed warning.
Precautions & Warnings
- Opdivo Qvantig has no listed contraindications.
- Its dosing and administration differ from intravenous nivolumab products, and it must be given under the skin only, never into a vein.
- Liver enzymes, creatinine and thyroid function are checked at the start and periodically.
- Treatment may be withheld or stopped for severe immune reactions.
- Fatal and other serious complications can occur in patients who have had or later have an allogeneic stem cell transplant.
- Women who could become pregnant must use effective contraception during treatment and for 5 months after the last dose.
- Do not breastfeed.
- The vial is stored at 2°C to 8°C, protected from light, and not frozen or shaken.
Avoid Interactions
- The US prescribing information for Opdivo Qvantig gives no specific drug interaction information.
- Because it acts on the immune system, tell your specialist about any corticosteroids, immunosuppressants or other cancer treatments you take, as their use is decided by the treating team.
- Do not use Opdivo Qvantig in combination with ipilimumab for most indications.
- Do not confuse it with intravenous nivolumab (Opdivo), which is dosed differently.
- Tell your healthcare provider about all prescription, non-prescription and herbal medicines you take.
References
Frequently Asked Questions
Nivolumab SC (Opdivo Qvantig, nivolumab and hyaluronidase-nvhy) is an immunotherapy given under the skin for several cancers, including kidney cancer, melanoma, lung cancer, head and neck, bladder, colorectal, liver, oesophageal and gastric cancers. It is not used with ipilimumab for most indications.
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is injected under the skin of the abdomen or thigh by a healthcare professional, over 3 to 5 minutes. It is typically 600 mg every 2 weeks or 1,200 mg every 4 weeks. It must not be given into a vein.
Opdivo Qvantig (nivolumab) commonly causes muscle and bone pain, tiredness, itching, rash, underactive thyroid, diarrhoea, cough and abdominal pain. About 8% have injection site reactions. Serious immune reactions can affect the lungs, bowel, liver, hormone glands, skin and kidneys.
No. Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is for subcutaneous use only, in the abdomen or thigh, and must not be given intravenously. Its dosing differs from intravenous nivolumab (Opdivo), so the two are not interchangeable.
During Opdivo Qvantig (nivolumab) treatment your team checks liver enzymes, creatinine and thyroid function at the start and periodically. Treatment may be paused or stopped if a serious immune reaction develops. Report new cough, severe diarrhoea, jaundice or rash promptly.
Opdivo Qvantig (nivolumab) may harm an unborn baby. If you could become pregnant, use effective contraception during treatment and for 5 months after your last dose. Do not breastfeed during treatment.
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