TM Owner Bristol Myers Squibb
Opdivo Qvantig 600mg/5ml (120mg/mL) Vial
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Indications & Clinical Uses
- Opdivo Qvantig is a subcutaneous formulation of nivolumab, a PD-1 immune checkpoint-inhibitor monoclonal antibody, combined with hyaluronidase-nvhy, an enzyme that helps disperse the large volume of drug under the skin.
- It is approved in the United States for most of the same adult solid-tumour indications as intravenous Opdivo, including melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma, colorectal cancer, and oesophageal and gastric cancers, alone or combined with ipilimumab or chemotherapy; it does not cover every IV Opdivo indication, so eligibility is checked by the oncology team for each tumour type.
- Opdivo Qvantig is given only by a healthcare professional as a subcutaneous injection into the abdomen or thigh, not the vein, and is a different formulation from intravenous Opdivo - the two are not interchangeable dose-for-dose.
Side Effects
- The most common side effects of Opdivo Qvantig, each affecting more than 1 in 10 people, include musculoskeletal pain, fatigue, itching, rash, thyroid dysfunction, diarrhoea, cough and abdominal pain; local injection-site reactions such as redness, swelling or pain can also occur.
- Like other nivolumab products, Opdivo Qvantig can trigger severe or fatal immune-mediated reactions affecting the lungs, bowel, liver, kidneys, hormone glands, skin, nervous system or other organs.
- There is no boxed warning on the current label, but these immune-related reactions are described prominently as the main safety concern.
- Tell your care team right away about new breathlessness, persistent cough, severe diarrhoea, abdominal pain, yellowing skin or eyes, unusual tiredness, or vision changes, and report any injection-site reaction that worsens or does not settle.
Precautions & Warnings
- Opdivo Qvantig must be given only by a healthcare professional, as a subcutaneous injection into the abdomen or thigh over 3 to 5 minutes with sites rotated between doses - it must never be given intravenously or self-injected at home.
- Liver, kidney, thyroid and other hormone function are monitored regularly during treatment to catch immune-related organ inflammation early.
- Opdivo Qvantig can cause harm to an unborn baby, so females of reproductive potential need effective contraception during treatment and for at least 5 months after the last dose, and breast-feeding is not recommended during this time.
- A history of organ transplant or autoimmune disease should be discussed with the oncology team before starting, as nivolumab-based treatment can trigger organ rejection or worsen autoimmune conditions.
- Complications, including graft-versus-host disease, have been reported with nivolumab used around the time of an allogeneic stem cell transplant.
- Live vaccines should be avoided during treatment.
Avoid Interactions
- Tell the oncology team about all other medicines, herbal products and supplements before and during treatment with Opdivo Qvantig.
- Corticosteroids or other immunosuppressants taken for reasons unrelated to managing a side effect, before starting treatment, may reduce how well the medicine works and are generally avoided unless clinically necessary; once an immune-related reaction develops, corticosteroids are then used deliberately to treat it.
- Live attenuated vaccines should be avoided while receiving Opdivo Qvantig, as safety with concurrent live vaccination has not been established.
- There are no known food, alcohol or grapefruit interactions, since nivolumab and hyaluronidase are proteins rather than medicines processed by liver drug-metabolising enzymes.
- Opdivo Qvantig must not be mixed with other medicines in the same syringe or injection.
References
Frequently Asked Questions
Opdivo Qvantig is a subcutaneous form of nivolumab, an immunotherapy that treats many advanced solid tumours, including melanoma, lung, kidney, bladder, liver and gastrointestinal cancers. It covers most of the same adult indications as intravenous Opdivo, sometimes combined with ipilimumab or chemotherapy.
A healthcare professional injects Opdivo Qvantig under the skin of your abdomen or thigh over 3 to 5 minutes, usually every 2 or 4 weeks depending on the fixed dose used. It is never given into a vein and is not self-injected at home.
Common side effects of Opdivo Qvantig include fatigue, joint or muscle pain, itching, rash, thyroid problems, diarrhoea and injection-site reactions. It can also cause serious immune-related inflammation of the lungs, bowel, liver or kidneys - report new cough, breathlessness or yellowing skin urgently.
Avoid live vaccines while on Opdivo Qvantig, and tell your oncology team about every medicine you take. Starting steroids or other immune-suppressing drugs for unrelated reasons before treatment may lessen how well it works, so check with your care team first.
Opdivo Qvantig contains nivolumab plus hyaluronidase, an enzyme that lets a large dose absorb under the skin instead of through a vein. It has a different concentration and dosing schedule from intravenous Opdivo, and the two formulations are not interchangeable dose-for-dose.
Opdivo Qvantig can harm an unborn baby, so effective contraception is required during treatment and for at least 5 months after the last dose. Breast-feeding is not recommended during this time. Discuss family planning with your oncology team beforehand.
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