Nivolunix 100 Injection

Indications

Nivolumab is an immunotherapy medicine used to treat several types of cancer, including melanoma (a skin cancer), non small cell lung cancer, kidney cancer, Hodgkin lymphoma, head and neck cancer, bladder cancer, some stomach, oesophageal and bowel cancers, liver cancer and mesothelioma. It may be used alone or with other cancer medicines, such as Ipilimumab or chemotherapy, and sometimes after surgery to lower the chance of the cancer returning.

How It Works

Nivolumab is a monoclonal antibody (a laboratory made protein). It blocks a switch on immune T cells called PD 1. Cancer cells use this switch to hide from the immune system. By blocking PD 1, Nivolumab releases the brakes on the immune system so it can recognise and attack cancer cells.

Dosage and Administration

Nivolumab is given in hospital or a cancer clinic by a doctor or nurse, as an infusion into a vein over about 30 to 60 minutes, usually every 2 to 4 weeks. The dose, schedule and length of treatment are set by your cancer specialist. Blood tests are done before each dose.

Interactions

Steroids such as Prednisolone or Dexamethasone and other medicines that suppress the immune system may reduce its effect if given before treatment starts; however, they are used to treat immune side effects when needed. Tell your doctor about all medicines, including herbal products and vaccines.

Contraindications

• Severe allergy to Nivolumab or any ingredient.

Side Effects

Common effects include tiredness, rash, itching, diarrhoea, nausea, joint or muscle pain, reduced appetite and changes in thyroid function. Because it activates the immune system, it can cause inflammation in almost any organ (immune related side effects), sometimes months after treatment.

Get urgent medical help if you have new or worse cough or breathlessness, severe or watery diarrhoea or blood in the stool, yellow skin or eyes, severe headache, unusual tiredness, dizziness or fainting, very high blood sugar (thirst, passing lots of urine), reduced urine, severe skin blistering, chest pain, muscle weakness, or confusion. Reactions during the infusion (fever, chills, flushing, breathlessness) should be reported immediately.

Pregnancy and Lactation

Nivolumab may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for at least 5 months after the last dose. Do not breastfeed during treatment and for some time afterwards, as advised by your doctor.

Precautions and Warnings

Tell your doctor if you have an autoimmune disease (such as rheumatoid arthritis, lupus, colitis or psoriasis), an organ transplant, lung disease or liver problems. Carry your treatment alert card and tell any doctor you see that you have received Nivolumab. Do not treat new symptoms yourself; side effects need prompt medical care and often steroids.

Overdose

Overdose is unlikely as it is given by health professionals. If it occurs, the patient is monitored closely for immune side effects and treated as needed.

Therapeutic Class

Antineoplastic (anticancer) immunotherapy; PD 1 blocking monoclonal antibody (immune checkpoint inhibitor).

Storage

Store vials in a refrigerator at 2 to 8°C, do not freeze. Keep in the original carton to protect from light. Hospital use only, as directed on the pack.