Gazyva

Indications

Obinutuzumab is a cancer medicine (monoclonal antibody) used to treat certain blood cancers of B-lymphocytes (a type of white blood cell): chronic lymphocytic leukaemia (CLL) in adults who have not been treated before, usually together with Chlorambucil or other medicines, and follicular lymphoma, together with chemotherapy and then alone as maintenance treatment.

How It Works

Obinutuzumab attaches to a protein called CD20 found on the surface of B-lymphocytes, including the cancerous ones. Once attached, it marks the cells for destruction by the immune system and can also trigger the cells to die directly. Healthy B-cells are also reduced for a time but recover after treatment ends.

Dosage and Administration

Obinutuzumab is given only in hospital by a doctor or nurse experienced in cancer treatment, as a slow infusion into a vein. The schedule and doses are set by the specialist according to the type of cancer and treatment plan, and given as prescribed. Medicines such as paracetamol, an antihistamine and a corticosteroid are usually given beforehand to reduce infusion reactions, and fluids and medicines may be given to prevent tumour lysis syndrome.

Interactions

• Live vaccines should not be given during treatment or until B-cells have recovered
• Blood pressure medicines may be stopped for 12 hours before each infusion because blood pressure can drop during the infusion
• Medicines that affect clotting (such as Warfarin, Aspirin, Clopidogrel) may increase bleeding risk if platelets are low

Contraindications

• Severe allergy to Obinutuzumab or any ingredient

Side Effects

Infusion-related reactions are very common, especially with the first infusion: fever, chills, flushing, nausea, headache, breathlessness, wheezing and changes in blood pressure. Other common effects include low white blood cells, low platelets, low red blood cells, infections (chest, urinary, cold sores, shingles), cough, diarrhoea or constipation, joint and back pain, and tiredness. Serious risks include tumour lysis syndrome, reactivation of hepatitis B, and a rare brain infection called PML.

Get urgent medical help for fever or signs of infection, unusual bleeding or bruising, difficulty breathing, chest pain, very little urine, yellowing of the skin or eyes, or new confusion, memory loss, difficulty speaking or walking, or changes in vision.

Pregnancy and Lactation

Obinutuzumab may harm an unborn baby and can lower the baby's B-cells. Women who could become pregnant should use effective contraception during treatment and for 18 months after the last dose. Do not breastfeed during treatment and for 18 months after the last dose.

Precautions and Warnings

All patients are tested for hepatitis B before treatment. Blood counts are checked regularly. Tell the doctor about heart or lung disease, infections, or recent vaccinations. Avoid driving if you feel unwell after an infusion. Drink plenty of fluids as advised.

Overdose

Because it is given in hospital, overdose is unlikely. If it occurs, the infusion is stopped and the patient is monitored closely.

Therapeutic Class

Antineoplastic; anti-CD20 monoclonal antibody.

Storage

Store in a refrigerator at 2 to 8°C, do not freeze, and keep the vial in the outer carton to protect from light. Hospital storage as directed on the pack.