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Obinutuzumab parenteral


Infusions of obinutuzumab.

Drugs List

  • GAZYVARO 1000mg/40ml concentrate for solution for infusion
  • obinutuzumab 1000mg/40ml concentrate for solution for infusion
  • Therapeutic Indications


    Follicular non-Hodgkin's lymphoma
    Leukaemia - chronic lymphocytic

    Treatment of previously untreated chronic lymphocytic leukaemia (CLL) in combination with chlorambucil in patients unsuitable for full-dose fludarabine based therapy.

    Treatment of follicular lymphoma (FL) in combination with bendamustine in patients who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab containing regimen.

    Treatment of FL in combination with chemotherapy followed by maintenance therapy, in patients with previously untreated advanced FL.


    Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
    Doses may vary significantly if this agent is used as monotherapy or different combinations.
    When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.

    Additional Dosage Information

    If a dose is missed, do not wait until the next planned dose it should be administered as soon as possible. The planned dose intervals should be maintained between doses.


    To be administered after dilution as an intravenous infusion.


    Acute infection
    Children under 18 years
    Hepatitis B

    Precautions and Warnings

    History of recurrent infection
    Lymphocyte count above 25 x 10 to the power of 9/L
    Cardiac disorder
    Hepatic impairment
    History of hepatitis B
    Pulmonary disease
    Renal impairment - creatinine clearance below 70ml/min

    Administration of live vaccines is not recommended
    Consider withholding antihypertensives 12 hours prior to treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating screen all patients for hepatitis B infection
    Consider premedication with hypouricaemic agent
    Hepatitis B: Refer prior to initiation to liver disease specialist
    Maintain adequate hydration of patient prior / during treatment
    Premedicate with intravenous corticosteroids and antihistamines
    Premedication with analgesic recommended
    Premedication with antipyretic recommended
    Treatment to be initiated and supervised by a specialist
    Concentrate must be diluted and used as an infusion
    Consult local policy on the safe use of anti-cancer drugs
    Record name and batch number of administered product
    Reduce infusion rate if mild to moderate infusion reaction occurs
    Resuscitation facilities must be immediately available
    Staff: Not to be handled by pregnant staff
    Consider immunosuppressant adjustment in the event of PML
    Monitor closely patients who develop neutropenia
    Monitor patient for infusion-associated reactions (IARs)
    Monitor patients for signs of tumour lysis syndrome
    Monitor patients with cardiac disorders
    Monitor patients with high tumour burden closely during therapy
    Monitor platelets
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Antimicrobial prophylaxis recommended if severe neutropenia occurs
    Discontinue if hypersensitivity reactions occur
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue permanently if life threatening infusion reactions occur
    Interrupt treatment if severe infusion reaction occurs
    Permanently discontinue treatment if severe respiratory symptoms occur
    Female: Contraception required during and for 18 months after treatment
    Breastfeeding: Do not breastfeed during & for 18 months after treatment

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.
    Patients at risk of tumour lysis syndrome including patients with a high tumour burden, lymphocyte count greater than 25 x 10 to the power of 9/L and/or creatinine clearance less than 70 ml/minute should receive prophylaxis. These patients should be carefully monitored during the initial days of treatment with special focus on renal function, potassium and uric acid values.
    Chronic Lymphocytic Leukaemia (CLL)
    Patients with CLL and a creatinine clearance less than 50 ml/minute are at a greater risk of serious adverse events including events leading to death.

    Pregnancy and Lactation


    Obinutuzumab is contraindicated during pregnancy.

    The manufacturer advises obinutuzumab is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. In case of exposure during pregnancy, depletion of B cells may be expected in newborns. Newborns should be monitored for B cell depletion and vaccinations should be postponed until the infant's B cell count has recovered.

    There is no experience of the use of obinutuzuamb in humans. However studies in monkeys showed no embryofoetal toxicity or teratogenic effects but did result in the complete depletion of B lymphocytes in offspring. Serum concentrations in offspring (similar to the mother at 28 days) also suggest that obinutuzumab crosses the placenta.


    Obinutuzumab is contraindicated during breastfeeding.

    The manufacturer advises breastfeeding should be discontinued during and for 18 months after obinutuzumab treatment.

    It is unknown if obinutuzumab is excreted in human breast milk. Obinutuzuamb is unlikely to be absorbed due to its molecular weight (around 150,000). Animal studies have shown excretion of obinutuzumab into breast milk, therefore the risk to the breastfed child cannot be excluded.

    Side Effects

    Angina pectoris
    Atrial fibrillation
    Back pain
    Bone pain
    Cardiac failure
    Cardiac symptoms
    Chest pain
    Cytokine release syndrome
    Extremity pain
    Gastro-intestinal perforation
    Herpes simplex
    Increase in alkaline phosphatase
    Increase in serum ALT/AST
    Infusion-related symptoms
    Laryngeal oedema
    Lung infection
    Lymph node pain
    Musculoskeletal pain
    Myocardial infarction
    Nasal congestion
    Night sweats
    Ocular hyperaemia
    Progressive multifocal leukoencephalopathy (PML)
    Reactivation of hepatitis B
    Reduced neutrophil count
    Respiratory symptoms
    Squamous cell carcinoma
    Throat irritation
    Tumour lysis syndrome
    Upper respiratory tract infection
    Urinary incontinence
    Urinary tract infections
    Weight gain
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    NICE Evidence Services Available at: Last accessed: 24 July 2019

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Gazyvaro 1000 mg concentrate for solution for infusion. Roche Products Ltd. Revised April 2019.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Obinutuzumab Last revised: 03 December 2018
    Last accessed: 08 August 2019

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