- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusions of obinutuzumab.
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.
Children under 18 years
Precautions and Warnings
History of recurrent infection
Lymphocyte count above 25 x 10 to the power of 9/L
History of hepatitis B
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
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.
Cytokine release syndrome
Increase in alkaline phosphatase
Increase in serum ALT/AST
Lymph node pain
Progressive multifocal leukoencephalopathy (PML)
Reactivation of hepatitis B
Reduced neutrophil count
Squamous cell carcinoma
Tumour lysis syndrome
Upper respiratory tract infection
Urinary tract infections
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2019
NICE Evidence Services Available at: www.nice.org.uk 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: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Obinutuzumab Last revised: 03 December 2018
Last accessed: 08 August 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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