- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusions of ocrelizumab.
Treatment of Multiple Sclerosis
Initial dose: 300mg intravenous infusion followed 2 weeks later by second 300mg intravenous infusion.
Subsequent doses: 600mg intravenous infusion 6 months after initial dose. Repeat every 6 months. Minimum interval between intravenous infusions is 5 months.
Additional Dosage Information
Severe infusion-related reaction
Interrupt infusion immediately. The infusion should only be restarted once all symptoms are resolved. The initial infusion rate at restart should be half of the infusion rate at the time of the onset of the reaction.
Mild to moderate infusion-related reaction
Reduce infusion rate to half the rate used at the onset of the reaction. Maintain the reduced rate for at least 30 minutes. If tolerated increase infusion rate to initial rate. Dose reductions are not required.
Delayed or Missed Doses
If the ocrelizumab infusion is missed, the dose should be administered as soon as possible. Do not wait until the next planned dose. A 6 month treatment interval (minimum of 5 months) should be maintained between doses for ocrelizumab.
Children under 18 years
Precautions and Warnings
History of acute infusion reactions
History of hepatitis B
Moderate hepatic impairment
Moderate renal impairment
New York Heart Association class III failure
New York Heart Association class IV failure
Administration of live vaccines is not recommended
Consider withholding antihypertensives 12 hours prior to treatment
Before initiating screen all patients for hepatitis B infection
Ensure relevant vaccinations administered at least 6 weeks before treatment
Patients must be premedicated with an antihistamine and corticosteroid
Premedication with antipyretic recommended
Treatment to be prescribed under the supervision of a specialist
Monitor patient for at least 1 hour after administration
Record name and batch number of administered product
Reduce infusion rate if mild to moderate infusion reaction occurs
Monitor for hypersensitivity reactions - risk of severe reactions
Monitor patient for infusion-associated reactions (IARs)
Perform neutrophil count in patients with signs and symptoms of infection
Advise patient to report headaches, seizures, confusion, visual disturbance
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
Female: Contraception required during and for 1 year after treatment
Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with similar agents. 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.
For neonates and infants born to mothers who have been exposed to ocrevus in utero, consider postponing vaccination with live or live-attenuated vaccines.
Cases of late onset neutropenia have been reported at least four weeks after the infusion with most of the cases being grade one or two.
Pregnancy and Lactation
Use ocrelizumab with caution during pregnancy.
The manufacturer recommends Ocrelizumab is not used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Ocrelizumab is a humanised monoclonal antibody. Immunoglobulins are known to cross the placental barrier, however animal studies do not indicate teratogenic effects.
There is a potential for b-cell depletion in infants exposed to ocrelizumab in utero. Postpone vaccinations with live or attenuated vaccines in infants until b-cell depletion recovered.
Use ocrelizumab with caution during breastfeeding.
The manufacturer advises discontinuation of breastfeeding during treatment with ocrelizumab. It is not known if ocrelizumab or its metabolites are excreted in human breast milk. Animal studies have shown excretion of ocrelizumab in milk.
LactMed suggests that ocrelizumab is a large protein molecule and thus the amount expressed in milk is likely to be low. LactMed suggests any amount of the drug is likely to be destroyed in the infant's gastrointestinal tract, limiting its absorption.
Infusion related reaction
Late onset of neutropenia
Progressive multifocal leukoencephalopathy (PML)
Respiratory tract infection
Upper respiratory tract infection
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: May 2019
Summary of Product Characteristics: Ocrevus 300mg concentrate for solution for infusion. Roche Products Limited. Revised March 2021.
Summary of Product Characteristics: Ocrevus 300mg concentrate for solution for infusion (Northern Ireland). Roche Products Limited. Revised March 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Ocrelizumab Last revised: 3 December 2018
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last accessed: 20 May 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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