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Ozanimod oral

Updated 2 Feb 2023 | Ozanimod


Oral formulations of ozanimod.

Drugs List

  • ozanimod 230microgram and ozanimod 460microgram capsules
  • ozanimod 920microgram capsules
  • ZEPOSIA 0.92mg capsules
  • ZEPOSIA TREATMENT INITIATION PACK 0.23mg + 0.46mg capsules
  • Therapeutic Indications


    Treatment of relapsing-remitting multiple sclerosis

    Treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.



    The recommended dose is 0.92mg once daily.

    Dose escalation regimen
    Days 1 to 4: 0.23mg once daily
    Days 5 to 7: 0.46mg once daily
    Days 8 and thereafter: 0.92mg once daily

    The same dose escalation regime above is recommended when treatment is interrupted for:
    1 day or more during the first 14 days of treatment.
    More than 7 consecutive days between day 15 and day 28 of treatment.
    More than 14 consecutive days after day 28 of treatment.
    If the treatment interruption is of a shorter duration than the above, the treatment should be continued with the next dose as planned.


    Children under 18 years
    Chronic infection
    Severe infection
    Cerebrovascular accident
    Decompensated cardiac failure
    History of atrioventricular block
    Immunodeficiency syndromes
    Long QT syndrome
    Malignant neoplasm
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Non-paced second degree atrioventricular block
    Non-paced sinus node dysfunction
    Non-paced third degree atrioventricular block
    Severe hepatic impairment
    Torsade de pointes
    Transient ischaemic attack
    Unstable angina
    Within 6 months of a myocardial infarction

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    History of immunosuppressant treatment
    Patients over 55 years
    Predisposition to infection
    Predisposition to prolongation of QT interval
    Predisposition to uveitis
    Cerebrovascular disorder
    Chronic obstructive pulmonary disease
    Diabetes mellitus
    Electrolyte imbalance
    Hepatic impairment
    History of cardiac arrest
    History of cardiac failure
    History of retinal disorder
    History of torsade de pointes
    Pulmonary fibrosis
    QTc interval greater than or equal to 500 msec
    Recurrent syncope
    Severe respiratory disease
    Severe sleep apnoea
    Uncontrolled hypertension

    Correct electrolyte disorders before treatment
    Do not administer if live vaccine given within last 30 days
    Live virus vaccine should not be given for 3 months after treatment
    Postpone treatment if there is active or suspected infection
    Treatment to be initiated and supervised by a specialist
    Blood counts should be performed before and periodically during treatment
    Ensure negative pregnancy test in week preceding initiation of treatment
    Perform ECG before treatment
    Monitor blood pressure regularly
    Monitor ECG in patients at risk of QT prolongation
    Monitor for bradycardia for 6 hours after first dose if HR < 55 bpm
    Monitor liver function if anorexia,nausea,vomiting,abdominal pain develop
    Monitor patient closely during drug discontinuation for rebound effect
    Monitor serum electrolytes
    Monitor transaminases/bilirubin at 1 month and every 3 months for 1 year
    Advise patient to report new visual problems and symptoms
    Advise patient to report symptoms of infection immediately
    Consider discontinuing treatment if serious infection occurs
    Immunosuppressive drugs may increase risk of malignancy
    Risk of developing opportunistic infections
    Discontinue if macular oedema occurs
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue if signs or symptoms of hepatic injury occur
    Interrupt therapy if hepatic transaminases > 5 times upper limit of normal
    Interrupt therapy if lymphocyte count less than 0.2 x10 to the power of 9/L
    Female: Contraception required during and for 3 months after treatment
    Advise patient to avoid exposure to direct sunlight

    In patients with a resting heart rate less than 55 beats per minute, second-degree atrioventricular block or a history of myocardial infarction or heart failure, 6 hour monitoring for signs and symptoms of symptomatic bradycardia is recommended following first dose of ozanimod.

    Additional monitoring after 6 hours is recommended in patients with a heart rate less than 45 beats per minute or if there is evidence of a new onset second-degree or higher atrioventricular block at the 6 hour post dose ECG. Appropriate management should be initiated and monitoring continued until the symptoms/findings have resolved. If required, monitoring should be continued overnight with a repeated 6 hour monitoring period following the second dose of ozanimod.

    Monitor for infections for up to 3 months following the discontinuation of ozanimod.

    There is an increased risk of immunosuppression if ozanimod is taken concurrently with antineoplastic, immunosuppressive or immune-modulating therapies. The half life and mode of action must be considered when switching to ozanimod from immunosuppressive products to minimize the risk of disease reactivation.

    Physicians should be vigilant for symptoms or MRI findings suggestive of progressive multifocal leukoencephalopathy (PML).

    Pregnancy and Lactation


    Ozanimod is contraindicated during pregnancy.

    Use of ozanimod during pregnancy is contraindicated by the manufacturer. A negative pregnancy test result must be available prior to treatment with ozanimod. Ozanimod should be stopped 3 months before planning a pregnancy, if a woman becomes pregnant during treatment, ozanimod must be discontinued. Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.


    Ozanimod is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking ozanimod. Animal data reports levels of ozanimod in the breast milk, however presence in human breast milk and the effects on exposed infants are unknown.

    Side Effects

    Alanine aminotransferase increased
    Gamma glutamyl transferase (GGT) increased
    Herpes zoster
    Hypersensitivity reactions
    Increased blood pressure
    Increases in hepatic enzymes
    Macular oedema
    Orthostatic hypotension
    Pulmonary function test abnormal
    Reduced lymphocyte count
    Respiratory tract infection
    Serum bilirubin increased
    Urinary tract infections



    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: December 2020.

    Reference Sources

    Summary of Product Characteristics: Zeposia hard capsules. Bristol-Myers Squibb Pharmaceuticals Limited. Revised October 2020.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.