Formulary
Ozanimod: Indications, Dosing, Side Effects and Interactions
Ozanimod is a sphingosine-1-phosphate receptor modulator, which prevents movement of lymphocytes out of lymph nodes, thereby limiting inflammation in the...
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Ozanimod: Indications, Dosing, Side Effects and Interactions
Ozanimod is a sphingosine-1-phosphate receptor modulator, which prevents movement of lymphocytes out of lymph nodes, thereby limiting inflammation in the...
Drug action
Ozanimod is a sphingosine-1-phosphate receptor modulator, which prevents movement of lymphocytes out of lymph nodes, thereby limiting inflammation in the central nervous system and intestine.
Indications and dose
**Multiple sclerosis (initiated by a specialist),Ulcerative colitis (initiated by a specialist)**
- **Adult** (By Mouth): Initially 0.23 mg once daily on days 1-4, then increased to 0.46 mg once daily on days 5-7, then increased to 0.92 mg once daily from day 8 onwards, the same dose escalation regimen is recommended when treatment is interrupted for 1 day or more during the first 14 days of treatment, for more than 7 consecutive days between days 15-28, or for more than 14 consecutive days after day 28. For interruptions of shorter duration, treatment may be continued with the next planned dose.
Cautions
Administration of vaccinations; cerebrovascular disease; chronic obstructive pulmonary disease; diabetes mellitus (increased risk of macular oedema); elderly (limited information available); heart failure; immunosuppression or other risk factors for infection; myocardial infarction; patients receiving QT-prolonging or heart rate-lowering drugs, including beta-blockers and heart rate-lowering calcium-channel blockers; pulmonary fibrosis; recurrent syncope; retinal disease (increased risk of macular oedema); risk of discontinuation effects, including disease rebound; second-degree Mobitz type I atrioventricular block; severe respiratory disease; severe untreated sleep apnoea; significant QT prolongation (QTc greater than 500 milliseconds); sinus bradycardia (heart rate below 55 beats per minute); uncontrolled hypertension; uveitis (increased risk of macular oedema) Cautions, further information Bradycardia and cardiac rhythm disturbance Ozanimod may cause transient bradycardia, atrioventricular conduction delays and heart block after the first dose. It is not recommended in patients with a history of cardiac arrest, cerebrovascular disease, symptomatic bradycardia or recurrent syncope, uncontrolled hypertension, severe untreated sleep apnoea, or significant QT prolongation or other risk factors for QT prolongation unless the anticipated benefits outweigh the potential risks, and advice from a cardiologist (including monitoring advice) is sought before initiation. M Vaccinations Vaccination may be less effective during and for up to 3 months after treatment. Live attenuated vaccines should be avoided during and for 3 months after treatment; if they are required they should be given at least 1 month prior to initiation. Immunisation against varicella zoster is recommended prior to treatment in those without documented immunity. M
Contraindications
Active malignancy; decompensated heart failure (requiring inpatient treatment) in the previous 6 months; heart failure (New York Heart Association class III or IV) in the previous 6 months; immunodeficiency; myocardial infarction in the previous 6 months; phototherapy with UV-B radiation or PUVA-photochemotherapy (increased risk of cutaneous neoplasm); posterior reversible encephalopathy syndrome (suspected or confirmed); progressive multifocal leukoencephalopathy; second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, or sick sinus syndrome, if the patient does not have a pacemaker; severe active infection; stroke (including transient ischaemic attack) in the previous 6 months; unstable angina in the previous 6 months
Side effects
Common or very common Bradycardia; headache; hypertension; increased risk of infection; lymphopenia; peripheral oedema; postural hypotension Rare or very rare Progressive multifocal leukoencephalopathy (PML) Frequency not known Non-melanoma skin cancer
Pregnancy
Avoid-toxicity in animal studies. M
Breast feeding
Avoid-present in milk in animal studies. M
Hepatic impairment
Avoid in severe impairment (no information available). M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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