Ozanimod Brand Name– ZEPOSIA
What is Ozanimod
Ozanimod is an oral sphingosine 1-phosphate receptor modulator. Similar to fingolimod, it is indicated for the treatment of relapsing forms of multiple sclerosis in adults, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Oral sphingosine 1-phosphate receptor modulators reduce the frequency of clinical exacerbations and delay the accumulation of physical disability.
The efficacy of ozanimod for the treatment of relapsing forms of MS was demonstrated in 2, randomized, double-blind, active comparator trials, in which ozanimod was compared to interferon beta-1a.
Across both trials, ocrelizumab significantly reduced annualized relapse rates compared to interferon beta-1a (relative reductions of 38% to 48%).
Ozanimod decreased proportion of patients with 3-month confirmed disability progression defined as a 1-point increase in the Expanded Disability Status Scale (7.6% ozanimod vs. 7.8% interferon beta-1a), although the difference between treatment arms was not statistically significant.
Patients with certain cardiac conditions or with hepatic impairment should not receive this drug.
Ozanimod was FDA-approved in March 2020.
Indications
- multiple sclerosis
Side Effects
- abdominal pain
- AV block
- back pain
- bradycardia
- breast cancer
- cystitis
- dyspnea
- elevated hepatic enzymes
- encephalopathy
- hepatotoxicity
- hypertension
- hypertensive crisis
- infection
- jaundice
- laryngitis
- lymphopenia
- macular edema
- multiple sclerosis exacerbation
- new primary malignancy
- orthostatic hypotension
- pharyngitis
- progressive multifocal leukoencephalopathy
- rash
- rhinitis
- rhinorrhea
- skin cancer
- tracheitis
- urticaria
- visual impairment
Hypersensitivity reactions may occur with ozanimod. Rash and urticaria have been reported with ozanimod use during active, controlled clinical trials.
Monitoring Parameters
- blood pressure
- CBC with differential
- ECG
- heart rate
- LFTs
- ophthalmologic exam
- serum bilirubin
Contraindications
- acquired immunodeficiency syndrome (AIDS)
- angina
- asthma
- AV block
- bradycardia
- breast-feeding
- cardiac arrhythmias
- chemotherapy
- chronic obstructive pulmonary disease (COPD)
- contraception requirements
- corticosteroid therapy
- diabetes mellitus
- encephalopathy
- fungal infection
- heart failure
- hepatic disease
- hepatotoxicity
- herpes infection
- human immunodeficiency virus (HIV) infection
- hypertension
- immunosuppression
- infection
- jaundice
- leukemia
- lymphoma
- MAOI therapy
- multiple sclerosis exacerbation
- mycobacterial infection
- myocardial infarction
- pregnancy
- progressive multifocal leukoencephalopathy
- pulmonary disease
- QT prolongation
- reproductive risk
- respiratory insufficiency
- sick sinus syndrome
- skin cancer
- sleep apnea
- stroke
- sunlight (UV) exposure
- uveitis
- vaccination
- viral infection
- visual disturbance
Interactions
- Acalabrutinib
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