Ozanimod: Drug information

For additional information see "Ozanimod: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Zeposia;
Zeposia 7-Day Starter Pack;
Zeposia Starter Kit

Brand Names: Canada

Zeposia;
Zeposia Initiation Pack

Pharmacologic Category

Sphingosine 1-Phosphate (S1P) Receptor Modulator

Dosing: Adult

Note: If live attenuated vaccine immunizations are required prior to administration, initiate ozanimod therapy at least 1 month following immunizations. In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other appropriate specialists (eg, liver specialists) regarding treatment options before initiating therapy (Ref).

Multiple sclerosis, relapsing

Multiple sclerosis, relapsing: Oral: Initial: 0.23 mg once daily on days 1 through 4; then 0.46 mg once daily on days 5 through 7; maintenance dose: 0.92 mg once daily starting on day 8.

Ulcerative colitis

Ulcerative colitis: Oral: Initial: 0.23 mg once daily on days 1 through 4; then 0.46 mg once daily on days 5 through 7; maintenance dose: 0.92 mg once daily starting on day 8.

Missed doses: If a dose is missed during the first 2 weeks of treatment, reinitiate the titration regimen with 0.23 mg once daily. If a dose is missed after the first 2 weeks of treatment, continue with treatment as planned.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

Hepatic impairment prior to initiation of treatment:

Mild to moderate impairment (Child-Pugh classes A and B): Initial: 0.23 mg once daily on days 1 through 4; then 0.46 mg once daily on days 5 through 7; maintenance dose: 0.92 mg once every other day starting on day 8.

Severe impairment (Child-Pugh class C): Use not recommended (has not been studied).

Hepatic impairment during treatment:

Significant liver injury: Discontinue ozanimod if significant liver injury is confirmed.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations

Cardiovascular effects

Transient, dose-dependent decreases in heart rate (≤1.2 bpm) and bradycardia have been observed following the first dose of ozanimod and with dose titration. Transient atrioventricular (AV) conduction delays may also occur with initiation; concern stems from AV block (first and second degree) observed rarely in studies with higher than recommended doses and without appropriate dose titration (Ref). Orthostatic hypotension is frequently observed upon initiation and dose titration, but in a cardiac safety trial, these events were described as transient and asymptomatic (Ref). Hypertension and hypertensive crisis have also been reported.

Mechanism: Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator; S1P receptors play a role in regulating vascular tone, heart rate, and cardiac repolarization (Ref).

Bradycardia: Dose-related; S1P modulators have been associated with negative chronotropic effects; however, these effects may attenuate over time secondary to S1P desensitization on atrial myocytes (Ref).

Onset:

Bradycardia/decreased heart rate: Rapid; ~5 hours after the first dose with a return to baseline at approximately hour 6. With continued up-titration, additional transient decreases in heart rate occur, with maximum heart rate effects seen by day 8.

Hypertension: Delayed; increased BP occurred ~3 months after initiation of therapy and persisted throughout the duration of therapy.

Orthostatic hypotension: Rapid; ~3 to 6 hours after initial dose and first up-titration of dose (Ref).

Risk factors:

Bradycardia/atrioventricular conduction delays:

• Preexisting conditions that may increase the risk for bradycardia or AV block. Of note, contraindications related to these risk factors exist.

Cutaneous malignancies

Cases of cutaneous malignancies, including basal cell carcinoma of skin, Kaposi sarcoma, squamous cell carcinoma of skin, and malignant melanoma, have been reported in patients treated with ozanimod (Ref). Merkel cell carcinoma has been reported with other sphingosine 1-phosphate (S1P) receptor modulators.

Risk factors:

• Patients at increased risk for skin cancer

Hepatotoxicity

Increased liver enzymes may occur with ozanimod therapy, including increased gamma-glutamyl transferase, hyperbilirubinemia, increased serum alanine aminotransferase (ALT), increased serum alkaline phosphatase, and increased serum aspartate aminotransferase (AST). Some patients experienced increases of ALT up to 5 × ULN and required discontinuation; however, most patients experienced increases in serum transaminases that were mild to moderate in severity, transient, and did not require therapy discontinuation. In patients with increases of ALT ≥3 × ULN, most patients had values returning to <3 × ULN within 2 to 4 weeks of continued therapy. Significant hepatic injury, including acute hepatic failure requiring transplant, has been reported.

Onset: Delayed; elevated liver enzymes and total bilirubin have been reported as early as 10 days after the first dose; median time to ALT ≥3 × ULN: 6 months.

Risk factors:

• History of significant liver disease (potential risk factor)

Lymphocytopenia/Infection

Reversible lymphocytopenia may occur during ozanimod therapy. Infections, including upper respiratory tract infection and urinary tract infection, have been reported; viral infections (eg, herpes zoster infection, herpes simplex infection) have also been reported. Infections may be serious, life-threatening, and potentially fatal. Fatal cryptococcal meningitis, disseminated cryptococcal infection, and progressive multifocal leukoencephalopathy cases have been reported with other sphingosine 1-phosphate (S1P) receptor modulators.

Mechanism: Dose-related; as an antagonist of the sphingosine 1-phosphate 1 receptor (S1P_1R), ozanimod results in the blocking of S1P_1R receptors on lymphocytes, a necessary signal for their release from peripheral lymphoid organs, causing a reduction in number of circulating lymphocytes. Sequestered lymphocytes remain in peripheral lymphoid organs preventing their movement to sites of inflammation where they would typically contribute to immune-mediated pathology (Ref).

Onset: Rapid; a single oral dose reduced circulating lymphocytes in a rapidly reversible manner (Ref).

Macular edema

Macular edema has occurred with ozanimod therapy. An increased risk of macular edema is also associated with other sphingosine 1-phosphate (S1P) receptor modulators.

Risk factors:

• History of diabetes

• History of uveitis

Respiratory effects

Decrease in forced vital capacity (FVC) and reduced forced expiratory volume over 1 second (FEV₁) have occurred with ozanimod therapy. There is insufficient evidence to determine whether changes in FEV₁ or FVC are reversible with drug discontinuation.

Mechanism: Dose-related; mechanism is unknown.

Onset: Varied; may occur as early as 3 months after therapy initiation.

Progressive multifocal leukoencephalopathy and sequelae

Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients taking sphingosine 1-phosphate (S1P) receptor modulators, including ozanimod (Ref). Symptoms may include progressive weakness on one side of the body or clumsiness of limbs, vision disturbances, and mental status changes. Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients who discontinued S1P receptor modulator therapy due to developing PML and can result in a rapid decline in patient condition, including characteristic changes on MRI, neurological symptoms, and death.

Mechanism: An opportunistic viral infection of the brain caused by the John Cunningham (JC) virus.

Onset: PML: Symptoms progress over days to weeks. IRIS: Occurred within a few months after discontinuation in most cases.

Risk factors:

• Longer duration of use (≥18 months)

• Use in immunocompromised patients

• Polytherapy with immunosuppressants

Posterior reversible encephalopathy syndrome

Posterior reversible encephalopathy syndrome (PRES) has been observed in patients taking sphingosine 1-phosphate receptor modulators, including ozanimod. Symptoms are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Permanent neurological sequelae may result from delayed diagnosis and treatment.

Onset: Delayed; in the single case report of PRES with ozanimod, onset was 10 months after starting therapy (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Hepatic: Increased liver enzymes (5% to 11%, including hyperbilirubinemia, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase) (table 1)Increased Liver Enzymes

**Ozanimod: Adverse Reaction: Increased Liver Enzymes**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
10%	5%	N/A	Multiple sclerosis	882	885	N/A
11%	N/A	2%	Ulcerative colitis	230	N/A	227
5%	N/A	0%	Ulcerative colitis	496	N/A	281

Infection: Infection (10% to 35%; serious infection: ≤1%) (table 2)Infection

**Ozanimod: Adverse Reaction: Infection**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)	Comments
35%	34%	N/A	Multiple sclerosis	882	885	N/A	N/A
1%	0.8%	N/A	Multiple sclerosis	882	885	N/A	Serious infection
23%	N/A	12%	Ulcerative colitis	230	N/A	227	N/A
10%	N/A	11%	Ulcerative colitis	496	N/A	281	N/A
0.9%	N/A	2%	Ulcerative colitis	230	N/A	227	Serious infection
0.8%	N/A	0.4%	Ulcerative colitis	496	N/A	281	Serious infection

Respiratory: Upper respiratory tract infection (5% to 26%) (table 3)Upper Respiratory Tract Infection

**Ozanimod: Adverse Reaction: Upper Respiratory Tract Infection**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
26%	23%	N/A	Multiple sclerosis	882	885	N/A
5%	N/A	4%	Ulcerative colitis	496	N/A	281

1% to 10%:

Cardiovascular: Hypertension (1% to 4%) (table 4)Hypertension, orthostatic hypotension (4%) (table 5)Orthostatic Hypotension, peripheral edema (3%)

**Ozanimod: Adverse Reaction: Hypertension**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
4%	2%	N/A	Multiple sclerosis	882	885	N/A
2%	N/A	2%	Ulcerative colitis	230	N/A	227
1%	N/A	0%	Ulcerative colitis	496	N/A	281

**Ozanimod: Adverse Reaction: Orthostatic Hypotension**
Drug (Ozanimod)		Comparator (Interferon Beta-1a)	Indication	Comparator Dose	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)
4%		3%	Multiple sclerosis	30 mcg once weekly	882	885

Gastrointestinal: Nausea (3%), upper abdominal pain (2%)

Genitourinary: Urinary tract infection (4%) (table 6)Urinary Tract Infection

**Ozanimod: Adverse Reaction: Urinary Tract Infection**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)		Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)
4%	3%		Multiple sclerosis	882	885

Hematologic & oncologic: Lymphocytopenia (2% to 3%)

Hepatic: Increased serum alanine aminotransferase (3 × ULN: 2% to 6%; 5 × ULN: ≤2%) (table 7)

**Ozanimod: Adverse Reaction: Increased Serum Alanine Aminotransferase**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
3 × ULN: 6%	3%	N/A	Multiple sclerosis	882	885	N/A
5 × ULN: 2%	1%	N/A	Multiple sclerosis	882	885	N/A
3 × ULN: 3%	N/A	0.5%	Ulcerative colitis	429	N/A	216
3 × ULN: 2%	N/A	0%	Ulcerative colitis	230	N/A	227
5 × ULN: 0.9%	N/A	0.5%	Ulcerative colitis	429	N/A	216
5 × ULN: 0.9%	N/A	0%	Ulcerative colitis	230	N/A	227

Infection: Herpes zoster infection (≤2%) (table 8)Herpes Zoster Infection

**Ozanimod: Adverse Reaction: Herpes Zoster Infection**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
0.6%	0.2%	N/A	Multiple sclerosis	882	885	N/A
2%	N/A	0.4%	Ulcerative colitis	230	N/A	227
0.4%	N/A	0%	Ulcerative colitis	496	N/A	281

Nervous system: Headache (4% to 5%)

Neuromuscular & skeletal: Arthralgia (3%), back pain (4%)

Miscellaneous: Fever (3%)

<1%:

Cardiovascular: Bradycardia (table 9)Bradycardia, hypertensive crisis

**Ozanimod: Adverse Reaction: Bradycardia**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)	Comments
0.8%	0.7%	N/A	Multiple sclerosis	882	885	N/A	After day 1 of treatment
0.6%	0%	N/A	Multiple sclerosis	882	885	N/A	Reported on the day of treatment
0.2%	N/A	0%	Ulcerative colitis	496	N/A	281	After day 1 of treatment
0.2%	N/A	0%	Ulcerative colitis	496	N/A	281	Reported on the day of treatment

Nervous system: Posterior reversible encephalopathy syndrome

Ophthalmic: Macular edema (table 10)Macular Edema

**Ozanimod: Adverse Reaction: Macular Edema**
Drug (Ozanimod)	Comparator (Interferon Beta-1a)	Placebo	Indication	Number of Patients (Ozanimod)	Number of Patients (Interferon Beta-1a)	Number of Patients (Placebo)
0.3%	0.3%	N/A	Multiple sclerosis	882	885	N/A
0.4%	N/A	0%	Ulcerative colitis	230	N/A	227
0.2%	N/A	0%	Ulcerative colitis	496	N/A	281

Frequency not defined:

Dermatologic: Basal cell carcinoma of skin, malignant melanoma

Genitourinary: Cervical carcinoma, malignant neoplasm of breast, testicular neoplasm (seminoma)

Hematologic & oncologic: Adenocarcinoma (including rectal adenocarcinoma)

Hypersensitivity: Hypersensitivity reaction

Infection: Herpes simplex infection

Respiratory: Decrease in forced vital capacity, reduced forced expiratory volume

Postmarketing:

Dermatologic: Squamous cell carcinoma of skin

Hematologic & oncologic: Kaposi sarcoma (Sandlow 2023)

Hepatic: Hepatic injury (including acute hepatic failure)

Nervous system: Progressive multifocal leukoencephalopathy (Sriwastava 2022)

Contraindications

Myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III or IV heart failure in the last 6 months; Mobitz type II second- or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial block, unless the patient has a functioning pacemaker; severe untreated sleep apnea; concomitant use of a monoamine oxidase inhibitor.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to ozanimod or any component of the formulation; patients at increased risk of opportunistic infections, including those who are immunocompromised due to treatment (eg, antineoplastic, immunosuppressive or immunomodulating therapies, total lymphoid irradiation, bone marrow transplantation) or disease (eg, immunodeficiency syndrome); severe active infections, including active chronic bacterial, fungal, or viral infections (eg, hepatitis, tuberculosis); known active malignancy (excluding basal cell carcinoma); pregnancy and women in childbearing years not using effective contraception.

Warnings/Precautions

Concerns related to adverse effects:

• Infections: Delay initiation of ozanimod in patients with active infections.

• Varicella zoster infections: Test for antibodies to varicella zoster virus (VZV) in patients without a health care professional–confirmed history of varicella (chickenpox) or without documentation of a full course of vaccination against VZV. In antibody-negative patients who require VZV vaccination, wait ≥1 month after a full vaccination course has been completed before initiating ozanimod treatment.

Disease-related concerns:

• Cardiovascular: Consult with a cardiologist before initiating ozanimod in individuals with significant QTc prolongation (QTcF >450 msec in males and >470 msec in females), with arrhythmias requiring treatment with class Ia or class III antiarrhythmic drugs, with ischemic heart disease, heart failure, cerebrovascular disease or uncontrolled hypertension, or those with a history of cardiac arrest, myocardial infarction, second-degree Mobitz type II or higher AV block, sick-sinus syndrome, or sinoatrial heart block.

• Hepatic impairment: Use is not recommended in patients with liver disease because the effects of hepatic impairment on the pharmacokinetics of ozanimod metabolites are unknown.

Other warnings/precautions:

• Discontinuation of therapy: In patients with multiple sclerosis, cases of rebound syndrome (clinical and radiological signs of severe exacerbation beyond what was expected) have been reported after stopping treatment with a sphingosine 1-phosphate receptor modulator. Monitor for development of immune reconstitution inflammatory syndrome in the setting of progressive multifocal leukoencephalopathy and severe increase in disability and begin appropriate treatment as needed. Rebound symptoms have included back and extremity pain, confusion, constipation, diplopia, facial muscle spasms, fatigue, increased leg weakness, nausea, paraparesis and paresthesias (Hatcher 2016; Willis 2017). Due to residual pharmacodynamic effects following treatment discontinuation (eg, decreased peripheral lymphocyte counts), use caution for 4 weeks after the last dose of therapy.

• Immunizations: Administer live-attenuated vaccines at least 1 month prior to administration of ozanimod. Avoid live-attenuated vaccines in patients who currently receive or have discontinued ozanimod in the past 3 months; consider using live-attenuated vaccines only if risk of infection is high and killed vaccines are unavailable (AAN [Farez 2019]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

Zeposia: 0.92 mg

Capsule Therapy Pack, Oral:

Zeposia Starter Kit: Ozanimod 0.23 mg (4 capsules), ozanimod 0.46 mg (3 capsules), and ozanimod 0.92 mg (21 capsules) (28 ea)

Capsule Therapy Pack, Oral, as hydrochloride:

Zeposia 7-Day Starter Pack: Ozanimod 0.23 mg (4 capsules) and ozanimod 0.46 mg (3 capsules) (7 ea)

Zeposia Starter Kit: Ozanimod 0.23 mg (4 capsules), ozanimod 0.46 mg (3 capsules), and ozanimod 0.92 mg (30 capsules) (37 ea [DSC])

Generic Equivalent Available: US

Pricing: US

Capsule Therapy Pack (Zeposia 7-Day Starter Pack Oral)

4 x 0.23MG &3 x 0.46MG (per each): $371.60

Capsule Therapy Pack (Zeposia Starter Kit Oral)

0.23MG &0.46MG0.92MG(21) (per each): $371.60

Capsules (Zeposia Oral)

0.92 mg (per each): $371.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Zeposia: 0.92 mg

Capsule Therapy Pack, Oral, as hydrochloride:

Zeposia Initiation Pack: Ozanimod 0.23 mg (4 capsules) and ozanimod 0.46 mg (3 capsules) (7 ea)

Administration: Adult

Oral: Swallow capsules whole, with or without food.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Zeposia: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf#page=25

Use: Labeled Indications

Multiple sclerosis, relapsing: Treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adults.

Medication Safety Issues

Sound-alike/look-alike issues:

Ozanimod may be confused with fingolimod.

Metabolism/Transport Effects

Substrate of BCRP, CYP2C8 (Major), CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Alemtuzumab: May increase immunosuppressive effects of Ozanimod. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Bradycardia-Causing Agents: Ozanimod may increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider Therapy Modification

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

Corticosteroids (Systemic): May increase immunosuppressive effects of Ozanimod. Risk C: Monitor

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP2C8 Inducers (Moderate): May decrease active metabolite exposure of Ozanimod. CYP2C8 Inducers (Moderate) may decrease serum concentration of Ozanimod. Risk X: Avoid

CYP2C8 Inhibitors (Moderate): May increase active metabolite exposure of Ozanimod. Risk C: Monitor

CYP2C8 Inhibitors (Strong): May increase active metabolite exposure of Ozanimod. Risk X: Avoid

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider Therapy Modification

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor

Immunosuppressants (Cytotoxic Chemotherapy): Sphingosine 1-Phosphate (S1P) Receptor Modulators may increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Immunosuppressants (Miscellaneous Oncologic Agents): Sphingosine 1-Phosphate (S1P) Receptor Modulators may increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Immunosuppressants (Therapeutic Immunosuppressant Agents): Sphingosine 1-Phosphate (S1P) Receptor Modulators may increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Ivabradine: Bradycardia-Causing Agents may increase bradycardic effects of Ivabradine. Risk C: Monitor

Lacosamide: Bradycardia-Causing Agents may increase AV-blocking effects of Lacosamide. Risk C: Monitor

Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor

Methotrexate: May increase immunosuppressive effects of Sphingosine 1-Phosphate (S1P) Receptor Modulators. Risk C: Monitor

Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Monoamine Oxidase Inhibitors: Ozanimod may increase hypertensive effects of Monoamine Oxidase Inhibitors. Risk X: Avoid

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider Therapy Modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Siponimod: Bradycardia-Causing Agents may increase bradycardic effects of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider Therapy Modification

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tobacco (Smoked): May decrease serum concentration of Ozanimod. Risk C: Monitor

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Varicella Virus-Containing Vaccines: Ozanimod may increase adverse/toxic effects of Varicella Virus-Containing Vaccines. The risk of developing a clinical infection from the live vaccine may be increased. Ozanimod may decrease therapeutic effects of Varicella Virus-Containing Vaccines. Risk X: Avoid

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who may become pregnant. Elimination of ozanimod takes ~3 months; to avoid potential fetal harm, patients should use effective contraception to avoid becoming pregnant during therapy and for 3 months after discontinuing treatment.

In general, disease-modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy except in patients at high risk of MS activity (AAN [Rae-Grant 2018]). Consider other agents in patients at high risk of disease reactivation who are planning to become pregnant. Delaying pregnancy is recommended for patients with persistent high disease activity; when disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Agents other than ozanimod may be preferred to treat inflammatory bowel disease in patients planning to become pregnant. Disease management should be optimized prior to pregnancy (Mahadevan 2019).

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to ozanimod may cause fetal harm.

In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in patients at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).

Pregnancy outcome information following use of ozanimod in patients with ulcerative colitis is limited (Sandborn 2021). Inflammatory bowel disease is associated with adverse pregnancy outcomes, including an increased risk of miscarriage, premature delivery, delivery of a low birth weight infant, and poor maternal weight gain. Management of maternal disease should be optimized prior to pregnancy. When treatment for inflammatory bowel disease is needed in pregnant patients, agents other than ozanimod may be preferred (Mahadevan 2019).

Data collection to monitor pregnancy and infant outcomes following exposure to ozanimod for the treatment of MS is ongoing. Health care providers are encouraged to enroll patients exposed to ozanimod during pregnancy in the Zeposia Pregnancy Registry (https://www.zeposiapregnancyregistry.com or 1-877-301-9314). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if ozanimod is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

CBC, including lymphocyte counts (baseline [within 6 months], then as clinically necessary, and for 3 months after stopping therapy).

Hepatic monitoring: Baseline bilirubin and transaminase levels in all patients prior to therapy initiation (within 6 months); monitor bilirubin and liver enzymes in patients who develop symptoms of hepatic injury (eg, unexplained nausea/vomiting, right abdominal pain, fatigue, anorexia, jaundice, dark urine).

ECG (baseline); heart rate; BP; signs and symptoms of bradycardia.

Ophthalmologic exam (baseline evaluation of the fundus, including the macula; repeat as clinically indicated, especially if vision changes; monitor more frequently in patients with diabetes or a history of uveitis), blurred vision, decreased visual acuity.

Respiratory function (spirometry, including FEV1 and forced vital capacity) if clinically indicated; skin examination (baseline or shortly after initiation), promptly evaluate suspicious lesions; varicella zoster virus (VZV) antibodies (prior to starting treatment; in patients with no health care professional-confirmed history of chickenpox or without documented previous full series VZV vaccination); latent infection screening (eg, hepatitis, tuberculosis) in high-risk populations or in countries with high tuberculosis burden (baseline); brain MRI for PML signs; severe increase in disability following discontinuation of therapy; signs and symptoms of immune reconstitution inflammatory syndrome; signs/symptoms of PRES (eg, behavioral changes, cognitive deficits, cortical visual disturbances, any other neurological cortical symptom/sign, symptoms/signs suggestive of increased intracranial pressure). Monitor for signs and symptoms of infection during treatment and at least 4 weeks after discontinuation. Promptly evaluate and treat patients with symptoms and signs of an infection, such as opportunistic ones (eg, Cryptococcal meningitis, disseminated infections).

Mechanism of Action

Ozanimod has a high affinity to sphingosine 1-phosphate receptors 1 and 5. Ozanimod blocks the lymphocytes' ability to emerge from lymph nodes; therefore, the amount of lymphocytes available to the CNS and intestine is decreased.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: 5,590 L.

Protein binding: Ozanimod: ~98.2%; CC112273 (active metabolite): ~99.8%; CC1084037 (active metabolite): ~99.3%.

Metabolism: By multiple enzymes to form circulating major active metabolites CC112273 and CC1084037 and minor active metabolites RP101988, RP101075, and RP112509 with similar activity and selectivity for S1P1 and S1P5. ~94% of circulating total active drug exposure is represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%), in humans.

Ozanimod is metabolized by ALDH/ADH to form carboxylate metabolite RP101988 and by CYP3A4 to form RP101075.

RP101075 is metabolized by NAT-2 to form RP101442 or by MAO-B to form CC112273.

CC112273 is metabolized by CYP2C8 to form RP112509 or reduced to form CC1084037.

CC1084037 is metabolized by AKR 1C1/1C2 and/or 3β- and 11β-HSD to form CC112273.

Half-life elimination: Ozanimod: ~21 hours; CC112273 and CC1084037 (active metabolites): ~11 days.

Time to peak: ~6 to 8 hours.

Excretion: Urine: ~26% (inactive metabolites); feces: 37% (inactive metabolites).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function: Ozanimod, CC112273, CC1084037 last AUC was 60%, 98%, and 107%, respectively, greater in patients with mild hepatic impairment compared to healthy patients and 17%, 38%, and 61%, respectively, greater in patients with moderate hepatic impairment compared to healthy patients.

Elderly: CC112273 steady state AUC in ulcerative colitis patients >65 years of age was ~3% to 4% greater than patients 45 to 65 years of age and 27% greater than patients <45 years of age.

Smoking: CC112273 steady-state AUC was ~50% lower in smokers compared to nonsmokers; the clinical impact of this difference is not significant.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Zeposia;
(AR) Argentina: Osiren ms | Zeposia;
(AT) Austria: Zeposia;
(AU) Australia: Zeposia;
(BE) Belgium: Zeposia;
(CH) Switzerland: Zeposia;
(CZ) Czech Republic: Zeposia;
(DE) Germany: Zeposia;
(ES) Spain: Zeposia;
(GB) United Kingdom: Zeposia;
(GR) Greece: Zeposia;
(HR) Croatia: Zeposia;
(HU) Hungary: Zeposia;
(IE) Ireland: Zeposia;
(IT) Italy: Zeposia;
(JP) Japan: Zeposia;
(LU) Luxembourg: Zeposia;
(NL) Netherlands: Zeposia;
(NO) Norway: Zeposia;
(PL) Poland: Zeposia;
(PR) Puerto Rico: Zeposia;
(PT) Portugal: Zeposia;
(QA) Qatar: Zeposia | Zeposia Initiation Pack;
(RU) Russian Federation: Zeposia;
(SE) Sweden: Zeposia;
(TW) Taiwan: Zeposia

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Zeposia (ozanimod) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; August 2024.
Zeposia (ozanimod) [product monograph]. Saint-Laurent, Quebec, Canada: Bristol-Myers Squibb Canada; August 2024.

Topic 127521 Version 147.0

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Ozanimod: Drug information