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ZEPOSIA is a brand name for Ozanimod, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZEPOSIA® (ozanimod) is indicated for: Multiple sclerosis (MS) • the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations. Ulcerative colitis • the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Prior to initiating treatment with ZEPOSIA the following assessments should be done to guide Product Monograph Master Template Template Date: September 2020 ZEPOSIA (ozanimod) Page 7 of 75 patient selection and treatment.
1 Pregnant Women and 9 DRUG INTERACTIONS for more complete information. 92 mg ozanimod dose via reversible retention in lymphoid organs and may increase the risk of infections. , within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count, before initiation of ZEPOSIA (see 7 WARNINGS AND PRECAUTIONS, Immune).
• Check varicella zoster virus (VZV) antibody status if there is no healthcare professional confirmed history of chickenpox or vaccination with varicella vaccine; VZV vaccination of antibody-negative patients is recommended, with a delay in treatment initiation for 1 month after vaccination (see 7 WARNINGS AND PRECAUTIONS, Immune).
• Vaccination against human papilloma virus (HPV) should be considered before initiating treatment with ZEPOSIA (see 7 WARNINGS AND PRECAUTIONS, Immune). • Delay the start of ZEPOSIA in patients with severe active infection until resolved (see 2 CONTRAINDICATIONS).
• In patients that are switched from previous MS therapies with a known association to progressive multifocal leukoencephalopathy (PML), a recent cerebral MRI should be considered before initiating treatment with ZEPOSIA to evaluate for findings suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Immune).
Cardiac effects Initiation of treatment with ZEPOSIA causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should: • Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present.
2 Drug Interactions Overview). 4 Administration). • For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
2 Clinical Trial Adverse Reactions). See 2 CONTRAINDICATIONS AND 7 WARNINGS AND PRECAUTIONS, Cardiovascular for more complete information regarding patients with certain cardiovascular conditions in which ZEPOSIA should not be used or may require additional monitoring.
). 1 Dosing Considerations for the cardiac assessments that should be performed before initiating treatment with ZEPOSIA. 4. Administration). 7bpm in the UC studies), returning to near baseline at Hour 6. With continued up-titration, the maximal heart rate effect of ozanimod occurred on Day 8.
Heart rates below 40 bpm were not observed. Initiation of ZEPOSIA without dose escalation may result in greater reductions in heart rate. 2 Recommended Dose and Dosage Adjustment). 5% of patients treated with ZEPOSIA compared to no patients who received IFN beta-1a.
7% of patients who received IFN beta-1a. 2% of patients treated with ozanimod and none in patients treated with placebo. 2% of patients treated with ozanimod. During the maintenance in TRUENORTH-M, bradycardia was not reported. 2 Clinical Trial Adverse Reactions, under Description of selected treatment emergent adverse events, for bradycardia events observed in MS and UC studies.
Atrioventricular Conduction Delays Initiation of ZEPOSIA may result in transient atrioventricular conduction delays. At ZEPOSIA exposures higher than the recommended dosage without dose titration, first- and second- degree type 1 atrioventricular blocks were observed in healthy volunteers; however, in the phase 3 clinical studies with dose titration, second- or third-degree atrioventricular blocks were not reported in patients treated with ZEPOSIA.
Treatment initiation recommendations in patients with certain cardiovascular conditions ZEPOSIA was not studied in patients who had: • Myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure (requiring inpatient treatment), or New York Heart Association Class III/IV heart failure (see 2 CONTRAINDICATIONS).
• Cardiac conduction or rhythm disorders, including complete left bundle branch block, sinus arrest or sino-atrial block, symptomatic bradycardia, sick sinus syndrome, Mobitz type II second degree AV block or higher grade AV block (either history or observed at screening), unless patient had a functioning pacemaker (see 2 CONTRAINDICATIONS).
, Cardiovascular). • In patients with a history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block, sick sinus syndrome, or sinoatrial block unless the patient has a functioning pacemaker (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
, immunodeficiency syndrome) (see 7 WARNINGS AND PRECAUTIONS, Immune). , hepatitis, tuberculosis), until resolution of the infection (see 7 WARNINGS AND PRECAUTIONS, Immune). • In patients with known active malignancies, except localized basal cell carcinoma of the skin (see 7 WARNINGS AND PRECAUTIONS, Neoplasm).
• In women (including female adolescents) who are pregnant or of childbearing potential not using effective contraception. 1 Pregnant Women). • With concomitant use of MAO inhibitors. ZEPOSIA should not be administered with other MAO inhibitors because of the increased risk of non-selective MAO inhibition that may lead to a hypertensive crisis.
4 Drug-Drug Interactions). 1 Dosing Considerations Prior to initiating treatment with ZEPOSIA the following assessments should be done to guide Product Monograph Master Template Template Date: September 2020 ZEPOSIA (ozanimod) Page 7 of 75 patient selection and treatment.
1 Pregnant Women and 9 DRUG INTERACTIONS for more complete information. 92 mg ozanimod dose via reversible retention in lymphoid organs and may increase the risk of infections. , within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count, before initiation of ZEPOSIA (see 7 WARNINGS AND PRECAUTIONS, Immune).
• Check varicella zoster virus (VZV) antibody status if there is no healthcare professional confirmed history of chickenpox or vaccination with varicella vaccine; VZV vaccination of antibody-negative patients is recommended, with a delay in treatment initiation for 1 month after vaccination (see 7 WARNINGS AND PRECAUTIONS, Immune).
ZEPOSIA is contraindicated: • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• In patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• In patients with a history or presence of second-degree atrioventricular (AV) block Type II or third-degree AV block, sick sinus syndrome, or sinoatrial block unless the patient has a functioning pacemaker (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
, immunodeficiency syndrome) (see 7 WARNINGS AND PRECAUTIONS, Immune). , hepatitis, tuberculosis), until resolution of the infection (see 7 WARNINGS AND PRECAUTIONS, Immune). • In patients with known active malignancies, except localized basal cell carcinoma of the skin (see 7 WARNINGS AND PRECAUTIONS, Neoplasm).
• In women (including female adolescents) who are pregnant or of childbearing potential not using effective contraception. 1 Pregnant Women). • With concomitant use of MAO inhibitors. ZEPOSIA should not be administered with other MAO inhibitors because of the increased risk of non-selective MAO inhibition that may lead to a hypertensive crisis.
4 Drug-Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ophthalmologic evaluation Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. It is recommended that patients with diabetes mellitus, uveitis or a history of retinal disorders undergo an ophthalmic evaluation prior to initiating ZEPOSIA therapy and during treatment (see 7 WARNINGS AND PRECAUTIONS, Ophthalmologic).
, within last 6 months) liver function test including transaminase and bilirubin levels prior to initiating treatment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). 3 Pharmacokinetics), which may increase the risk of adverse reactions.
2 Recommended Dose and Dosage Adjustment). Use of ZEPOSIA is not recommended in patients with severe hepatic impairment. Skin cancer Skin cancers have been reported in patients treated with S1P modulators, including ZEPOSIA. Monitor for suspicious skin lesions before initiating treatment with ZEPOSIA, particularly in patients with risk factors for skin cancer (see 7 WARNINGS AND PRECAUTIONS, Neoplasm).
1 Pregnant Women).
Product Monograph Master Template Template Date:
September 2020 ZEPOSIA (ozanimod) Page 9 of 75 • A negative pregnancy test must be obtained before initiation of treatment in women of childbearing potential. Current or prior medications For patients taking antineoplastic, non-corticosteroid immunosuppressive, or immune- modulating therapies, including other disease modifying treatments and corticosteroids, or if there is a history of prior use of such drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with ZEPOSIA (see 7 WARNINGS AND PRECAUTIONS, Immune).
2 Recommended Dose and Dosage Adjustment Treatment initiation Treatment has to be initiated in all patients with an initiation pack that lasts for 7 days. The initial dose escalation regimen of ZEPOSIA from Day 1 to Day 7 is […]
• Cardiac arrhythmias requiring treatment with Class Ia or III antiarrhythmic drugs.
Product Monograph Master Template Template Date:
September 2020 ZEPOSIA (ozanimod) Page 14 of 75 • Significant QT prolongation (QTcF >450 msec males, >470 msec females). • Severe untreated sleep apnea. • A resting heart rate less than 55 beats per minute (bpm) at baseline. If treatment with ZEPOSIA is considered in the context of the following cardiac conditions, an evaluation from a cardiologist should be sought prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects.
• Patients with a pre-existing significant QT prolongation (QTcF > 450 msec in males, > 470 msec in females). • Patients with ischemic heart disease, heart failure, a history of cardiac arrest or myocardial infarction, cerebrovascular disease, uncontrolled hypertension or severe untreated sleep apnea.
ZEPOSIA should not be used in these patients because significant bradycardia may be poorly tolerated. • Patients with a history of with second-degree Mobitz type II or higher AV block, sick- sinus syndrome, or sinoatrial heart block.
• A history of recurrent syncope or symptomatic bradycardia. • With arrhythmias requiring treatment with Class 1a or Class III antiarrhythmic drugs. g. ivabradine or digoxin). 2 Drug Interactions Overview). If concomitant treatment with a drug that reduces heart rate is considered during initiation of treatment with ZEPOSIA, advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering drugs or appropriate monitoring for treatment initiation.
Increased Blood Pressure In the MS pivotal clinical studies, patients treated with ZEPOSIA had an average increase of approximately 1 to 2 mm Hg in systolic pressure over patients who received interferon (IFN) β-1a, and no effect on diastolic pressure.
The increase in systolic pressure was first detected after approximately 3 months of treatment and persisted throughout treatment. 3% of patients who […]
• Vaccination against human papilloma virus (HPV) should be considered before initiating treatment with ZEPOSIA (see 7 WARNINGS AND PRECAUTIONS, Immune). • Delay the start of ZEPOSIA in patients with severe active infection until resolved (see 2 CONTRAINDICATIONS).
• In patients that are switched from previous MS therapies with a known association to progressive multifocal leukoencephalopathy (PML), a recent cerebral MRI should be considered before initiating treatment with ZEPOSIA to evaluate for findings suggestive of PML (see 7 WARNINGS AND PRECAUTIONS, Immune).
Cardiac effects Initiation of treatment with ZEPOSIA causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should: • Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present.
2 Drug Interactions Overview). 4 Administration). • For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
2 Clinical Trial Adverse Reactions). See 2 CONTRAINDICATIONS AND 7 WARNINGS AND PRECAUTIONS, Cardiovascular for more complete information regarding patients with certain cardiovascular conditions in which ZEPOSIA should not be used or may require additional monitoring.
Ophthalmologic evaluation Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. It is recommended that patients with diabetes mellitus, uveitis or a history of retinal disorders undergo an ophthalmic evaluation prior to initiating ZEPOSIA therapy and during treatment (see 7 WARNINGS AND PRECAUTIONS, Ophthalmologic).
, within last 6 months) liver function test including transaminase and bilirubin levels prior to initiating treatment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). Exposure to active metabolites of ozanimod, CC112273 and […]