Drug Detail:Ozanimod (Ozanimod [ oh-zan-i-mod ])
Drug Class: Selective immunosuppressants
Usual Adult Dose for Multiple Sclerosis
DOSE TITRATION REGIMEN:
- Days 1 through 4: 0.23 mg orally once a day
- Days 5 through 7: 0.46 mg orally once daily
- Day 8 and thereafter: 0.92 mg orally once a day
MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8
Uses:
- For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
- For the treatment of moderately to severely active ulcerative colitis
Usual Adult Dose for Ulcerative Colitis
DOSE TITRATION REGIMEN:
- Days 1 through 4: 0.23 mg orally once a day
- Days 5 through 7: 0.46 mg orally once daily
- Day 8 and thereafter: 0.92 mg orally once a day
MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8
Uses:
- For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
- For the treatment of moderately to severely active ulcerative colitis
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Not recommended.
Dose Adjustments
REINITIATION OF THERAPY AFTER INTERRUPTION:
- If a dose is missed during the first 2 weeks of therapy, reinitiate therapy using the titration regimen.
- If a dose is missed after the first 2 weeks of therapy, continue with the dosing as planned.
Precautions
CONTRAINDICATIONS:
- Patients, who in the last 6 months, have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure
- Patients who have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless the patient has a functioning pacemaker
- Patients who have severe untreated sleep apnea
- Patients who are taking a monoamine oxidase (MAO) inhibitor
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Swallow capsules whole; do not divide, chew, or crush.
- This drug may be administered with or without food.
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
Monitoring:
Before initiation of therapy, assess the following:
- Delay therapy in patients with an active infection until the infection is resolved.
- Complete blood count (CBC)
- Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) CBC, including lymphocyte.
- Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present.
- In patients with preexisting conditions, advice from a cardiologist should be sought.
- Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels.
- In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula.
- If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating therapy with this drug.
- Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction.
- Test patients for antibodies to varicella zoster virus (VZV) before initiating this drug; VZV vaccination of antibody-negative patients is recommended prior to commencing therapy with this drug.
- If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of this drug.
Patient advice:
- Advise the patient to read the approved patient labeling (Medication Guide).
- Before taking this drug tell your healthcare provider if you have a fever or infection, or you are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system.
- Inform your healthcare provider if you have received a vaccine in the past 30 days or are scheduled to receive a vaccine.
- Before you start treatment with this drug, your healthcare provider may give you a chicken pox (Varicella Zoster Virus) vaccine if you have not had one before.
- Inform you healthcare provider about all the prescription and non-prescription medications that you take or have recently taken.
- Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea.
- Advise patients that they should contact their healthcare provider if they have any unexplained nausea, sudden onset of severe headache, altered mental status, visual disturbances, seizure. vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
- Advise patients that this drug may cause macular edema, and that they should contact their healthcare provider if they experience any changes in their vision.
- Advise patients that they may continues to have side effects, such as lowering effects on peripheral lymphocyte count, for up to 3 months after the last dose.
Frequently asked questions
- What are the new drugs used for multiple sclerosis (MS)?
- Is Zeposia (ozanimod) a biologic? How does it work?
- How long does it take Zeposia (ozanimod) to work?
- Why does Zeposia (ozanimod) slow down your heart rate?
