Ozanimod

What is Ozanimod?

Ozanimod (ZEPOSIA) is a sphingosine 1-phosphate receptor modulator.

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What are the uses of this medicine?

This medicine is used to treat:

• adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• adults with moderately to severely active ulcerative colitis.

How does this medicine work?

• Ozanimod orally bioavailable sphingosine-1-phosphate (s1p) receptors 1 (s1pr1, s1p1) and 5 (s1pr5, s1p5) modulator, with potential anti-inflammatory and immunomodulating activities.
• ozanimod selectively targets and binds to s1pr1 on lymphocytes and induces s1pr1 internalization and degradation.
• This results in the sequestration of lymphocytes in lymph nodes.
• By preventing egress of lymphocytes, ozanimod reduces both the amount of circulating peripheral lymphocytes and the infiltration of lymphocytes into target tissues.
• This prevents a lymphocyte-mediated immune response and may reduce inflammation.
• S1pr1, a g-protein coupled receptor, plays a key role in lymphocyte migration from lymphoid tissues.
• Modulation of s1pr5 by ozanimod may be neuroprotective.

Who Should Not Use this medicine ?

• This medicine cannot be used in patients with:
• have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months.
• have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker.
• have untreated, severe breathing problems during your sleep (sleep apnea).
• take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid).

What drug interactions can this medicine cause?

• Avoid use of live attenuated vaccines during and for up to 3 months after treatment with ZEPOSIA.
• Initiating treatment with ZEPOSIA after alemtuzumab is not recommended because of the characteristics and duration of alemtuzumab immune suppressive effects.
• ZEPOSIA can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
• Co-administration of ZEPOSIA with drugs or over-the-counter medications that can increase norepinephrine or serotonin (e.g., opioid drugs, SSRIs, SNRIs, tricyclics, tyramine) is not recommended.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Assessments are required prior to initiating ZEPOSIA.
• Titration is required for treatment initiation

Recommended Dosage

• The recommended maintenance dosage is 0.92 mg orally once daily.
• If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned.

Administration You will receive a 7-day starter pack. You must start ZEPOSIA by slowly increasing doses over the first week. Follow the dose schedule as given below:

• Days 1-4:Take 0.23 mg (capsule in light grey color) 1 time a day
• Days 5-7:Take 0.46 mg (capsule in half-light grey and half-orange color) 1 time a day
• Days 8 and thereafter: Take 0.92 mg (capsule in orange color) 1 time a day

• Take ZEPOSIA exactly as your healthcare provider tells you to take it.
• Take ZEPOSIA 1 time each day.
• Swallow ZEPOSIA capsules whole.
• Take ZEPOSIA with or without food.
• Avoid certain foods that are high (over 150 mg) in tyramine such as aged, fermented, cured, smoked and pickled foods. Eating these foods while taking ZEPOSIA may increase your blood pressure.
• Do not stop taking ZEPOSIA without talking with your healthcare provider first.
• Do not skip a dose.
• Start taking ZEPOSIA with a 7-day starter pack.
• If you miss 1 or more days of your ZEPOSIA dose during the first 14 days of treatment, talk to your healthcare provider. You will need to begin with another ZEPOSIA 7-day starter pack.
• If you miss a dose of ZEPOSIA after the first 14 days of treatment, take the next scheduled dose the following day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 0.23 mg, 0.46 mg, 0.92 mg ozanimod

This medicine is available in fallowing brand namesː

• ZEPOSIA

What side effects can this medication cause?

Common possible side effects of this medicine include:

• upper respiratory tract infections
• elevated liver enzymes
• low blood pressure when you stand up (orthostatic hypotension)
• painful and frequent urination (signs of urinary tract infection)
• back pain
• high blood pressure
• headache

ZEPOSIA may cause serious side effects, including:

• liver problems
• increased blood pressure
• breathing problems
• a problem with your vision called macular edema
• swelling and narrowing of blood vessels in your brain
• severe worsening of multiple sclerosis (MS) after stopping ZEPOSIA

What special precautions should I follow?

• ZEPOSIA may increase the risk of infections. Obtain a complete blood count (CBC) before initiation of treatment. Monitor for infection during treatment and for 3 months after discontinuation. Do not start ZEPOSIA in patients with active infections.
• ZEPOSIA may result in transient decrease in heart rate; titration is required for treatment initiation. Check an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting ZEPOSIA. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate.
• This medicine may cause liver injury. Discontinue if significant liver injury is confirmed. Obtain liver function tests before initiating ZEPOSIA.
• Women of childbearing potential should use effective contraception during treatment and for 3 months after stopping ZEPOSIA.
• Monitor BP during treatment.
• This medicine may cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated
• A prompt ophthalmic evaluation is recommended if there is any change in vision while taking ZEPOSIA.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Ozanimod
• FDA Ozanimod

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