Ozanimod (Oral route)

Pronunciation:

oh-ZAN-i-mod

Brand Names:

Zeposia

Dosage Forms:

Capsule

Classifications:

Therapeutic—

Immune Modulator

Pharmacologic—

Sphingosine 1-Phosphate Receptor Modulator

Uses of This Medicine:

Ozanimod is used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease. It is also used to treat moderate to severe ulcerative colitis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ozanimod in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ozanimod in the elderly. However, elderly patients are more likely to have liver or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amphetamine
Benzphetamine
Bupropion
Codeine
Desvenlafaxine
Dexmethylphenidate
Dextroamphetamine
Dextromethorphan
Duloxetine
Escitalopram
Fluoxetine
Fluvoxamine
Furazolidone
Gepirone
Hydroxyamphetamine
Iproniazid
Isocarboxazid
Levomilnacipran
Linezolid
Lisdexamfetamine
Methamphetamine
Methylene Blue
Milnacipran
Moclobemide
Nialamide
Paroxetine
Phenelzine
Procarbazine
Rasagiline
Safinamide
Selegiline
Serdexmethylphenidate
Tranylcypromine
Vilazodone
Viloxazine
Vortioxetine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate
Adenovirus Vaccine, Live
Albuterol
Alemtuzumab
Alfentanil
Alfuzosin
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Anagrelide
Anileridine
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bacillus of Calmette and Guerin Vaccine, Live
Bedaquiline
Benzhydrocodone
Bepridil
Buprenorphine
Buserelin
Butalbital
Butorphanol
Capmatinib
Ceritinib
Chloroquine
Chlorpromazine
Cholera Vaccine, Live
Ciprofloxacin
Cisapride
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clozapine
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Darolutamide
Dasatinib
Degarelix
Delamanid
Dengue Tetravalent Vaccine, Live
Desipramine
Deslorelin
Deutetrabenazine
Diacetylmorphine
Dibenzepin
Difenoxin
Dihydrocodeine
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Dronedarone
Droperidol
Ebastine
Ebola Zaire Vaccine, Live
Efavirenz
Eltrombopag
Enasidenib
Encorafenib
Entrectinib
Eribulin
Erythromycin
Ethylmorphine
Famotidine
Felbamate
Fentanyl
Fingolimod
Flecainide
Fluconazole
Formoterol
Foscarnet
Fosphenytoin
Galantamine
Gatifloxacin
Gemfibrozil
Gemifloxacin
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydromorphone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Influenza Virus Vaccine, Live
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Ketobemidone
Ketoconazole
Lapatinib
Leniolisib
Lenvatinib
Leuprolide
Levofloxacin
Levorphanol
Lofepramine
Lofexidine
Lumefantrine
Macimorelin
Measles Virus Vaccine, Live
Mefloquine
Melitracen
Meperidine
Mesoridazine
Methadone
Methotrimeprazine
Metronidazole
Midostaurin
Mifepristone
Mizolastine
Momelotinib
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Mumps Virus Vaccine, Live
Nafarelin
Nalbuphine
Nefazodone
Nelfinavir
Nicomorphine
Nilotinib
Norepinephrine
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Osimertinib
Oxycodone
Oxymorphone
Paliperidone
Panobinostat
Papaveretum
Papaverine
Paregoric
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenobarbital
Pimavanserin
Pimozide
Pipamperone
Piperaquine
Piritramide
Pitolisant
Poliovirus Vaccine, Live
Posaconazole
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Remifentanil
Ribociclib
Rifampin
Risperidone
Ritonavir
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Saquinavir
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Smallpox Monkeypox Vaccine, Live Non-Replicating
Smallpox Vaccine
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sparfloxacin
Sufentanil
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tafamidis
Tamoxifen
Tapentadol
Telaprevir
Telavancin
Telithromycin
Terfenadine
Tetrabenazine
Thioridazine
Tianeptine
Tilidine
Tolterodine
Toremifene
Tramadol
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Typhoid Vaccine, Live
Valbenazine
Vandetanib
Vardenafil
Varicella Virus Vaccine, Live
Velpatasvir
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voriconazole
Vorinostat
Voxilaprevir
Yellow Fever Vaccine
Ziprasidone
Zoster Vaccine, Live
Zotepine
Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose
Chlorpropamide
Glimepiride
Glipizide
Glyburide
Insulin
Insulin Aspart, Recombinant
Insulin Bovine
Insulin Degludec
Insulin Detemir
Insulin Glargine, Recombinant
Insulin Glulisine
Insulin Lispro, Recombinant
Metformin
Nateglinide
Repaglinide
Tolazamide
Tolbutamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tyramine Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Angina (chest pain), unstable (within the last 6 months) or
Heart attack (within the last 6 months) or
Heart failure (within the last 6 months) or
Heart rhythm problems (eg, Mobitz type II second-degree, third-degree heart block, sick sinus syndrome), without a pacemaker or
Sleep apnea, severe and untreated or
Stroke, including transient ischemic attack (within the last 6 months)—Should not be used in patients with these conditions.

Breathing problems or
Heart rhythm problems (eg, slow heartbeat, QT prolongation) or
Hypertension (high blood pressure) or
Liver disease or
Lymphopenia (low white blood cells) or
Macular edema (swelling at the back of your eye)—Use with caution. May make these conditions worse.

Diabetes, history of or
Uveitis (eye problem), history of—May increase risk of macular edema.

Infection (eg, chicken pox, herpes zoster)—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush or chew it. You may take this medicine with or without food.

Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged or fermented, such as most cheese, most alcohol, cured meat (eg, salami), sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.

Dosing—

For oral dosage form (capsules):
- For multiple sclerosis and ulcerative colitis:
  - Adults—On Days 1 to 4, 0.23 milligrams (mg) once a day. Then, on Days 5 to 7, 0.46 mg once a day. And on Day 8 and after, 0.92 mg once a day.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

If you missed a dose during the first 2 weeks, you may need to restart the medicine from the Day 1 dosing regimen. If you missed a dose after the first 2 weeks, take the next scheduled dose the following day.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are also using an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, or Parnate®), or after receiving alemtuzumab (Campath®, Lemtrada®) within the past 14 days. Using these medicines together may cause serious unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Ozanimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

Herpes zoster and other serious infections may occur while taking this medicine. Symptoms include painful blisters on the trunk of your body, itching skin, rash, or trouble breathing. These symptoms should be treated first before taking this medicine.

While you are being treated with ozanimod, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should be given at least 3 months after your last dose of this medicine.

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision or any other change in vision occurs during treatment with this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common: Body aches or pain; cough or hoarseness; dark-colored urine; difficulty in breathing; ear congestion; fever or chills; general feeling of tiredness or weakness; headache; light-colored stools; loss of voice; lower back or side pain; painful or difficult urination; runny or stuffy nose; sneezing; sore throat; unusual tiredness or weakness; yellow eyes or skin

Less common: Bladder pain; bloody or cloudy urine; blurred vision; cold sweats; confusion; dizziness; dizziness, faintness, or lightheadedness when getting up from lying or sitting position; frequent urge to urinate; nervousness; pounding in the ears; slow or fast heartbeat

Rare: Painful blisters on the trunk of the body

Incidence not known: Back pain; burning or stinging of the skin; change in size, shape, or color of existing mole; changes in vision; chest pain, tightness, or discomfort; clear or bloody discharge from nipple; difficulty in moving; dimpling of breast skin; drowsiness; hives, itching, or skin rash; inverted nipple; irritation; joint pain, stiffness, or swelling; lump in the breast or under the arm; mole that leaks fluid or bleeds; muscle pain or stiffness; nausea; new mole; painful cold sores or blisters on the lips, nose, eyes, or genitals; persistent crusting or scaling of nipple; persistent non-healing sore; pink growth; reddish patch or irritated area; redness of the skin; redness or swelling of the breast; seizures; severe headache; shiny bump; sore on the skin of the breast that does not heal; stiff neck or back; stomach pain, continuing; sweating; swelling of the eyelids, face, lips, hands, or feet; trouble swallowing; vomiting; white, yellow or waxy scar-like area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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