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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
  • Dexmethylphenidate
  • Dextroamphetamine
  • Furazolidone
  • Hydroxyamphetamine
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Lisdexamfetamine
  • Methamphetamine
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • Selegiline
  • Serdexmethylphenidate
  • Tranylcypromine
  • Viloxazine

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
  • 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
  • Butorphanol
  • Capmatinib
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Cholera Vaccine, Live
  • Ciprofloxacin
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Darolutamide
  • Dasatinib
  • Degarelix
  • Delamanid
  • Dengue Tetravalent Vaccine, Live
  • Desipramine
  • Deslorelin
  • Desvenlafaxine
  • Deutetrabenazine
  • Diacetylmorphine
  • Dibenzepin
  • Difenoxin
  • Dihydrocodeine
  • Diphenoxylate
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Dronedarone
  • Droperidol
  • Duloxetine
  • Ebastine
  • Ebola Zaire Vaccine, Live
  • Efavirenz
  • Eltrombopag
  • Enasidenib
  • Encorafenib
  • Entrectinib
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Ethylmorphine
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluvoxamine
  • 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
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Levomilnacipran
  • Levorphanol
  • Lofepramine
  • Lofexidine
  • Lumefantrine
  • Macimorelin
  • Measles Virus Vaccine, Live
  • Mefloquine
  • Melitracen
  • Meperidine
  • Mesoridazine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Midostaurin
  • Mifepristone
  • Milnacipran
  • Mizolastine
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Mumps Virus Vaccine, Live
  • Nafarelin
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Nicomorphine
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Osimertinib
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Papaveretum
  • Papaverine
  • Paregoric
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Pimavanserin
  • Pimozide
  • Pipamperone
  • Piperaquine
  • Piritramide
  • Pitolisant
  • Poliovirus Vaccine, Live
  • Posaconazole
  • 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
  • Vandetanib
  • Vardenafil
  • Varicella Virus Vaccine, Live
  • Velpatasvir
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Vortioxetine
  • Voxilaprevir
  • Yellow Fever Vaccine
  • Ziprasidone
  • Zoster Vaccine, Live
  • Zotepine
  • Zuclopenthixol

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—

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.

  • 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.

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.

Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

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
changes in vision
chest pain, tightness, or discomfort
difficulty in moving
drowsiness
hives, itching, or skin rash
irritation
joint pain, stiffness, or swelling
muscle pain or stiffness
nausea
painful cold sores or blisters on the lips, nose, eyes, or genitals
redness of the skin
seizures
severe headache
stiff neck or back
stomach pain, continuing
sweating
swelling of the eyelids, face, lips, hands, or feet
trouble swallowing
vomiting

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: 8/5/2022

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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