Ozanimod (oral route)

Brand Name

US Brand Name

Zeposia

Description

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.

This product is available in the following dosage forms:

Capsule

Before Using

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.

Pediatric

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.

Geriatric

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.

Breastfeeding

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.

Drug Interactions

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
Carbamazepine
Citalopram
Codeine
Desvenlafaxine
Dexmethylphenidate
Dextroamphetamine
Dextromethorphan
Dihydrocodeine
Duloxetine
Escitalopram
Fluoxetine
Fluvoxamine
Gepirone
Hydroxyamphetamine
Isocarboxazid
Levomilnacipran
Linezolid
Lisdexamfetamine
Meperidine
Methamphetamine
Methylene Blue
Methylphenidate
Milnacipran
Morphine
Morphine Sulfate Liposome
Paroxetine
Phenelzine
Procarbazine
Rasagiline
Safinamide
Selegiline
Serdexmethylphenidate
Sertraline
Tramadol
Tranylcypromine
Venlafaxine
Vilazodone

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.

Adenovirus Vaccine Type 4, Live
Adenovirus Vaccine Type 7, Live
Albuterol
Alemtuzumab
Alfentanil
Alfuzosin
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amoxapine
Anagrelide
Anileridine
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asciminib
Asenapine
Astemizole
Atazanavir
Azithromycin
Bacillus of Calmette and Guerin Vaccine, Live
Bedaquiline
Benzhydrocodone
Bepridil
Buprenorphine
Buserelin
Butalbital
Butorphanol
Capmatinib
Carbidopa
Ceritinib
Chloroquine
Chlorpromazine
Cholera Vaccine, Live
Ciprofloxacin
Cisapride
Clarithromycin

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

Proper Use

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.

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

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. Your doctor will also check your skin for any changes before and during treatment with this medicine.

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.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may cause macular edema (swelling of the back of the eye). Check with your doctor right away if blurred vision, difficulty reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor (ophthalmologist) to check your eyes.

This medicine may increase your risk for skin cancer (eg, basal cell carcinoma, melanoma, squamous cell carcinoma). Tell your doctor right away if you notice any unusual moles, skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear protective clothing and sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

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

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
diarrhea
difficulty in moving
dimpling of breast skin
drowsiness
hives, itching, or skin rash
inverted nipple
irritation
joint pain, stiffness, or swelling
loss of appetite
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
shivering
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 sleeping
trouble swallowing
upper right stomach tenderness
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.

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