Zeposia Initiation Pack

The starting dose of Zeposia Initiation Pack (Ozanimod) is 0.23 mg taken by mouth once daily for the first 4 days. For the next 3 days (days 5 to 7) the daily dose is 0.46 mg. This gradual increase in dose helps to keep the heart rate from dropping too much and to prevent other side effects that can occur when starting Zeposia Initiation Pack (Ozanimod). After the first 7 days, the daily dose is 0.92 mg daily.

The starter pack of Zeposia Initiation Pack (Ozanimod) contains 7 capsules only. This is enough to complete the first 7 days of treatment before continuing with the maintenance dose. Capsules should be swallowed whole, with a glass of water. Do not break, crush, or chew the capsules. Zeposia Initiation Pack (Ozanimod) may be taken with or without food.

Depending on other medical conditions, you may be asked to take the first dose of Zeposia Initiation Pack (Ozanimod) in your doctor's office or clinic and stay at the office for at least 6 hours after the first dose. This will allow the doctor to monitor for side effects such as slowed heartbeat and treat the effects before they become an emergency.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Zeposia Initiation Pack (Ozanimod) exactly as prescribed by your doctor.

If you have been taking Zeposia Initiation Pack (Ozanimod) for less than 14 days and you forget to take a dose for one day or more, or if you stop taking Zeposia Initiation Pack (Ozanimod) for more than 7 days between weeks 2 to 4 of treatment, contact your doctor as soon as possible. Your doctor may choose to monitor you for heart and blood pressure effects before you restart the medication.

If Zeposia Initiation Pack (Ozanimod) is stopped for more than 2 weeks, contact your doctor. You will be monitored for heart and blood pressure effects again when you restart the medication. You will need to restart with the lowest available dose and gradually increase your daily dose as before.

After the first 2 weeks of treatment, if you miss a dose take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store Zeposia Initiation Pack (Ozanimod) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

0.23 mg
Each size 4, opaque hard gelatin capsule, with light grey body and light grey cap, imprinted in black ink with "OZA" on cap and "0.23 mg" on the body, contains 0.23 mg of Zeposia Initiation Pack (Ozanimod). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

0.46 mg
Each size 4, opaque hard gelatin capsule, with light grey body and orange cap, imprinted in black ink with "OZA" on cap and "0.46 mg" on the body, contains 0.46 mg of Zeposia Initiation Pack (Ozanimod). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

0.92 mg
Each size 4, opaque hard gelatin capsule, with orange body and orange cap, imprinted in black ink with "OZA" on cap and "0.92 mg" on the body, contains 0.92 mg of Zeposia Initiation Pack (Ozanimod). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; capsule shell: black iron oxide (E172), gelatin, pharmaceutical ink, red iron oxide (E172), titanium dioxide (E171), and yellow iron oxide (E172).

Initiation Pack
The "initiation pack" is a folding wallet containing 4 x 0.23 mg capsules and 3 x 0.46 mg capsules.

Do not take Zeposia Initiation Pack (Ozanimod) if you:

• are allergic to Zeposia Initiation Pack (Ozanimod) or any ingredients of the medication
• have a severe active infection or an active chronic infection such as hepatitis or Tuberculosis
• have a weakened immune system due to disease (e.g., immunodeficiency syndrome) or use medicines or treatments that suppress the immune system (e.g., to treat cancer or bone marrow transplantation)
• have an active cancer (except for a type of Skin Cancer called basal cell carcinoma)
• have had a Heart Attack, unstable Angina, Stroke, a Transient Ischemic Attack (mini-stroke), or heart failure in the past 6 months
• have severe irregular heartbeat and taking certain medications to treat the condition
• have heart block or sick-sinus syndrome and do not have a pacemaker
• are taking a monoamine oxidase inhibitor (MAOI), such as Tranylcypromine, Moclobemide, or Selegiline
• are or may become pregnant and are not using effective birth control

There may be an interaction between Zeposia Initiation Pack (Ozanimod) and any of the following:

• Abatacept
• alpha-agonists (e.g., Clonidine, methyldopa)
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• Anakinra
• antiarrhythmics (e.g., Amiodarone, Disopyramide, Dronedarone, Flecainide, Propafenone)
• anticancer medications (e.g., Capecitabine, Chlorambucil, Cladribine, Doxorubicin, Paclitaxel)
• atazanavir
• Atomoxetine
• Azathioprine
• Baricitinib
• BCG
• beta-2 agonists (e.g., formoterol, Indacaterol, olodaterol, salbutamol, salmeterol)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• calcium channel blockers (e.g., Diltiazem, Verapamil)
• Ceritinib
• clonidine
• Clopidogrel
• Cobicistat
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• Denosumab
• dexmethylphenidate
• Digoxin
• Donepezil
• Doxepin
• echinacea
• Eltrombopag
• Eluxadoline
• Etanercept
• Fentanyl
• Fingolimod
• Galantamine
• Gemfibrozil
• Guanfacine
• Haloperidol
• Hepatitis C antivirals (e.g., elbasvir, glecaprevir and pibrentasvir, grazoprevir, ledipasvir, velpatasvir, voxilaprevir)
• Ivabradine
• Lacosamide
• Lanreotide
• Leflunomide
• Linezolid
• lumacaftor and Ivacaftor
• Methadone
• methylene blue
• Methylphenidate
• mifepristone
• Mirtazapine
• monoamine oxidase inhibitors ((M.O.S. e.g., moclobemide, Phenelzine, tranylcypromine)
• monoclonal antibodies (e.g., alemtuzumab, Natalizumab, Rituximab, Sarilumab)
• mycophenolate
• Octreotide
• Pasireotide
• Pimecrolimus
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, Idelalisib, imatinib, Lapatinib, Nilotinib, Regorafenib)
• quinine
• rifampin
• Rivastigmine
• Roflumilast
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• siponimod
• Tacrolimus
• Teriflunomide
• Theophylline
• Tizanidine
• Tofacitinib
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine)
• Tryptophan
• upadacitinib
• vaccines
• Ziprasidone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Zeposia Initiation Pack (Ozanimod). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Zeposia Initiation Pack (Ozanimod).

Blood pressure: Zeposia Initiation Pack (Ozanimod) may increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how Zeposia Initiation Pack (Ozanimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zeposia Initiation Pack (Ozanimod), and whether any special monitoring is needed.

Additionally, foods with a high tyramine content are known to interact with Zeposia Initiation Pack (Ozanimod), which can cause severe increases in blood pressure. People taking Zeposia Initiation Pack (Ozanimod) should avoid aged, fermented, cured, smoked, and pickled foods. Examples included aged cheeses, smoked or pickled fish, processed meats and sausages, and yeast extracts. In particular, avoid meat, fish, or daily products that may have undergone protein breakdown by aging, pickling, fermentation, or smoking to improve flavour.

Cancer: Medications such as Zeposia Initiation Pack (Ozanimod) may increase your risk for certain cancers, particularly skin cancer. Your doctor will monitor you for skin cancer while you are taking Zeposia Initiation Pack (Ozanimod). Report any changes to your skin, such as change in size, colour, or shape of moles, to your doctor as soon as possible.

Depression: People with MS often experience depression more often than the general public. Zeposia Initiation Pack (Ozanimod) may contribute to the symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Zeposia Initiation Pack (Ozanimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zeposia Initiation Pack (Ozanimod), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Zeposia Initiation Pack (Ozanimod) contact your doctor as soon as possible.

Eye problems: People who have Diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. It is recommended that you have an eye examination after taking Zeposia Initiation Pack (Ozanimod) for 3 or 4 months to check for changes in your eyes that have not caused symptoms. Report any changes in vision to your doctor as soon as possible.

Heart problems: Zeposia Initiation Pack (Ozanimod) causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start Zeposia Initiation Pack (Ozanimod). You may be asked to stay at your doctor's office or clinic for 6 hours after your first dose to allow the doctor to monitor your heart rate and treat any problems before they become an emergency. It may be necessary to be monitored for a longer period of time if you develop very low heart rate or an irregular heartbeat.

If you have a heart problem, discuss with your doctor how Zeposia Initiation Pack (Ozanimod) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zeposia Initiation Pack (Ozanimod), and whether any special monitoring is needed.

Infections: Zeposia Initiation Pack (Ozanimod) works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking Zeposia Initiation Pack (Ozanimod) may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible. Zeposia Initiation Pack (Ozanimod) stays in your body for about 3 months after you stop taking it, so you will continue to be at risk of infection during this time.

Liver function: People taking Zeposia Initiation Pack (Ozanimod) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Zeposia Initiation Pack (Ozanimod). If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Zeposia Initiation Pack (Ozanimod). PML is a rare viral infection that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes, or difficulty walking, contact your doctor immediately.

Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare disease of the brain that may occur when using Zeposia Initiation Pack (Ozanimod). If you have had a previous episode of PRES, this may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of PRES, such as headache, nausea, vomiting, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

Serotonin syndrome: Severe reactions are possible when Zeposia Initiation Pack (Ozanimod) is combined with other medications that act on serotonin, such as serotonin reuptake inhibitors, medications used to treat depression, and certain migraine medications. These combinations should be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible.

Stopping Zeposia Initiation Pack (Ozanimod): Zeposia Initiation Pack (Ozanimod) works while it is being taken properly. Because it stays in the body for a long period of time, you may experience the benefit of having taken Zeposia Initiation Pack (Ozanimod) for several weeks after stopping. After that, symptoms of MS may return and be more severe than before starting to take Zeposia Initiation Pack (Ozanimod). Speak to your doctor before stopping Zeposia Initiation Pack (Ozanimod).

Vaccines: Talk to your doctor to determine whether you need any vaccines before starting treatment. During and for up to 3 months after stopping treatment you should avoid any vaccines containing live viruses.

Pregnancy: Zeposia Initiation Pack (Ozanimod) may cause harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking Zeposia Initiation Pack (Ozanimod), contact your doctor immediately. Women who could become pregnant who are taking Zeposia Initiation Pack (Ozanimod) should use an effective method of birth control (e.g., birth control pill, condoms) during treatment, and for 3 months after stopping treatment with Zeposia Initiation Pack (Ozanimod).

Breast-feeding: It is not known if Zeposia Initiation Pack (Ozanimod) passes into breast milk. If you are breast-feeding and are taking Zeposia Initiation Pack (Ozanimod), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Zeposia Initiation Pack (Ozanimod) have not been established for children.