| What is the most important information I should know about PONVORY? |
| PONVORY may cause serious side effects, including: |
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Infections.PONVORY can increase your risk of serious infections that can be life-threatening and cause death. PONVORY lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 1 to 2 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking PONVORY.
Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with PONVORY and for 1 to 2 weeks after your last dose of PONVORY:
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- fever
- tiredness
- body aches
- chills
- nausea
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- vomiting
- headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)
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| Your healthcare provider may delay starting or may stop your PONVORY treatment if you have an infection. |
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Slow heart rate (bradycardia or bradyarrhythmia) when you start taking PONVORY.PONVORY can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of PONVORY.
Only start your treatment with PONVORY using the Starter Pack.You must use the PONVORY Starter Pack to slowly increase the dose over a 14-day period to help reduce the effect of slowing of your heart rate. It is important to follow the recommended dosing instructions. See "
How should I take PONVORY?"
Call your healthcare provider if you experience the following symptoms of slow heart rate:
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- dizziness
- lightheadedness
- feeling like your heart is beating slowly or skipping beats
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- shortness of breath
- confusion
- chest pain
- tiredness
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Follow directions from your healthcare provider when starting PONVORY and when you miss a dose. See
"
How should I take PONVORY?"
See "
What are possible side effects of PONVORY?" for more information about side effects.
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What is PONVORY?
- PONVORY is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- It is not known if PONVORY is safe and effective in children.
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| Do not take PONVORY if you: |
- have had a heart attack, chest pain called unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months.
- have certain types of heart block or irregular or abnormal heartbeat (arrhythmia), unless you have a pacemaker.
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| Talk to your healthcare provider before taking PONVORY if you have any of these conditions, or do not know if you have any of these conditions. |
| Before you take PONVORY, tell your healthcare provider about all of your medical conditions, including if you: |
- have a fever or infection, or you are unable to fight infections due to a disease or taking medicines that weaken your immune system.
- have had chicken pox or have received the vaccine for chicken pox. Your healthcare provider may do a blood test for chicken pox virus. You may need to get the full course of vaccine for chicken pox and then wait 1 month before you start taking PONVORY.
- have slow heart rate.
- have an irregular or abnormal heartbeat (arrhythmia).
- have a history of stroke.
- have heart problems, including a heart attack or chest pain.
- have breathing problems, including during your sleep (sleep apnea).
- have liver problems.
- have high blood pressure.
- had or now have a type of skin cancer called basal cell carcinoma (BCC), melanoma, or squamous cell carcinoma.
- have eye problems, especially an inflammation of the eye called uveitis.
- have diabetes.
- are pregnant or plan to become pregnant. PONVORY may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a woman who can become pregnant, you should use effective birth control during your treatment with PONVORY and for 1 week after you stop taking PONVORY. Talk to your healthcare provider about what method of birth control is right for you during this time. Tell your healthcare provider right away if you do become pregnant while taking PONVORY or within 1 week after you stop taking PONVORY.
- are breastfeeding or plan to breastfeed. It is not known if PONVORY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PONVORY.
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Tell your healthcare provider about all the medicines you take, includingprescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Using PONVORY and other medicines together may affect each other causing serious side effects.
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Especially tell your healthcare provider if you take or have taken:
- medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heart beat (such as calcium channel blockers or beta-blockers).
- medicines that affect your immune system, such as alemtuzumab.
- medicines such as rifampin, phenytoin, or carbamazepine.
- You should not receive
livevaccines during treatment with PONVORY, for at least 1 month before taking PONVORY, and for 1 to 2 weeks after you stop taking PONVORY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with PONVORY.
Talk with your healthcare provider if you are not sure if you take any of these medicines.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
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How should I take PONVORY?
You will receive a 14-day starter pack. You must start PONVORY by slowly increasing doses over the first two weeks. Follow the dose schedule in the table below. This may reduce the risk of slowing of the heart rate.
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| Starter Pack Day | Daily Dose | |
| Day 1 | 2 mg tablet 1 time a day | |
| Day 2 | 2 mg tablet 1 time a day | |
| Day 3 | 3 mg tablet 1 time a day | |
| Day 4 | 3 mg tablet 1 time a day | |
| Day 5 | 4 mg tablet 1 time a day | |
| Day 6 | 4 mg tablet 1 time a day | |
| Day 7 | 5 mg tablet 1 time a day | |
| Day 8 | 6 mg tablet 1 time a day | |
| Day 9 | 7 mg tablet 1 time a day | |
| Day 10 | 8 mg tablet 1 time a day | |
| Day 11 | 9 mg tablet 1 time a day | |
| Day 12 | 10 mg tablet 1 time a day | |
| Day 13 | 10 mg tablet 1 time a day | |
| Day 14 | 10 mg tablet 1 time a day | |
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| Maintenance | Daily Dose | |
| Day 15 and thereafter | 20 mg tablet 1 time a day | |
- Take PONVORY exactly as your healthcare provider tells you to take it.
- Take PONVORY 1 time each day.
- Swallow PONVORY tablets whole.
- Take PONVORY with or without food.
- Do not stop taking PONVORY without talking with your healthcare provider first.
- Do not skip a dose.
- Start taking PONVORY with a 14-day starter pack.
- If you miss taking 1, 2, or 3 tablets in a row of PONVORY in the 14-day starter pack, continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember. Then, take 1 tablet a day to continue with the starter pack dose as planned.
- If you miss taking 1, 2, or 3 tablets in a row of PONVORY while taking the 20 mg maintenance dose, continue treatment with the 20 mg maintenance dose.
- If you miss taking 4 or more tablets in a row of PONVORY, while taking the 14-day starter pack or the 20 mg maintenance dose, you need to restart treatment with a new 14-day starter pack. Call your healthcare provider if you miss 4 or more doses of PONVORY. Do not restart PONVORY after stopping it for 4 or more days in a row without talking to your healthcare provider. If you have certain heart conditions, you may need to be monitored by your healthcare provider for at least 4 hours when you take your next dose.
- Write down the date you start taking PONVORY so you will know if you miss 4 or more doses in a row.
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What are the possible side effects of PONVORY?
PONVORY may cause serious side effects, including:
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- See
"
What is the most important information I should know about PONVORY?"
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breathing problems.Some people who take PONVORY have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
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liver problems.PONVORY may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking PONVORY. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
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- unexplained nausea
- vomiting
- stomach (abdominal) pain
- tiredness
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- loss of appetite
- yellowing of the whites of your eyes or skin
- dark urine
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increased blood pressure.Your healthcare provider should check your blood pressure during treatment with PONVORY.
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types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma.Certain types of skin cancer have happened with drugs in the same class. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with PONVORY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
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a problem with your vision called macular edema. Tell your healthcare provider about any changes in your vision. Your healthcare provider should test your vision before you start taking PONVORY and any time you notice vision changes during treatment with PONVORY. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.
Call your healthcare provider right away if you have any of the following symptoms:
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- blurriness or shadows in the center of your vision
- a blind spot in the center of your vision
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- sensitivity to light
- unusually colored (tinted) vision
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swelling and narrowing of the blood vessels in your brain.A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you stop taking PONVORY. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms:
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- sudden severe headache
- sudden confusion
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- sudden loss of vision or other changes in your vision
- seizure
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severe worsening of multiple sclerosis (MS) after stopping PONVORY.When PONVORY is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking PONVORY for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping PONVORY.
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The most common side effects of PONVORY include:
- upper respiratory tract infections
- elevated liver enzymes (abnormal liver tests)
- high blood pressure
These are not all of the possible side effects of PONVORY.
For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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| How should I store PONVORY? |
- Store PONVORY at room temperature between 68°F to 77°F (20°C to 25°C).
- Store PONVORY in the original package.
- The bottle of PONVORY contains a desiccant sachet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.
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| Keep PONVORY and all medicines out of the reach of children. |
| General information about the safe and effective use of PONVORY. |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PONVORY for conditions for which it was not prescribed. Do not give PONVORY to other people, even if they have the same symptoms that you have. It may harm them. |
| You can ask your healthcare provider or pharmacist for information about PONVORY that is written for health professionals. |
| What are the ingredients in PONVORY? |
| Active ingredient: ponesimod
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| Inactive ingredients: |
| Tablet core: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, silica colloidal anhydrous, and sodium lauryl sulfate.
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| Tablet coating: ferrosoferric oxide (included in 4 mg, 5 mg, 8 mg and 9 mg film-coated tablets), hydroxypropyl methylcellulose 2910, iron oxide red (included in 3 mg, 4 mg, 7 mg, 8 mg, 9 mg and 10 mg film-coated tablets), iron oxide yellow (included in 3 mg, 5 mg, 7 mg, 9 mg, 10 mg and 20 mg film-coated tablets), lactose monohydrate, polyethylene glycol 3350, titanium dioxide, and triacetin.
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Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, USA
© 2021 Janssen Pharmaceutical Companies
For more information, go to www.ponvory.com or call 1-800-526-7736.
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