Uses

What is Ponvory used for?

Ponvory (ponesimod) is commonly used to treat relapsing forms of multiple sclerosis (MS).

Ponvory may also be used for other conditions as determined by your healthcare provider.

How does Ponvory work (mechanism of action)?

In multiple sclerosis, lymphocytes (a part of your immune system) mistakenly attack myelin (a protective coating of the nerves) in your brain and spinal cord. Ponvory may lower the number of lymphocytes that can get into your brain and spinal cord to attack myelin.

How is Ponvory supplied (dosage forms)?

Brands and other names

  • Ponvory

Dosage forms and strengths

  • 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg oral tablets (starter pack)
  • 20 mg oral tablets

How should I store Ponvory?

Ponvory should be stored in the original packaging at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place. Do not remove the desiccant from the bottle, as this helps protect Ponvory from moisture.

Side Effects

What are the most common side effects of Ponvory?

The most common side effects of Ponvory are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Liver damage (see below)
  • Increased blood pressure (see below)

There may be other side effects of Ponvory that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ponvory?

While less common, the most serious side effects of Ponvory are described below, along with what to do if they happen.

Severe Allergic Reactions. Ponvory may cause allergic reactions, which can be serious. Stop taking Ponvory and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Breathing Problems. Ponvory may cause you to have shortness of breath. Call your healthcare provider right away if you have new breathing problems or breathing problems that seem to be worse while taking Ponvory.

Infections. Ponvory may increase your risk of serious infections because it lowers your lymphocytes (white blood cells that fight infection). Some of these infections can be life threatening. If you have taken or currently take medicine that weakens your immune system, your risk for infection may be higher. Stop taking Ponvory and talk to your healthcare provider if you have the following signs of infection while you are taking Ponvory or within two weeks after stopping it.

Progressive Multifocal Leukoencephalopathy (PML). People taking Ponvory may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop taking Ponvory and call your healthcare provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Heart Rate Changes. Ponvory can make your heart beat slower than normal (bradycardia) when you first start taking it. Your health care provider will likely do an electrocardiogram (ECG) before you start taking Ponvory to look at the electrical activity of your heart. When you start taking Ponvory, you will use a starter pack (starts with a low dose and slowly increases it). Follow the starter pack directions to reduce your risk of bradycardia. Call your healthcare provider right away if you have any of the following symptoms of bradycardia. 

  • Lightheadedness, dizziness, or fainting
  • Confusion
  • Feeling weak or easily tired
  • Slow heartbeat or feeling of skipped heartbeats 
  • Chest pain
  • Shortness of breath

Liver Damage. Liver damage, also called hepatotoxicity, may happen when taking Ponvory. Keep all appointments to have your blood checked. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure. Ponvory may increase your blood pressure or make your high blood pressure (hypertension) worse. Your healthcare provider will likely monitor your blood pressure while you are taking Ponvory. Tell your healthcare provider if you check your blood pressure and it is high or higher than usual.

Skin Cancer. Ponvory may increase your risk of skin cancer, such as basal cell carcinoma, melanoma, and squamous cell carcinoma. Limit the amount of time you spend in the sun while taking Ponvory. Wear protective clothing and use sunscreen with a high sun protection factor. Keep any appointments to have your skin checked while taking Ponvory. Tell your healthcare provider if you notice any of the following symptoms of skin cancer.

  • Changes in a mole on your skin
  • A new darkened area on your skin
  • A sore that does not heal
  • Growths on your skin, such as a bump

Vision Problems. Ponvory may increase your risk  of macular edema. Macular edema happens when fluid builds up in the back of your eye. People with eye inflammation (uveitis) or diabetes may have a higher risk of macular edema while taking Ponvory. Your healthcare provider will likely check your vision before you start taking Ponvory. Keep any scheduled eye exams. Call your healthcare provider right away if you have any of the following symptoms suggestive of macular edema.

  • Blurriness or shadows in the middle of your vision
  • Light sensitivity
  • A blind spot in the middle of your vision
  • Unusually colored or tinted vision

Posterior Reversible Encephalopathy Syndrome (PRES). Ponvory may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your healthcare provider right away if you have the following symptoms of PRES.

  • Changes in thinking  or behavior
  • Confusion or hallucinations
  • Sudden decrease or change in vision 
  • Sudden severe headache
  • Seizures

Warnings & Precautions

Who should not use Ponvory?

Allergies to Ingredients. People who are allergic to any of the following should not take Ponvory.

  • Ponesimod
  • Ponvory
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ponvory.

Heart Problems. You should not take Ponvory if you have had any of the following heart problems in the last six months.

Heart Rhythm Problems. You should not take Ponvory if you have any of the following heart rhythm problems unless you have a working pacemaker.

  • Complete heart block (third-degree) or Mobitz type II second-degree atrioventricular (AV) block
  • Sick sinus syndrome
  • Sino-atrial block

What should I know about Ponvory before using it?

Do not take Ponvory unless it has been prescribed to you by a healthcare provider. Take it as prescribed. You will start taking a low dose of Ponvory and slowly increase the dose over two weeks, using a starter pack. After you finish the starter pack you will take the same dose of Ponvory every day.

Do not share Ponvory with other people, even if they have the same condition as you. It may harm them.

Keep Ponvory out of the reach of children.

Swallow the Ponvory tablets whole.

Before you start taking Ponvory, your healthcare provider will likely check your heart rate. If you have a slow heart rate or certain heart conditions, you may need to be observed in a hospital or clinic for about 4 hours after you take your first dose. Tell your healthcare provider about any heart conditions you have.

Do not suddenly stop taking Ponvory without talking to your healthcare provider. Stopping it suddenly may cause harmful effects. Call your healthcare provider if your symptoms of multiple sclerosis get worse after stopping Ponvory.

The effects of Ponvory on your immune system may last up to one or two weeks after you stop taking it.  Talk to your healthcare provider if you have any concerns.

If you took the medicine alemtuzumab, talk with your healthcare provider before taking Ponvory.

Before you start taking Ponvory, your healthcare provider may check to see if you have antibodies against the varicella-zoster virus. If you need to get the varicella zoster vaccine you will likely wait about four weeks after receiving the vaccine before you start taking Ponvory. 

What should I tell my healthcare provider before using Ponvory?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ponvory is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Diabetes
  • Eye problems, such as inflammation of the eye (uveitis)
  • High blood pressure
  • Liver problems
  • Breathing problems or sleep apnea
  • Heart problems, such as a heart attack or chest pain
  • Stroke
  • Irregular heart rhythm (arrhythmia)
  • Slow heart rate
  • Fever, infection, or a weak immune system
  • Chickenpox infection
  • Skin cancer

Other Medicines and Supplements. Ponvory may interact with other medicines and supplements. Before using Ponvory, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section below for more details.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before, while taking, or for about two weeks after you stop taking Ponvory. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Pregnancy. Ponvory may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you can become pregnant, you should use effective birth control while taking Ponvory and for one week after you stop taking it. Tell your healthcare provider right away if you become pregnant while taking Ponvory or within one week after you stop taking it.

Breastfeeding. It is not known if Ponvory passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Ponvory while breastfeeding.

How can I get more information about Ponvory?

For more information about Ponvory, you can visit the manufacturer’s website at www.ponvory.com or call them at 800-526-7736.

Interactions

Does Ponvory interact with foods or drinks?

There are no known interactions between Ponvory and foods or drinks.

It is unknown if drinking alcohol will affect Ponvory, but both Ponvory and alcohol can cause liver damage. It is likely best to limit the amount of alcohol you drink while taking Ponvory.

Does Ponvory interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Ponvory.

  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • A medicine for high blood pressure
  • A beta-blocker, such as metoprolol (Lopressor, Toprol XL, and others), atenolol (Tenormin), or propranolol (Inderal LA, Innopran XL), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
  • Diltiazem (Cardizem CD and others), which is a medicine used for high blood pressure and other conditions
  • Verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or chest pain
  • Medicines that can cause QT prolongation, such as quinidine, procainamide, amiodarone, or sotalol, which is a potentially dangerous heart rhythm problem
  • A medicine used to control your heart rate or rhythm (antiarrhythmic)
  • Any medicine that affects or weakens your immune system
  • Antineoplastic medicine or chemotherapy, which is a medicine used to treat cancer 
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Alemtuzumab (Lemtrada, Campath), which is a medicine used to treat multiple sclerosis or a certain type of cancer

Many other medicines may alter the blood levels of Ponvory. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Ponvory. Always check with your healthcare provider.

Does Ponvory (ponesimod) interact with other drugs you are taking?
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Overdose/Missed Dose

What should I do if I accidentally use too much Ponvory?

If you or someone else has taken too much Ponvory, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ponvory?

Ponvory is taken once a day. Write down the date you start the medicine, so you will know if you miss four or more doses in a row.  If this happens, call your healthcare provider right away. Do not take Ponvory without talking with your healthcare provider because you may need to be monitored when you restart the medicine. If you miss up to three doses in a row, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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