All About Ponvory

What are Ponvory’s side effects?

Like most drugs, Ponvory may cause mild to serious side effects. The lists below describe some of the more common side effects the drug may cause, but don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Ponvory. They can also suggest ways to help reduce side effects.

Mild side effects

Below is a list of some of the mild side effects that Ponvory can cause. To learn about other mild side effects, talk with your doctor or pharmacist or read the drug’s prescribing information.

Mild side effects of Ponvory that have been reported include:

• upper respiratory infection, such as the common cold
• high liver enzyme levels*
• urinary tract infection (UTI)
• dizziness
• cough
• pain in your hands or feet
• sleepiness
• fever
• vertigo
• mild allergic reaction†

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* High liver enzyme levels usually don’t cause symptoms. But in rare cases, they may be a sign of liver injury, a serious side effect Ponvory may cause.
† To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Ponvory can occur, but they aren’t common. If you have serious side effects from this drug, call your doctor right away. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects of Ponvory that have been reported include:

• high blood pressure
• slowed heart rate or heart block
• low white blood cell count, which increases your risk of serious infection
• breathing problems, including shortness of breath
• liver injury
• skin cancer, including melanoma
• macular edema (fluid and protein buildup in a part of your eye called the retina)
• posterior reversible encephalopathy syndrome*
• severe allergic reaction†

* This side effect wasn’t reported in studies of Ponvory. But it has happened with other drugs similar to Ponvory used to treat multiple sclerosis (MS).
† To learn more about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Ponvory. Although it doesn’t appear allergic reaction was reported in studies of the drug, it can still happen.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Ponvory. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

What does Ponvory cost?

Prescription drug prices can vary depending on many factors. These include what your insurance plan covers and which pharmacy you use.

If you have questions about how to pay for Ponvory, talk with your doctor or pharmacist. A program called Janssen CarePath may be available. You can also check out this article to learn more about saving money on prescription drugs.

You can also check out this article to learn more about saving money on prescriptions.

What is Ponvory used for?

Ponvory is a prescription drug used to treat clinically isolated syndrome (CIS) and certain kinds of relapsing multiple sclerosis (MS) in adults.

About multiple sclerosis (MS)

MS is a chronic (long-term) autoimmune condition, which occurs when your immune system mistakenly attacks your body’s own cells.

Ponvory is used to treat the following MS-related conditions:

• CIS. CIS refers to the first episode of MS-like symptoms that last at least 24 hours. Although not everyone diagnosed with CIS will experience MS symptoms again, it’s still considered part of the MS disease course by the National MS Society.
• Relapsing-remitting MS (RRMS). Relapsing forms of MS, such as RRMS, involve periods of symptoms followed by remission. With remission, MS symptoms are mild or absent and don’t get worse. People with relapsing MS will experience cycles between periods of symptoms and periods of remission.
• Active secondary-progressive MS (SPMS). Active SPMS usually starts as RRMS, but MS symptoms continue to get worse over time.

With MS, your immune system attacks myelin, a protective tissue that wraps itself in layers around your nerve fibers. When myelin is damaged, your nervous system can’t function as it should. This can result in a wide range of symptoms.

MS symptoms can vary depending on the kind of MS you have, but some common symptoms include:

• trouble with coordination, balance, speech, or walking
• pain that doesn’t go away
• fatigue (low energy)
• vision problems, including blurry vision

What Ponvory does

Exactly how Ponvory works to treat MS isn’t clear. It’s thought the drug may work by reducing the number of immune system cells that are in your nervous system. (Remember that autoimmune conditions, including MS, are caused by your immune system mistakenly attacking your body’s own cells.)

What are some frequently asked questions about Ponvory?

Find answers to some commonly asked questions about Ponvory.

How does Ponvory compare with other drugs used for multiple sclerosis, such as Ocrevus or Aubagio?

If you’re considering treatment with Ponvory, you may wonder how it compares with other drugs for treating multiple sclerosis (MS).

This table shows a high-level comparison between Ponvory, Ocrevus, and Aubagio:

* This is an injection into a vein given over time.

Talk with your pharmacist or doctor to learn more about how Ponvory compares with other drugs used to treat MS.

Can Ponvory cause long-term side effects?

Yes, it’s possible for Ponvory to cause long-term side effects. But these are thought to be rare.

Long-term side effects refer to side effects that either:

• start during treatment and continue for a long time, possibly after treatment ends, or
• start after you’ve taken the drug for a long time or after ending treatment

According to the drug’s studies, possible long-term side effects from Ponvory include the following:

• Low white blood cell count. A low white blood count increases your risk of serious infection. You’re at risk of this side effect for as long as you take Ponvory.
• Breathing problems. It’s not clear whether breathing problems, such as shortness of breath, will go away if Ponvory treatment is stopped.
• Liver injury. Mild and moderate symptoms should go away once Ponvory is stopped. But it’s possible for liver injury to include damage that isn’t reversible.
• Skin cancer. Taking Ponvory increases your risk of developing skin cancers, including melanoma, throughout your treatment. It’s not clear whether you’re still at risk if you stop taking Ponvory.
• Macular edema. This is the name for fluid buildup in the part of your eye called the retina. Macular edema often goes away with treatment.

Talk with your doctor or pharmacist to learn more about Ponvory and possible long-term side effects it could cause.

Does Ponvory cure MS?

No, Ponvory doesn’t cure MS. There currently isn’t a cure for MS. But medications like Ponvory can help slow the condition’s progress and help stop or slow your symptoms worsening over time. (MS is a progressive disease, which means symptoms will worsen over time without treatment.)

What is Ponvory’s dosage?

Below are commonly used Ponvory dosages, but always take the dosage your doctor prescribes. They’ll recommend the right dosage for you.

Form and strengths

Ponvory comes as a tablet you swallow. It’s available in the following strengths:

• 2 milligrams (mg)
• 3 mg
• 4 mg
• 5 mg
• 6 mg
• 7 mg
• 8 mg
• 9 mg
• 10 mg
• 20 mg

Recommended dosage

For treating multiple sclerosis (MS), you’ll take Ponvory once daily. When you first start treatment, your doctor will prescribe a low dose. Then, they’ll gradually increase your dose over your first 14 days of taking Ponvory. This helps your body get used to the drug and lowers your risk of side effects.

To learn more about Ponvory’s dosage, see this article.

Questions about Ponvory’s dosing

Below are some common questions about Ponvory’s dosing.

• What if I miss a dose of Ponvory? If you miss a dose of Ponvory, take it as soon as you remember. But if it’s nearly time for your next dose, skip the missed dose and take your next dose as scheduled. Do not take two doses at once. Taking more than one Ponvory dose can increase your risk of side effects from the drug. If you miss four or more consecutive doses of Ponvory, contact your doctor. They’ll likely have you restart treatment with the lowest starting dose.
• Will I need to take Ponvory long term? Yes, if you and your doctor agree that Ponvory is safe and effective for treating your condition, you’ll likely take it long term.
• How long does Ponvory take to work? Ponvory begins working with your first dose. But you may not notice a reduction in your MS symptoms for several weeks or even months after starting treatment. Ponvory is used to lower your risk of MS relapse (sudden worsening of symptoms) and to help slow the worsening of MS symptoms over time.

What should be considered before taking Ponvory?

Before starting treatment with Ponvory, there are important considerations to discuss with your doctor. These include any medical conditions you may have and all other medications you take. This information will enable your doctor to check for any interactions with Ponvory.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Before taking Ponvory, be sure to tell your doctor about all the drugs you take, including prescription and over-the-counter kinds. You should also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Ponvory.

For information about drug-condition interactions, see the “Warnings” section below.

Interactions with drugs or supplements

Ponvory can interact with several kinds of drugs. These include:

• chemotherapy drugs, such as:
  • carboplatin
  • fluorouracil
• immunosuppressant drugs, such as:
  • tacrolimus (Astagraf XL, Prograf, others)
  • cyclosporine (Gengraf, Sandimmune, others)
• immunomodulators, such as:
  • fingolimod (Gilenya)
  • dimethyl fumarate (Tecfidera)
• antiarrhythmic drugs, such as:
  • amiodarone (Pacerone)
  • sotalol (Betapace)

Ponvory can also interact with other drugs that can affect your heart rate, including:

• beta-blockers, such as:
  • metoprolol (Lopressor, Toprol XL)
• calcium channel blockers, such as:
  • diltiazem (Cardizem, Cartia XT, others)
  • verapamil (Calan SR, Verelan, others)
• digoxin (Lanoxin)

And finally, Ponvory can interact with drugs that affect how well your body absorbs it, including:

• rifampin (Rimactane)
• these antiepileptic drugs:
  • phenytoin (Dilantin)
  • carbamazepine (Epitol, Equetro, Tegretol, Teril)

This list does not contain all the kinds of drugs that may interact with Ponvory. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Ponvory.

Other interactions

Vaccines may be less effective if you get them while you’re taking Ponvory or for up to 2 weeks after your last dose. You should avoid receiving a live vaccine while you’re taking Ponvory and for at least 2 weeks after your last dose.

Live vaccines are made using a weakened form of the germ the vaccine protects against. If your immune system isn’t strong enough, the live vaccine could cause an infection. (Ponvory works by reducing your immune system activity.)

Examples of live vaccines include:

• nasal (nose) flu spray (FluMist)
• measles, mumps, rubella (MMR vaccine)
• yellow fever vaccine

Talk with your doctor or pharmacist before receiving a vaccine while you’re taking Ponvory. They can advise you on whether it’s safe.

Warnings

Ponvory can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Ponvory is a good treatment option for you.

Talk with your doctor about your health history before starting Ponvory. Factors to consider include those described below.

Certain heart or blood vessel problems. If you have severe heart failure or have had any of the following in the past 6 months, doctors will likely not prescribe Ponvory for your condition:

• heart attack
• stroke
• ministroke
• hospitalization for heart failure
• unstable angina

This is because Ponvory can cause heart-related side effects, including high blood pressure and heart block. And these can increase your risk of the conditions listed above.

Your doctor can provide more information on whether Ponvory is safe for you to take based on your heart problems. Depending on your heart health and the severity of your heart problems, they may suggest a different treatment option for you.

Certain heart rhythm problems. Be sure to let your doctor know if you’ve been told you have a heart block, sick sinus syndrome, or another heart rhythm problem. Depending on your specific condition, your doctor may not prescribe Ponvory for your condition.

This is because the drug can cause heart-related side effects, including a slowed heart rate. And your risk of heart-related side effects from taking Ponvory is higher if you have a heart problem such as heart disease or a heart arrhythmia. Instead, your doctor can discuss other treatment options that may be safer for you.

Active infection. It’s important to treat any active infection you have before you start Ponvory. The drug works by reducing your immune system activity. While this can help treat multiple sclerosis (MS) symptoms, it makes it harder for your immune system to fight infection. Your doctor can advise on the best treatment for your infection and can make sure it’s fully cleared before prescribing Ponvory for your condition.

Breathing problems, including sleep apnea. Treatment with Ponvory may not be safe if you have a breathing problem, such as asthma, chronic obstructive pulmonary disease (COPD), or severe sleep apnea. This is because the drug is known to cause side effects related to breathing, such as shortness of breath. Your risk may be higher if you have an existing breathing problem. If you do, talk with your doctor to learn more about whether Ponvory is safe for you to take.

Diabetes. People with diabetes are at an increased risk of macular edema, a known side effect Ponvory may cause, if they take this drug. Your doctor will tell you more about getting regular eye exams if you have diabetes and are prescribed Ponvory.

Liver problems. Depending on the severity of your liver problem, Ponvory may not be safe for you to take. The drug is known to cause liver-related side effects, including liver dysfunction. In addition, your body relies on your liver to break down and clear Ponvory after you take a dose.

People with moderate to severe liver problems may have an increased risk of side effects from Ponvory since it’s not cleared from their system as well. If your liver problems make Ponvory unsafe for you, your doctor can suggest other treatments for MS that are safer for you.

No history of chickenpox infection or chickenpox vaccine. Before you start taking Ponvory, let your doctor know if you haven’t had chickenpox or the chickenpox vaccine. Your doctor may want to order a blood test to determine whether you have antibodies against chickenpox. Depending on these test results, they may suggest getting the chickenpox vaccine before you start taking Ponvory.

Allergic reaction. If you’ve had an allergic reaction to Ponvory or any of its ingredients, your doctor will likely not prescribe it for you. Ask them about other treatments that might be better options.

Ponvory and alcohol

It should be safe to drink alcohol during Ponvory treatment. Talk with your doctor if you have questions about consuming alcohol while taking this drug.

Pregnancy and breastfeeding

It’s not known whether Ponvory is safe to take while pregnant or breastfeeding. There haven’t been studies in pregnant or breastfeeding people to determine whether the drug is safe and effective in these populations.

If you can become pregnant, your doctor will likely suggest you use effective birth control throughout your treatment with Ponvory and for at least 1 week afterward. Talk with them about safe treatment options for MS if you’re pregnant, planning to become pregnant, or breastfeeding.

How is Ponvory taken?

Your doctor will explain how you should take Ponvory. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Ponvory

Ponvory comes as a tablet that you swallow.

Accessible medication containers and labels

If it’s hard for you to read the label on your prescription, tell your doctor or pharmacist. Certain pharmacies may provide medication labels that:

• have large print
• use braille
• contain a code you can scan with a smartphone to change the text to audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Also, if you’re having trouble opening your medication bottles, let your pharmacist know. They may be able to put Ponvory in an easy-open container. Your pharmacist may also recommend tools to help make it simpler to open the drug’s container.

Questions about taking Ponvory

Below are some common questions about taking Ponvory.

• Can Ponvory be chewed, crushed, or split? The manufacturer of Ponvory hasn’t stated whether it’s safe to chew, crush, or split the tablets. Talk with your pharmacist or doctor if you’re having trouble swallowing pills, or check out these helpful tips.
• Should I take Ponvory with food? You may take Ponvory doses with or without food.
• Is there a best time of day to take Ponvory? No, you can take your Ponvory dose at any time of day.

What should be done in case of overdose?

Do not take more Ponvory than your doctor prescribes, as this can cause harmful effects.

Effects of overdose

An overdose can cause:

• slow heart rate
• low blood pressure
• dizziness
• fainting
• shortness of breath
• feeling more tired than usual

What to do in case you take too much Ponvory

Call your doctor if you think you’ve taken too much Ponvory. You can also call America’s Poison Centers at 800-222-1222 or use their online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.