Ponvory
Ponvory (ponesimod) is a medication that's taken by mouth daily and used to treat relapsing forms of multiple sclerosis (MS) in adults. If it's your first time taking Ponvory (ponesimod), you'll need to start with the starter pack before taking the maintenance dose. This medication can cause side effects in different parts of your body, including heart, liver, and eyes, so you might need to get lab tests or exams done regularly to check your health. Because Ponvory (ponesimod) is brand name only, it can be expensive.
What is Ponvory (ponesimod)?
What is Ponvory (ponesimod) used for?
- Treatment of mutiple sclerosis (MS) relapses, including clinically isolated syndrome, relapsing-remiting disease, and active secondary progressive disease
How Ponvory (ponesimod) works
Ponvory (ponesimod) is a sphingosine 1-phosphate receptor modulator. It's not known exactly how Ponvory (ponesimod) works for multiple sclerosis, but it might be due to how this medication lowers the number of lymphocytes (white blood cells) from entering your nervous system and preventing it from causing swelling and damage to your body.
Drug facts
Side effects of Ponvory (ponesimod)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Upper respiratory infection (37%)
- Abnormal liver tests (23%)
- High blood pressure (10%)
- Urinary tract infection (6%)
- Difficulty breathing (5%)
- Dizziness (5%)
- Cough (4%)
- Arm and leg pain (4%)
- Sleepiness (3%)
- Fever (2%)
- Rise in C-reactive protein levels (measures inflammation) (2%)
- High cholesterol (2%)
- Off balance or lightheadedness (2%)
Less Common Side Effects
- Viral infection
- Herpes zoster
- High potassium level
- Low white blood cell count
- Swelling in the eyes
Ponvory (ponesimod) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Infections: fever, tiredness, body aches, chills, nausea, vomiting, headache with fever, neck stiffness, sensitivity to light, or confusion
- Slow heart rate: dizziness, lightheadedness, shortness of breath, confusion, chest pain, tiredness, or feeling like your heart is beating slowly or skipping a beat
- Breathing problems: shortness of breath
- Liver problems: unexplained nausea, vomiting, stomach pain, tiredness, anorexia (eating disorder), yellowing of skin or eyes, or dark urine
- Vision changes: blurry vision, blind spot in center of vision, sensitivity to light, unusually colored vision
The following Ponvory (ponesimod) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Increase in blood pressure
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Shortness of breath
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
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Pros and cons of Ponvory (ponesimod)
Pros
- Can be taken with or without food
- Only taken once daily
- Most people can take their first dose at home
Cons
- Only available as brand medication so it might be expensive
- Not known if safe and effective in children
- Need to raise the dose slowly following a dosing schedule
Pharmacist tips for Ponvory (ponesimod)
- Let your provider know before starting Ponvory (ponesimod) if you are currently taking or previously taking other medications that suppresses (weakens) your immune system, such as Lemtrada (alemtuzumab). Depending on your medication history, your provider will let you know when you can start Ponvory (ponesimod).
- People who are starting new treatment must take the starter pack. It's important to slowly raise the dose because Ponvory (ponesimod) can slow down your heart rate. If you've missed 4 or more doses in a row, you might have to start at a lower dose and go up slowly again.
- If you have a history of heart problems, you will need to take your first Ponvory (ponesimod) dose at the provider's office and be monitored for at least 4 hours because this medication can affect your heart.
- Don't stop taking Ponvory (ponesimod) without talking to your provider first because doing so can make multiple sclerosis gets worse.
- You can be at a higher risk of getting an infection while taking Ponvory (ponesimod) and for 1 to 2 weeks after stopping treatment, so let your provider know right away if you experience any signs of infections, such as fever, chills, cough, or body aches.
- Let your provider know right away if you have trouble breathing while taking Ponvory (ponesimod). This medication can cause breathing problems.
- Ponvory (ponesimod) can put you at higher risk for skin cancer. Avoid being outside and exposing your skin to the sun for a long period of time. Wear protective clothing and suncreen when going outside. Let your provider know if you have any skin lesions that might look cancerous, so it can get checked.
- Let your provider know if you are pregnant or planning to become pregnant before or while taking Ponvory (ponesimod) because this medication can cause harm to your unborn baby.
- It's not known if Ponvory (ponesimod) passes into your breast milk, so let your provider know if you are breastfeeding while taking this medication.
Common questions about Ponvory (ponesimod)
Before, and sometimes even during or after treatment with Ponvory (ponesimod), you'll need certain tests done to make sure this medication is safe for you. Because this medication can affect different parts of your body, your provider will check your eye health, heart, liver, and blood panel. You can look at the full list of tests here. Talk with your provider and make sure you have appointments scheduled for the tests you need.
Most people without any health problems can take their first dose at home, but depending on your condition, you might have to take the first dose at a provider's office. Let your provider know your full health history before starting Ponvory (ponesimod). People with a history of heart problems need to be monitored for at least 4 hours after taking their first dose in the provider's office.
Since Ponvory (ponesimod) can cause harm to the unborn baby, this medication shouldn't be taken during pregnancy. Females who can potentially get pregnant should take an effective form of birth control while taking Ponvory (ponesimod) to prevent pregnancy. Speak to your provider to determine which form of birth control is right for you. It takes about one week for Ponvory (ponesimod) to fully leave the body after stopping treatment, so birth control should be continued during this time.
If you are getting a live vaccine, make sure to get it at least 1 month before starting Ponvory (ponesimod). Avoid getting a live vaccine during treatment, and for 1 to 2 weeks after stopping this medication because it can raise your risk of getting infections from the vaccines. Let your provider know if you've ever had chickenpox or shingles, or received the vaccine for chickenpox or shingles. Depending on your history, you might need to get the chickenpox or shingles vaccine 1 month before starting Ponvory (ponesimod).
Ponvory (ponesimod) can affect your heart and slows down your heart rate, so you have to start with a lower dose to get your body adjusted to the medication. When you first start your treatment with Ponvory (ponesimod), you need to take the starter pack. This pack starts with 2 mg, then slowly raise the dose every day until you reach 10 mg on day 14. After your starter pack, your provider will change you to a maintenance dose of 20 mg daily. Slowly raising your dose until you get to the maintenance dose can lower your risk of heart problems while taking Ponvory (ponesimod).
If you missed taking Ponvory (ponesimod) for up to 3 days in a row either in your starter pack or maintenance dose, take the first tablet that you missed as soon as you remember and continue your treatment as planned. If you miss 4 or more tablets in a row, call your provider right away to find out how to restart your treatment.
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Risks and warnings for Ponvory (ponesimod)
Ponvory (ponesimod) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infections
- Risk factors: Immunocompromised (weak immune system) | Taking medications that lower the immune system
Ponvory (ponesimod) can lower the levels of white blood cells in the body called lymphocytes. White blood cells are needed to help the body fight off infections. There is a higher risk of getting infections while taking Ponvory (ponesimod), such as herpes, chickenpox, meningitis, viral brain infection (progressive multifocal leukoencephalopathy), and others. Your provider will order a blood test to check for your lymphocyte levels before starting Ponvory (ponesimod). If you currently have an infection, it's best to wait until your infection goes away before starting this medication. Let you provider know right away if you experience an infection while taking Ponvory (ponesimod). Your lymphocyte count can get back to normal within 1 to 2 weeks after stopping Ponvory (ponesimod).
Heart problems
- Risk factors: Heart problems | Taking other medications that affect your heart
Ponvory (ponesimod) can temporarily lower heart rate, usually within an hour of taking the medication. It can also cause temporary problems with the electrical system of the heart. The risk is higher when you start this medication for the first time. Because of the risk for heart problems, your provider will order a test to check your heart before you start Ponvory (ponesimod). The starter pack is used to help you lower the risk for heart problems by starting at a lower dose so that your body can get used to this medication. If you have certain heart problems, you might need to take your first dose of this medication at your provider's office so that they can monitor your heart afterwards. Talk with your provider if you have any heart problems so that they can let you know the benefit and risk of taking this medication.
Breathing problems
- Risk factors: Pulmonary fibrosis | Asthma | Chronic obstructive pulmonary disease (COPD)
Ponvory (ponesimod) can cause certain lung problems, which can affect your breathing. This usually happens during the first month of starting Ponvory (ponesimod). Let your provider know before starting this medication if you have a history of lung or breathing problems, and they can monitor your lungs during the treatment. Report any breathing problems or shortness of breath while taking Ponvory (ponesimod).
Liver damage
- Risk factors: Liver problems
Ponvory (ponesimod) can cause liver problems, which usually happens within 3 months of starting this medication. Your provider will order blood test to check your liver before starting Ponvory (ponesimod) if you haven't had it checked within the last 6 months. You might need to stop this medication if you have liver damage. Let your provider know if you experience any symptoms of liver problems during your treatment, such as unexplained nausea, vomiting, stomach pain, tiredness, eating disorder (anorexia), rash, yellowing of the eyes or skin, or dark urine.
High blood pressure
Ponvory (ponesimod) can raise your blood pressure levels. This can happen as early as after 1 month of treatment, and continue throughout your treatment. Check your blood pressure often and let your provider know of any changes.
Skin cancer
- Risk factors: Older adult | Lighter colored skin | Family history of skin cancer
Ponvory (ponesimod) might raise the risk of skin cancer. Speak to your provider about checking your skin occasionally, especially if you are at a higher risk for getting skin cancer. Let your provider know right away if you have a skin lesion that you are concerned about. Avoid being exposed to sunlight or ultraviolet light for a long time, and make sure you wear protective clothing and sunscreen when going outside.
Can cause harm to unborn baby
Ponvory (ponesimod) can cause harm to the unborn baby, so make sure you use an effective birth control during the treatment and 1 week after stopping the medication.
Swelling in the eyes
- Risk factors: Uveitis (eye inflammation) | Diabetes
Ponvory (ponesimod) can raise the risk of swelling, or build up of fluid, under the specific part of the eye called macula. Your provider might check your eyes before starting you on this medication. Let your provider know if you experience any vision changes while taking Ponvory (ponesimod).
Swelling and narrowing of blood vessels in the brain
Although rare, medications that are similar to Ponvory (ponesimod) have caused a problem in the brain called posterior reversible encephalopathy syndrome (PRES). This problem is usually reversible once the medication is stopped. Although PRES has never been reported by people taking Ponvory (ponesimod), let your provider know right away if you have symptoms of PRES such as sudden severe headache, behavior changes, vision changes, confusion, and seizures. If so, stop Ponvory (ponesimod) and get medical help right away before it worsens into more serious problems like a stroke or bleeding in the brain.
Effects after stopping Ponvory (ponesimod)
Although rare, your condition might worsen after you stop taking Ponvory (ponesimod). Continue to follow up with your provider after your treatment, and let them know if your multiple sclerosis gets worse.
Ponvory (ponesimod) will stay in your body for up to 1 week after stopping your treatment. There is a risk of an interaction if you are to start on a new medication during this time. Although the white blood cell count can return to normal levels after a week in some people, other side effects can stay up to 2 weeks after your last dose. Speak to your provider before starting any medications that can weaken your immune system within 2 weeks of stopping Ponvory (ponesimod).
Ponvory (ponesimod) dosage
Typical dosage for Ponvory (ponesimod)
Starting new treatment:
If you're starting Ponvory (ponesimod) for the first time, your provider will typically prescribe the Ponvory (ponesimod) starter pack. You'll start with 2 mg by mouth once daily and follow the dose titration schedule for 2 weeks to reach 10 mg daily.
Maintenance dose:
After completing the starter pack, the typical maintenance dose for Ponvory (ponesimod) is 20 mg by mouth once daily.
How much does Ponvory (ponesimod) cost?
$4,551.90
Ponvory (ponesimod) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ponvory (ponesimod) will not be safe for you to take.
- Heart attack, chest pain, stroke, or heart failure within the last 6 months
- Have certain heart problems, such as Mobitz type II second-degree, third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless you have a pacemaker
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