- Side Effects
- Drug Interactions
What is Ponvory (ponesimod), and what is it used for?
Brand name: Ponvory
Ponvory (ponesimod) is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), 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.
What are the side effects of Ponvory?
What are the serious side effects of Ponvory?
Ponvory may cause serious side effects, including:
- 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.
- 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:
- increased blood pressure. Your healthcare provider should check your blood pressure during treatment with Ponvory.
- 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, skincolored, 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.
- 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:
- blurriness or shadows in the center of your vision
- sensitivity to light
- a blind spot in the center of your vision
- unusually colored (tinted) vision
- 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:
- 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.
What are the common side effects of Ponvory?
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.
What is the dosage for Ponvory?
Assessments Prior To First Dose Of Ponvory
- Before initiation of treatment with Ponvory, assess the following:
Complete Blood Count
- Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) complete blood count (CBC), including lymphocyte count.
- Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought and first-dose monitoring is recommended [see First Dose Monitoring In Patients With Certain Preexisting Cardiac Conditions].
- Determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction.
Liver Function Tests
- Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels.
- Obtain an evaluation of the fundus, including the macula.
Current Or Prior Medications With Immune System Effects
- If patients are taking anti-neoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with Ponvory.
- Test patients for antibodies to varicella zoster virus (VZV) before initiating Ponvory; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with Ponvory. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of Ponvory.
- After dose titration is complete (see Treatment Initiation), the recommended maintenance dosage of Ponvory is 20 mg taken orally once daily starting on Day 15.
- Administer Ponvory orally once daily. Swallow the tablet whole. Ponvory can be taken with or without food.
- A starter pack must be used for patients initiating treatment with Ponvory. Initiate Ponvory treatment with a 14-day titration; start with one 2 mg tablet orally once daily and progress with the titration schedule as shown in Table 1.
Table 1: Dose Titration Regimen
|Titration Day||Daily Dose|
|Days 1 and 2||2 mg|
|Days 3 and 4||3 mg|
|Days 5 and 6||4 mg|
|Day 7||5 mg|
|Day 8||6 mg|
|Day 9||7 mg|
|Day 10||8 mg|
|Day 11||9 mg|
|Days 12, 13, and 14||10 mg|
|Day 15 and thereafter||20 mg|
- If dose titration is interrupted, missed dose instructions must be followed [see Reinitiation Of Ponvory After Treatment Interruption].
First Dose Monitoring In Patients With Certain Preexisting Cardiac Conditions
- Because initiation of Ponvory treatment results in a decrease in heart rate (HR), first-dose 4-hour monitoring is recommended for patients with sinus bradycardia [HR less than 55 beats per minute (bpm)], first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure occurring more than 6 months prior to treatment initiation and in stable condition.
First Dose 4-Hour Monitoring
- Administer the first dose of Ponvory in a setting where resources to appropriately manage symptomatic bradycardia are available. Monitor patients for 4 hours after the first dose for signs and symptoms of bradycardia with a minimum of hourly pulse and blood pressure measurements. Obtain an ECG in these patients prior to dosing and at the end of the 4-hour observation period.
Additional Monitoring After 4-Hour Monitoring
If any of the following abnormalities are present after 4 hours (even in the absence of symptoms), continue monitoring until the abnormality resolves:
- The heart rate 4 hours post-dose is less than 45 bpm
- The heart rate 4 hours post-dose is at the lowest value post-dose, suggesting that the maximum pharmacodynamic effect on the heart may not have occurred
- The ECG 4 hours post-dose shows new onset second-degree or higher AV block
If post-dose symptomatic bradycardia, bradyarrhythmia, or conduction related symptoms occur, or if ECG 4 hours post-dose shows new onset second degree or higher AV block or QTc greater than or equal to 500 msec, initiate appropriate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no pharmacological treatment is required. If pharmacological treatment is required, continue monitoring overnight and repeat 4-hour monitoring after the second dose.
Advice from a cardiologist should be sought to determine the most appropriate monitoring strategy (which may include overnight monitoring) during treatment initiation, if treatment with Ponvory is considered in patients:
- With some preexisting heart and cerebrovascular conditions
- With a prolonged QTc interval before dosing or during the 4-hour observation, or at additional risk for QT prolongation, or on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes
- Receiving concurrent therapy with drugs that slow heart rate or AV conduction
Reinitiation Of Ponvory After Treatment Interruption
Interruption during treatment, especially during titration, is not recommended; however:
- If fewer than 4 consecutive doses are missed:
- during titration: resume treatment with the first missed titration dose and resume the titration schedule at that dose and titration day.
- during maintenance: resume treatment with the maintenance dosage.
- If 4 or more consecutive doses are missed during titration or maintenance:
- treatment should be reinitiated with Day 1 of the titration regimen (new starter pack).
If treatment needs to be reinitiated with Day 1 of the titration regimen (new starter pack), complete first-dose monitoring in patients for whom it is recommended [see First Dose Monitoring In Patients With Certain Preexisting Cardiac Conditions].
What drugs interact with Ponvory?
Anti-Neoplastic, Immune-Modulating, Or Immunosuppressive Therapies
Ponvory has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune effects during such therapy and in the weeks following administration.
When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered in order to avoid unintended additive effects on the immune system.
Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with Ponvory after alemtuzumab is not recommended.
Ponvory can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That May Decrease Heart Rate
Ponvory has not been studied in patients taking QT prolonging drugs.
Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) anti-arrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. If treatment with Ponvory is considered, advice from a cardiologist should be sought.
Because of the potential additive effects on heart rate, treatment with Ponvory should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties, heart rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., digoxin). If treatment with Ponvory is considered, advice from a cardiologist should be sought.
Caution should be applied when Ponvory is initiated in patients receiving treatment with a beta-blocker because of the additive effects on lowering heart rate; temporary interruption of the beta-blocker treatment may be needed prior to initiation of Ponvory. Beta-blocker treatment can be initiated in patients receiving stable doses of Ponvory.
During, and for up to 1 to 2 weeks after discontinuation of, treatment with Ponvory, vaccinations may be less effective. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during Ponvory treatment and for 1 to 2 weeks after discontinuation of treatment with Ponvory.
Strong Cyp3a4 And Ugt1a1 Inducers
In vitro assessments and limited clinical data indicated that concomitant use of strong CYP3A4 and UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine) may decrease the systemic exposure of ponesimod. It is unclear whether this decrease in ponesimod systemic exposure would be considered of clinical relevance. Coadministration of Ponvory with strong CYP3A4 and UGT1A1 inducers is not recommended.
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Ponvory contraindications, and pregnancy and breastfeeding safety
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.
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.
Ponvory (ponesimod) is a prescription medication that is used to treat relapsing forms of multiple sclerosis (MS). Serious side effects of Ponvory include breathing problems, liver problems, increased blood pressure, skin cancer, and macular edema.
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Multiple Sclerosis (MS)
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