Ponvory

Last reviewed on RxList: 3/26/2021
Ponvory Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ponvory?

Ponvory (ponesimod) is a sphingosine 1-phosphate receptor modulator used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

What Are Side Effects of Ponvory?

Side effects of Ponvory include:

Dosage for Ponvory

The recommended maintenance dosage of Ponvory is 20 mg taken orally once daily.

Ponvory In Children

Safety and effectiveness of Ponvory in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Ponvory?

Ponvory may interact with other medicines such as:

  • live attenuated vaccines,
  • strong CYP3A4 and UGT1A1 inducers,
  • anti-neoplastic therapies,
  • immune-modulating therapies,
  • immunosuppressants,
  • alemtuzumab,
  • anti-arrhythmic drugs, and
  • beta-blockers

Tell your doctor all medications and supplements you use.

Ponvory During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ponvory; it may harm a fetus. Woman of childbearing potential should use effective birth control during treatment with Ponvory and for 1 week after stopping treatment. It is unknown if Ponvory passes into breast milk or ow it might affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Ponvory (ponesimod) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Ponvory Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

  • Infections [see WARNINGS AND PRECAUTIONS]
  • Bradyarrhythmia and Atrioventricular Conduction Delays [see WARNINGS AND PRECAUTIONS]
  • Respiratory Effects [see WARNINGS AND PRECAUTIONS]
  • Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Increased Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Cutaneous Malignancies [see WARNINGS AND PRECAUTIONS]
  • Fetal Risk [see WARNINGS AND PRECAUTIONS]
  • Macular Edema [see WARNINGS AND PRECAUTIONS]
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see WARNINGS AND PRECAUTIONS]
  • Severe Increase in Disability After Stopping PONVORY [see WARNINGS AND PRECAUTIONS]
  • Immune System Effects After Stopping PONVORY [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 1438 MS patients have received PONVORY at doses of at least 2 mg daily. These patients were included in Study 1 (2-year active-controlled versus teriflunomide 14 mg) [see Clinical Studies] and in a Phase 2 (6-month placebo-controlled) study in patients with MS and the uncontrolled extension studies.

In Study 1, 82% of PONVORY-treated patients completed 2 years of study treatment, compared to 82.2% of patients receiving teriflunomide 14 mg. Adverse events led to discontinuation of treatment in 8.7% of PONVORY-treated patients, compared to 6% of patients receiving teriflunomide 14 mg. The most common adverse reactions (incidence at least 10%) in PONVORY-treated patients in Study 1 were upper respiratory tract infection, hepatic transaminase elevation, and hypertension. Table 3 lists adverse reactions that occurred in at least 2% of PONVORY-treated patients and at a higher rate than in patients receiving teriflunomide 14 mg.

Table 3: Adverse Reactions Reported in Study 1 Occurring in at Least 2% of PONVORY-Treated Patients and at a Higher Rate Than in Patients Receiving Teriflunomide 14 mg

Adverse Reaction PONVORY
N=565 (%)
Teriflunomide 14 mg
N=566 (%)
Upper respiratory infection a 37 34
Hepatic transaminase elevation b 23 12
Hypertension c 10 9
Urinary tract infection 6 5
Dyspnea 5 1
Dizziness 5 3
Cough 4 2
Pain in extremity 4 3
Somnolence 3 2
Pyrexia 2 1
C-reactive protein increased 2 1
Hypercholesterolemia 2 1
Vertigo 2 1
a Includes the following terms: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, respiratory tract infection viral, viral upper respiratory tract infection, tracheitis, and laryngitis.
b Includes the following terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased.
c Includes the following terms: hypertension, hypertensive crisis, blood pressure increased, blood pressure systolic increased, and blood pressure diastolic increased.

In Study 1, the following adverse reactions occurred in less than 2% of PONVORY-treated patients, but at a rate at least 1% higher than in patients receiving teriflunomide 14 mg: viral infection, herpes zoster, hyperkalemia, lymphopenia [see WARNINGS AND PRECAUTIONS, and macular edema [see WARNINGS AND PRECAUTIONS].

Adverse reactions in patients treated with PONVORY in an additional 6-month placebo-controlled study were generally similar to those in Study 1. The following additional adverse reactions occurred in at least 2% of PONVORY 20 mg-treated patients and at a higher rate than in patients receiving placebo (but did not meet the reporting rate criteria for inclusion in Study 1): rhinitis, fatigue, chest discomfort, peripheral edema, joint swelling, blood cholesterol increased, migraine, insomnia, depression, dyspepsia, dry mouth, bradycardia, back pain, and sinusitis.

Additionally, in uncontrolled extension trials, the adverse reaction of pneumonia was reported.

Seizures

In Study 1, cases of seizures were reported in 1.4% of PONVORY-treated patients, compared to 0.2% in patients receiving teriflunomide 14 mg. It is not known whether these events were related to the effects of MS, to PONVORY, or to a combination of both.

Respiratory Effects

In Study 1, dose-dependent reductions in forced expiratory volume over 1 second (FEV1) were observed in patients treated with PONVORY [see WARNINGS AND PRECAUTIONS].

Malignancies

In Study 1, two cases of basal cell carcinoma (0.4%) were reported in PONVORY-treated patients, compared to one case of basal cell carcinoma (0.2%) in patients receiving teriflunomide 14 mg, and a case of malignant melanoma was reported in a PONVORY-treated patient. An increased risk of cutaneous malignancies has been reported in association with other S1P receptor modulators, including PONVORY [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

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 [see WARNINGS AND PRECAUTIONS].

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 [see WARNINGS AND PRECAUTIONS].

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) [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. If treatment with PONVORY is considered, advice from a cardiologist should be sought.

Beta-Blockers

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 [see WARNINGS AND PRECAUTIONS]. Beta-blocker treatment can be initiated in patients receiving stable doses of PONVORY.

Vaccination

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 [see WARNINGS AND PRECAUTIONS].

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.

Read the entire FDA prescribing information for Ponvory (Ponesimod Tablets)

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow

© Ponvory Patient Information is supplied by Cerner Multum, Inc. and Ponvory Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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