Ponesimod (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- PONVORY
Indications and Usage
PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Contraindications
PONVORY is contraindicated in patients who: In the last 6 months, have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure [see Warnings and Precautions (5.2)] Have presence of Mobitz type II second-degree, third-degree AV block, sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker [see Warnings and Precautions (5.2)]
Adverse Reactions
The following serious adverse reactions are described elsewhere in labeling: Infections [see Warnings and Precautions (5.1)] Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2)] Respiratory Effects [see Warnings and Precautions (5.3)] Liver Injury [see Warnings and Precautions (5.4)] Increased Blood Pressure [see Warnings and Precautions (5.5)] Cutaneous Malignancies [see Warnings and Precautions (5.6)] Fetal Risk [see Warnings and Precautions (5.7)] Macular Edema [see Warnings and Precautions (5.8)] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.9)] Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see Warnings and Precautions (5.10)] Severe Increase in Disability After Stopping PONVORY [see Warnings and Precautions (5.11)] Immune System Effects After Stopping PONVORY [see Warnings and Precautions (5.12)]
Mechanism of Action
Ponesimod is a S1P receptor 1 modulator that binds with high affinity to S1P receptor 1. Ponesimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ponesimod exerts therapeutic effects in MS is unknown, but may involve reduction of lymphocyte migration into the central nervous system.
Overdosage
Symptoms and Signs In patients with overdosage of PONVORY, especially upon initiation/reinitiation of treatment, it is important to observe for signs and symptoms of bradycardia as well as AV conduction blocks, which may include overnight monitoring. Regular measurements of pulse rate and blood pressure are required, and ECGs should be performed [see Warnings and Precautions (5.2, 5.5) and Clinical Pharmacology (12.2)]. Treatment There is no specific antidote to ponesimod. Neither dialysis nor plasma exchange would result in meaningful removal of ponesimod from the body. The decrease in heart rate induced by PONVORY can be reversed by atropine. In the event of overdose, PONVORY should be discontinued, and general supportive treatment given until clinical toxicity has been diminished or resolved. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.