Ponvory

About Ponesimod

• Ponvory, containing ponesimod, was approved by the FDA on March 18, 2021, for treating adults with various forms of multiple sclerosis (MS), encompassing clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is a selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1), indicated for managing relapsing forms of MS. 
• This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The medication functions by sequestering lymphocytes in lymph nodes, thereby diminishing their migration into the central nervous system and potentially ameliorating MS symptoms. 
• Ponesimod (Ponvory) operates as a sphingosine-1-phosphate (S1P) receptor modulator, with a specific affinity for S1P1 receptors. Its action involves binding to these receptors, effectively entrapping lymphocytes in lymph nodes. 
• By impeding lymphocyte migration into the central nervous system, ponesimod may contribute to the therapeutic effects observed in multiple sclerosis.

Strength: 

• Ponvory tablets of 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mg

Recommended Dosage:

Before initiating treatment, assess the following: Obtain a recent complete blood count (CBC), including lymphocyte count. Conduct an electrocardiogram (ECG) to check for preexisting conduction abnormalities. Evaluate liver function with recent transaminase and bilirubin levels. Perform an ophthalmic evaluation, including the fundus. 

Consider potential additive immunosuppressive effects of current or prior medications affecting the immune system. Test for varicella-zoster virus (VZV) antibodies and vaccinate antibody-negative patients before starting Ponvory tablets, administering live attenuated vaccines at least 1 month prior.

• To maintain the prescribed dosage of the medicine after titration, administer 20 mg orally once daily, beginning on Day 15. 
• Take the tablet whole, with or without food. Treatment initiation requires the use of a starter pack and a 14-day titration schedule, as outlined below:
• Start with one 2 mg tablet orally once daily for Days 1 and 2.
• Increase the dosage according to the titration schedule:
•   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

If dose titration is interrupted, follow missed dose instructions accordingly.

Important:

Drug interactions should be carefully considered when prescribing Ponvory. Avoid administering live attenuated vaccines during treatment and for up to 1-2 weeks afterward. Additionally, coadministration with strong CYP3A4 and UGT1A1 inducers is not recommended due to potential interactions. These precautions help ensure the effectiveness and safety of the treatment.

Prior to initiating Ponesimod tablet, it’s essential to inform your healthcare provider about your pregnancy status, plans, or breastfeeding, as well as any current medications and medical conditions. This information allows your doctor to tailor the treatment plan to your specific needs and ensure your safety and well-being throughout the course of treatment.

Warnings & Precautions

• Ponvory is contraindicated in patients who have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure within the last 6 months. 
• Additionally, patients with Mobitz type II second-degree, third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block are contraindicated unless they have a functioning pacemaker. These contraindications are important to consider before initiating treatment to ensure patient safety.
• Ponvory poses several risks that require careful monitoring and consideration. Before initiating treatment, conduct a comprehensive assessment, including obtaining a complete blood count to evaluate infection risk and liver function tests to assess potential liver injury. 
• Titrate the dosage carefully due to the risk of transient bradyarrhythmia and atrioventricular conduction delays, and consider an electrocardiogram to assess preexisting cardiac abnormalities. 
• Monitoring for respiratory effects and increased blood pressure is advised, alongside periodic skin examinations for cutaneous malignancies. 
• Women of childbearing potential should use effective contraception, and an ophthalmic evaluation is recommended before starting treatment, especially for patients with diabetes mellitus or uveitis. 
• Close monitoring throughout treatment and for a period after discontinuation is crucial to mitigate these potential risks effectively.

Common Ponvory Side Effects:

• Upper respiratory tract infections 
• Elevated liver enzymes (abnormal liver tests) 
• High blood pressure 
• Drowsiness
• Dizziness
• Insomnia
• Depression
• Anxiety
• Cough
• Dyspnea (shortness of breath)
• Rhinitis (inflammation of the nasal mucous membrane)

Use in Specific Population

• Ponvory has not been extensively studied in pregnant women, and there is insufficient data regarding its presence in human milk or its effects on breastfeeding infants. 
• Therefore, the decision to use Ponvory in women who are pregnant or breastfeeding should be carefully weighed against the potential risks to the fetus or infant and the clinical need for the medication. 
• Prior to starting treatment, women of childbearing potential should be counseled about the potential risks to the fetus and the importance of using effective contraception during treatment and for up to one week after discontinuation, considering the time it takes for the drug to be eliminated from the body. 
• Safety and efficacy in pediatric patients have not been established, and studies did not include patients aged 65 and older. 
• Caution should be exercised when using the medicine in elderly patients due to potential differences in response and the higher prevalence of decreased hepatic, renal, or cardiac function, as well as concomitant diseases or drug therapies.
• Patients with mild hepatic impairment generally do not require dosage adjustment, but Ponvory is not recommended in patients with moderate or severe hepatic impairment due to an increased risk of adverse reactions.

Storage and Handling

• Store Ponvory at 20ºC to 25ºC (68ºF to 77ºF), with excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
• Do not dispose of the desiccant. 
• Keep the medicine protected from moisture.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.