Ponvory

Indication and use

Ponvory is indicated for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS).

It is not known if Ponvory is safe and effective in children under age 18 or adults over 65.

Administration and dose

Ponvory is a 20 mg capsule taken orally once a day, with or without food. Individuals must start Ponvory by slowly increasing doses over the first week using a 14-day up-titration pack following the dose schedule below. This may reduce the risk of slowing of the heart rate.

• Do not stop taking Ponvory without talking with your healthcare provider first.
• Do not skip a dose.
• Start taking Ponvory with a 14-day starter pack.

Mechanism of action (MOA)

Although the exact mechanism of action for Ponvory in multiple sclerosis is not fully understood, it may involve the reduction of lymphocyte migration into the central nervous system. Ponvory is a sphingosine 1-phosphate (S1P) receptor modulator that activates with high potency the S1P receptor 1 subtype (S1P1). Ponvory prevents harmful immune cells – specifically B cells and T cells – from being activated and released from the lymph nodes and thymus gland into the blood circulation and, hence, the brain and spinal cord.

Side effects

Most common side effects - Upper respiratory infection, elevated liver enzymes, and high blood pressure. More serious side effects may include:

Infection: Ponvory may increase the risk of infections. Obtain a complete blood count (CBC) before starting treatment. Monitor for infection during treatment and for 3 months after discontinuation. Do not start treatment with Ponvory if you have an active infection.

Cardiac effects: Ponvory may result in a temporary decrease in heart rate; drug titration is required for treatment initiation. Complete an electrocardiogram (ECG) to assess for pre-existing cardiac conduction abnormalities before starting Ponvory. Consult a cardiologist for conduction abnormalities or concurrent use with other medications that decrease heart rate.

Liver damage: Obtain liver function tests before starting Ponvory. Discontinue treatment if significant liver injury is confirmed.

Fetal risk: Women of childbearing potential should use effective contraception during treatment and for 3 months after stopping Ponvory due to risk of the medication on the fetus.

Increased Blood Pressure (BP): monitor blood pressure during treatment

Respiratory function: May cause a decline in respiratory function. Have your respiratory function assessed if indicated by your physician.

Macular edema: A prompt ophthalmic evaluation is recommended if there is any change in vision while taking PONVORY. Diabetes mellitus and uveitis increase the risk of macular edema; patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to starting treatment.

Severe exacerbation of disease after stopping ponesimod: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ponesimod treatment.

This is not a comprehensive list of all possible side effects of Ponvory. Please see the Ponvory product monograph for a list of other potentially serious side effects. It is important that individuals discuss side effects of any medication they are considering with their physician. (*Health Canada, product monograph for Ponvory.)

Clinical trials

In OPTIMUM, 1133 patients were randomized to receive either ponesimod (N=567) or teriflunomide (N=566), beginning with a 14-day dose titration starting with 2 mg for 108 weeks (approximately 2 years). The study included participants with relapsing MS from onset (RRMS or SPMS with superimposed relapses) and an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, having experienced at least one relapse within the prior year, or two relapses within the prior two years, or having at least one gadolinium-enhancing (Gd+) lesion on a brain MRI within the prior 6 months or at baseline. Results from the study showed that compared with teriflunomide, ponesimod significantly reduced relapses and disease activity on MRI. No significant difference was found between ponesimod and teriflunomide in slowing disability progression.

Cost reimbursement

The cost of Ponvory unknown. Ponvory is not covered through government drug plans. For more information, speak to your healthcare provider or private insurance provider.

Drug support program

Janssen Medical Information: 1-800-567-3331