ponesimod: clinical use

Prescribing considerations

• Initiate under a clinician experienced in managing multiple sclerosis.
• Review recent full blood count with differential, liver tests, ECG, infection history, previous immune therapies and vaccination status.
• Confirm varicella immunity and arrange vaccination before treatment when indicated.
• Perform baseline fundus and macular assessment; assess pregnancy status where relevant.
• Consider cardiology advice and first-administration observation for specified cardiac conditions.
• Use caution in significant respiratory disease, diabetes, uveitis, previous liver disease and people aged over 65.

Contraindications and cautions

• Hypersensitivity to ponesimod or an excipient
• Immunodeficient state
• Specified recent major cardiovascular or cerebrovascular events, or advanced heart failure
• Mobitz type II second-degree or third-degree atrioventricular block, or sick-sinus syndrome, without a functioning pacemaker
• Severe active or active chronic infection
• Active malignancy
• Moderate or severe hepatic impairment
• Pregnancy or childbearing potential without effective contraception

Monitoring

• Heart rate, blood pressure and ECG where cardiac risk requires observation
• Full blood count and lymphocyte count periodically
• Blood pressure regularly
• Liver tests and symptoms of hepatic injury
• New visual symptoms and follow-up eye examinations in higher-risk patients
• Signs of infection during treatment and shortly after stopping
• Respiratory function when clinically indicated
• Skin surveillance and sun-protection counselling
• Return or rebound of multiple-sclerosis activity after discontinuation

Clinical pharmacology

Ponesimod selectively modulates S1P receptor 1, reversibly sequestering lymphocytes in lymphoid tissue. Peripheral lymphocyte counts generally recover rapidly after discontinuation. It is extensively metabolised through several enzyme systems, with no single pathway making a major contribution.

Formulation and product differences

• The selected product is a film-coated maintenance tablet.
• Treatment initiation uses a separate pack containing stepwise-strength film-coated tablets.
• The tablets contain lactose and are essentially sodium-free.

Tablet

Route: Oral

Strengths: 10 mg, 20 mg