Sipomid® (Siponimod)

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0.25, 1, 2 mg film coated tablets

Siponimod is an sphingosine-1-phosphate (S1P) receptor modulator. Siponimod binds with high affinity to S1P receptors 1 and 5.

INDICATIONS

Sipomid^® is a sphingosine 1-phosphate (S1P) receptor modulator 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.

It is not known if Sipomid^® is safe and effective in children.

DOSAGE AND ADMINISTRATION

Assessments are required prior to initiating Sipomid^®.
Titration is required for treatment initiation.
The recommended maintenance dosage is 2 mg.
The recommended maintenance dosage in patients with a CYP2C9*1/*3 or *2/*3 genotype is 1 mg.
First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree [Mobitz type I] atrioventricular (AV) block, or a history of myocardial infarction or heart failure.

WARNINGS AND PRECAUTIONS

increased blood pressure.
liver pronlems
breathing problems.
swelling and narrowing of the blood vessels in your brain
severe worsening of multiple sclerosis after stopping Sipomid®.
types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma.
slow heart rate (bradycardia or bradyarrhythmia) when you start taking Sipomid®.
infections.
macular edema.

DRUG INTERACTIONS

Vaccination: During and for up to one month after discontinuation of treatment with Sipomid^®, vaccinations may be less effective. Avoid live attenuated vaccines during and for up to 4 weeks after discontinuation of treatment with Sipomid^®.
CYP2C9 and CYP3A4 Inhibitors: Increase in Sipomid^® exposure; concomitant use of Sipomid^® with moderate CYP2C9 and moderate or strong CYP3A4 inhibitors is not recommended (e.g., fluconazole as a moderate CYP2C9/CYP3A4 dual inhibitor)
Caution should be exercised for concomitant use of Sipomid^® with moderate CYP2C9 inhibitors.
CYP2C9 and CYP3A4 Inducers: Decrease in Sipomid^® exposure; concomitant use of Sipomid^® with moderate CYP2C9 and strong CYP3A4 inducers is not recommended for all patients (e.g., rifampin or carbamazepine as a moderate CYP2C9/strong CYP3A4 dual inducer). Caution should be exercised for concomitant use of Sipomid^® with moderate CYP2C9 inducers.
Anti-arrhythmic medicinal products, QT-prolonging medicinal products, medicinal products that may decrease heart rate: During treatment initiation, Sipomid^® should not be concomitantly used in patients receiving class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) anti-arrhythmic medicinal products, QT-prolonging medicinal products with known arrhythmogenic properties, heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem) or other substances that may decrease heart rate (e.g. ivabradine or digoxin) because of the potential additive effects on heart rate.
Beta blockers: Caution should be exercised when Sipomid^® is initiated in patients receiving beta blockers due to the additive effects on lowering heart rate. Beta-blocker treatment can be initiated in patients receiving stable doses of Sipomid^®.
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. Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with Sipomid^® after alemtuzumab is not recommended. Sipomid^® can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.

Siponimod

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