Siponimod

Siponimod is a prescription medication used to treat relapsing multiple sclerosis (MS) in adults.

• Siponimod is available under various brand names: Mayzent

Common side effects of Siponimod include:

• headache.
• increased blood pressure; or
• abnormal liver function tests.

Serious side effects of Siponimod include:

• hives. 
• difficult breathing. 
• swelling of your face, lips, tongue, or throat.
• slow or irregular heartbeats.
• vision problems, blurred vision, eye pain, or having a blind spot or shadows in the center of your vision (vision problems may occur 1 to 4 months after you start taking Siponimod);
• headache, confusion, and change in mental status.
• a seizure.
• sores in the mouth and throat, cold sores, sores on the genital or anal area.
• skin changes, unusual moles that change in color or size.
• shortness of breath.
• liver problems--nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
• symptoms of meningitis--fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, and increased sensitivity to light.

Rare side effects of Siponimod include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 0.25 mg
• 2 mg

Multiple sclerosis:

Adult dosage

• CYP2C9 Genotype *1/*1, *1/*2, or *2/*2:
  • Initial: 0.25 mg once daily on Days 1 and 2, then 0.5 mg once daily on Day 3, then 0.75 mg once daily on Day 4, then 1.25 mg once daily on Day 5.
  • Maintenance: 2 mg once daily, beginning on Day 6.
• CYP2C9 Genotype *1/*3 or *2/*3:
  • Initial: 0.25 mg once daily on Days 1 and 2, then 0.5 mg once daily on Day 3, then 0.75 mg once daily on Day 4.
  • Maintenance: 1 mg once daily, beginning on Day 5.
  • Missed dose: If a dose is missed for more than 24 hours during the initial titration regimen, reinitiate with Day 1 of the titration regimen. If treatment with Siponimod is interrupted for 4 or more consecutive daily doses after completion of initial titration, reinitiate treatment with Day 1 of the titration regimen, including first-dose monitoring when appropriate.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Siponimod has severe interactions with the following drugs:
  • lefamulin
  • saquinavir
  • thioridazine
• Siponimod has serious interactions with at least 274 other drugs.
• Siponimod has moderate interactions with at least 290 other drugs.
• Siponimod has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• You should not use Siponimod if you are allergic to it, or if you have certain serious heart conditions, especially:
• "AV block" (2nd or 3rd degree).
• sick sinus syndrome (unless you have a pacemaker).
• recent (within the past 6 months) heart failure, heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problems.
• Siponimod is not approved for use by anyone younger than 18 years old.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Siponimod?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Siponimod?”

Cautions

• You should not use Siponimod if you have a serious heart condition such as "AV block," sick sinus syndrome and no pacemaker, or if you've recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.
• Siponimod can slow your heart rate when you start taking it. You will receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may also need to restart Siponimod under medical observation.
• You may get infections more easily, even serious, or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, increased sensitivity to light, or problems with coordination, thought, vision, or muscle movement.
• Some heart rhythm medications can cause unwanted or dangerous effects when used with siponimod. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.
• Before you take siponimod, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking siponimod.

Pregnancy and Lactation

• Siponimod may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for at least 10 days after your last dose. Tell your doctor if you become pregnant during this time.
• If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Siponimod on the baby.
• Lactation
  • It may not be safe to breastfeed while using siponimod. Ask your doctor about any risks.