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Siponimod

Generic name: siponimod [sye-POE-ni-mod]

Brand names: Mayzent, Mayzent Starter Pack
Oral tablet (0.25%, 0.25mg, 1 mg, or 2mg)
Drug class: selective immunosuppressants

What is Siponimod?

Adults can use siponimod to treat relapsing multiple sclerosis. Siponimod can only be used if you possess a certain genotype. You will be tested by your doctor for this genotype. Siponimod can be used in other ways not mentioned in this guide.

Side effects of Siponimod

If you experience any of the following signs of an allergic reaction: difficulty breathing, hives or swelling to lips, face, tongue or throat. Seek medical assistance immediately.

Siponimod may cause serious side effects. If you experience:

  • Slow or irregular heartbeats
  • Vision problems, such as blurred vision, eye discomfort, a blind spot in the middle of your vision, or a strange colour (vision problems can occur between 1 and 4 months after starting siponimod);
  • Headache, confusion, and mental state change
  • A seizure;
  • Cold sores or sores around the genital area, mouth, throat, and genital region
  • Skin changes include moles that have changed in size or colour.
  • Shortness of breath
  • Liver problems: nausea, vomiting, upper abdominal pain, fatigue, loss of appetite, and dark urine (yellowing on the skin or in the eyes).
  • Meningitis symptoms include fever, chills, and body aches. They can also cause nausea, vomiting, neck stiffness, and increased sensitivity to light.

Side effects of siponimod include:

  • Headache;
  • Increased blood pressure
  • Abnormal liver function tests

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

Aubagio, Copaxone, Tecfidera, Gilenya, Avonex, and Tysabri

Warnings

Siponimod should not be used if you suffer from a serious condition of the heart, like "sick sinus" syndrome or "AV block", or if a recent heart condition has occurred, such as a heart block or heart failure. Siponimod may slow down your heart rate as soon as you begin taking it. Your first dose may be administered in an environment where your heart rate can be monitored. Siponimod may need to be restarted under medical supervision if you miss a dose.

You could get more infections, including serious or deadly infections. Contact your doctor immediately if you experience a fever, chills or aches, fatigue, nausea, confusion, a stiff neck, or any problems with thought, coordination, vision, or muscle movement. You may be at risk for infection up to four weeks after stopping siponimod.

Siponimod may cause increased sensitivity to light, blurred or clouded vision, or a blind spot in your centre of vision. You may also experience unusual colours or other visual problems. These symptoms may appear 1 to 4 months after your initial dose.

Siponimod should not be used if you have a certain genotype. Your doctor will run tests to ensure that siponimod treatment is right for you.

Before you take this drug

Siponimod should not be used if:

  • A specific genotype;
  • "AV block" (second or third degree);
  • If you have an abnormal or irregular heart rhythm, or if you do not use a pacemaker
  • Recent heart problems (within 6 months) include heart failure, heart attacks, tias, chest pain (unstable angina), and other serious heart conditions.

Siponimod can have unwanted or harmful effects when combined with certain heart rhythm medicines. If you are also taking amiodarone or disopyramide (or dronedarone), flecainide, ibutilide, procainamide, propafenone, and quinidine, your doctor may alter your treatment plan.

Tell your doctor before taking siponimod if this is the first time you've had chickenpox or if it's been a while since you received the varicella vaccination. It may be necessary to get the varicella vaccine, then wait a month before taking siponimod.

Tell your doctor if:

  • Weak immune system (caused either by illness or certain medications);
  • Fever, active, or chronic infection
  • High blood pressure
  • Slow or irregular heartbeats
  • Heart problems, heart attacks, strokes, or chest pain
  • Asthma, sleep apnea, or other breathing disorders;
  • Skin cancer
  • Uveitis is a condition of the eye.
  • Diabetes
  • Liver disease.

Tell your doctor whether you've recently received a vaccination or are scheduled to get one. Siponimod can harm an unborn child. Use effective contraception during the use of siponimod and for 10 days following your last dose. Inform your physician immediately if you suspect pregnancy.

You may find your name on a registry if you're pregnant to track siponimod's effects on the baby. Ask your doctor if you can safely breastfeed while taking this medication.

How to take Siponimod?

Read and follow all instructions included with your medication. During the first five to six days, your dose will gradually increase. Follow the instructions on your prescription. Before you begin taking siponimod, you may need to undergo medical tests, including blood tests and ecgs, an eye exam, liver and heart function tests, and a skin examination.

Siponimod may slow down your heart rate as soon as you begin taking it. Your first dose may be administered in a medical environment. You may need to have your blood pressure and heartbeat constantly monitored for 6 hours following the first dose.

Siponimod can affect your immune system. You could get more infections, including serious or deadly infections. You will be examined by your doctor on a regular schedule. You may be at risk for infection up to four weeks after stopping siponimod. Your MS symptoms can return if you stop taking Siponimod. Some people with MS who stop taking siponimod may experience worse symptoms than they did before or while on the medication.

Do not restart taking siponimod without consulting your doctor. If you are restarting this medication, you may be required to undergo medical supervision. Siponimod should not be crushed, broken, or divided. Do not chew or break it. Take siponimod either with food or without. Do not freeze siponimod that hasn't been opened. Store siponimod at room temperature, away from moisture or heat, for 3 months after opening. When you stop taking siponimod, watch for symptoms of MS worsening. Call your doctor immediately if new or worsening ones appear.

What happens if I miss the dose?

For instructions, call your doctor. You may be required to take the next dose in a medical environment if you missed one or more doses of your first or maintenance doses. Refill your prescription before you run out.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Do not receive a vaccination without consulting your doctor. You may find that the vaccine does not work well when you use siponimod. You may develop an infection if you receive a "live vaccine" while taking siponimod. Live vaccines are available for measles (chickenpox), rubella (MMR), yellow fever, typhoid (rotavirus), polio (MMR), varicella (chickenpox), zika (shingles), and influenza (nasal flu).

Siponimod should be stopped at least one week before a vaccination. You should wait 4 weeks after receiving the vaccination before starting siponimod. Siponimod should not be stopped without consulting your doctor. Ask your doctor before stopping or starting siponimod.

Interaction with other drug

It is sometimes not safe to take certain medications at the same time. Using certain drugs together can cause side effects and/or reduce the effectiveness of other medications. Siponimod may cause serious heart problems. You may have a higher risk if you are also taking certain other medications for infection, asthma, heart disease, high blood pressure, or depression.

Siponimod has a long-lasting effect on your body and your immune system. Tell any doctor you see for 3 to 4 weeks that you used siponimod.

Inform your doctor of all the medications you are taking. Siponimod can be affected by many drugs, including:

  • Drugs that suppress the immune system, such as steroids, cancer medicines, and drugs to prevent transplant rejection,
  • Other medicines to treat MS symptoms
  • Heart medications are available in many different forms.

This list is incomplete, and other drugs can also affect siponimod. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.