Siponimod

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

Siponimod is used only if you have a specific genotype. Your doctor will test you for this genotype.

Siponimod may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your dose will be increased gradually during the first 5 to 6 days of taking siponimod. Use the medicine exactly as directed.

You may need medical tests before you start taking siponimod, including blood tests, ECG, eye evaluation, heart and liver function tests, and skin exam.

Siponimod can slow your heart rate when you start taking it. You may receive your first dose in a medical setting. Your blood pressure and heart rate may be constantly monitored for at least 6 hours after your first dose of siponimod.

Siponimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you regularly. Your risk of infection could last 3 to 4 weeks after you stop taking siponimod.

Always ask your doctor before you stop taking siponimod for any reason. When you stop taking siponimod, your MS symptoms may return. In rare cases, some people who stopped taking siponimod had MS symptoms that were worse than before or during treatment with this medicine.

If you stop taking siponimod, do not start taking it again without asking your doctor. You may need to be under medical observation when you restart this medication.

Do not crush, break, or split siponimod. Swallow it whole.

You may take siponimod with or without food.

Store unopened siponimod in the refrigerator; do not freeze.

After opening, store siponimod in the original container at room temperature away from moisture and heat for up to 3 months.

If you stop taking siponimod, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.

You should not use siponimod if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a 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 may receive your first dose in a place 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, or problems with coordination, thought, vision, or muscle movement. Your risk of infection could last for 3 to 4 weeks after you stop taking siponimod.

You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking siponimod, which may occur 1 to 4 months after your first dose.

You should not use siponimod if you have a specific genotype. Your doctor will perform tests to make sure siponimod is the right treatment for you.

You should not use Siponimod if you are allergic to it, or if you have:

• a specific genotype;
• "AV block" (2nd or 3rd degree);
• irregular or abnormal heart rhythm (unless you have a pacemaker); or
• recent (within the past 6 months) heart failure, heart attack, stroke, 'mini-stroke' or TIA, chest pain (unstable angina), or other serious heart problem.

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. You may need to receive the vaccine and then wait 1 month before taking siponimod.

Tell your doctor if you have or ever had:

• weak immune system (caused by disease or by using certain medicines);
• fever or an active or chronic infection;
• high blood pressure;
• slow or irregular heart beats;
• heart problems, a heart attack, a stroke, or chest pain;
• asthma, sleep apnea (breathing stops during sleep), or other breathing disorder;
• skin cancer (melanoma);
• an eye condition called uveitis;
• diabetes; or
• liver disease.

Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.

Siponimod may harm an unborn baby. Use effective birth control while using siponimod and for at least 10 days after your last dose. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of siponimod on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Siponimod may cause serious side effects. Call your doctor right away if you have:

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

Common side effects of siponimod may include:

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Call your doctor for instructions. If you miss 1 or more of your first doses, or 4 or more of your maintenance doses, you may need to take your next dose under medical observation in a medical setting.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting a vaccine without consulting your doctor. The vaccine may not be as effective while you are taking siponimod. Receiving a "live" vaccine while on siponimod may lead to an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

If you need to get a vaccine, you should stop taking siponimod for at least 1 week beforehand. After getting the vaccine, you should wait another 4 weeks before starting siponimod again. Do not stop taking siponimod without your doctor's guidance.

Always consult your doctor before stopping or starting siponimod for any reason.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Siponimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Siponimod can have long-lasting effects on your body, especially on your immune system. For 3 or 4 weeks after your last dose, tell any doctor who treats you that you have used siponimod.

Tell your doctor about all your current medicines. Many drugs can affect siponimod, especially:

• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;
• other medicines to treat MS symptoms; or
• heart medications.

This list is not complete, and many other drugs may affect siponimod. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.