What is the most important information I should know about siponimod?
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.
What is siponimod?
Siponimod is used to treat relapsing multiple sclerosis (MS) in adults. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
Siponimod is used only if you have a specific genotype. Your doctor will test you for this genotype.
Siponimod may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking siponimod?
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 problem.
Siponimod is not approved for use by anyone younger than 18 years old.
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.
Tell your doctor if you have ever had:
- weak immune system (caused by disease or by using certain medicine);
- an active or chronic infection;
- a very slow heart rate;
- high blood pressure;
- heart problems, a heart attack, a stroke, or chest pain;
- asthma, sleep apnea, or other breathing disorder;
- liver disease; or
- an eye condition called uveitis.
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 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.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I take siponimod?
Your doctor will check your heart function before you start taking siponimod.
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.
Siponimod can slow your heart rate when you start taking it. You will 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.
You may take siponimod with or without food.
Siponimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last 3 to 4 weeks after you stop taking this medicine.
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 will need to be under medical observation when you restart this medication.
Store unopened siponimod in the refrigerator, do not freeze.
After opening, store siponimod in the original package at room temperature away from moisture and heat.
- You may keep the blister (Starter) pack at room temperature for up to 1 week after removing the first tablet.
- You may keep the bottle of tablets at room temperature for up to 1 month after opening.
If you stop taking siponimod, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking siponimod?
Avoid getting a vaccine without first asking your doctor. While you are taking siponimod, some vaccines may not work as well and may not fully protect you from disease.
Receiving a "live" vaccine while using siponimod may cause you to develop an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
If you need to receive a vaccine, you should stop taking siponimod for at least 1 week ahead of time. After receiving the vaccine, you should wait another 4 weeks before you start taking siponimod again. Do not stop taking siponimod without your doctor's advice.
Always ask your doctor before you stop or start taking siponimod for any reason.
What are the possible side effects of siponimod?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- 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, 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, 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, increased sensitivity to light.
Common side effects may include:
- 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.
What other drugs will affect siponimod?
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.
Tell your doctor about all your other medicines, especially:
- drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection; or
- other medicines to treat MS symptoms (a beta interferon, glatiramer, Avonex, Betaseron, Copaxone, Extavia, Glatopa, Rebif).
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.
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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