How does this medication work? What will it do for me?
Siponimod belongs to the class of medications called sphingosine 1-phosphate (S1P) receptor modulators. It is used to treat the secondary progressive form of multiple sclerosis (MS) with active disease. People who have this form of multiple sclerosis, experience relapses or their MRI shows changes, and have gradual worsening of physical problems.
Siponimod does not cure MS, but it is used to slow the buildup of physical problems due to MS (disability progression).
Siponimod works by lowering the number of white blood cells (lymphocytes) circulating in your blood by keeping them within the lymph nodes. In MS, when white blood cells reach the brain and spinal cord, they are thought to cause the inflammation that contributes to loss of the protective sheath (called myelin) that normally covers the nerve fibres and ensures that they work properly. Siponimod may keep these cells from reaching the brain and spinal cord.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each pale red, round, biconvex, bevelled-edged, film-coated tablet with the Novartis logo on one side and "T" on other side, contains 0.25 mg of siponimod. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, lactose monohydrate, microcrystalline cellulose; tablet coating: iron oxide red and iron oxide black iron, lecithin (soya), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
Each pale yellow, round, biconvex, bevelled-edged, film-coated tablet with the Novartis logo on one side and "II" on other side, contains 2 mg of siponimod. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, glyceryl behenate, lactose monohydrate, microcrystalline cellulose; tablet coating: red iron oxide, yellow iron oxide, lecithin (soya), polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
How should I use this medication?
The recommended starting dose of siponimod is 0.25 mg taken by mouth once a day on days 1 and 2, then gradually increased over several days until your target daily dose is reached. Different people metabolize or break down this drug differently. Your doctor will do a genetic test before you start this medication to determine the best maintenance dose for you. The maintenance dose is usually 1 mg or 2 mg taken once daily.
This medication should be taken in the morning at approximately the same time each day. Swallow the tablets whole with some water. It may be taken with or without food.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose during the first 6 days of treatment, contact your doctor, as the increasing doses will need to be re-started at day 1. After the first week, if you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss taking a dose for 4 or more days in a row, contact your doctor, as you will have to restart treatment at the starting dose. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .
Store this medication in the refrigerator, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to siponimod, peanut or soya, or any ingredients of the medication
- have a severe active infection or an active chronic infection such as hepatitis or tuberculosis
- have a weakened immune system due to disease (e.g., immunodeficiency syndrome) or use medicines or treatments that suppress the immune system (e.g., cancer treatments, bone marrow transplantation, or immune modulating treatments)
- have an active cancer (except for a type of skin cancer called basal cell carcinoma)
- have the genetic characteristic CYP2C9*3*3, which affects how this medication is removed from the body
- have had a myocardial infarction (MI), unstable angina, certain kinds of heart failure, stroke, or a transient ischemic attack (TIA or mini-stroke) in the past 6 months
- have a heart arrhythmia (certain kinds of atrioventricular [AV] block or sick sinus syndrome), and do not have a pacemaker
- are or may be pregnant
- are of child-bearing age and not using birth control
- lack of energy
- pain in the hands and feet
- high blood pressure (e.g., shortness of breath, dizziness or fainting, swelling in ankles and legs, fast or pounding heartbeat)
- signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, tightness in chest, fast or irregular breathing)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- slow or irregular heartbeat (e.g., chest pain; dizziness; rapid, pounding heartbeat; shortness of breath)
- swollen hands, ankles, legs, or feet
- symptoms of chicken pox (e.g., rash of small fluid-filled blisters)
- unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- unusual growth, sore, or wart on the skin that does not heal
- vision changes (e.g., blurry vision, blurry or wavy vision in centre of field of vision, faded colour)
- headache with vomiting
- headache with stiff neck, light sensitivity, nausea, or confusion
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
- alpha-agonists (e.g., clonidine, methyldopa)
- antiarrythmics (e.g., amiodarone, disopyramide, dronedarone, procainamide, propafenone, quinidine, quinine)
- beta-blockers (e.g., atenolol, metoprolol, propranolol)
- calcium channel blockers (e.g., diltiazem, verapamil)
- cancer medications (e.g., capecitabine, cisplatin, doxorubicin, paclitaxel, vincristine, vinorelbine)
- corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
- immune modulating medications (e.g., azathioprine, baricitinib, leflunomide, natalizumab, tofacitinib, upadacitinib)
- lumacaftor and ivacaftor
- protein kinase inhibitors (e.g. ceritinib, dabrafenib)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Blood pressure: Siponimod may also increase blood pressure and is not recommended for people who have uncontrolled high blood pressure. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Breathing disorders: Siponimod may affect lung function for people with respiratory problems such as pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease. If you have respiratory problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor if you experience any new or worsening shortness of breath.
Cancer: Siponimod may increase your risk of developing cancer, especially cancer of the skin and lymphoid tissue.
While you are taking siponimod, it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking this medication. Talk to your doctor if you have any concerns.
Eye problems: People who have diabetes or a history of inflammation of the middle of the eye are at an increased risk of developing swelling in the macula of the eye. You should have an eye examination before starting and during treatment with siponimod to check for changes in your eyes. Report any changes in vision to your doctor as soon as possible.
Heart problems: Siponimod causes a decrease in heart rate a few hours after taking the first dose. Your doctor will want to check your heart before you start this medication. You will also need to be observed in a doctor's office or clinic for 6 hours after your first dose. This allows the doctor to monitor your heart rate and treat any problems before they become an emergency. People with certain heart conditions in the past 6 months such as heart arrhythmias, angina, congestive heart failure or heart attack, should not take siponimod.
If you have a heart problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart rhythm: This medication can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infections: Siponimod works by decreasing the number of white blood cells in the blood stream. White blood cells are responsible for fighting infection in the body. As a result, people taking siponimod may have an increased risk of infections. If you notice signs of an infection, such as fever, redness, or swelling, contact your doctor as soon as possible.
Lactose: This medication contains lactose. If you have hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, discuss this with your doctor before starting this medication.
Liver function: This medication may reduce liver function. If you have a history of liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Seizures: Some people with a history of seizures have experienced an increase in the number and frequency of seizures they have while taking siponimod. If you have seizures or a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Self-harm or suicidal behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Vaccines: If you have not had chickenpox or been vaccinated against chickenpox, talk to your doctor about receiving the chickenpox (Varicella zoster) vaccine at least 1 month before starting siponimod. While taking siponimod and for up to 4 weeks after the last dose, some vaccines may not work well enough to protect you. Talk to your doctor about which vaccinations you need before starting treatment, and which vaccines to avoid during treatment.
Pregnancy: Siponimod should not be used during pregnancy. It can cause serious harm to the developing baby if it is taken by the mother during pregnancy. Women who may become pregnant must use effective birth control while taking siponimod and for at least 10 days following the last dose. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if siponimod passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors are more likely to experience side effects of taking siponimod as a result of reduced heart and lung function. Doses for seniors should generally be lower and increase more slowly than for other adults.
What other drugs could interact with this medication?
There may be an interaction between siponimod and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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