Description
Ponesiimod is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ponesimod in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ponesimod in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Acecainide
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Ajmaline
- Alemtuzumab
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amlodipine
- Anagrelide
- Apomorphine
- Aranidipine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Azithromycin
- Bacillus of Calmette and Guerin Vaccine, Live
- Bedaquiline
- Betaxolol
- Bisoprolol
- Bretylium
- Buprenorphine
- Buserelin
- Carbamazepine
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine, Live
- Cilnidipine
- Ciprofloxacin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (chest pain), unstable (within the last 6 months) or
- Heart attack (within the last 6 months) or
- Heart failure (Class III or IV) (within the last 6 months) or
- Heart rhythm problems (eg, Mobitz type II second-degree, third-degree heart block, sick sinus syndrome), without a pacemaker or
- Stroke, including transient ischemic attack (within the last 6 months)���Should not be used in patients with these conditions.
- Asthma or
- Bradycardia (slow heartbeat), history of or
- Chronic obstructive pulmonary disease (COPD) or
- Fainting, recurrent, history of or
- Hypertension (high blood pressure) or
- Liver disease, or history of or
- Pulmonary fibrosis or
- Skin cancer, or history of—Use with caution. May make these conditions worse.
- Diabetes or
- Uveitis (eye swelling), history of or
- Weak immune system—Use with caution. May increase risk for more serious side effects.
- Infection—May decrease your body's ability to fight infections.
- Liver disease, moderate or severe—Use is not recommended in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
If you are using this medicine and have certain heart conditions, your doctor may want you to stay in the medical facility for at least 4 hours when you take the next dose.
Swallow the tablet whole. Do not split, crush, or chew it. You may take this medicine with or without food.
Dosing
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
- For oral dosage form (tablets):
- For relapsing forms of multiple sclerosis:
- Adults—You will need to take this medicine with a 14-day titration schedule. 2 milligrams (mg) once a day on Days 1 and 2, 3 mg once a day on Days 3 and 4, 4 mg once a day on Days 5 and 6, 5 mg once a day on Day 7, 6 mg once a day on Day 8, 7 mg once a day on Day 9, 8 mg once a day on Day 10, 9 mg once a day on Day 11, and 10 mg once a day on Days 12, 13, and 14. Then, a maintenance dose of 20 mg once a day starting on Day 15.
- Children—Use and dose must be determined by your doctor.
- For relapsing forms of multiple sclerosis:
Missed Dose
Call your doctor or pharmacist for instructions.
- If you miss 1, 2, or 3 doses in a row during the initial dose titration or the maintenance dose, take it as soon as you remember, then go back to your regular dosing schedule.
- If you miss a dose for 4 or more days in a row during the initial dose titration or the maintenance dose, you will need to restart the dose titration.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.
Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may increase your risk of developing infections, including a herpes infection or a serious brain infection called meningitis or progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
Ponesimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.
This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.
Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.
This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma, squamous cell carcinoma). Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).
While you are being treated with ponesimod, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Do not use this medicine 1 to 2 weeks before and for 4 weeks after receiving a vaccine. Ponesimod may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Agitation
- back pain
- bladder pain
- body aches or pain
- burning or stinging of the skin
- chest pain, discomfort, or tightness
- chills
- coma
- confusion
- cough
- cough producing mucus
- dark urine
- difficult, burning, or painful urination
- dizziness
- drowsiness
- ear congestion
- fever
- general feeling of illness
- hallucinations
- headache
- hoarseness
- irritability
- lightheadedness, dizziness, or fainting
- loss of appetite
- loss of voice
- lower back or side pain
- mood or mental changes
- nausea
- nervousness
- nosebleeds
- numbness or tingling in the face, arms, or legs
- painful cold sores or blisters on the lips, nose, or genitals
- pounding in the ears
- runny or stuffy nose
- seizures
- skin rash on the face, scalp, or stomach
- slow or irregular heartbeat
- stiff neck or back
- sneezing
- sore throat
- stomach pain
- tender, swollen glands in the neck
- trouble breathing
- trouble in swallowing
- unusual tiredness or weakness
- vision problems
- voice changes
- vomiting
- yellow eyes or skin
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision or other change in vision
- discouragement
- feeling of constant movement of self or surroundings
- feeling sad or empty
- headache, severe and throbbing
- loss of interest or pleasure
- painful blisters on the trunk of the body
- rapid weight gain
- sensation of spinning
- tingling of the hands or feet
- trouble concentrating
- trouble sleeping
- unusual weight gain or loss
Rare
- Change in size, shape, or color of the existing mole
- new mole
- mole that leaks fluid or bleeds
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- white, yellow, or waxy scar-like area
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acid or sour stomach
- belching
- dry mouth
- heartburn
- indigestion
- pain in the arms or legs
- pain or tenderness around the eyes and cheekbones
- sleepiness or unusual drowsiness
- sleeplessness
- stomach discomfort or upset
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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