2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 20 mg film-coated tablets
ponesimod
What Ponvory is and what it is used f
What Ponvory is
Ponvory contains the active substance ponesimod. Ponesimod belongs to a group of medicines called sphingosine 1‑ phosphate (S1P) receptor modulators.
What Ponvory is used for
Ponvory is used to treat adults with “relapsing multiple sclerosis” (RMS) with active disease. Active disease in RMS is when there is a relapse or when the results of a magnetic resonance imaging examination (magnetic resonance imaging, MRI) show signs of inflammation.
What is multiple sclerosis?
Multiple sclerosis (MS) affects the nerves in the brain and spinal cord ( central nervous system ).
In MS, the body’s immune system (one of the body’s main defense systems) does not work properly. The immune system attacks a protective shell on the nerve cells called myelin sheath – this causes inflammation. This breakdown of the myelin sheath (also called demyelinating) leads to the nerves not functioning properly.
The symptoms of MS depend on which part of the brain and spinal cord is affected. These can include gait and balance problems, weakness, numbness, double vision, and blurred vision, poor coordination, and bladder problems.
When the relapse is over, the symptoms may disappear completely, but some problems may persist.
How Ponvory works
Ponvory reduces circulating lymphocytes ( white blood cells involved in the immune system) by retaining them in the lymphatic organs ( lymph nodes ). This means that fewer lymphocytes are available to attack the myelin sheath around the nerves in the brain and spinal cord.
By reducing nerve damage in patients with MS, the number of attacks ( relapses ) is reduced and thus the deterioration of the disease is slowed down.
What you need to know before taking Ponvory
Do not take Ponvory
- if you are allergic to ponesimod or any of the other ingredients of this medicine (listed in section 6).
- if healthcare professionals have said that you have a severely weakened immune system.
- if you have had a heart attack, chest pain called unstable angina, stroke or minor stroke ( transient ischemic attack, TIA ), or certain types of heart failure in the last 6 months.
- if you have certain types of heart block (normal heart curve on ECG [electrocardiogram], usually with a slow heart rhythm) or irregular or abnormal heartbeat ( arrhythmias ), if you do not have a pacemaker.
- if you have a severe active infection or active chronic infection.
- if you have active cancer.
- if you have moderate or severe liver problems.
- if you are pregnant or a fertile woman and do not use effective contraception.
If you are not sure if any of these apply to you, talk to your doctor before taking Ponvory.
Warnings and cautions
Talk to your doctor before taking Ponvory if:
- you have an irregular or abnormal or slow heartbeat
- you have ever had a stroke or other diseases related to the blood vessels in the brain
- you have suddenly fainted ( syncope )
- you have a fever or infection
- you have an immune system that is not working properly due to an illness or if you are taking medicines that weaken the immune system
- you have never had chickenpox (varicella) and have not received a chickenpox vaccine. Your doctor may take a blood sample for the chickenpox virus. You may need to get a complete chickenpox vaccine program and then wait 1 month before starting Ponvory.
- you have breathing problems (such as severe respiratory disease, pulmonary fibrosis, or chronic obstructive pulmonary disease )
- you have liver problems
- you have diabetes. The risk of developing macular edema (see below) is higher in patients with diabetes.
- you have eye problems, especially an inflammation of the eye called uveitis
- you have high blood pressure.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ponvory.
Tell your doctor immediately if you get any of the following side effects while taking Ponvory:
Slow heart rate ( bradycardia or bradyarrhythmia)
Ponvory can make your heartbeat slower, especially after you have taken the first dose. You should do an electrocardiogram ( ECG, to check the electrical activity of the heart) before taking the first dose of Ponvory or before starting treatment with Ponvory after stopping treatment.
- If you have an increased risk of side effects due to the heart beating more slowly, your doctor may monitor your heart rate and blood pressure for at least 4 hours after taking the first dose of Ponvory.
- You may also have an ECG after the 4 hours. If you still have a very slow or decreased heart rate, you may need to be monitored until these problems have been resolved.
Infection is
Ponvory can increase the risk of serious infections that can be life-threatening. Ponvory reduces the number of lymphocytes in the blood. These blood cells fight infection. Their number usually returns to normal levels within 1 week after the end of treatment. Your doctor will examine your blood cells in a blood sample taken before you start taking Ponvory.
Contact your doctor immediately if you get any of these symptoms of an infection during treatment with Ponvory or 1 week after your last dose of Ponvory:
- fever
- fatigue
- body aches
- overindulge
- nausea
- vomiting
- headache with fever, stiffness in the neck, photosensitivity, nausea, and confusion (these can be symptoms of meningitis ( meningitis ), an infection of the membranes around the brain and spinal cord).
Macular edema
Ponvory can cause vision problems called macular edema (accumulation of fluid in the back of the eye (retina) that can cause vision changes, including blindness).
The symptoms of macular edema can cause similar visual symptoms as in an MS‑ ( optic neuritis ) relapse. In the early course, there may be no symptoms. If you experience vision changes, be sure to tell your doctor. If macular edema occurs, this usually happens during the first 6 months after you start taking Ponvory.
Your doctor should check your vision before you start taking Ponvory and if you notice any vision changes during treatment. The risk of developing macular edema is higher if you have diabetes or if you have had an inflammation of the eye called uveitis.
Contact a doctor immediately if you get any of the following symptoms:
- blurred vision or shadows in the middle of the field of view
- a blind spot in the middle of the field of view
- photosensitivity
- unusually colored (toned) vision.
Liver problem
Ponvory can cause liver problems. Your doctor will take blood samples to check your liver function before you start taking Ponvory.
Contact your doctor immediately if you get any of the following symptoms of liver problems:
- nausea
- vomiting
- abdominal pain
- fatigue
- reduced appetite
- yellow skin or whites of the eyes
- dark-colored urine.
Increased blood pressure
Because Ponvory may increase your blood pressure, your doctor should check your blood pressure regularly during treatment with Ponvory.
Exposure to the sun and protection from the sun
Because Ponvory may increase the risk of skin cancer, you should limit your exposure to sunlight and UV (ultraviolet) light by:
- wear sunscreen
- regularly apply sunscreen with a high sun protection factor.
Respiratory problems
Some people taking Ponvory experience shortness of breath. Contact a doctor immediately if you experience new or worsening breathing problems.
Swelling and narrowing of the blood vessels in the brain
A condition called PRES (posterior reversible encephalopathy syndrome) has arisen with drugs that work in a similar way to Ponvory. The symptoms of PRES usually improve when you stop taking Ponvory. If left untreated, however, it can lead to a stroke.
Contact your doctor immediately if you get any of the following symptoms:
- sudden severe headache
- sudden confusion
- sudden loss of vision or other changes in vision
- cramps.
Exacerbation of multiple sclerosis after discontinuation of Ponvory
If you stop taking Ponvory, the symptoms of MS may return. They may get worse compared to before or during treatment. Always talk to your doctor before stopping Ponvory. Tell your doctor if the symptoms of MS have worsened after you stop taking Ponvory.
Children and young people
Ponvory has not been studied in children and adolescents and is therefore not recommended for children and adolescents under 18 years of age.
Other medicines and Ponvory
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, over-the-counter medicines, vitamins, and herbal supplements. In particular, tell your doctor if you are taking:
- drugs to control heart rhythm ( antiarrhythmics ), blood pressure et (antihypertensive drugs), or heart rate (such as calcium channel blockers or beta-blockers that can reduce heart rate).
- drugs that affect the immune system due to possible side effects on the immune system.
Vaccine and Ponvory
Tell your doctor if you have recently received any vaccinations or if you are planning to get vaccinated. You should avoid receiving live vaccines during treatment with Ponvory. If you are given a live vaccine, you can get the infection that the vaccine would protect you against. Ponvory treatment should be stopped 1 week before and for 4 weeks after receiving a live vaccine. It is also possible that other vaccines do not work as well if they are given while you are being treated with Ponvory.
Pregnancy, contraception, and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
- Do not use Ponvory during pregnancy. If Ponvory is used during pregnancy, there is a risk of harm to the unborn baby.
- Do not use Ponvory if you are trying to conceive or if you are a woman who may become pregnant and is not using effective contraception.
Women who may become pregnant / contraceptives in women
If you are a woman who may become pregnant:
- Before starting treatment with Ponvory, your doctor will inform you about the risk of injuring your unborn child and you will perform a pregnancy test to check that you are not pregnant.
- you must use effective contraception when you take Ponvory and for 1 week after you stop taking Ponvory.
Talk to your doctor about effective contraception.
If you become pregnant while taking Ponvory, stop taking Ponvory and contact your doctor immediately.
If you become pregnant within 1 week of stopping Ponvory, contact your doctor.
Breast-feeding
You should not breastfeed while taking Ponvory. This is to prevent the risk of side effects in the baby as Ponvory may pass into breast milk.
Driving and using machines
Ponvory is not expected to affect your ability to drive or use machines.
Ponvory contains lactose
Ponvory contains lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ponvory contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Ponvory
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How to take
- Take Ponvory exactly as your doctor has told you. Do not change dose one and do not stop taking Ponvory unless your doctor tells you to.
- Take only 1 tablet per day. To help you remember to take your medicine, you should take it at the same time each day.
- Taken with or without food.
Deposit packaging (14 days)
- Only use Ponvory’s deposit pack when starting treatment. The deposit pack is used to gradually increase your dose over 14 days. The purpose of the step-by-step injection is to reduce any side effects due to your heart beating slower at the beginning of treatment.
- Make a note of the date you start taking the medicine next to day 1 on the Ponvory deposit pack.
- Follow this 14-day schedule.
| Deposit packaging day | Daily dose |
| Day 1 | 2 mg |
| Day 2 | 2 mg |
| Day 3 | 3 mg |
| Day 4 | 3 mg |
| Day 5 | 4 mg |
| Day 6 | 4 mg |
| Day 7 | 5 mg |
| Day 8 | 6 mg |
| Day 9 | 7 mg |
| Day 10 | 8 mg |
| Day 11 | 9 mg |
| Day 12 | 10 mg |
| Day 13 | 10 mg |
| Day 14 | 10 mg |
Maintenance dose
- After taking the tablets in the insert pack, continue treatment with the maintenance dose of 20 mg.
- Make a note of the date you start taking the 20 mg maintenance dose next to week 1 on the Ponvory 20 mg blister pack.
If you take more Ponvory than you should
If you take more Ponvory than you should, contact a doctor or hospital immediately. Take the medicine pack and this leaflet with you.
If you forget to take Ponvory
Do not take a double dose to make up for a forgotten tablet.
- If you forget to take up to 3 tablets in a row, either from the insert pack or the maintenance dose, you can continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember and then take 1 tablet a day to continue with the insertion pack dose or the maintenance dose as planned.
- If you have forgotten 4 or more Ponvory tablets in a row, either from the deposit pack or the maintenance dose, you will need to start treatment again with a new 14-day deposit pack. Contact your doctor immediately if you miss 4 or more doses of Ponvory.
Make a note of the date you start taking the medicine so that you know if you have missed 4 or more doses in a row.
Do not stop taking Ponvory without talking to your doctor.
Do not start Ponvory again after stopping treatment for more than 4 consecutive days without consulting your doctor. You will need to start treatment again with a new deposit pack.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be or maybe serious
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (may affect up to 1 in 10 people)
- urinary tract infection
- tracheal catarrh
- influenza
- viral infection of the nose, throat, or breast (viral infection of the respiratory tract)
- virus infection
- herpes zoster virus infection ( shingles )
- pneumonia _ _ _
- spinning sensation (dizziness)
- fever ( pyrexia )
- accumulation of fluid in the back of the eye (retina) that can lead to vision changes, including blindness ( macular edema )
Uncommon (may affect up to 1 in 100 people)
- slow heart rate ( bradycardia )
Other side effects are
Very common (may affect more than 1 user in 10)
- infection of the nose, sinuses, or throat ( nasopharyngitis, respiratory tract infection)
- elevated levels of liver enzymes in the blood (a sign of liver problems)
- the low number of a type of white blood cell called lymphocyte (lymphopenia)
Common (may affect up to 1 in 10 people)
- high blood pressure ( hypertension )
- back pain
- great feeling of tiredness (fatigue)
- dizziness
- shortness of breath ( dyspnoea )
- high levels of cholesterol in the blood ( hypercholesterolemia )
- joint pain ( arthralgia )
- arm or leg pain
- Depression
- insomnia
- cough
- itchy or runny nose or nasal congestion ( rhinitis ), infected or irritated throat ( pharyngitis, laryngitis ), sinus infection ( sinusitis )
- anxiety (anxiety)
- impaired sensation or sensitivity, especially in the skin ( hypoesthesia )
- increased levels of a protein in the blood that may indicate an infection or inflammation (increased C ‑ reactive protein (CRP))
- drowsiness ( somnolence )
- digestive problems ( dyspepsia )
- swollen hands, ankles, or feet (peripheral edema )
- migraine
- ligament sprain
- the feeling of discomfort in the chest
Uncommon (may affect up to 1 in 100 people)
- high levels of potassium in the blood (hyperkalemia)
- joint swelling
- dry mouth
How to store Ponvory
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should n
not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ponesimod
- Other ingredients are: Tablet core Croscarmellose
sodium, lactose monohydrate (see ‘Ponvory contains lactose’), magnesium stearate, microcrystalline cellulose, Povidone K30, colloidal anhydrous silica, and sodium lauryl sulfate. Tablet coating Hypromellose, lactose monohydrate, macrogol, titanium dioxide, and triacetin. Ponvory 3 mg film-coated tablets Red iron oxide (E172) and yellow iron oxide (E172) Ponvory 4 mg film-coated tablets Red iron oxide (E172) and black iron oxide (E172) Ponvory 5 mg film-coated tablets Black iron oxide (E172) and yellow iron oxide (E172 ) mg film-coated tablets Red iron oxide (E172) and yellow iron oxide (E172)
Ponvory 8 mg film-coated tablets
Red iron oxide (E172) and black iron oxide (E172) Ponvory 9 mg film-coated tablets Red iron oxide (E172) and black iron oxide (E172), yellow iron oxide (E172) Ponvory 10 mg film-coated tablets Red iron oxide (E172) iron oxide (E172) Ponvory 20 mg film-coated tablets Yellow iron oxide (E172)
What the medicine looks like and the contents of the pack
Ponvory 2 mg film-coated tablets are white, round, biconvex, 5 mm diameter film-coated tablets with “2” on one side and a bow on the other side.
Ponvory 3 mg film-coated tablets are red, round, biconvex, 5 mm diameter film-coated tablets with “3” on one side and an arc on the other side.
Ponvory 4 mg film-coated tablets are purple, round, biconvex, 5 mm diameter film-coated tablets with “4” on one side and a bow on the other side.
Ponvory 5 mg film-coated tablets are green, round, biconvex, 8.6 mm-diameter film-coated tablets with a “5” on one side and an arc and an “A” on the other side.
Ponvory 6 mg film-coated tablets are white, round, biconvex, 8.6 mm diameter film-coated tablets with a “ 6 ” on one side and an arc and an “A” on the other side.
Ponvory 7 mg film-coated tablets are red, round, biconvex, film-coated tablets with a diameter of 8.6 mm with a “7” on one side and an arc and an “A” on the other side.
Ponvory 8 mg film-coated tablets are purple, round, biconvex, film-coated tablets with a diameter of 8.6 mm with “8” on one side and a bow and an “A” on the other side.
Ponvory 9 mg film-coated tablets are brown, round, biconvex, film-coated tablets with a diameter of 8.6 mm with a “ 9 ” on one side and an arc and an “A” on the other side.
Ponvory 10 mg film-coated tablets are orange, round, biconvex, 8.6 mm diameter film-coated tablets with a “10” on one side and an arc and an “A” on the other side.
Ponvory 20 mg film-coated tablets are yellow, round, biconvex, 8.6 mm-diameter film-coated tablets with “20” on one side and an arc and an “A” on the other side.
Ponvory deposit packaging (folding packaging)
Each blister pack of 14 film-coated tablets for 2 weeks of treatment contains:
2 film-coated tablets of 2 mg
2 film-coated tablets of 3 mg
2 4 mg film-coated tablets
1 5 mg film-coated tablet
1 film-coated tablet of 6 mg
1 film-coated tablet of 7 mg
1 8 mg film-coated tablet
1 9 mg film-coated tablet
3 film-coated tablets of 10 mg
Ponvory 20 mg film-coated tablets (maintenance pack) (folding pack)
A pack containing 28 film-coated tablets for 4 weeks of treatment or a multi-pack containing 84 (3 packs of 28) film-coated tablets for 12 weeks of treatment.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Janssen ‑ Cilag International NV
Turnhoutseweg 30
B ‑ 2340 Beerse
Belgium
Manufacturer
Janssen Pharmaceutica NV
Turnhoutseweg 30
B ‑ 2340 Beerse
Belgium