231 mg hard enteric capsules diroximel
fumarate (diroximel fumarate)
What Vumerity is and what it is used for
What Vumerity is
Vumerity contains the active substance diroximel fumarate.
What Vumerity is used for
Vumerity is used to treat relapsing-remitting multiple sclerosis (MS) in adults.
MS is a long-term disease in which the immune system, the body’s natural defense, malfunctions and attacks parts of the central nervous system (the brain, spinal cord, and optic nerve one to the eye) and causes inflammation that damages the nerves and the insulation around them. Relapsing-remitting MS is characterized by repeated attacks (attacks ) on the nervous system. Symptoms vary between patients but usually include walking problems, a feeling of poor balance, and vision problems (eg, blurred vision or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.
How Vumerity works
The drug is believed to work by increasing the effect that a protein called “Nrf2” exerts, i.e. it controls certain genes that form antioxidants that help protect cells from damage. This helps control immune system activity and reduce damage to the brain and spinal cord.
What you need to know before taking Vumerity
Do not take Vumerity
- if you are allergic to proximal fumarate, related substances (so-called fumarates or fumaric acid esters), or any other ingredient in this medicine (listed in section 6).
- if you are suspected of suffering from a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if you have confirmed PML.
Warnings and precautions
Vumerity can affect your white blood cells, kidneys, and liver. Before you start taking Vumerity, your doctor will test your blood to count the number of white blood cells and check that your kidneys and liver are working properly. The doctor tests this regularly during the treatment. If your white blood cell count drops during treatment, your doctor may consider taking additional tests or stopping your treatment.
Talk to your doctor straight away if you think your MS is getting worse (eg weakness or vision changes) or if you notice new symptoms. These may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or be life-threatening. Read the information about PML and low lymphocyte counts in section 4 of this leaflet.
Talk to your doctor before taking Vumerity if you have:
- a serious infection (eg pneumonia )
- severe kidney disease
- severe liver disease
- a disease of the stomach or intestine
Skin flushing ( redness on the face and body) is a common side effect. Severe reddening of the skin with additional symptoms may be a sign of a severe allergic reaction and has been seen in a small number of patients – see ‘Severe allergic reactions’ in section 4 of this leaflet. Talk to your doctor if you experience skin redness that bothers you. Your doctor may be able to give you medication to treat the redness.
Vumerity can cause a serious allergic reaction called a hypersensitivity reaction. You need to know all the important signs and symptoms to watch out for when taking Vumerity. Read the information about serious allergic reactions in section 4 of this leaflet.
Shingles ( herpes zoster ) may occur during treatment with Vumerity. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect that you have any symptoms of shingles. The symptoms are described in section 4 of this leaflet.
A rare but serious kidney disease (Fanconi syndrome) has been reported for a drug containing active substances related to Vumerity (dimethyl fumarate, in combination with other fumaric acid esters). If you notice that you urinate more, are thirstier, and drink more than usual, or if your muscles seem weak, if you break a bone or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Children and young people
Vumerity should not be given to children and adolescents as the experience of the safety and efficacy of this medicine in this patient group is limited.
Other medicines and Vumerity
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Especially:
- medicines containing fumaric acid esters (fumarates)
- medicines that affect the body’s immune system including chemotherapy, immunosuppressants, or other medicines used to treat MS
- medicines that affect the kidneys including some antibiotics (such as aminoglycosides used to treat infections ), ” water tablets ” ( diuretics ), certain types of painkillers (such as ibuprofen and other similar anti-inflammatory medicines and over-the-counter medicines) and medicines containing lithium
- If you take Vumerity with certain types of vaccines ( live vaccines ), you may get an infection and you should therefore avoid such vaccines. The doctor will decide whether other types of vaccines ( non-live vaccines ) should be given.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Vumerity if you are pregnant unless you have first discussed it with your doctor. This is because Vumerity could harm your unborn baby. If you can get pregnant, use reliable contraception.
Breast-feeding
It is unknown whether proximal fumarate or its metabolite is passed into breast milk. Your doctor will help you decide whether to stop breastfeeding or stop using Vumerity. This means that the benefit of breastfeeding for the baby is compared to the benefit of the treatment for you.
Driving ability and use of machinery
Vumerity is not expected to affect the ability to drive or use machines.
How to take Vumerity
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
Starting dose
The recommended starting dose is 231 mg (one capsule) twice daily.
Take the starting dose for the first 7 days and then take the maintenance dose.
Maintenance dose
The recommended maintenance dose is 462 mg (two capsules) twice daily.
Vumerity should be swallowed.
Swallow the capsules whole with water. Do not crush or chew the capsule and do not sprinkle the contents of the capsule over food as this may increase some side effects.
You can take Vumerity with food or on an empty stomach. If you have side effects such as skin redness or stomach upset, taking them with food can reduce these symptoms.
If you have taken too much Vumerity
If you have taken too many capsules, talk to your doctor immediately. You may experience side effects similar to those described below in section 4.
If you forget to take Vumerity
Do not take a double dose to make up for a missed dose.
If it is still at least 4 hours until your next scheduled dose, you can take the missed dose. Otherwise, skip the missed dose and take the next scheduled dose at the usual time.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
PML and decreased lymphocyte counts
The frequency of PML cannot be estimated from the available data (no known frequency).
Vumerity can lower the number of lymphocytes (a type of white blood cell ). Having a low white blood cell count can increase your risk of infection, including the risk of getting an unusual brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or be life-threatening. PML has occurred after 1 to 5 years of treatment with the related drug dimethyl fumarate and the doctor should therefore continue to check the white blood cell count throughout treatment you should be alert for any symptoms of PML described below. The risk of PML may be higher if you have previously taken medication that weakens the body’s immune system.
The symptoms of PML can be similar to an MS relapse. Symptoms may include new or worsening weakness on one side of the body, clumsiness, vision changes, thinking, or memory, confusion or personality changes, or speech and communication difficulties that last longer than a few days.
It is therefore very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while you are being treated with Vumerity. Also, talk to your partner or carer and tell them about your treatment. Symptoms may occur that you do not notice yourself.
- Contact a doctor immediately if you experience any of these symptoms
Severe allergic reactions
The frequency of severe allergic reactions cannot be estimated from the available data (no frequency is known).
Skin redness is a very common side effect. If, however, you develop redness on your face or body along with a red rash or hives and experience any of these symptoms:
- swelling of the face, lips, mouth, or tongue ( angioedema )
- wheezing, difficulty breathing, or shortness of breath ( dyspnea, hypoxia )
- dizziness or fainting ( hypotension )
it could be a severe allergic reaction ( anaphylactic reaction ).
- Stop taking Vumerity and see a doctor immediately
Other side effects ar
Very common (may affect more than 1 in 10 people)
- redness of the face or body, feeling of heat, hotness, burning, or itching ( flush )
- loose stools (diarrhea)
- nausea
- stomach pain or stomach cramps
Side effects that can show up in blood or urine tests
- substances called ketones, which are produced naturally in the body, are very common in urine tests while taking Vumerity.
- a low number of white blood cells ( lymphopenia, leukopenia ) in the blood. A reduced number of white blood cells can mean that the body has less ability to fight infection. If you get a serious infection (e.g. pneumonia ), you must talk to your doctor straight away
Talk to your doctor about how to manage these side effects. The doctor may lower the dose. Do not lower the dose unless your doctor tells you to.
Common (may affect up to 1 in 10 people)
- inflammation of the intestines ( gastroenteritis )
- vomiting
- indigestion ( dyspepsia )
- inflammation of the stomach ( gastritis )
- indigestion ( disorder in the gastrointestinal tract )
- burning sensation
- hot flush, feeling of warmth
- itching of the skin ( pruritus )
- rash
- pink or red spots on the skin ( erythema )
- hair loss ( alopecia )
Side effects that can show up in blood or urine tests
- protein ( albumin ) in the urine ( proteinuria )
- elevation of liver enzymes ( ALT, AST ) in the blood
Uncommon (may affect up to 1 in 100 people)
- allergic reactions ( hypersensitivity )
- decreased number of platelets
Frequency not known (cannot be estimated from available data)
- liver damage due to drugs and elevated levels of liver enzymes checked with blood tests ( ALT or AST in combination with bilirubin )
- – shingles ( herpes zoster) with symptoms such as blisters, burning sensation, itching, or pain in the skin, typically on one side of the upper body or face, and other symptoms such as fever and weakness during the early stages of infection followed by numbness, itching or red spots with severe pain.
- runny nose ( rhinorrhea )
How Vumerity should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after EXP.
The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Store in the original jar. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is proximal fumarate.
Each capsule contains 231 mg of proximal fumarate.
Other ingredients are Capsule content: methacrylic acid-ethyl acrylate copolymer (1:1) of type A; crospovidone type A; microcrystalline cellulose; colloidal anhydrous silica; triethyl citrate; talc; magnesium stearate. Capsule shell: hypromellose; titanium dioxide (E171); potassium chloride; carrageenan. Capsule print: black iron oxide (E172), shellac, potassium hydroxide.
Appearance and package sizes of the medicine
Vumerity 231 mg hard enteric capsules are white and marked with “DRF 231 mg” in black ink.
Vumerity is available in packs containing 120 or 360 (3 x 120) capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Manufacturer
Alkermes Pharma Ireland Limited
Monksland
Athlone
Co. Westmeath
Ireland
N37 EA09