285 mg solution for injection in a pre-filled syringe
volanesorsen
What Waylivra is and what it is used for
Waylivra contains the active substance volanesorsen, which is used to treat the condition of familial chylomicronemia (FCS ). FCS is a genetic disorder that causes abnormally high levels of blood fats called triglycerides. This can lead to inflammation of the pancreas, which causes severe pain. Along with a controlled low-fat diet, Waylivra helps lower the triglyceride levels in your blood.
You can receive Waylivra after you have already received other medicines used to lower the levels of triglycerides in your blood without any particular effect.
You will only receive Waylivra if it has been confirmed by genetic testing that you have FCS and your risk of pancreatitis is considered very high.
During treatment with Waylivra, you must continue with the low-fat diet prescribed by the doctor.
This medicine is intended for patients who are 18 years of age and older.
What you need to know before using Waylivra
Do not use Waylivra:
- if you are allergic to volanesorsen or any of the other ingredients of this medicine (listed in section 6).
- if you have thrombocytopenia, which means you have a very low number of platelets (less than 140 x 10 9 /l). This can be noticed if you get an injury that causes bleeding and it takes a long time for it to stop (more than 5-6 minutes for a scratch on the skin). The doctor will take samples for this before starting treatment with this medicine. You may not know beforehand that you have this condition or what may have caused it.
If any of the above apply to you, or if you are not sure, talk to your doctor, pharmacist, or nurse before using Waylivra.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Waylivra if you have or have had any of the following medical problems:
- very high triglyceride levels that are not due to FCS.
- a low number of platelets, a type of cell in the blood that clumps together so the blood can clot ( thrombocytopenia ). The doctor will take a blood test before you start using this medicine to check the number of platelets in your blood.
- liver or kidney problems.
Blood samples
Your doctor will take a blood test before you start taking this medicine to check your platelet count and then at regular intervals after you start using Waylivra to check your platelet count.
See a doctor immediately if you have signs or symptoms of a low platelet count, e.g. unusual or prolonged bleeding, red spots on the skin (called petechiae ), unexplained bruising, bleeding that does not stop or nosebleeds, or if you have a stiff neck or severe headache.
The doctor may also take a blood test every three months to check for signs of liver damage. See a doctor immediately if you have signs or symptoms of liver damage, e.g. yellowing of the skin and whites of the eyes, pain or swelling in the abdomen, nausea or vomiting, confusion, or feeling generally unwell.
If necessary, the doctor may decide to change how often you use this medicine or decide on a treatment break. It may be necessary to consult with a doctor who specializes in blood disorders to decide whether or not to continue treatment with Waylivra.
Urine sample
The doctor may take a urine and or blood test every three months to check for signs of kidney damage. See a doctor immediately if you have signs or symptoms of kidney damage, e.g. swelling of the ankles, legs, and feet, passing less urine than usual, shortness of breath, nausea, confusion, or if you feel very tired or drowsy.
Diet
Before starting treatment with this medicine, you should eat a diet designed to lower blood triglyceride levels. You must continue to eat the triglyceride-lowering diet during treatment with Waylivra.
Children and young people
Do not use Waylivra if you are under 18 years of age. Waylivra has not been studied in patients under 18 years of age.
Other medicines and Waylivra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must tell the doctor if you are already being treated with any of the following:
- medicines that inhibit blood coagulation, e.g. aspirin, dipyridamole, or warfarin.
- other medicines that can affect blood clotting, include non-steroidal anti-inflammatory medicines such as ibuprofen, medicines used to prevent heart attack and strokes such as clopidogrel, ticagrelor, and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce the amount of stomach acid) and quinine (used to treat malaria ).
- medicines that can cause problems with the liver, e.g. paracetamol.
Waylivra with alcohol
The effect of using Waylivra with alcohol is unknown. You should avoid drinking alcohol during treatment with this medicine because of the risk of liver problems.
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. Use of Waylivra during pregnancy should preferably be avoided.
It is unknown whether Waylivra is excreted in breast milk. You should discuss breastfeeding with your doctor to find out what is best for you and your baby.
Driving ability and use of machinery
Waylivra is unlikely to affect the ability to drive or use machines.
Waylivra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How to use Waylivra
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Before you receive this medicine, other causes of high triglyceride levels, such as diabetes or problems with the thyroid gland, are to be ruled out by the doctor.
The doctor will tell you how often to take this medicine. Depending on your blood and urine test results or possible side effects, the doctor may decide to change how often you use this medicine, decide on a treatment break or stop the medicine altogether.
You or your healthcare provider will be shown how to use Waylivra according to the instructions for use in this leaflet. Waylivra should be injected under the skin ( subcutaneous or sc administration ) in the same way as the doctor, nurse or pharmacist has shown you and you should make sure that you inject all the liquid in the syringe. Each single-use pre-filled syringe of this medicine gives you a dose of 285 mg in 1.5 ml.
Before using this medicine, you must read, understood, and carefully follow the instructions for use.
Instructions for use can be found at the end of this leaflet.
If you use too much Waylivra
If you inject too much Waylivra, contact your doctor or pharmacist, or go to an emergency department even if you have no symptoms.
If you forget to use Waylivra
If you forget a dose, contact the doctor and ask when you should take the next dose. If a dose is missed and less than 48 hours have passed before it is discovered, the missed dose should be given as soon as possible. If more than 48 hours have passed before it is detected, the missed dose should be skipped and the next injection given as usual. Do not inject more than one dose within 2 days.
If you stop using Waylivra
Do not stop using Waylivra unless you have discussed stopping treatment with your doctor.
If you have further questions about this medicine, contact your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Contact your doctor immediately if you experience any of the following side effects:
- Symptoms that may indicate a low number of blood platelets ( platelets play an important role in blood clotting ). See a doctor immediately if you have signs or symptoms of a low platelet count, e.g. unusual or prolonged bleeding, red spots on the skin (called petechiae ), unexplained bruising, bleeding that does not stop or nosebleeds, or if you have a stiff neck or severe headache.
Other side effects ar
Very common (may affect more than 1 in 10 people)
- injection site reactions (rash, pain, redness, heat, dryness, swelling, itching, tingling, induration, hives, blistering, swelling, bruising, bleeding, numbness, pallor, discoloration, or burning at the injection site). You can reduce the risk of injection site reactions by waiting until Waylivra has reached room temperature before injection and by applying ice after injection.
- headache
- muscle pain
- overindulge.
Common (may affect more than 1 in 10 users)
- blood tests that show unusually high levels of white blood cells
- blood tests showing unusually low levels of white blood cells (lymphopenia)
- easy bruising, large bruises, or bruising for no apparent reason
- bleeding under the skin that appears as a rash, bleeding gums or bleeding in the mouth, blood in the urine or stool, nosebleeds, or heavy menstrual bleeding
- an allergic reaction with symptoms including rash, joint stiffness, or fever
- blood or protein in the urine
- changed results for certain blood tests, including:
- an increased level of certain constituents in the blood: creatinine, urea, transaminases, liver enzymes
- an increased blood clotting time (the time it takes for the blood to clot)
- a reduced amount of hemoglobin in the blood
- a lower flow rate of blood passing through the kidneys
- diabetes with symptoms including thirst, frequent urination (especially at night), extreme hunger, severe fatigue, and unexplained weight loss
- sleep difficulties
- numbness, tingling, tingling, fainting or fainting, dizziness or shaking
- visual disturbances, e.g. flashes of light or short-term, temporary blindness in one eye, bleeding under the surface of the eye, or blurred vision
- high blood pressure
- hot flashes increased sweating, night sweats, feeling hot, pain, flu-like symptoms, or feeling generally unwell
- cough, difficulty breathing, nasal congestion, swelling of the throat, wheezing
- nausea or vomiting, dry mouth, diarrhea, swelling of the throat, face, or gums, abdominal pain or bloating, indigestion
- skin redness, rash, pimples, thickening or scarring of the skin, or hives
- pain in the hands or feet, pain in the large joints of the arms and legs, e.g. elbows, wrists, knees, and ankles, other joint pain or stiffness, back pain, neck pain, jaw pain, muscle cramps, or other body aches
- severe fatigue, weakness or lack of energy, fluid retention, and chest pain unrelated to the heart.
How to store Waylivra
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and syringe after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C‑8°C).
Store in the original packaging. Light sensitive.
Waylivra can be stored at room temperature (up to 30 °C) in the original packaging for up to 6 weeks after removal from the refrigerator. During this time, the medicine can be stored either at room temperature or put back in the refrigerator as needed. Record the date you first took the package out of the refrigerator on the outer carton in the area provided. If the medicine is not used within 6 weeks after the first time it was taken out of the refrigerator, it should be thrown away. If the expiration date on the syringe label has passed during the 6 weeks at room temperature, the syringe should not be used and should be discarded.
Do not use this medicine if the solution is cloudy or contains particles. The solution should be clear and colorless to slightly yellow.
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 volanesorsen. Each ml contains 200 mg of volanesorsen sodium, which corresponds to 190 mg of volanesorsen. Each pre-filled single-dose syringe contains 285 mg of volanesorsen in 1.5 ml of solution.
- The other ingredients are water for injections, sodium hydroxide, and hydrochloric acid (to adjust the acidity, see section 2 under Waylivra contains sodium ).
Appearance and package sizes of the medicine
Waylivra is supplied in a carton as a single-dose syringe with a needle and needle guard, pre-filled with a clear, colorless slightly yellow solution. It is filled to give 1.5 ml of the solution when the syringe plunger is fully depressed.
It is supplied either in a carton containing 1 pre-filled syringe or as a multipack of 4 pre-filled syringes (4 packs of 1 syringe ).
Marketing Authorisation Holder
Akcea Therapeutics Ireland Ltd.
St. James House
72 Adelaide Road, Dublin 2
D02 Y017
Ireland
Manufacturer
Almac Pharma Services Ireland Ltd.
Finnabair Industrial Estate
Dundalk
Co. Louth
Ireland