WAYLIVRA
Generic Name/API: volanesorsen
Manufacturer: Almac Pharma
Dosage Forms & Strength & Pack Size:
Injection: 285mg mg/1.5 mL injection in pre-filled syringe
Storage:
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 syringe label after ‘EXP’. Please note that the expiry date refers to the last day of that month.
Store in a refrigerator (2 ° – 8 °C).
Store in the original carton to protect from light.
Waylivra can be kept at room temperature (up to 30 °C) in the original carton for up to 6 weeks after removing from the refrigerator. During this time this medicine may be kept at either room temperature or put back into the refrigerator, as needed. Record the date you first remove the pack from the refrigerator on the outer carton in the space indicated. If you do not use it within 6 weeks after first removing from the refrigerator, discard the medicine. If the expiry date on the syringe label has passed during the 6 week period at room temperature, do not use the syringe and discard it.
Do not use this medicine if the solution is cloudy or contains particles; it should be clear and colourless to slightly yellow.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Waylivra contains the active substance volanesorsen, which helps to treat a condition called familial chylomicronemia syndrome (FCS). FCS is a genetic disease which gives rise to abnormally high levels of fats called triglycerides in the blood. This can lead to inflammation of your pancreas, causing severe pain. Together with a controlled low-fat diet, Waylivra helps to lower the levels of triglycerides in your blood.
Waylivra may be given after you have already received other medicines used to lower the levels of triglycerides in blood without them having much effect.
You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high..
You should continue the very low-fat diet that your doctor has prescribed during treatment with 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 which are not due to FCS.
− A low number of platelets, a type of cell in your blood that clump together to help it clot (thrombocytopenia); your doctor will do a blood test before you start using this medicine to check the number of platelets in your blood.
− Any liver or kidney problems.
Blood tests
Your doctor will do a blood test before you start using this medicine to check the number of platelets, and then at regular intervals once you have started using Waylivra to check on platelet levels.
You should see your doctor immediately if you have any signs of low platelet levels, such as unusual or prolonged bleeding, patches of red appearing on the skin (called petechiae), unexplained bruising, bleeding which will not stop, or nosebleeds, or if you get neck stiffness or a severe headache.
Your doctor may also do a blood test every 3 months to check for signs of damage to your liver. You
should see your doctor immediately if you have any signs of liver damage, such as yellowing of your
skin and eyeballs, pain or swelling in your abdomen, feeling or being sick, confusion or a general
feeling of being unwell.
If necessary, your doctor may change how often you use this medicine, or may stop it for a period. It may be necessary to consult a doctor specialising in blood disorders to determine whether you should continue treatment with Waylivra or not.
Urine tests
Your doctor may do a urine and/or blood test every 3 months to check for signs of damage to your kidneys. You should see your doctor immediately if you have any signs of kidney damage, such as swelling in your ankles, legs and feet, passing smaller amounts of urine than usual, shortness of breath, feeling sick, confusion or feeling very tired or drowsy.
Diet
Before starting this medicine, you should be on a diet designed to help lower triglyceride levels in your blood.
It is important that you maintain this triglyceride-lowering diet whilst using Waylivra.
Children and adolescents
Do not use Waylivra if you are under 18 years old. Waylivra has not been studied in patients under 18 years old.
Other medicines and Waylivra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is important to tell your doctor if you are already being treated with any of the following:
− Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamol or warfarin.
− Other medicines that may change how your blood clots, including non-steroidal anti-inflammatory medicines like ibuprofen, medicines used to prevent heart attacks and strokes such as clopidogrel, ticagrelor and prasugrel, antibiotics such as penicillin, medicines such as ranitidine (used to reduce stomach acid), and quinine (used to treat malaria).
− Medicines that may cause problems with your liver, such as paracetamol.
Waylivra with alcohol
The effect of using Waylivra with alcohol is not known. You should avoid alcohol during treatment with this medicine due to risk of liver issues.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is preferable to avoid the use of Waylivra during pregnancy.
It is not known if Waylivra passes into breast milk. It is recommended that you discuss breast-feeding with your doctor to see what is best for you and your child.
Driving and using machines
Waylivra is not likely to affect your ability to drive or use machines.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
