Waylivra 285 mg solution for injection in pre-filled syringe
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Waylivra 285 mg solution for injection in pre-filled syringe
volanesorsen
?This medicinal product is subject to additional monitoring, which will facilitate the detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, consult your doctor, pharmacist, or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
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If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Waylivra is and what it is used for
- What you need to know before using Waylivra
- How to use Waylivra
- Possible adverse reactions
- How to store Waylivra
- Contents of the pack and other information
1. What Waylivra is and what it is used for
Waylivra contains the active substance volanesorsen, which helps treat a condition called familial chylomicronaemia syndrome (FCS). FCS is a genetic disease that causes abnormally high levels in the blood of a type of fat known as triglycerides. This can lead to inflammation of the pancreas, which is very painful. Together with a low-fat diet, Waylivra helps reduce the concentration of triglycerides in the blood.
Waylivra may be prescribed to you if other medications to reduce triglyceride levels in the blood have not been sufficiently effective.
You will only be given Waylivra if genetic testing confirms that you have FCS and you are considered to be at very high risk of pancreatitis.
While being treated with Waylivra, you must continue to follow the low-fat diet prescribed by your doctor.
This medicine is for patients aged 18 years and older.
2. What you need to know before using Waylivra
Do not use Waylivra:
- if you are allergic to volanesorsen or to any of the other ingredients of this medicine (listed in section 6).
- if you have a condition called thrombocytopenia, which means you have very low platelet counts in your blood (less than 140 × 109/l). You may notice this if you have a wound that bleeds and takes a long time to stop (more than 5 to 6 minutes for a skin scratch). Your doctor will perform a blood test to determine this before administering this medicine. You may not know that you have this condition or what may have caused it.
If any of the above situations apply to you, or if you are unsure, consult your doctor, nurse, or pharmacist before using Waylivra.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Waylivra if you have or have had any of the following medical conditions:
- Very high triglyceride levels, but not due to FCS.
- Low platelet count (thrombocytopenia), a type of blood cell that helps blood to clot; before you start using this medicine, your doctor will perform a blood test to measure the number of platelets in your blood.
- Any type of liver or kidney problems.
Blood tests
Before using this medicine, your doctor will perform a blood test to measure your platelet count and then, at regular intervals while you are receiving Waylivra, to monitor your platelet count.
Contact your doctor immediately if you experience any signs indicating a low platelet count, such as unusual or prolonged bleeding, red spots on the skin (called petechiae), unexplained bruising, bleeding that does not stop, nosebleeds, or if you develop neck stiffness or a severe headache.
Your doctor may also request blood tests every 3 months to check for any liver problems. Contact your doctor immediately if you experience signs of liver damage, such as yellowing of the skin or eyes, abdominal pain or swelling, dizziness, confusion, or a general feeling of being unwell.
If necessary, your doctor may adjust the dosing frequency of this medicine or temporarily suspend treatment. You may need to consult a specialist doctor in blood disorders to determine whether you can continue receiving Waylivra.
Urine tests
Your doctor may request urine or blood tests every 3 months to monitor kidney function. Contact your doctor immediately if you experience signs of kidney damage, such as swelling in the ankles, legs, and feet, reduced urine output, difficulty breathing, dizziness, confusion, or severe fatigue or drowsiness.
Diet
Before starting to receive this medicine, you must follow a diet designed to help lower your blood triglyceride levels.
It is important that you maintain this low-triglyceride diet while receiving Waylivra.
Children and adolescents
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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is important to inform your doctor if you are receiving treatment with any of the following:
- Medicines to prevent blood clots, e.g., acetylsalicylic acid, dipyridamole, or warfarin.
- Other medicines that may affect blood clotting, such as non-steroidal anti-inflammatory drugs like ibuprofen, medicines used to prevent myocardial infarction and stroke, such as clopidogrel, ticagrelor, and prasugrel, antibiotics such as penicillin, and medicines such as ranitidine (used to reduce stomach acidity) and quinine (used to treat malaria).
- Medicines that may cause liver problems, such as paracetamol.
Use of Waylivra with alcohol
The effect of using Waylivra with alcohol is unknown. You should avoid alcohol during treatment with this medicine due to the risk of liver problems.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using Waylivra during pregnancy.
Driving and using machines
It is unlikely that Waylivra will affect your ability to drive or use machines.
Waylivra contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially “sodium-free”.
3. How to use Waylivra
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Before administering this medicine, your doctor must rule out other causes of elevated triglycerides, such as diabetes or thyroid problems.
Your doctor will tell you how often this medicine should be administered. They may change how frequently you need to use it or ask you to stop receiving it temporarily or permanently, depending on the results of your blood and urine tests or the occurrence of side effects.
You (or your caregiver) will be trained to use Waylivra according to the instructions in this leaflet. Waylivra must be injected under the skin (subcutaneous administration, or SC), as shown to you by your doctor, nurse, or pharmacist, and you must ensure that all the liquid has been injected from the syringe. Each single-dose pre-filled syringe of this medicine delivers a dose of 285 mg in 1.5 ml.
Before using this medicine, it is important that you read, understand, and carefully follow the administration instructions.
The instructions for use are provided at the end of this leaflet.
If you use more Waylivra than you should
If you inject too much Waylivra, contact your doctor or pharmacist immediately or go to the emergency room, even if you do not have symptoms.
If you forget to use Waylivra
Do not take a double dose to make up for missed doses. If you forget to administer a dose and realize within 48 hours of the scheduled time, take the missed dose as soon as possible. However, if more than 48 hours have passed, wait for your next scheduled dose. Do not inject more than one dose within a 2-day period.
If you stop using Waylivra
Do not stop using Waylivra without first discussing it with your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
If you experience any of the following adverse effects, contact your doctor immediately:
- Symptoms that could indicate a low platelet count in the blood (platelets are cells important for blood clotting). You should contact your doctor immediately if you notice signs of a low platelet count, such as unusual or prolonged bleeding, appearance of red spots on the skin (called petechiae), unexplained bruising, bleeding that does not stop, or nosebleeds, or if you experience neck stiffness or a severe headache.
Other adverse effects
Very common (may affect more than 1 in 10 people)
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Reactions at the injection site (rash, pain, redness, warmth, dryness, swelling, itching, tingling, hardening, hives, blisters, pimples, bruising, bleeding, numbness, paleness, color change, or burning sensation at the injection site). You can reduce the likelihood of experiencing an injection site reaction by waiting for Waylivra to reach room temperature before injecting and by applying ice to the injection site after administration.
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Headache
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Muscle pain
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Chills
Common (may affect up to 1 in 10 people)
- Abnormally high levels of white blood cells in blood tests
- Abnormally low levels of white blood cells (known as lymphopenia) in blood tests
- Easy or excessive bruising, or bruising without an obvious cause
- Bleeding under the skin that appears as a rash, bleeding from gums or in the mouth, blood in urine or stools, nosebleeds, or abnormally heavy menstrual periods
- Allergic reaction, with symptoms such as skin rash, joint stiffness, or fever
- Presence of blood or protein in urine
- Changes in certain blood test results, such as:
- increased levels of certain blood components: creatinine, urea, transaminases, liver enzymes
- prolonged blood clotting time
- decreased hemoglobin concentration in blood
- decreased blood filtration rate in the kidneys
- Diabetes, with symptoms such as increased thirst, frequent urination (especially at night), extreme hunger, severe fatigue, and unexplained weight loss
- Difficulty sleeping
- Numbness, tingling, or prickling sensations, feeling faint or dizzy, dizziness, or restlessness
- Vision disorders, such as seeing flashes of light, brief transient blindness in one eye, bleeding under the surface of the eye, or blurred vision
- High blood pressure
- Flushing, increased sweating, night sweats, feeling of warmth, flu-like illness, or general malaise
- Cough, difficulty breathing, nasal congestion, throat swelling, wheezing
- Feeling unwell, dry mouth, diarrhea, swelling of the neck, face, or gums, stomach pain or swelling, indigestion
- Skin redness, rash, pimples, thickening, scarring, or skin itching known as urticaria
- Pain in hands or feet, pain in large joints of arms and legs, including elbows, wrists, knees, and ankles, other types of joint pain or stiffness, back pain, neck pain, jaw pain, muscle spasms, or other body pains
- Severe fatigue, weakness, or lack of energy, fluid retention, non-cardiac chest pain
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Waylivra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the syringe following "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Keep in the original carton to protect from light.
Waylivra may be kept at room temperature (up to 30 °C) in the original carton for up to 6 weeks after removal from the refrigerator. During this period, and as needed, this medicine may be stored either at room temperature or in the refrigerator. Record the date when the carton is first removed from the refrigerator in the space provided on the carton. If not used within 6 weeks after first removal from the refrigerator, the medicine must be discarded. If during the 6-week period during which the syringe may be kept at room temperature the expiry date printed on its label is reached, do not use the syringe and discard it.
Do not use this medicine if the solution appears cloudy or contains particles; it should be clear and colourless to pale yellow.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.
6. Contents of the pack and other information
Composition of Waylivra
- The active substance is volanesorsen. Each ml contains 200 mg of volanesorsen sodium, equivalent to 190 mg of volanesorsen. Each single-dose pre-filled 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 acidity; see section 2, "Sodium").
Appearance of the product and contents of the pack
Waylivra is supplied in a pack containing a single-dose pre-filled syringe with needle and needle cover, containing a clear, colourless to pale yellow solution. The syringe is filled to deliver 1.5 ml of solution when the plunger is fully depressed.
It is available in a pack containing one pre-filled syringe or in a multiple pack containing 4 (4 packs of 1) pre-filled syringes.
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
Date of the most recent review of this summary: 11/2022
This medicinal product has been authorised under a "conditional approval". This type of approval means that further information on this medicinal product is expected.
The European Medicines Agency will review new information on this medicinal product at least once a year, and this summary of product characteristics (SmPC) will be updated as necessary.
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Instructions for use
Waylivra is an injection administered subcutaneously using a single-use, disposable, pre-filled syringe.
Do not use Waylivra until you fully understand the procedure described below. If you have any questions about how to use Waylivra, contact your doctor or pharmacist.
Parts of the pre-filled syringe
Preparation for injection
- Wash your hands and gather the necessary items for injection
Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.
Place the following items on a clean, flat surface in a well-lit area (Figure A).
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Figure A
- Allow the injection to reach room temperature
If the syringe has been stored in the refrigerator, allow it to reach room temperature by removing it from the refrigerator at least 30 minutes before injection. If the injected liquid is cold, it may cause injection site reactions such as pain, redness, or swelling. Do not heat the syringe in any other way, including in the microwave or with hot water. |
Figure B |
- Check the expiry date
Check the expiry date on the carton. The expiry date on the packaging refers to the shelf life of the medicine when refrigerated. The first time the pack is removed from the refrigerator, you must record the date in the space provided on the carton. Do not use Waylivra if it has passed the expiry date or if it has been kept at room temperature for more than 6 weeks. Contact your doctor or pharmacist to obtain a new medicine. |
- Remove the syringe and inspect the medication
Open the box and remove the syringe, hold it by the cylinder and pull until it is removed (Figure C). |
Figure C |
Inspect the liquid in the syringe. It should be clear to pale yellow in color. It is normal to see one large air bubble (Figure D). Do not attempt to remove the bubble before injection. It is safe to inject the solution with the bubble. Do not use the pre-filled syringe if the liquid appears cloudy or contains floating particles. |
Figure D |
- Choose an injection site
If you are self-administering: Abdomen – Shown are the abdominal areas, except for the 5 cm surrounding the navel. Thighs – Shown are the front and middle sides (Figure E). |
Figure E |
If the injection is administered by a caregiver, in addition to these two areas, the injection may also be given in: Arms – Back of the upper arm, as shown (Figure F). For all injections: Rotate injection sites. Avoid injecting in the waist area: clothing may rub or press on the injection site. Do not inject into tattoos, moles, scars, birthmarks, bruises, rashes, or areas of skin that are tender, red, hard, damaged, burned, or inflamed. If you are unsure where to administer the injection, consult your healthcare professional. |
Figure F |
Injection
- Prepare the injection site
Clean the selected area with cotton soaked in alcohol (Figure G). |
Figure G |
- Remove the syringe protector
Remove the needle cover by holding the barrel of the syringe so that the needle does not point toward you, and pull the cover straight off (Figure H). A drop of liquid at the tip of the needle may be visible. This is normal. Do not touch the plunger or its support when removing the needle cover. Do not use the pre-filled syringe if the needle appears damaged. Do not use the pre-filled syringe if it is dropped after removing the needle cover. |
Figure H |
- Pinch the skin
Pinch the skin around the injection site with your free hand (Figure I). |
Figure I |
- Lock the needle
Insert the needle into the injection site with a quick, firm motion, without pressing the plunger. The needle should be inserted at a 45-degree angle to the skin surface (Figure J). |
Figure J |
- Inject Waylivra
Inject the liquid while holding the syringe with your thumb on the plunger, and push it slowly to the end of its travel, until the syringe is completely empty (Figures K and L). |
Figure K |
Figure L |
- Remove the needle
Remove the needle from the injection site by pulling it out at the same angle at which it was inserted (Figure M). |
Figure M |
After the injection
- Dispose of the used syringe in a sharps container
Immediately after injection, dispose of the used syringe as instructed by your healthcare professional, usually in sharps disposal containers (Figure N) by following the steps below. Remove the needle cap after injection. Do not recap the syringe. If you do not have a sharps disposal container, you may dispose of it in a container at home if it:
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Figure N |
When the sharps disposal container is nearly full, follow local guidelines for its safe disposal. There may be local regulations regarding the disposal of used needles and syringes. Ask your pharmacist or visit the website of your local public health authority (if applicable) for more information on how to properly dispose of sharps in your area. Do not throw your sharps disposal container into the household trash. Do not recycle your used sharps disposal container. Always keep the sharps disposal container out of reach of children and pets. |
- Treatment of the injection site
If blood comes out at the injection site, press the area gently with the sterile cotton ball or gauze and dressing, if necessary (Figure O). Do not rub the area after the injection. |
Figure O |
You may also apply ice to the injection site to reduce pain, redness, or discomfort (Figure P). |
Figure P |
Storage
Information on storage
The first time you are given Waylivra, keep the pre-filled syringes in their packaging in the refrigerator (between 2 °C and 8 °C). Waylivra can be stored at room temperature (between 8 °C and 30 °C) in the original carton protected from light for up to 6 weeks. During these 6 weeks, this medicine can be stored either at room temperature or in the refrigerator. Do not freeze the pre-filled syringe of Waylivra. Do not remove it from its packaging or take off the needle cover until you are ready for injection. Dispose of this medicine immediately if it has not been used within 6 weeks after first removing it from the refrigerator. To be sure, refer to the date you recorded on the carton. |