Ficha técnica de Waylivra 285 mg solucion inyectable en jeringa precargada – Espanha

Como usar Waylivra 285 mg solucion inyectable en jeringa precargada

Introduction

Summary of Product Characteristics: Information for the User

Waylivra 285 mg pre-filled syringe

volanesorsén

?This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help us by reporting any side effects you experience. The final part of section 4 includes information on how to report these side effects.

Read this leaflet carefully before you start using this medicinal product, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicinal product has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.What is Waylivra and what it is used for

2.What you need to know before using Waylivra

3.How to use Waylivra

4.Possible side effects

5.Storage of Waylivra

6.Contents of the pack and additional information

1. What is Waylivra and how is it used

Waylivra contains the active ingredient volanesorsen, which helps to treat a disease known as familial chylomicronemia syndrome (FCAS, for its English acronym). FCAS is a genetic disease that leads to abnormally high levels of a type of fat called triglycerides in the blood. This can lead to pancreatitis, which is very painful. Along with a low-fat diet, Waylivra helps to reduce the concentration of triglycerides in the blood.

You may be prescribed Waylivra after receiving other medications to reduce triglyceride levels in the blood that have not had sufficient effect.

You will only receive Waylivra if a genetic test confirms that you have FCAS and your risk of pancreatitis is considered very high.

During treatment with Waylivra, you should continue with the low-fat diet prescribed by your doctor.

This medication is for patients 18 years and older.

2. What you need to know before starting to use Waylivra

Do not use Waylivra:

if you are allergic to volanesorsen or any of the other components of this medication (listed in section 6).
if you have a condition called thrombocytopenia, which means you have very few platelets in your blood (less than 140 × 10^9/l). You may notice it if you have a cut that bleeds and takes a long time to stop (more than 5 to 6 minutes for a skin scratch). Your doctor will do a test to find out before giving you this medication.You may not know 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

Consult your doctor, pharmacist, or nurse before starting to use Waylivra if you have or have had any of the following medical problems:

Very high levels of triglycerides, but not due to SQF.
A low number of platelets (thrombocytopenia), a type of blood cell that helps to clot; before starting to use this medication, your doctor will do a blood test to measure the number of platelets you have in your blood.
Any type of liver or kidney problems.

Blood tests

Before using this medication, your doctor will do a test to measure the number of platelets and then, at regular intervals, while you are receiving Waylivra to control the number of platelets.

Consult your doctor immediately if you have any signs indicating a low number of platelets, such as unusual or prolonged bleeding, red spots on the skin (called petechiae), unexplained ecchymoses, bleeding that does not stop, nasal bleeding, or if you have neck stiffness or a severe headache.

Your doctor may also ask you to have a blood test every 3 months to see if there is any problem with the liver. Consult your doctor immediately if you have signs of liver damage, such as yellow skin and eyes, abdominal pain or swelling, dizziness, confusion, or a general feeling of discomfort.

If necessary, your doctor will change the frequency of administration of this medication or suspend it for some time. You may need to consult a specialist in blood disorders to determine if you can continue to receive Waylivra.

Urine tests

Your doctor may ask you to have urine or blood tests every 3 months to check the state of your kidneys. Consult your doctor immediately if you have signs of kidney damage, such as swelling in your ankles, legs, and feet, decreased urine output, difficulty breathing, dizziness, confusion, or intense fatigue or drowsiness.

Diet

Before starting to receive this medication, you will need to follow a diet designed to help you lower your blood triglyceride levels.

It is essential to maintain this diet to lower your triglycerides while receiving 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 medications and Waylivra

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. It is essential to inform your doctor if you receive treatment with any of the following:

Medications to prevent blood clots, e.g., aspirin, dipyridamole, or warfarin.
Other medications that may affect blood clotting, such as nonsteroidal anti-inflammatory drugs like ibuprofen, medications used to prevent heart attacks and strokes, such as clopidogrel, ticagrelor, and prasugrel, antibiotics like penicillin, medications like ranitidine (used to reduce stomach acid) and quinine (used to treat malaria).
Medications 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 drinking alcohol during treatment with this medication, due to the risk of liver problems.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. It is recommended to avoid using Waylivra during pregnancy.

Driving and operating machinery

It is unlikely that Waylivra will affect your ability to drive or operate machinery.

Waylivra contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

3. How to use Waylivra

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before administering this medication, your doctor must rule out other causes of elevated triglycerides, such as diabetes or thyroid problems.

Your doctor will tell you how often to administer this medication. It may change the frequency of use or ask you to stop receiving it for a while or forever, depending on the results of your blood and urine tests or the appearance of side effects.

You will be taught (you or your caregiver) to use Waylivra following the instructions in this leaflet. Waylivra must be injected under the skin (subcutaneous administration, or SC) as instructed by your doctor, nurse, or pharmacist, and check that all the liquid from the syringe has been injected. Each preloaded syringe of this medication administers a dose of 285 mg in 1.5 ml.

Before using this medication, it is essential that you read, understand, and carefully follow the administration instructions.

The usage instructions are recorded at the end of this leaflet.

If you use more Waylivra than you should

If too much Waylivra is injected, contact your doctor or pharmacist, or go to the emergency room immediately, even if you do not have symptoms.

If you forgot to use Waylivra

Do not take a double dose to make up for the missed doses. If you forget to administer a dose and realize it before 48 hours from the scheduled time, administer the missed dose as soon as possible. However, if more than 48 hours have passed, wait for the next scheduled administration. Do not inject more than one dose within a 2-day period.

If you interrupt treatment with Waylivra

Do not stop administering Waylivra without having spoken to your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

If you experience any of the following side effects, contact your doctor immediately:

Symptoms that may indicate low platelet count in the blood (platelets are important cells for blood clotting). Consult your doctor immediately if you experience signs of low platelet count, such as unusual or prolonged bleeding, appearance of red spots on the skin (known as petechiae), unexplained cardinals, bleeding that does not stop or nasal bleeding, or if you experience stiffness in the neck or intense headache.

Other side effects

Very common(may affect more than 1 in 10 people)

Reactions at the injection site (rash, pain, redness, heat, dryness, swelling, itching, tingling, hardening, rashes, blisters, pimples, hematomas, bleeding, numbness, paleness, color change or burning sensation at the injection site). You can reduce the likelihood of experiencing a reaction at the injection site by waiting for Waylivra to reach room temperature before injecting it and applying ice to the injection site after doing so.
Headache
Muscle pain
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
Easily forming cardinals or excessive formation of these, or appearance of cardinals without apparent cause
Bleeding under the skin that appears as a rash, bleeding in the gums or mouth, presence of blood in the urine or stool, nasal bleeding or abnormally heavy menstrual bleeding
Allergic reaction, whose symptoms may be skin rash, joint stiffness or fever
Presence of blood or proteins in urine
Changes in the results of certain blood tests, such as:
- Increased levels of certain blood components: creatinine, urea, transaminases, liver enzymes
- Increased coagulation time
- Decreased hemoglobin concentration in the blood
- Decreased glomerular filtration rate in the kidneys
Diabetes, whose symptoms may be increased thirst, frequent urination (especially at night), extreme hunger, intense fatigue and unexplained weight loss
Difficulty sleeping
Numbness, tingling or pins and needles, feeling of fainting or dizziness, dizziness or agitation
Eye disorders, such as flashing vision or brief transient blindness in one eye, bleeding under the surface of the eye or blurred vision
High blood pressure
Heat, increased sweating, nocturnal sweating, feeling of heat, flu-like illness or general feeling of malaise
Cough, difficulty breathing, nasal congestion, throat swelling, wheezing
Feeling of illness, dry mouth, diarrhea, swelling of the neck, face or gums, stomach pain or inflammation, indigestion
Redness of the skin, rash, pimples, thickening or appearance of scars 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 pain or joint stiffness, back pain, neck pain, jaw pain, muscle spasms or other body aches
Intense fatigue, weakness or lack of energy, fluid retention, non-cardiac chest pain.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse,even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about thesafety of this medicine.

5. Waylivra Storage

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the syringe label after «EXP». The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).

Store in the original box to protect it from light.

Waylivra can be at room temperature (up to 30 °C) in the original box for up to 6 weeks after removing it from the refrigerator. During that time, and as needed, this medication can be at room temperature or in the refrigerator. Record the date when the package is first removed from the refrigerator in the space indicated on the box. If you do not use it within 6 weeks after the first time you removed it from the refrigerator, discard the medication. If during the 6-week period in which the syringe can be at room temperature the expiration date listed on its label is passed, do not use the syringe and discard it.

Do not use this medication if you observe that the solution is cloudy or contains particles, it must be transparent and colorless to pale yellow.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

6. Content of the packaging and additional information

Composition of Waylivra

The active ingredient is volanesorsen. Each milliliter contains 200 mg of volanesorsen sodium, equivalent to 190 mg of volanesorsen. Each pre-filled syringe of single-dose contains 285 mg of volanesorsen in 1.5 mL of solution.
The other ingredients are water for injection, sodium hydroxide, and hydrochloric acid (to adjust the acidity, see section 2, "Sodium").

Appearance of the product and contents of the pack

Waylivra is presented in a pack containing a pre-filled syringe, with needle and needle guard, pre-filled with a transparent, colourless to pale yellow solution. Filled to administer 1.5 mL of solution by fully pushing the plunger of the syringe.

It is marketed in a pack with a pre-filled syringe or in a multiple pack with 4 (4 packs of 1 pack) 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

Last update of this leaflet: 11/2022

This medicinal product has been authorised under a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information on this medicinal product at least once a year and this leaflet or the summary of product characteristics (SmPC) will be updated as necessary.

Other sources of information

Further 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 that is given under the skin with a pre-filled syringe, disposable and for single use.

Do not use Waylivra until you understand the procedure described below. If you have any doubts about the use of Waylivra, contact your doctor or pharmacist.

Parts of the pre-filled syringe

Preparation for injection

Wash your hands and gather what you need for the injection

Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.

Place the following items on a flat, clean surface, in a well-lit area (Figure A).

Figure A

Let the injection come to room temperature

If the syringe is in the refrigerator, let it reach room temperature by taking it out of the refrigerator at least 30 minutes before the injection.

If the injected liquid is cold, it may cause reactions at the injection site such as pain, redness, or swelling.

Do notheat the syringe in any other way, nor in the microwave nor with hot water.

Figure B

Check the expiry date

Check the expiry date on the box.

The expiry date on the pack refers to the shelf life of the medicinal product when refrigerated.

The first time you take the pack out of the refrigerator, you should note the date in the space provided on the box.

Do notuse Waylivra if the expiry date has passed or if it has been at room temperature for more than 6 weeks. Contact your doctor or pharmacist to obtain a new medicinal product.

Take out the syringe and inspect the medicinal product

Open the box and take out the syringe, holding it by the barrel and pulling it out (Figure C).

Figure C

Observe the liquid in the syringe. It should be transparent to pale yellow. It is normal to see a large air bubble (Figure D).

Do nottry to remove the bubble before the injection. It does not matter if the solution is injected with the bubble.

Do notuse the pre-filled syringe if the liquid appears cloudy or if it contains floating particles.

Figure D

Choose an injection site

If self-administering:

Abdomen – The abdominal areas are shown, except for the 5 cm around the navel.

Thighs – The front and middle faces are shown (Figure E).

Figure E

If a caregiver is administering the injection, in addition to these two areas, the injection can also be given in:

Arms – The back of the arm, as shown (Figure F).

For all injections:

Rotate the injection sites.

Avoid injecting in the waist: clothing may rub or press on the injection site.

Do notinject in tattoos, moles, scars, birthmarks, rashes, or areas of skin that are painful to the touch, red, hard, damaged, burned, or inflamed.

If you are unsure where to inject, talk to your healthcare professional.

Figure F

Injection

Prepare the injection site

Clean the chosen area with an alcohol-soaked cotton swab (Figure G).

Figure G

Remove the needle guard

Remove the needle guard by holding the barrel of the syringe without the needle pointing at you and pulling the guard off (Figure H).

You may see a drop of liquid at the tip of the needle. This is normal.

Do notsqueeze the plunger or support when removing the needle guard.

Do notuse the pre-filled syringe if the needle appears damaged.

Do notuse the pre-filled syringe if it falls after removing the needle guard.

Figure H

Pinch the skin

Pinch the skin around the injection site with your free hand (Figure I).

Figure I

Insert the needle

Insert the needle into the injection site with a quick and firm movement, without touching the plunger support. The needle should be inserted at an angle of 45 degrees with the skin surface (Figure J).

Figure J

Inject Waylivra

Inject the liquid by holding the syringe with your thumb on the plunger andpushing it slowlyuntil 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 the injection, dispose of the used syringe as instructed by your healthcare professional, usually in a sharps container (Figure N) following the steps below.

Remove the needle guard after the injection.

Do notre-cap the syringe.

If you do not have a sharps container, you can dispose of it in a container at home if:

it is made of resistant plastic,
it can be closed with a tight-fitting lid and is resistant to punctures, so that sharp objects cannot escape,
it is upright and stable during use,
it is leak-proof,
it is correctly labelled warning that it contains hazardous waste.

Figure N

When the sharps container is almost full, you should follow local guidelines for safe disposal. There may be local regulations on how to dispose of needles and used syringes. Ask your pharmacist or consult the website of the local public health authority (if applicable) for more information on how to dispose of sharp objects in your area.

Do notthrow away your sharps container in the trash.

Do notrecycle your used sharps container.

Keep the sharps container out of reach of children and pets.

Treatment of the injection site

If blood comes out where you injected, press a little on the area with a sterile cotton ball or gauze and dressing, if necessary (Figure O).

Do notrub the area after the injection.

Figure O

You can also apply ice to the injection site to reduce pain, redness, or discomfort (Figure P).

Figure P

Storage

Storage information

The first time you receive Waylivra, store the pre-filled syringes in the refrigerator (between 2°C and 8°C).

Waylivra can be stored at room temperature (between 8°C and 30°C) in the protected box for up to 6 weeks. During these 6 weeks, this medicinal product can be stored at room temperature or in the refrigerator.

Do notfreeze the pre-filled syringe of Waylivra.

Do notremove the syringe from its pack or remove the needle guard until you are ready to inject.

Dispose of this medicinal product immediately if you have not used it within 6 weeks of the first time you took it out of the refrigerator. To be sure, check the date you noted on the box.