Cablivi 10 mg polvo y disolvente para solucion inyectable

Prospect: information for the user

Cablivi 10 mg powder and solvent for injection solution

caplacizumab

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section4.

1.What is Cablivi and for what it is used

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

3.How to use Cablivi

4.Possible adverse effects

5.Storage of Cablivi

6.Contents of the package and additional information

Cablivi contains the active ingredient caplacizumab. It is used to treat an episode ofacquired thrombotic thrombocytopenic purpurain adults and adolescents 12 years of age or older who weigh at least 88 pounds. This is a rare disorder of blood clotting in which blood clots form in small blood vessels. These blood clots can block blood vessels and damage the brain, heart, kidneys, or other organs. Cablivi prevents the formation of these blood clots by preventing blood platelets from clumping. In this way, Cablivi reduces the risk of experiencing another episode ofacquired thrombotic thrombocytopenic purpura (aTTP)shortly after the first one.

Do not use Cablivi

• if you areallergicto caplacizumab or to any of the other components of this medication (listed in section6).

Warnings and precautions

Inform your doctor if:

• you bleed excessively or experience unusual symptoms such as headache, difficulty breathing, fatigue, or dizziness that may indicate severe internal bleeding. Your doctor may ask you to suspend treatment. Your doctor will tell you when you can start treatment again.
• you are using medications that prevent or treat blood clots such as warfarin, heparin, rivaroxaban, apixaban. Your doctor will decide how to treat.
• you are using antiplatelet medications such as aspirin or low molecular weight heparin (which prevent blood clots). Your doctor will decide how to treat.
• you have a bleeding disorder, such as hemophilia. Your doctor will decide how to treat.
• you have severely impaired liver function.Your doctor will decide how to treat.
• you are about to undergo surgery or dental treatment. Your doctor will decide if it can be postponed or if Cablivi should be suspended before surgery or dental treatment.

Children and adolescents

Cablivi is not recommended for children under 12 years and weighing less than 40 kg.

Other medications and Cablivi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Also inform your doctor if you are using anticoagulant medications such asvitamin K antagonists, rivaroxaban or apixaban, for the treatment of blood clots, or antiplatelet medications such as aspirin or low molecular weight heparin, which prevent blood clots.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or intend to become pregnant. Cablivi is not recommended during pregnancy.

Inform your doctor if you are breastfeeding. Your doctor will advise you if you need to interrupt breastfeeding or not use Cablivi, taking into account the benefits of breastfeeding for the baby and the benefits of Cablivi for you.

Driving and operating machinery

No significant effect on the ability to drive or operate machinery is expected from Cablivi.

Cablivi contains sodium

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

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

Cablivi treatment is initiated by an experienced doctor in blood disorders.

The recommended treatment is

• first dose

• 1 vial injected into a vein by a healthcare professional
• The medication will be administered before starting plasma exchange.

• subsequent doses

• 1 vial once a day as a subcutaneous injection (under the skin of the abdomen)
• The subcutaneous injection will be administered after each daily plasma exchange
• After the daily plasma exchange is completed, Cablivi treatment will continue for at least 30 days with a daily injection of 1 vial
• Your doctor may ask you to continue daily treatment until the underlying signs of your disease are resolved.

Your doctor may decide that you or your caregiver administer the Cablivi injection. In this case, your doctor or healthcare professional will train you or your caregiver on how to use Cablivi.

Instructions for use

The first injection of Cablivi into a vein should be administered by a healthcare professional. Instructions for healthcare professionals on how to inject Cablivi into a vein are located at the end of the leaflet.

For each injection, use a new container to prepare the injection solution. Do not attempt to administer the Cablivi injection until a healthcare professional has taught you how to do so. Do not use the contents of the container for any other injection.

Step 1- Cleaning

• Wash your hands thoroughly with water and soap.
• Prepare a clean and flat surface to place the contents of the container.
• Make sure to have a waste container handy.

Step 2 -Before use

• Make sure the container is complete.
• Check the expiration date. Do not use it after the expiration date.
• Do not use the container if the components it contains are damaged in any way.
• Place all the components of the container on the clean and flat surface.
• If the container was not stored at room temperature, wait for the vial and syringe to reach room temperature (15 °C – 25 °C) by leaving them at room temperature for a few minutes. Do not heat them in any other way.

Step 3- Disinfecting the rubber stopper

• Remove the plastic cap from the vial. Do not use the vial if the green plastic cap is missing.
• Clean the exposed rubber stopper with one of the alcohol wipes provided and let it dry for a few seconds.
• After cleaning, do not touch the rubber stopper or let it touch any surface.

Step 4- Placing the adapter

• Take the adapter from the packaged vial and remove the paper cover. Leave the adapter in the plastic container. Do not touch the adapter.

• Place the adapter on the vial, while keeping the adapter in its plastic container.

• Press firmly down until the adapter fits in place, with the tip of the adapter piercing the vial stopper. Leave the adapter connected to the vial,stillin its outer plastic container.

Step 5- Preparing the syringe

• Holding the syringe in your hand, break the white cap with the other hand.
• Do not use the syringe if the white cap is missing, loose, or damaged.

• Do not touchthe syringe tip or let it touch any surface.
• Place the syringe on the clean and flat surface.

Step 6– Connecting the syringe with the adapter and vial

• Take the vial with the connected adapter.
• Remove the plastic container from the adapter by holding the vial with one hand, pressing the sides of the adapter container with the other hand, and then lifting the container upwards. Be careful not to let the adapter come out of the vial.

• Holding the adapter with one hand and the vial connected, place the syringe tip in the connector of the vial adapter.
• Gently fix the syringe to the vial by turning it clockwise until you feel resistance.

Step 7- Preparing the solution

• Hold the vial vertically on the surface with the syringe pointing downwards.
• Push the plunger of the syringe slowly downwards until the syringe is empty. Do not remove the syringe from the vial.
• With the syringe still connected to the vial adapter, gently turn the vial with the connected syringe until the powder dissolves. Avoid forming foam.Do not shakethe vial.

• Leave the vial with the connected syringe on the surface for5 minutesat room temperature to allow the solution to dissolve completely. The plunger may rise back up again; this is normal.
• Go directly to Step 8 immediately after these 5 minutes.

Step 8- Extracting the solution

• Check if the solutionhas particles. The powder should have dissolved completely and the solution should be transparent.
• Pull the plunger of the syringe all the way down.
• Turn the vial, adapter, and syringe completely upside down.
• While holding it vertically, pull the plunger slowly to put all the solution into the syringe. Do not shake it.

Step 9 – Preparing the syringe for administration

• Turn the vial, adapter, and syringe (with the syringe at the top) completely upright. Disconnect the full syringe from the adapter by holding the adapter with one hand and gently turning the syringe counterclockwise.
• Place the vial and connected adapter in the waste container provided.
• Do not touchthe needle tip or let it touch any surface. Place the syringe on the clean and flat surface.
• Go to Step 10 to inject caplacizumab under the skin of the abdomen. Instructions for healthcare professionals on how to inject Cablivi into a vein are located at the end of the leaflet.

Step 10 -Injection

• Remove the needle by breaking the paper cover of the needle container and removing the needle with the protective cap.

• Without removing the protective cap, insert the needle into the syringe by turning it clockwise until you feel resistance.
• Pull back the safety cap of the needle.
• Check the contents of the syringe. Do not use the medication if you observe that it is cloudy, has lumps, or anything that does not appear normal. Contact your doctor or nursing staff if this happens.

Step 11- Preparing the injection site for subcutaneous injection

• Select a suitable injection site (injection site) on your abdomen for the subcutaneous injection.

Avoid the area around the navel. Select a different injection site from the one used the previous day so that the skin can recover after the injection.

• Use the second alcohol wipe to clean the injection site you have chosen.

Step 12- Administration

• Carefully remove the protective cap from the needle and discard it. Make sure the needle does not touch anything before the injection.
• Hold the syringe at eye level with the needle pointing upwards.
• Remove any air bubbles by tapping the side of the syringe with your finger to make the bubbles rise to the tip. Then, push the plunger slowly until a small amount of liquid comes out of the needle.
• Gently pinch the clean skin between your thumb and index finger to make a fold.

• Hold this skin fold throughout the injection.
• Insert the entire needle into the skin fold at the angle shown in the illustration.
• Push the plunger all the way down as far as you can.

• Pull the needle out with the same angle as you inserted it. Do not rub the injection site.

Step 13- After administration

• Immediately after the injection, place the safety cap of the needle over the needle until it fits in place.

• Place the syringe with the needle in a waste container.

If you use more Cablivi than you should

A overdose is unlikely, as a vial contains only a single dose. Inform your doctor if you think you have had an overdose.

If you forget to use Cablivi

If you forget a dose, administer it if it has not been more than 12 hours since the scheduled time. If more than 12 hours have passed since the dose should have been administered, do not administer the missed dose, but inject the next dose at the usual time.

If you interrupt Cablivi treatment

To get the most benefit from your treatment, it is essential to use Cablivi as prescribed and for the duration your doctor indicates. Inform your doctor before stopping treatment, as stopping it too soon may cause your disease to reappear.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Get in touch withyour doctorimmediatelyif any of the followingserious side effectsoccur.

Prolonged or excessive bleeding.

Your doctor may decide to keep you under closer observation or change your treatment.

The side effects reported in a clinical study were as follows:

Very common:may affect more than 1 in 10people

• bleeding gums
• fever
• fatigue
• headache
• nasal bleeding

• hives

Common:may affect up to 1 in 10people

• ocular bleeding
• vomiting blood

• blood in the stool

• black, tarry stools

• gastric bleeding

• bleeding hemorrhoids
• rectal bleeding

• muscle pain

• stroke (cerebral vascular accident)

• blood in the urine

• excessive bleeding during menstruation
• vaginal bleeding
• coughing up blood
• shortness of breath
• bruising

Reporting side effects

If you experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Cablivi can be stored at a temperature not exceeding 25°C for a single period of up to 2 months, but not after the expiration date. Cablivi should not be refrigerated again after having been stored at room temperature.. Do not expose it to temperatures above 30 °C.

Do not use Cablivi if you observe particles orcolor alterationbefore administration.

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

Content of Cablivi

• powder for solution for injection

-The active substance is caplacizumab.

Cada vial contains 10 mg of caplacizumab.

-The other components are sucrose, anhydrous citric acid, trisodium citrate dihydrate (see section 2 “Cablivi contains sodium”) and polisorbate 80.

• pre-filled syringe

The pre-filled syringe contains 1 ml of water for injection.

Appearance of Cablivi and contents of the pack

Cablivi is provided as:

• a white powder for injection in a glass vial, and
• water for injection in a pre-filled syringe to dissolve the powder.

After dissolving the powder in the solvent, the solution is transparent, colourless or slightly yellowish.

Cablivi is available in

• individual packs containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol wipes
• multiple packs containing 7 individual packs
• multi-dose packs containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol wipes.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Responsible Person for Manufacturing

Ablynx NV

Technologiepark 21

9052 Zwijnaarde

Belgium

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder.

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/

--------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

The intravenous bolus injection of Cablivi administered at the start of treatment should be administered by a healthcare professional. The preparation of a Cablivi dose for intravenous injection should be done in the same way as for a subcutaneous injection (see Instructions for use, steps 1 to 9, in section 3).

Cablivi can be administered intravenously by connecting the prepared syringe to standard Luer lock connections of intravenous lines or using an appropriate needle. The line can be flushed with a 9 mg/ml sodium chloride solution for injection.