10 mg powder and solvent for injection , solution
kaplacizumab
1. What Cablivi is and what it is used for
Cablivi contains the active substance caplacizumab. It is used to treat an episode of acquired thrombotic thrombocytopenic purpura in adults and adolescents 12 years of age and older weighing at least 40 kg. This is a rare coagulation disease 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 the platelets (platelets) in the blood from clotting. In this way, Cablivi reduces the risk of a new episode of acquired thrombotic thrombocytopenia purpura (aTTP) shortly after the first.
2. What you need to know before taking Cablivi
Do not use Cablivi
- if you are allergic to caplacizumab or any of the other ingredients of this medicine (listed in section 6)
Warnings and cautions
Tell your doctor if you:
- bleeds unusually much during treatment. Your doctor may ask you to stop treatment. Your doctor will tell you when you can start treatment again.
- use anticoagulants as vitamin K antagonists, rivaroxaban, apixaban (which treats blood clots). Your doctor will decide how you should be treated.
- use blood-thinning drugs such as acetylsalicylic acid or low molecular weight heparin (which prevents the formation of blood clots). Your doctor will decide how you should be treated.
- have a bleeding disorder such as hemophilia. Your doctor will decide how you should be treated.
- has a severe hepatic impairment. Your doctor will decide how you should be treated.
- should undergo surgery or dental treatment. Your doctor will decide if it can be postponed or if you should stop taking Cablivi before the operation or dental treatment.
Children and young people
Cablivi is not recommended for children under 12 years and under 40 kg body weight.
Other medicines and Cablivi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also tell your doctor if you are taking anticoagulants such as vitamin K antagonists, rivaroxaban, or apixaban (which treat blood clots), or if you are taking blood thinners such as acetylsalicylic acid or low molecular weight heparin (which prevents blood clots from forming).
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or planning to become pregnant. Cablivi is not recommended during pregnancy.
Tell your doctor if you are breast-feeding. Your doctor will advise you on whether to stop breastfeeding or stop taking Cablivi and weigh the benefits of breastfeeding for your baby against the benefits of Cablivi for you.
Driving and using machines
Cablivi is not considered to affect the ability to drive or use machines.
Cablivi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
3. How to take Cablivi
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Cablivi is started by a doctor who has experience with blood diseases.
The recommended treatment is
- first dose one
- The contents of one vial are injected into a blood vessel (a vein) by a healthcare professional
- the drug is given before plasma exchange treatment
- the following doses:
- The contents of one vial are injected subcutaneously (under the skin of the abdomen) once daily
- the subcutaneous dose is given after each daily plasma exchange treatment
- when the daily plasma exchange treatment is completed, treatment with Cablivi will continue for at least 30 days with an injection of the contents of one vial daily.
- your doctor may ask you to continue your daily treatment until the underlying symptoms of the disease have disappeared
Your doctor may decide that you or your healthcare provider may inject Cablivi. In this case, your doctor or healthcare professional will give you or your healthcare provider instructions on how to use Cablivi.
Instructions for use
The first injection of Cablivi into your vein must be given by a healthcare professional. Instructions for healthcare professionals on how to inject Cablivi into your vein can be found at the end of this leaflet.
For each individual injection, use a new injection kit to prepare injection solution one. Do not try to inject Cablivi until you have been taught by healthcare professionals how to do it. Do not use this injection kit for any other injection.
Step 1 – Cleaning
- Wash your hands thoroughly with soap and water.
- Prepare a clean, smooth work surface where you place the injection kit.
- Make sure you have a trash can nearby.
Step 2 – Before use
- Make sure the injection kit is complete.
- Check the expiration date. Do not use this medicine after the expiry date.
- Do not use the kit if the packaging of the articles in it are damaged in any way.
- Place all components on the clean, smooth work surface.
- If the package is not stored at room temperature, allow the vial and syringe to reach room temperature (15 ºC – 25 ºC) by allowing them to stand at room temperature for a few minutes. Do not heat them in any other way.
Step 3 – Disinfect 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 compresses provided in the package and allow the stopper to dry for a few seconds.
- Do not touch the rubber stopper after cleaning and do not allow it to come into contact with any object.
Step 4 – Attach the connection plug
- Remove the packaged connection plug and remove the paper. Leave the connection plugin the opened plastic package. Do not touch the connection plug itself.
- Put the stopper on the vial while keeping the stopper in its plastic package.
- Press firmly downwards until the connecting plug snaps into place, where the tip of the connecting plug penetrates the rubber stopper of the vial. Leave the stopper on the vial, still in its outer carton.
Step 5 – Prepare the syringe
- Hold the syringe in one hand and break off the white cap with the other hand.
- Do not use the syringe if this white cap is missing, loose, or damaged.
- Do not touch the syringe tip or allow it to come into contact with other objects.
- Place the sprayer on the clean, smooth work surface.
Step 6 – Place the syringe on the connection stopper and vial
- Take the vial with the plug attached.
- Remove the plastic package from the connector by holding the vial in one hand, squeezing the sides of the connector package with the other hand, and then lifting the package upward. Make sure that the connector does not come loose from the vial.
- Hold the connector with the connected vial in one hand. Place the tip of the syringe in the connector on the connector plug.
- Carefully lock the syringe against the vial by turning it clockwise until it receives.
Step 7 – Prepare the solution
- Hold the vial vertically against the work surface with the syringe pointing downwards.
- Slowly push the syringe plunger down until the syringe is empty. Do not remove the syringe from the vial.
- With the syringe still connected to the stopper, gently swirl the vial with the connected syringe until the powder has dissolved. Avoid foaming. Do not shake the vial.
- Leave the vial with the connected syringe on the work surface for 5 minutes at room temperature to allow the powder to completely dissolve. It may happen that the spray piston goes back upwards by itself – this is normal.
- Go to step 8 immediately after these 5 minutes.
Step 8 – Draw up the solution
- Check for particles in the solution. All the powder must have dissolved and the solution must be ready.
- Slowly push the plunger into the bottom.
- Turn the entire device – vial, stopper, and syringe – upside down.
- Hold it vertically and slowly pull out the syringe plunger so that all the solution is transferred to the syringe. Do not shake
Step 9 – Prepare the syringe for injection
- Turn the entire device – vial, stopper, and syringe – back in the correct direction (with the syringe on top). Remove the filled syringe from the connector by holding the connector with one hand and gently turning the syringe counterclockwise.
- Place the vial and stopper in the waste bin.
- Do not touch the end of the syringe or allow it to come into contact with any object. Place the sprayer on the clean, smooth work surface.
- Go to step 10 to inject kaplacizumab under the skin of the abdomen. Instructions for healthcare professionals on how to inject Cablivi into your vein can be found at the end of this leaflet.
Step 10 – Attach the needle
- Take out the needle by tearing the paper from the needle package and removing the needle with the protective sleeve.
- Without removing the protective sleeve, attach the needle to the syringe by turning it clockwise until it receives.
- Pull the safety guard away from the needle.
- Check the contents of the syringe. Do not use this medicine if it is cloudy or if there are lumps or anything else that looks abnormal. Contact your doctor or nurse if this occurs.
Step 11 – Prepare the injection site for injection under the skin
- Select a suitable site (“injection site”) on the abdomen for injection under the skin. Avoid the area around the navel. Choose a different injection site than the one you used the day before to help the skin recover after the injection one.
- Use the other alcohol swab to clean the injection site of your choice.
Step 12 – Injection
- Carefully remove the protective sleeve from the needle and discard the protective sleeve. Make sure the needle does not touch anything before injecting one.
- 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 top of the syringe. Then slowly push in the syringe plunger until a small amount of liquid comes out of the needle.
- Gently pinch the cleansed skin between your thumb and forefinger to create a crease.
- Hold the skin fold during the entire injection.
- Insert the entire needle into the skin fold at the angle shown in the picture.
- Push the syringe plunger down as far as it will go.
- Pull out the needle at the same angle you used when inserting it. Do not rub the injection site.
Step 13 – After injection a
- Immediately after injection one, turn the safety guard over the needle until it clicks into place.
- Place the syringe with the needle in the waste bin.
If you take more Cablivi than you should
An overdose is unlikely because a syringe contains only a single dose. Tell your doctor if you think you have overdosed.
If you forget to take Cablivi
If you have missed a dose, you should take it, if it is within 12 hours of the scheduled time. If it has been more than 12 hours since you should have taken dose one, skip the missed dose one and inject the next dose one at the usual time.
If you stop taking Cablivi
To get the most out of your treatment, it is important to take Cablivi as prescribed and as long as your doctor tells you to take the medicine. Talk to your doctor before stopping treatment, as the condition may return if you stop treatment too soon.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if any of the following serious side effects occur:
Prolonged or heavy bleeding.
Your doctor may decide to monitor you closely or change your treatment.
In a clinical study, adverse reactions were reported with the following frequency:
Very common: may affect more than 1 in 10 people
- bleeding gums
- fever
- fatigue
- headache
- nosebleeds
- hives
Common: may affect up to 1 in 10 people
- bleeding in the eye
- vomiting blood
- blood in the stool
- black, tar-colored stools
- bleeding from the stomach
- bleeding hemorrhoids
- bleeding from the rectum
- injection site reactions: redness, itching, and bleeding
- bleeding in the brain that manifests itself as the severe headache that comes quickly, vomiting, decreased consciousness, fever, sometimes seizures, and neck stiffness or pain in the neck
- muscle pain
- stroke
- blood in the urine
- heavy bleeding during menstruation
- vaginal bleeding
- bloody vomiting
- shortness of breath
- bruises
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cablivi
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 label and carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ºC – 8 ºC). Do not freeze.
Store in the original package. Sensitive to light.
Cablivi can be stored at room temperature, not above 25 ºC, for a continuous period of up to two months, but not longer than the expiry date. Do not put Cablivi back in the refrigerator after storage at room temperature. Never expose Cablivi to temperatures above 30 ºC.
Do not use Cablivi if you see solid particles or discoloration before injecting one.
Medicines should not be disposed of via wastewater or household waste. Question
pharmacy staff how to discard medicines that are no longer used. These measures will help to protect the environment.
6. Contents of the packaging and other information
What Cablivi contains
- vial of powder
- The active substance is caplacizumab.Each vial contains 10 mg of caplacizumab.
- The other ingredients are sucrose, anhydrous citric acid, trisodium citrate dihydrate, and polysorbate 80.
- pre-filled syringe
- The pre-filled syringe contains 1 ml of water for injections.
What Cablivi looks like and package sizes
Cablivi is delivered as:
- a white powder for solution for injection in a glass vial, and
- water for injections in a pre-filled syringe. The liquid (water) in the syringe is used to dissolve the powder. After the powder has dissolved in the liquid, a clear, colorless, or slightly yellowish solution is obtained.
Cablivi is available in a
- a single-dose pack containing 1 vial of caplaciumab powder, 1 pre-filled syringe with liquid, 1 connecting stopper, 1 needle, and 2 alcohol swabs
- multi-dose pack with 7 single-dose packs.
- a multi-dose pack containing 7 vials of caplacizumab powder, 7 pre-filled syringes of liquid, 7 stoppers, 7 needles, and 14 alcohol swabs
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Ablynx NV
Technology Park 21
9052 Zwijnaarde
Belgium
Contact the representative of the marketing authorization holder to find out more about this medicine.
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