Rystiggo 140 mg/ml solucion inyectable

Prospect: information for the patient

Rystiggo 140 mg/ml injectable solution

rozanolixizumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because 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, pharmacist, or nurse.
• 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section 4.

What is Rystiggo

Rystiggo contains the active ingredient rozanolixizumab. Rozanolixizumab is a monoclonal antibody (a type of protein) designed to recognize and bind to FcRn, a protein that maintains immunoglobulin G (IgG) antibodies in the body for a longer period.

Rystiggo is used in combination with standard treatment in adults to treat generalized myasthenia gravis (MGg), an autoimmune disease that causes muscle weakness and affects multiple muscle groups in the body. The condition may also cause difficulty breathing, extreme fatigue, and difficulty swallowing. Rystiggo is used in adults with MGg who produce IgG autoantibodies against acetylcholine receptors or muscle-specific kinase.

In generalized myasthenia gravis (MGg), these IgG autoantibodies (immune system proteins that attack parts of a person's own body) attack and damage proteins that participate in communication between nerves and muscle, known as acetylcholine receptors or muscle-specific kinase.

By binding to FcRn, Rystiggo reduces the amount of IgG antibodies, including autoantibodies (antibodies against the body's own organism) IgG, thus contributing to improving the symptoms of the disease.

No use Rystiggo

• If you are allergic to rozanolixizumab or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medication if you are in any of the following situations:

Myasthenic crisis

Your doctor may not prescribe this medication if you are using a ventilator, or are likely to be, due to the muscle weakness caused by MG (myasthenic crisis).

Asymptomatic meningitis (inflammation of the membranes surrounding the brain and spinal cord)

Asymptomatic meningitis has been observed in association with this medication. Seek immediate medical attention if you develop symptoms of asymptomatic meningitis, such as intense headache, fever, neck stiffness, nausea, vomiting, and/or intolerance to bright light.

Infections

This medication may reduce your natural resistance to infections. Before starting treatment with this medication or during treatment, inform your doctor if you experience any symptoms of infection (feeling hot, fever, chills, or shivering, cough, sore throat, or facial rash may be signs of an infection).

Hypersensitivity (allergic reactions)

This medication contains a protein that may cause reactions such as skin rash, swelling, or itching in some people. You will be monitored to detect signs of a reaction to the infusion during treatment and 15 minutes after treatment.

Vaccinations (vaccines)

Inform your doctor if you have received a vaccine in the last 4 weeks or plan to be vaccinated in the future.

Children and adolescents

Do not administer this medication to children under 18 years of age, as the use of Rystiggo has not been studied in this age group.

Other medications and Rystiggo

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

The use of Rystiggo with other medications may reduce the effectiveness of those medications, including therapeutic antibodies (such as rituximab) or subcutaneous or intravenous immunoglobulins. Other medications, including subcutaneous or intravenous immunoglobulins, or procedures such as plasmapheresis (a process in which the liquid part of the blood, or plasma, is separated from the blood extracted from a person), may affect the effect of Rystiggo. Inform your doctor if you are taking or plan to take any other medication.

Before being vaccinated, inform your doctor about your treatment with Rystiggo. This medication may affect the effect of vaccines. It is not recommended to vaccinate with live or attenuated microorganism vaccines during treatment with Rystiggo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The effects of this medication on pregnancy are unknown. Do not use this medication if you are pregnant or think you may be, unless your doctor has specifically recommended it.

The passage of this medication into breast milk is unknown. Your doctor will help you decide if you should breastfeed and use Rystiggo.

Driving and operating machinery

It is unlikely that Rystiggo will affect your ability to drive and operate machinery.

Rystiggo contains proline

This medication contains 29 mg of proline per milliliter of medication.

Proline may be harmful to patients with hyperprolinemia, a rare genetic disorder in which an excess of the amino acid proline accumulates in the body.

If you have hyperprolinemia, inform your doctor and do not use this medication unless recommended.

Rystiggo contains polysorbate 80

This medication contains 0.3 mg of polysorbate 80 per ml of medication. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

The treatment with Rystiggo will be initiated and supervised by a specialist doctor with experience in the treatment of neuromuscular or neuroinflammatory disorders.

How much Rystiggo is administered and for how long

Rystiggo will be administered in cycles of 1 infusion per week for 6 weeks.

Your doctor will calculate the correct dose for you based on your weight:

• If you weigh at least 100 kg, the recommended dose is 840 mg per infusion (you need 6 ml per administration)
• If you weigh between 70 kg and less than 100 kg, the recommended dose is 560 mg per infusion (you need 4 ml per administration)
• If you weigh between 50 kg and less than 70 kg, the recommended dose is 420 mg per infusion (you need 3 ml per administration)
• If you weigh between 35 kg and less than 50 kg, the recommended dose is 280 mg per infusion (you need 2 ml per administration)

The frequency of treatment cycles varies for each patient and your doctor will consider whether it is appropriate for you to receive a new treatment cycle and, if so, when.

Your doctor will inform you for how long you should receive treatment with this medication.

How Rystiggo is administered

A doctor or nurse will administer Rystiggo to you.

You can also self-administer Rystiggo. You and your doctor or nurse will decide whether, after receiving training from a healthcare professional, you can self-administer this medication. Another person can also administer the injections after receiving training. Do not self-administer Rystiggo or allow someone else to administer it to you until you have been trained to do so.

If you or your caregiver administer Rystiggo injections, you must carefully read and follow the Administration Instructions found at the end of this prospectus (see “Instructions for use”).

You will receive this medication through subcutaneous infusion under the skin. It is usually injected in the lower abdomen, below the navel. Injections should not be administered in areas where the skin is painful, bruised, red, or hardened.

The administration is performed using a perfusion pump at a flow rate of up to 20ml/h.

Rystiggo can also be administered manually (through slow manual injection, i.e., without a perfusion pump) at a comfortable rate for you.

If you receive more Rystiggo than you should

If you suspect that you have accidentally received a dose of Rystiggo higher than the prescribed dose, seek advice from your doctor.

If you forget or miss a scheduled appointment to receive Rystiggo

If you miss a dose, contact your doctor immediately for advice and schedule another appointment to receive Rystiggo within the next 4days. The next dose should then be administered according to the original administration schedule until the treatment cycle is completed.

If you interrupt treatment with Rystiggo

Do not stop using this medication without first consulting your doctor. Stopping or suspending treatment with Rystiggo may cause the symptoms of generalized myasthenia gravis to reappear.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects, presented in decreasing order of frequency, have been observed with Rystiggo:

Very Frequent:may affect more than 1 in 10 people

• Headache (including migraine)
• Diarrhea
• Fever (pyrexia)

Frequent:may affect up to 1 in 10 people

• Rapid inflammation under the skin in areas such as the face, throat, arms, and legs (angioedema)
• Joint pain (arthritis)
• Skin rash, sometimes with red bumps (papular skin rash)
• Reaction at the injection site, such as skin rash at the injection site, redness of the skin (erythema), inflammation, discomfort, and pain at the infusion site
• Upper respiratory tract and throat infections

Unknown Frequency(cannot be estimated from available data): reversible non-infectious inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis):

• Headache
• Fever
• Stiffness in the neck
• Nausea
• Vomiting
• and/or intolerance to bright light

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the vial label and the outer packaging after the CAD date. 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 the vial in the original packaging to protect it from light.

Each injectable solution vial must be used only once (single use). Dispose of any unused product or material according to local regulations.

Do not use this medication if you observe that the liquid appears cloudy, contains foreign particles, or has changed color.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Rystiggo

• The active principle is rozanolixizumab. Each milliliter of solution contains 140 mg of rozanolixizumab. Each vial of 2 ml contains 280 mg of rozanolixizumab. Each vial of 3 ml contains 420 mg of rozanolixizumab. Each vial of 4 ml contains 560 mg of rozanolixizumab. Each vial of 6 ml contains 840 mg of rozanolixizumab.
• The other components are: histidine, hydrochloride of histidine monohydrate, proline, polisorbate 80, and water for injectable preparations. See section 2 Rystiggo contains proline and Rystiggo contains polisorbate 80.

Aspect of the product and content of the packaging

Rystiggo is an injectable solution. Each package contains 1 vial of 2 ml, 3 ml, 4 ml, or 6 ml of injectable solution.

It may only be marketed in some vials.

The solution is colorless to pale yellowish brown, transparent to slightly opalescent (pearl white).

The materials used for administration must be obtained separately.

Holder of the marketing authorization

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium

Responsible for manufacturing

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Date of the last review of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency: https://www.ema.europa.eu There are also links to other websites about rare diseases and orphan drugs.

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INSTRUCTIONS FOR USE

Rystiggo (rozanolixizumab)
Rystiggo 140 mg/ml injectable solution for subcutaneous use

Single-use vial

Read all these instructions before starting to use Rystiggo. A doctor or nurse will show you how to administer Rystiggo before you use it for the first time. Another person may also administer the infusions after receiving the necessary training. Do not administer Rystiggo or have it administered by someone else until you have been shown how to do it. This information does not replace consulting your doctor about your disease or treatment.

If you are going to use a pump infusion (also called a syringe pump) to administer Rystiggo, read the instructions for setting up the pump provided by your doctor or nurse.

! Important information you should know before administering Rystiggo or having it administered by someone else

• For exclusive subcutaneous use (under the skin).
• Use each vial only once.
• Check your dose (you may need more than 1 vial to prepare the prescribed dose).

Do not use Rystiggo after the expiration date.

• Do not use Rystiggo if the dose indicated on the package does not match the prescribed dose. Contact your doctor or nurse to find out what to do next.
• Do not use the vial if the liquid has visible particles. The medication must be colorless to pale yellowish brown and transparent to slightly opalescent (pearl white).

• Do not shake the vial.
• Do not use the vial if the protective cap is missing or damaged. If any of the vials are broken or do not have a cap, notify and return them to the pharmacy.
• If you are going to use a non-programmable pump, follow the manufacturer's instructions and your nurse's instructions to fill the infusion tube and set the dose.

Storage of Rystiggo

• Store in the refrigerator (between 2°C and 8°C).
• Do not freeze.
• Store Rystiggo in the original package to protect it from light.
• Remove the package from the refrigerator before the infusion. To make the infusion more comfortable, let the vial reach room temperature before using the medication. This may take between 30 and 120 minutes. Do not heat it in any other way.

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

Content of the package

• 1 vial of Rystiggo (2 ml, 3 ml, 4 ml, or 6 ml depending on the prescribed dose).
• Rystiggo leaflet with Instructions for Use.

Step-by-step instructions

1. Prepare

Step 1: Gather all the materials you will need on a clean and flat work surface:

• Included in the Rystiggo package:
• Vial of Rystiggo.
• Rystiggo leaflet.

! Check your dose (you may need more than 1 vial to prepare the prescribed dose).

Step 2: Prepare the vial and syringe

! Check your dose (you may need more than 1 vial to prepare the prescribed dose).

Step 3: Remove the protective cap from the vial

• Remove the protective cap from the vial by holding the rim and lifting it up.
• Clean the rubber stopper with an alcohol-soaked swab. Let it dry.
• Leave the aluminum seal in place.
• Check your dose (if you need more than one vial to prepare the prescribed dose, remove all the caps and clean the stoppers).

! If you are going to use a vial adapter with a ventilation filter instead of a transfer needle, you can go directly to step 7.

Step 4: Connect the transfer needle to the syringe

• Take the syringe and transfer needle out of their respective plastic containers. Do not touch the tip of the syringe or the base of the needle to avoid germs.
• With the cap still on the needle, gently push or turn the needle to attach it to the syringe until it is securely connected.

Step 5: Introduce air into the syringe

• Pull the plunger slowly to introduce air into the syringe.
• Fill the syringe with approximately the same amount of air as the amount of medication in the vial.
• Keep the cap on the needle while doing this.

Step 6: Remove the cap from the transfer needle

• Hold the syringe with one hand.
• With the other hand, hold the cap on the transfer needle and pull it off.
• Place the cap on the table to dispose of it later.
• Do not touch the tip of the needle.
• Do not let the tip of the needle touch any material after removing the cap.

Step 7: Introduce the transfer needle or vial adapter directly into the vial

Follow the instructions corresponding to the infusion method you will use:

With transfer needle

• Place the vial on the table and introduce the transfer needle directly through the rubber stopper.

With vial adapter

• Place the vial on the table and introduce the vial adapter directly through the rubber stopper.
• Connect the syringe to the vial adapter with a ventilation filter.

Step 8: Turn the vial and syringe

• Now place the vial and syringe upside down.
• Keep the transfer needle or vial adapter inside the vial.

! If you are going to use a vial adapter with a ventilation filter, you can go directly to step 11.

Step 9: Push the air from the syringe into the vial

• Check that the transfer needle is pointing upwards and make sure the tip of the needle is in the space above the medication.
• Pull the plunger slowly to introduce all the air from the syringe into the vial.
• Keep the tip of the needle in the space above the medication at all times.
• Do not push the air into the medication, as bubbles may form.

Step 10: Prepare to fill the syringe

• Keep your finger pressing on the plunger. With the other hand, pull the vial slowly and carefully upwards to keep the tip of the needle completely covered by the liquid medication.

Step 11: Fill the syringe with the maximum amount of medication possible

! Check your dose (you may need more than 1 vial to prepare the prescribed dose).

• Now pull the plunger slowly downwards and fill the syringe with the medication.

If you are using a transfer needle to fill the syringe, do the following:

• • Continue pulling the vial slowly and carefully upwards to keep the tip of the needle completely covered by the liquid.
  • Adjust the tip of the needle to keep it in the liquid. This will help you extract the maximum amount of medication from the vial.
• You should now have more medication in the syringe than the prescribed dose. This excess will be adjusted later.

! There will also be a very small amount of medication that you cannot extract from the vial. You will need to dispose of it along with the vial later.

! If you are using a vial adapter with a ventilation filter, disconnect the syringe from the adapter. Leave the vial adapter with a ventilation filter in the vial. You can dispose of it at the end of the infusion. Now you can go directly to step 14.

Step 12: Remove the air from the syringe

• If there is any space between the liquid in the syringe and the top of the syringe, pull the plunger slowly to introduce air back into the vial.
• If you see air bubbles in the syringe, you can remove them by gently tapping the syringe with your index finger. Now pull the plunger slowly to introduce the air back into the vial.

Step 13: Remove the transfer needle from the vial and syringe

• Turn the vial and syringe over and place the vial on the work surface.
• Remove the transfer needle and syringe from the vial by pulling the syringe upwards.
• Remove the transfer needle from the syringe by gently turning or pulling the base of the needle.
• Do not touch the needle.
• Do not put the cap back on the needle.
• Dispose of the needle in the sharp object container.
• If you are using a vial adapter with a ventilation filter instead of a transfer needle, you do not need to remove the adapter from the vial before disposing of it.

Step 14: Check your dose again

• If you need to use another vial to prepare the prescribed dose, repeat steps 4-13 with the same syringe and a new transfer needle or a new vial adapter with a ventilation filter to avoid contamination.

3. Prepare for the infusion

Step 15: Connect the infusion tube to the syringe

• Place the syringe on the clean work surface while preparing the infusion tube.
• Take the infusion tube out of the protective bag.
• Remove the cap from the end of the infusion tube by turning it. Place the cap on the work surface to dispose of it later.
• Connect the infusion tube to the syringe until they are securely attached.
• Do not touch the tip of the syringe or the base of the infusion tube to avoid germs.
• Do not remove the cap from the infusion tube.

Step 16: Fill the infusion tube with the medication

• Make sure you have a cup or absorbent paper handy to collect the excess medication from the infusion tube.
• Keep the cap on the infusion tube and hold it over the cup. Then, hold the syringe vertically and fill the infusion tube with the medication by slowly pushing the plunger of the syringe.
• The amount of liquid left in the syringe should match the prescribed dose.
• If you are using a pump syringe, read the manufacturer's instructions to set up and use the pump and fill the infusion tube.

Step 17: Choose and prepare the infusion site

• Choose an infusion site on the lower left or right side of the abdomen (belly), below the navel.
• • Do not use a skin area that:
  • is sensitive, bruised, red, or hard;
  • has scars or stretch marks.

• Prepare the infusion site:
• Clean the infusion site with an alcohol-soaked swab and let it dry.

Step 18: Introduce the infusion tube needle

• Remove the cap from the infusion tube needle carefully.
• Double the wings of the needle to bring them closer together and hold them with your thumb and index finger.
• Pinch the skin with two fingers to create a fold.
• Insert the needle into the center of the skin and push it under the skin.
• The needle should enter easily. If it is difficult, you can remove a little of the needle.
• You may be using an infusion tube without a butterfly needle at the end. Your nurse or doctor will explain how to insert the needle.

Step 19: Secure the infusion tube needle

• Use a transparent dressing to keep the needle in place. Some infusion equipment has an adhesive built-in.
• You can use adhesive tape to secure the infusion tube to the skin.

4. Infuse and finish

Step 20: Start the infusion

Follow the instructions corresponding to the infusion method you will use:

Manual injection

• Sit comfortably and push the plunger firmly to infuse the medication.
• You should infuse the medication at a comfortable speed. Continue pushing until there is no medication left in the syringe.
• Before and during the infusion, make sure the infusion tube does not bend or twist. If this happens, the medication flow may be interrupted. In this case, correct the curvature of the infusion tube and try again.
• If you feel uncomfortable or some of the medication flows back into the infusion tube, you can push more slowly.

Pump syringe

• Before using a pump syringe, make sure you understand the following:
• How to set up the pump syringe (set a flow rate of 20 ml per hour or less).
• How to set the occlusion alarm to maximum.
• How to start the pump syringe.
• What the different sounds and alarms of the pump syringe mean and what to do in each case.
• How to stop the pump syringe.

• When you are ready for the infusion:
• Place the sy