Rystiggo

Package leaflet: Information for the patient

Rystiggo 140 mg/mL solution for injection

rozanolixizumab

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

What this leaflet contains

1. What Rystiggo is and what it is used for
2. What you need to know before using Rystiggo
3. How to use Rystiggo
4. Possible side effects
5. How to store Rystiggo
6. Contents of the pack and other information

1. What Rystiggo is and what it is used for

What Rystiggo is
Rystiggo contains the active substance rozanolixizumab. Rozanolixizumab is a monoclonal antibody (a type of protein) designed to recognise and bind to FcRn, a protein that causes antibodies of the immunoglobulin G (IgG) class to remain in the body for longer.

In adults, Rystiggo is used in combination with standard therapy for the treatment of generalized Myasthenia Gravis (gMG), an autoimmune disease causing muscle weakness that can affect multiple muscle groups throughout the body. This condition may also cause shortness of breath, extreme fatigue, and difficulty swallowing. Rystiggo is used in adults with gMG who have IgG autoantibodies against acetylcholine receptors or muscle-specific kinase.

In generalized Myasthenia Gravis (gMG), IgG autoantibodies (proteins of the immune system that attack parts of the body itself) attack and damage proteins involved in nerve-muscle communication, known as acetylcholine receptors or muscle-specific kinase. By binding to FcRn, Rystiggo reduces levels of IgG antibodies, including IgG autoantibodies, thereby helping to improve disease symptoms.

2. What you need to know before using Rystiggo

Do not use Rystiggo

• if you are allergic to rozanolixizumab or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using this medicine if any of the following apply to you:

Myasthenic crisis
Your doctor may not prescribe this medicine if you are using or are at risk of needing a ventilator due to muscle weakness caused by gMG (myasthenic crisis).

Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
Cases of aseptic meningitis have been observed with this medicine. If you develop symptoms of aseptic meningitis, such as severe headache, fever, neck stiffness, nausea, vomiting and/or sensitivity to bright light, seek medical attention immediately.

Infections
This medicine may reduce your body's natural resistance to infections. Before starting or during treatment with this medicine, inform your doctor if you have any signs of infection (such as feeling unwell, fever, chills or shaking, cough, sore throat, or fever blisters), as these may be signs of an infection.

Hypersensitivity (allergic reactions)
This medicine contains a protein that, in some people, may cause allergic reactions such as rash, swelling, or itching. You will be monitored for any signs of infusion-related reactions during and for 15 minutes after the infusion.

Immunisations (vaccinations)
Inform your doctor if you have received a vaccine within the last 4 weeks or if you have a vaccination scheduled in the near future.

Children and adolescents
Do not give this medicine to children under 18 years of age, as the use of Rystiggo has not been studied in this age group.

Other medicines and Rystiggo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Rystiggo together with other medicines may reduce the effectiveness of those medicines, including antibody therapies (such as rituximab) or subcutaneous or intravenous immunoglobulins. Other medicines, 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 blood drawn from a person), may reduce the effect of Rystiggo. Inform your doctor if you are taking or plan to take any other medicines.
Inform your doctor about your treatment with Rystiggo before receiving any vaccination. This medicine may reduce the effectiveness of vaccines. Vaccination with so-called live attenuated or live vaccines is not recommended during treatment with Rystiggo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The effects of this medicine during pregnancy are unknown. You must not use this medicine if you are pregnant or suspect you may be pregnant, unless specifically recommended by your doctor.
It is not known whether this medicine passes into breast milk. Your doctor will help you decide whether to breastfeed while using Rystiggo.

Driving and using machines
It is unlikely that Rystiggo will affect your ability to drive or operate machinery.

Rystiggo contains proline
Each mL of this medicine contains 29 mg of proline.
Proline may be harmful in patients with hyperprolinemia, a rare genetic disorder in which excess of the amino acid proline accumulates in the body.
If you have hyperprolinemia, inform your doctor and do not use this medicine unless recommended by your doctor.

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

3. How to use Rystiggo

Treatment with Rystiggo will be initiated and supervised by a specialist doctor experienced in the management of neuromuscular or neuroinflammatory disorders.

How much Rystiggo is administered and for how long

You will receive Rystiggo in cycles of 1 infusion per week for 6 weeks.

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

• if you weigh at least 100 kg, the recommended dose is 840 mg for each infusion (6 mL per administration)
• if you weigh from 70 kg to less than 100 kg, the recommended dose is 560 mg for each infusion (4 mL per administration)
• if you weigh from 50 kg to less than 70 kg, the recommended dose is 420 mg for each infusion (3 mL per administration)
• if you weigh from 35 kg to less than 50 kg, the recommended dose is 280 mg for each infusion (2 mL per administration)

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

Your doctor will advise you on the duration of treatment with this medicine.

How Rystiggo is administered

Rystiggo will be administered to you by a doctor or nurse.

You may also self-inject Rystiggo. Together with your doctor or nurse, you will decide whether, after proper training by a healthcare professional, you can self-administer the drug. Another person may also administer the injections after receiving appropriate instruction. Do not administer Rystiggo to yourself or to others before receiving adequate training.

If you or your caregiver administers Rystiggo, you must read carefully and follow the administration instructions provided at the end of this leaflet (see "Instructions for use").

You will receive the medicine as a subcutaneous infusion (subcutaneous use). The injection is usually given in the lower abdomen, below the navel. Injections must not be administered in areas where the skin is painful, bruised, red, or hardened.

Administration is performed using an infusion pump set to a flow rate of up to 20 mL/h.

Administration may also be performed manually (by manual push, i.e., without an infusion pump) at the most comfortable flow 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 prescribed, contact your doctor for advice.

If you miss or skip a Rystiggo treatment appointment

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

If you stop treatment with Rystiggo

Do not stop treatment with this medicine without first discussing it with your doctor. Stopping or interrupting treatment with Rystiggo may cause the return of symptoms of generalized Myasthenia Gravis.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Rystiggo, listed in order of decreasing frequency:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Rapid swelling under the skin in areas such as the face, throat, arms and legs (angioedema)
• Joint pain (arthralgia)
• Skin rash, sometimes with red bumps (papular rash)
• Injection site reaction, including rash at injection site, redness of the skin (erythema), inflammation, discomfort and pain at infusion site
• Infections of the nose and throat

Not known (frequency cannot be estimated from the available data)

• Non-infectious, reversible inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis):
  • headache
  • fever
  • neck stiffness
  • nausea
  • vomiting
  • and/or light sensitivity

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rystiggo

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 of the vial and on the
outer carton after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Each vial of injectable solution is for single use only (single-dose). Unused medicine and waste
materials resulting from this medicine must be disposed of in accordance with local regulations.
Do not use this medicine if you notice that the liquid appears cloudy, contains foreign particles, or
has changed colour.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rystiggo contains

• The active substance is rozanolixizumab. Each mL of solution contains 140 mg of rozanolixizumab. Each 2 mL vial contains 280 mg of rozanolixizumab. Each 3 mL vial contains 420 mg of rozanolixizumab. Each 4 mL vial contains 560 mg of rozanolixizumab. Each 6 mL vial contains 840 mg of rozanolixizumab.
• The other components are: histidine, monohydrochloride monohydrate histidine, proline, polysorbate 80, and water for injections. See section 2 "Rystiggo contains proline" and "Rystiggo contains polysorbate 80".

Description of the appearance of Rystiggo and contents of the pack
Rystiggo is an injectable solution. Each pack contains 1 vial of 2 mL, 3 mL, 4 mL, or 6 mL of injectable solution.
Not all vial sizes may be marketed.
The solution ranges from colourless to pale yellowish-brown, from clear to slightly opalescent (pearly white).
Administration devices must be purchased separately.

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
UCB Pharma S.A./NV UAB Medfiles
Tél/Tel: +32 / (0)2 559 92 00 Tel: + 370 5 246 16 40

България Luxembourg/Luxemburg
Ю СИ БИ България ЕООД UCB Pharma S.A./NV
Teл.: +359 (0) 2 962 30 49 Tél/Tel: +32 / (0)2 559 92 00 (Belgique/Belgien)

Česká republika Magyarország
UCB s.r.o. UCB Magyarország Kft.
Tel: +420 221 773 411 Tel.: +36-(1) 391 0060

Danmark Malta
UCB Nordic A/S Pharmasud Ltd.
Tlf.: +45 / 32 46 24 00 Tel: +356 / 21 37 64 36

Deutschland Nederland
UCB Pharma GmbH UCB Pharma B.V.
Tel: +49 / (0) 2173 48 4848 Tel: +31 / (0)76-573 11 40

Eesti Norge
OÜ Medfiles UCB Nordic A/S
Tel: + 372 730 5415 Tlf: +47 / 67 16 5880

Ελλάδα Österreich
UCB Α.Ε. UCB Pharma GmbH
Τηλ: +30 / 2109974000 Tel: +43-(0)1 291 80 00

España Polska
UCB Pharma, S.A. UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.
Tel: +34 / 91 570 34 44 Tel.: +48 22 696 99 20

France Portugal
UCB Pharma S.A. UCB Pharma (Produtos Farmacêuticos), Lda
Tél: +33 / (0)1 47 29 44 35 Tel: +351 21 302 5300

Hrvatska România
Medis Adria d.o.o. UCB Pharma Romania S.R.L.
Tel: +385 (0) 1 230 34 46 Tel: +40 21 300 29 04

Ireland Slovenija
UCB (Pharma) Ireland Ltd. Medis, d.o.o.
Tel: +353 / (0)1-46 37 395 Tel: +386 1 589 69 00

Ísland Slovenská republika
Vistor hf. UCB s.r.o., organizačná zložka
Sími: +354 535 7000 Tel: +421 (0) 2 5920 2020

Italia Suomi/Finland
UCB Pharma S.p.A. UCB Pharma Oy Finland
Tel: +39 / 02 300 791 Puh/Tel: +358 9 2514 4221

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd UCB Nordic A/S
Τηλ: +357 22 056300 Tel: +46 / (0) 40 294 900

Latvija
Medfiles SIA
Tel: + 371 67 370 250

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. Additionally, links to other websites on rare diseases and their therapeutic treatments are provided.

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INSTRUCTIONS FOR USE

Rystiggo (rozanolixizumab), 140 mg/mL solution for subcutaneous use

Single-use vial
Before using Rystiggo, read all the instructions below. Before your first use,
a doctor or nurse will show you how to self-administer Rystiggo.
Another person may also administer the injections after receiving proper training.
Do not administer Rystiggo to yourself or to others until you have been shown how to do so.
These instructions do not replace discussions with your healthcare provider regarding your medical condition or treatment.
If you are using an infusion pump (also known as a syringe pump) to administer Rystiggo,
read the instructions provided by your doctor or nurse on how to set up the pump.

Important information you must know before

administering Rystiggo to yourself or to others

• For subcutaneous use only (under the skin).
• Use each vial only once.
• Check your dose – more than one vial may be needed to prepare the prescribed dose.
• Do not use Rystiggo if the expiration date has passed.
• Before using Rystiggo, verify that the dose on the package (or packages) matches the prescribed dose. Do not use if the dose does not match the

prescription. Contact your doctor or nurse for

further instructions.

• Do not use the vial if the liquid contains visible particles.
  The solution should be colorless to pale yellow-brown, clear to slightly opalescent (pearly white).

• Do not shake the vial.

• Do not use the vial if the protective cap is missing or damaged. If any vial is damaged or missing its cap, report it and return it to the pharmacy.

• If you are using a non-programmable pump, refer to the manufacturer’s instructions for use and your nurse’s guidance on how to fill the infusion line and set the dose.

How to store Rystiggo

• Store in the refrigerator (2 °C - 8 °C).
• Do not freeze.

• Keep Rystiggo in its original packaging to protect it from light.

• Remove the packaging from the refrigerator before infusion. For more comfortable administration, allow the vial to reach room temperature before using. This may take 30 to 120 minutes. Do not heat it in any other way.
  Keep this medicine out of the sight and reach of children.
  What’s in the package

• 1 vial of Rystiggo: 2 mL, 3 mL, 4 mL or 6 mL, depending on the prescribed dose.

• Rystiggo package insert including the Instructions for Use.

Step-by-step instructions

1. Preparation

Step 1: Gather all necessary materials on a clean, flat work surface:

• Included in the Rystiggo packaging:
  o Rystiggo vial
  o Rystiggo Instructions for Use

Check the dose – more than one vial may be needed to prepare the prescribed dose.

Not included in the Rystiggo packaging:

• o Syringe (5–10 mL, depending on the prescribed dose)

o Transfer needle with an 18G or larger diameter needle, or a vented vial adapter
o Infusion line with a 26G or larger diameter needle. The infusion line must be
61 cm or shorter.

o Alcohol wipes
o Adhesive tape or transparent dressing
o

o Bandage

o Sharps container
o Bowl or paper towel to collect excess liquid when priming the infusion line
o Syringe pump – if using a pump

The materials shown above are for illustrative purposes only. Specific materials may look different.

Step 2: Clean the work surface and hands

• Clean the work surface with a disinfectant and thoroughly wash hands with soap and water, or use a hand disinfectant. Dry with a clean towel.

2. Preparation of the vial(s) and syringe

Check the dose – more than one vial may be needed to
prepare the prescribed dose.
Step 3: Remove the protective cap from the vial(s)

• Remove the protective cap from the vial (or vials) by holding the rim and lifting it off.
• Clean the rubber stopper with an alcohol swab. Allow it to air dry.
• Leave the aluminum seal in place.
• Check the dose – if more than one vial is required to prepare the prescribed dose, remove all caps and clean all stoppers.

If using a vented vial adapter instead of a transfer needle,
you may skip directly to step 7.

Step 4: Attach the transfer needle to the syringe

• Remove the plastic protective covers from the syringe and transfer needle. Do not touch the tip of the syringe or the base of the needle to avoid germ contamination.

• With the protective needle cap still in place, press or

gently twist the transfer needle onto the syringe
until it is securely attached.

Step 5: Draw air into the syringe

• Slowly pull down the plunger of the syringe to draw air into the syringe.
• Fill the syringe with approximately the same volume of air as the amount of medication contained in the vial.
• Keep the protective needle cap in place during this step.

Step 6: Remove the protective needle cap from the transfer
needle

• Hold the syringe with one hand.
• With the other hand, hold the protective needle cap and remove it from the needle.
• Place the cap on the table to dispose of later.
• Do not touch the needle tip.
• Do not let the needle tip touch anything after removing the cap.

Step 7: Insert the transfer needle or vented vial adapter directly
into the vial

Follow instructions according to the infusion method being used:
Using the transfer needle

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

Using the vial adapter

• Place the vial on the table and insert the vial adapter directly through the rubber stopper.
• Attach the syringe to the vented vial adapter.

Step 8: Turn the vial and syringe upside down

• Now invert the vial and syringe.
• Keep the transfer needle or vented vial adapter inserted into the vial.

If using a vented vial adapter, you may skip directly to step 11.
Step 9: Push air from the syringe into the vial

• Ensure the transfer needle is now pointing upward and confirm that the needle tip is in the space above the medication.
• Slowly push the syringe plunger upward to transfer all air from the syringe into the vial. Keep your thumb pressed on the plunger

throughout this process – to prevent air from re-entering
the syringe.

• Keep the needle tip in the space above the medication at all times.
• Do not inject air into the medication, as this may create bubbles.

Step 10: Prepare to fill the syringe

• Keep your thumb pressed on the syringe plunger. With the other hand, slowly and carefully pull the vial upward so that the needle tip is fully submerged in the liquid.

Step 11: Fill the syringe with as much medication as possible
Check the dose – more than one vial may be needed to prepare the prescribed dose.

• Slowly pull down the syringe plunger to fill the syringe with medication.

If using a transfer needle to fill the syringe, proceed as follows:
o Continue to slowly and carefully pull the vial upward to keep the needle tip fully submerged in the liquid.
o Adjust the needle tip to remain in the liquid. This will allow you to withdraw the maximum possible amount of medication from the vial (or vials).

• You should now have more medication in the syringe than the prescribed dose. You will adjust this later.

A very small amount of medication will remain in the vial and
cannot be withdrawn. This will be discarded with the vial later.
If using a vented vial adapter, detach the syringe from the vented
vial adapter. Leave the vented vial adapter in the vial. It can be
discarded at the end of the infusion. You may now skip directly
to step 14.

Step 12: Remove air from the syringe

• If there is space between the liquid in the syringe and the top of the syringe, slowly push the plunger to push the air back into the vial.

• If air bubbles are visible in the syringe, gently tap the syringe with your index finger to dislodge them. Then slowly push the plunger to return the air to the vial.

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

• Turn the vial and syringe upright and place the vial on the work surface.
• Remove the transfer needle and syringe from the vial by pulling the syringe upward.
• Remove the transfer needle from the syringe by pulling or

carefully rotating the base of the needle.

• Do not touch the needle. Do not replace the protective needle cap.
• Dispose of the needle in a sharps container.
• If using a vented vial adapter instead of a transfer needle, it is not necessary to remove the vented adapter from the vial before discarding.

Step 14: Recheck the dose

• If another vial is needed to prepare the prescribed dose, and to avoid contamination, repeat steps 4–13 using the same syringe and a new transfer needle or vented vial adapter.

3. Preparation of the infusion

Step 15: Attach the infusion line to the syringe

• During preparation of the infusion line, place the syringe on a clean work surface.
• Remove the infusion line from its protective pouch.
• Remove the cap from the end of the infusion line by twisting it off. Place the cap on the work surface for disposal at a later time.
• Attach the infusion line to the syringe until it is securely connected. Do not touch the tip of the syringe or the base of the infusion line to avoid germ contamination.
• Do not remove the needle cover cap from the needle of the infusion line.

Step 16: Fill the infusion line with the
medication

• Ensure you have a bowl or paper towel nearby to collect any excess medication from the infusion line that is not needed.
• Keep the needle cover cap on the infusion line needle and hold it over the bowl. Now hold the syringe in an upright position and fill the infusion line with medication by gently pushing the plunger of the syringe.
• The amount of liquid remaining in the syringe must correspond to the prescribed dose.
• If using a syringe pump, read the manufacturer's instructions on how to set up and use the pump, and fill the infusion line accordingly.

Step 17: Choose and prepare the infusion site

• Choose an infusion site: lower right or lower left quadrant of the abdomen, below the navel. Do not use an area of skin that:
  • is tender, bruised, red, or hard
  • has scars or stretch marks.
• Preparation of the infusion site:
  • Clean the infusion area with an alcohol wipe and allow it to air dry.

Step 18: Insert the needle of the infusion line

• Carefully remove the needle cover cap from the needle of the infusion line.

• Pinch together the butterfly wings and hold them with the thumb and index finger of one hand.

• With the other hand, pinch the skin between two fingers to create a skin fold.

• Insert the needle into the center of the skin fold and push it beneath the skin.

• The needle should go in easily. If resistance is met, gently withdraw slightly.

• You may use an infusion line without a butterfly needle at the end. Your nurse or doctor will explain how to insert the needle.

Step 19: Secure the infusion line needle

• Use a transparent dressing to secure the needle in place. Some infusion sets include an adhesive patch.
• You may use adhesive tape to keep the infusion line attached to the skin.

4. Infusion and Conclusion

Step 20: Start the infusion
Follow the instructions for the infusion method you are using:

Manual push

• Sit comfortably and firmly push the plunger of the syringe to administer the medicine.
• The medicine should be administered at a comfortable rate. Continue pushing until no medicine remains in the syringe.
• Before and during the infusion, ensure that the infusion line does not twist or kink. If this occurs, the flow of medicine may stop. In this case, correct the kink in the infusion line and try again.
• If you feel discomfort or if some of the medicine flows back into the infusion line, you may push more slowly.

Syringe pump

• Before using a syringe pump, make sure you understand the following:

  • How to set up the syringe pump (set an infusion rate of up to 20 mL per hour).
  • How to set the occlusion alarm to the maximum value.
  • How to start the syringe pump.
  • What the various sounds and alarms of the syringe pump mean and how to manage them.
  • How to stop the syringe pump.

• When ready for infusion:

  • Place the syringe into the pump holder and start the pump according to the pump instructions.
  • Sit comfortably while the pump administers the medicine.
  • Before and during the infusion, ensure that the infusion line does not twist or kink. If this occurs, the flow of medicine may stop. In this case, correct the kink in the infusion line and try again.
  • At the end, stop the pump according to the pump instructions.
  • Remove the syringe from the syringe pump.

Note: Some medicine will remain in the infusion line. This is normal and the line can be discarded
in the sharps container.

Step 21: Conclude the infusion and clean up

• After the infusion is complete, do not attempt to remove the dressing from the needle. Remove both the needle and dressing from the skin and dispose of them together with the syringe in the sharps container.
• After needle removal, one or two drops of liquid at the infusion site may be present. This is normal.
• Dispose of any used vials and leftover medicines in the sharps container.
• Cover the infusion site with a clean dressing, such as a plaster.
• Dispose of any other used materials in household waste.

Always keep the sharps container out of sight and reach of children.