Imaavy

Package leaflet: Information for the patient

Imaavy 185 mg/mL concentrate for solution for infusion

nipocalimab

This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Imaavy is and what it is used for

What Imaavy is
Imaavy contains the active substance nipocalimab. Nipocalimab binds to a protein in the body called
FcRn. By binding to FcRn, nipocalimab reduces the level of IgG autoantibodies. IgG autoantibodies are
immune system proteins that mistakenly attack parts of a person's body.

What Imaavy is used for
Imaavy is used in combination with standard therapy for the treatment of adult patients and adolescent
patients aged 12 years and older with generalized myasthenia gravis (gMG), an autoimmune disease that
causes muscle weakness and can affect multiple muscle groups throughout the body. The condition may
also cause shortness of breath, extreme fatigue, and difficulty swallowing.

In patients with gMG, IgG autoantibodies attack and damage certain proteins on nerve cells called
acetylcholine receptors. Due to this damage, nerves are unable to make muscles contract normally,
resulting in muscle weakness and difficulty moving. By binding to the FcRn protein and reducing levels of
autoantibodies, Imaavy may improve the muscles' ability to contract, relieve disease symptoms, and
reduce their impact on daily activities.

2. What you need to know before using Imaavy

Do not use Imaavy

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

Warnings and precautions
Infusion reactions and allergic reactions
Imaavy contains a protein that may cause reactions such as headache, nausea, rash, fatigue, chills, skin flushing, and dizziness in some people. You will be monitored for signs of an infusion reaction or a serious allergic (anaphylactic) reaction during treatment and for at least 30 minutes afterwards. Signs of a severe allergic reaction include: swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or loss of consciousness, or rash. If you experience any of these symptoms, contact your doctor immediately.
Infections
Treatment with Imaavy may reduce your natural resistance to infections. Before starting or during treatment with this medicine, inform your doctor if you have any symptoms of infection (such as fever, chills or shaking, cough or sore throat).
Treatment with Imaavy may allow reactivation of herpes zoster infection (shingles). Inform your doctor if you develop painful skin rashes with blisters, as these may be signs of herpes zoster infection.
Additional monitoring tests
After treatment with Imaavy, your doctor will carry out blood tests to check your blood fat levels (cholesterol) (see section 4).
Vaccinations
Inform your doctor if you have received a vaccine within the last 4 weeks or if you plan to receive one in the near future (within a couple of weeks).
Children
Imaavy is not intended for use in children under 12 years of age, as it has not been studied in these patients.
Other medicines and Imaavy
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Imaavy, when taken together with other medicines such as therapeutic antibodies or immunoglobulins, may reduce their effectiveness. Other treatments, such as plasma exchange (plasmapheresis), may compromise the effect of Imaavy.
Pregnancy, breastfeeding and fertility
There is limited information on the use of Imaavy during pregnancy or breastfeeding. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Imaavy is not expected to affect the ability to drive vehicles or operate machinery.
Imaavy contains polysorbate
This medicine contains 0.97 mg (300 mg vial) or 3.9 mg (1,200 mg vial) of polysorbate 80 per single-use vial, equivalent to 0.60 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Imaavy

Treatment will be administered by a doctor or another healthcare professional.
What dose of Imaavy you will receive and how often
The dose you will receive depends on your body weight and will be given directly into the blood through an intravenous infusion (intravenous drip) every 2 weeks.
If you receive more Imaavy than you should
The dose of this medicine will be carefully calculated by your doctor. If you suspect that you have accidentally received a higher dose of Imaavy than prescribed, contact your doctor for advice.
If you miss an appointment for treatment with Imaavy
If you miss an appointment, contact your doctor immediately for advice and refer to the following section “If you stop treatment with Imaavy”.
If you stop treatment with Imaavy
Stopping or permanently discontinuing treatment with Imaavy may cause symptoms of gMG to reappear. Consult your doctor before stopping Imaavy. Your doctor will discuss with you the possible side effects and risks. Your doctor may monitor you closely.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Imaavy before you start treatment.

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

• high levels of lipids (fats) or cholesterol in the blood
• decreased level of 'albumin' (a protein) in the blood
• muscle spasms
• swollen hands, ankles or feet (peripheral oedema)

Common (may affect up to 1 in 10 people)

• urinary tract infection (may cause pain or a burning sensation when passing urine)
• chest infection (such as pneumonia or bronchitis)
• shingles (herpes zoster virus infection)
• difficulty sleeping (insomnia)
• dizziness
• diarrhoea
• stomach (abdominal) pain
• nausea
• fever

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor. 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 Imaavy

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 carton and label 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 in the original packaging to protect from light.
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 Imaavy contains
The active substance is nipocalimab.

• Each 1.62 mL vial contains 300 mg of nipocalimab (185 mg/mL).
• Each 6.5 mL vial contains 1,200 mg of nipocalimab (185 mg/mL).

The other components are: arginine hydrochloride, histidine, histidine monohydrochloride monohydrate, methionine,
polysorbate 80 (E433), sucrose and water for injections.
Description of the appearance of Imaavy and contents of the pack
Imaavy is available as a sterile concentrate for infusion solution (300 mg or 1,200 mg in a
vial, pack size of 1).
Imaavy is a liquid, from colourless to slightly brownish, from clear to slightly opalescent.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
Leiden, 2333 CB
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: + 32 14 64 94 11 Tel.: + 370 5 278 68 88
[email protected] [email protected]
България Luxembourg/Luxemburg
“Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: + 359 2 489 94 00 Tél/Tel: + 32 14 64 94 11
[email protected] [email protected]
Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: + 420 227 012 227 Tel.: + 36 1 884 2858
[email protected]
Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: + 45 4594 8282 Tel: + 356 2397 6000
[email protected]
Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0 800 086 9247/+ 49 2137 955 6955 Tel: + 31 76 711 1111
[email protected] [email protected]
Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel: + 372 617 7410 Tlf: + 47 24 12 65 00
[email protected] [email protected]
Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: + 43 1 610 300
Tηλ: + 30 210 80 90 000
España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: + 34 91 722 81 00 Tel.: + 48 22 237 60 00
[email protected]
France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75/+ 33 1 55 00 40 03 Tel: + 351 214 368 600
[email protected]
Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: + 385 1 6610 700 Tel: + 40 21 207 1800
[email protected]
Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: + 386 1 401 18 00
[email protected] [email protected]
Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: + 421 232 408 400
Sími: + 354 535 7000
[email protected]
Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777/+ 39 02 2510 1 Puh/Tel: + 358 207 531 300
[email protected] [email protected]
Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: + 357 22 207 700 Tfn: + 46 8 626 50 00
[email protected]
Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: + 371 678 93561
[email protected]
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/en.

The following information is intended for healthcare professionals only:
In order to improve the traceability of biological medicinal products, the name and batch number of the administered product must be clearly recorded.

1. How is Imaavy supplied?

The vials contain:

• 300 mg of nipocalimab in 1.62 mL of concentrate for solution for infusion OR
• 1,200 mg of nipocalimab in 6.5 mL of concentrate for solution for infusion. The concentration is 185 mg of nipocalimab/mL in all vials.

2. Before administration

Imaavy must be prepared for administration by a qualified healthcare professional using
an aseptic technique.
Based on the formula reported in the table below, calculate the following:

• The required dose of Imaavy is based on the patient's body weight at the recommended initial single dose of 30 mg/kg or the maintenance dose of 15 mg/kg.
• The volume of concentrate required is calculated based on the concentration of 185 mg/mL. Each vial contains 300 mg or 1 200 mg of nipocalimab.
• The number of vials required is calculated based on the volume of concentrate.

Table 1. Formula

3. Preparation and administration

• Do not administer by rapid intravenous injection or as a bolus injection.
• Administer only by intravenous infusion as described below.

Preparation

• Check that the solution in each vial is from colorless to slightly brownish, from clear to slightly opalescent, and free from visible particles. Do not use if visible particles are present or if the solution has a different color than expected (from colorless to slightly brownish). Do not shake the vials.
• Gently withdraw the calculated volume of concentrate from the vial(s). Discard any unused portions of the vials.
• Dilute the total withdrawn volume of concentrate by adding it to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) infusion solution for patients weighing at least 40 kg, or to an infusion bag containing 100 mL of sodium chloride 9 mg/mL (0.9%) infusion solution for patients weighing less than 40 kg. Use only infusion bags made of polyolefin, polypropylene, or polyvinyl chloride.
• Gently invert the infusion bag at least 10 times to mix the solution. Do not shake.
• Visually inspect to confirm a homogeneous solution has been obtained. Do not use if particulate matter or discoloration is observed.

Administration

• Administer the diluted solution by intravenous infusion using a sterile, non-pyrogenic, low-protein-binding administration set with an in-line or add-on filter made of polyethersulfone or polysulfone (pore size ≤ 0.2 micrometers). Administration sets must be made of polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinyl chloride.
• Do not co-infuse the diluted concentrate with other agents in the same intravenous line.
• Administer the infusion intravenously over approximately 30 minutes for the initial dose (30 mg/kg) and approximately 15 minutes for subsequent doses (15 mg/kg).
• If an adverse reaction occurs during administration, the infusion may be slowed or stopped at the discretion of the healthcare provider.
• From a microbiological standpoint, unless the dilution method excludes the risk of microbial contamination, the diluted solution should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user. If immediate administration is not possible, the diluted solution may be refrigerated for up to 24 hours at a temperature between 2 °C and 8 °C, followed by up to 12 hours at room temperature between 15 °C and 30 °C, including infusion time. Do not freeze.

4. Special precautions for handling and storage

Store vials in the refrigerator (2 °C - 8 °C) until use. Do not freeze. Keep in the original packaging to protect the medicinal product from light.
Do not use this medicinal product after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.