InfoCons Consumer Protection informs you – Darzalex – Package Leaflet

Before anything else

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What DARZALEX is and what it is used for

What DARZALEX is DARZALEX is a medicine that contains the active substance daratumumab. It belongs to a group of medicines called “monoclonal antibodies”. Monoclonal antibodies are proteins that have been designed to recognise and atta ch to specific targets in the body. Daratumumab has been designed to attach to specific abnormal blood cells in your body, so that your immune system can destroy the se cells.

What DARZALEX is used for

DARZALEX is used in adults 18 years or older, who have a type of cancer called “multiple myeloma”. This is a cancer of your bone marrow.

DARZALEX is used in adults 18 years or older, who have a type of blood and bone marrow disorder called “smouldering multiple myeloma” that can become multiple myeloma.

DAR ZALEX is also used in adults 18 years or older, who have a type of blood disorder called “AL amyloidosis.” In AL amyloidosis, abnormal blood cells make excessive amounts of abnormal proteins that deposit in various organs, causing these organs to not funct ion properly.

⚠️ 2. What you need to know before you are given DARZALEX

You must not be given DARZALEX

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

Do not use DARZALEX if the above applies to yo u. If you are not sure, talk to your doctor or nurse before you are given DARZALEX.

Warnings and precautions

Talk to your doctor or nurse before you are given DARZALEX .

107Infusion -related reactions DARZALEX is given as a subcutaneous injection using a small needle to inject the medicine under your skin. Before and after each injection, you will be given medicines which help to lower the chance of infusion -related reactions (see “Medicines given during treatment with DARZALEX” in section 3).

These reacti ons are most likely to happen with the first injection and most reactions occur on the day of injection. If you have had an infusion -related reaction once it is less likely to happen again.

However, delayed reactions can happen up to 3 -4days after the inj ection. Your doctor may decide not to use DARZALEX if you have a strong reaction after the injection.

In some cases you may have a severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). See section 4.

Tell your doctor or nurse straight away if you get any of the infusion -related reactions or related symptoms listed at the top of section 4. If you get infusion -related reactions, you may need other medicines to treat your symptoms, or the injections may need to be stopped. When these reactions go away, or get better, the injection can be started again.

Decreased blood cell counts DARZALEX can decrease white blood cell counts which help fight infections, and bloo d cells called platelets which help to clot blood. Tell your healthcare provider if you develop any symptoms of infection such as fever or any symptoms of decreased platelet counts such as bruising or bleeding.

Blood transfusions If you need a blood trans fusion, you will have a blood test first to match your blood type.

DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.

Hepatitis B Tell your doctor if you have ever had or might now have a hepati tisB infection. This is because DARZALEX could cause hepatitis B virus to become active again. Your doctor will check you for signs of this infection before, during and for some time after treatment with DARZALEX. Tell your doctor right away if you get wo rsening tiredness, or yellowing of your skin or white part of your eyes.

Children and adolescents

Do not give DARZALEX to children or adolescents below 18 years of age. This is because it is not known how the medicine will affect them.

Other medicines an d DARZALEX Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

This includes medicines you can get without a prescription, and herbal medicines.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby , ask your doctor for advice before you are given this medicine .

If you become pregnant while being treated with this medicine, tell your doctor or nurse straight away.

You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.

Contraception Women who are being given DARZALEX should use effective contraception during treatment and for 3months after treatment.

Breast -feeding You and your doctor will decide if the benefit of breas t-feeding is greater than the risk to your baby.

This is because the medicine may pass into the mother’s milk and it is not known how it will affect the baby.

108Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.

DARZALEX solution for subcutaneous injection contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 15mL, that is to say essentially ‘sodium -free’.

DARZALEX solution for subcutaneous injection contai ns sorbitol Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fruc tose, talk to your doctor before you take this medicine.

DARZALEX solution for subcutaneous injection contains polysorbate

This medicine contains 0.4 mg of polysorbate 20 in each mL, which is equivalent to 6.0 mg per 15 mL vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How DARZALEX is given

How much is given The dose of DARZALEX solution for subcutaneous injection is 1800 mg.

DARZALEX may be given alone or together with other medicines used to t reat multiple myeloma , or with other medicines used to treat AL amyloidosis . DARZALEX is usually given as follows:  once a week for the first 8 weeks  then once every 2 weeks for 16 weeks  then once every 4 weeks after that as long as your condition does not worsen.

When DARZALEX is given together with other medicines your doctor may change the time between doses as well as how many treatments you will receive.

How the medicine is given DARZALEX will be given to you by a doctor or nurse as an injection under your skin (subcutaneous injection) over approximately 3 to 5 minutes. It is given in the stomach area (abdomen), not in other sites of the body, and not into areas of the abdomen where the skin is red, bruised, tender, hard or where there are scars.

If you experience pain during the injection, the doctor or nurse may interrupt the injection and give you the remaining injection in another area of your abdomen.

Medicines given during treatment with DARZALEX You may be given medicines to lower the chance of getting shingles.

Before each injection of DARZALEX you will be given medicines which help to lower the chance of infusion -related reactions. These may include:  medicines for an allergic reaction (anti -histamines)  medicines for inflammation (corticostero ids)  medicines for fever (such as paracetamol).

After each injection of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion -related reactions.

People with breathing problems If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be given medicines to inhale which help your breathing problems:  medicines to help the airways in your lungs stay open (bronchodilators)  medicines to lower swelling and irritation in your lungs (corticosteroids) .

109If you are given more DARZALEX than you should This medicine will be given by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.

If you forget your a ppointment to have DARZALEX It is very important to go to all your appointments to make sure your treatment works. If you miss an appointment, make another one as soon as possible.

If you have any further questions on the use of this medicine, ask your doc tor or nurse.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Infusion -related reactions Tell your doctor or nurse straight away if you get any of the following symptoms within 3 -4days after the injection. You may need other medicines, or the injection may need to be interrupted or stopped.

These reactions include the following symptoms:

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

 chills  sore throat, cough  feeling sick (nau sea)  vomiting  itchy, runny or blocked nose  feeling short of breath or other breathing problems.

Common (may affect up to 1 in 10 people)

 chest discomfort  dizziness or lightheadedness (hypotension)  itching  wheezing.

Rare (may affect up to 1 in 1000 people)

 severe allergic reaction which may include a swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing or an itchy rash (hives). See section 2.  eye pain  blurred vision.

If you get any of the infusion -related reactions above, tell your doctor or nurse straight away.

Injection site reactions Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX solution for subcutaneous injection. These reactions are very commo n (may affect more than 1 in 10 people) .Symptoms at the site of injection may include redness of the skin , itching , swelling , pain, bruising, rash, bleeding.

Other side effects

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

 fever  feeling very tired  diarrhoea  constipation  abdominal pain 110 decreased appetite  difficulty sleeping  headache  nerve damage that may cause tingling, numbness, or pain  rash  muscle spasms  muscle and joint pain (including back pain and chest muscle pain)  swollen hands, ankles or feet  feeling weak  lung infection (pneumonia)  bronchitis  infections of the airways –such as nose, sinuses or throat  low number of red blood cells which carry oxygen in the blood (anaemia)  low number of white blood cells which help fight infections (neutropenia, lymphopenia, leukopenia)  low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)  low level of potassium in the blood (hypokal aemia)  COVID -19.

Common (may affect up to 1 in 10 people)

 irregular heart beat (atrial f ibrillation)  build up of fluid in the lungs making you short of breath  urinary tract infection  severe infection throughout the body (sepsis)  dehydration  high level of sugar in the blood  low level of calcium in the blood  low level of antibodies called ‘immunoglobulins’ in the blood which help fight infections (hypogammaglobulinemia)  feeling dizzy  fainting  chills  itching  unusual feeling in the skin (such as a tingling or crawling feeling)  inflamed pancreas  high blood pressure .

Uncommon (may affect up to 1 in 100 people)

 inflamed liver (hepatitis)  type of herpes virus infection (cytomegalovirus infection) .

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you c an help provide more information on the safety of this medicine.

🌡️ 5. How to store DARZALEX

DARZALEX solution for subcutaneous injection will be stored at the hospital or clinic.

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

111Do not use this medicine after the expiry date which is stated on the carton and the vial 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.

Store in the original package in order to protect from l ight.

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

📦 6. Contents of the pack and other inform ation

What DARZALEX contains

 The active substance is daratumumab. One mL of solution contains 120 mg daratumumab. One vial of 15 mL solution for injection contains 1800 mg of daratumumab.  The other ingredients are recombinant human hyaluronidase (rHuPH20), L -histidine, L -histidine hydrochloride monohydrate, L -methionine, polysorbate 20 (E432), sorbitol (E420), and water for injections (see “DARZALEX contains sodium and sorbitol” in section 2).

What DARZALEX looks like and contents of the pack

DARZALEX solution for subcutaneous injection is a colourless to yellow liquid.

DARZALEX solution for subcutaneous injection is supplied as a carton pack containing 1 single -dose glass vial.

Marketing Authorisation Holder

Janssen -Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101 NL-2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Janssen -Cilag NV Tel/Tél: +32 14 64 94 11 [email protected] UAB “JOHNSON & JOHNSON ” Tel: +370 5 278 68 88 [email protected] България „Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00 [email protected]/Luxemburg Janssen -Cilag NV Tél/Tel: +32 14 64 94 11 [email protected] Česká republika Janssen -Cilag s.r.o.

Tel: +420 227 012 227Magyarország Janssen -Cilag Kft.

Tel.: +36 1 884 2858 [email protected] 112Danmark Janssen -Cilag A/S Tlf.: +45 4594 8282 [email protected] AM MANGION LTD Tel: +356 2397 6000 Deutschland Janssen -Cilag GmbH Tel: 0800 086 9247 / +49 2137 955 6955 [email protected] Janssen -Cilag B.V.

Tel: +31 76 711 1111 [email protected] Eesti UAB “JOHNSON & JOHNSON ”Eesti filiaal Tel: +372 617 7410 [email protected] Janssen -Cilag AS Tlf: +47 24 12 65 00 [email protected] Ελλάδα Janssen -Cilag Φαρμακευτική Μονοπρόσωπη Α.Ε.Β.Ε.

Tηλ: +30 210 80 90 000Österreich Janssen -Cilag Pharma GmbH Tel: +43 1 610 300 España Janssen -Cilag, S.A.

Tel: +34 91 722 81 00 [email protected] Janssen -Cilag Polska Sp. Zo.o.

Tel.: +48 22 237 60 00 France Janssen -Cilag Tél: 0 800 25 50 75 / +33 1 55 00 40 03 [email protected] Janssen -Cilag Farmacêutica, Lda.

Tel: +351 214 368 600 Hrvatska Johnson & Johnson S.E. d.o.o.

Tel: +385 1 6610 700 [email protected]ânia Johnson & Johnson Rom ânia SRL Tel: +40 21 207 1800 Ireland Janssen Sciences Ireland UC Tel: 1 800 709 122 [email protected] Johnson & Johnson d.o.o.

Tel: +386 1 401 18 00 JNJ-SI-safety @its.jnj.com Ísland Janssen -Cilag AB c/o Vistor ehf.

Sími: +354 535 7000 [email protected]á republika Johnson & Johnson, s.r.o.

Tel: +421 232 408 400 Italia Janssen -Cilag SpA Tel: 800.688.777 / +39 02 2510 1 [email protected]/Finland Janssen -Cilag Oy Puh/Tel: +358 207 531 300 [email protected] Κύπρος Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700Sverige Janssen -Cilag AB Tfn: +46 8 626 50 00 [email protected] 113Latvija UAB “JOHNSON & JOHNSON” filiāle Latvijā Tel: +371 678 93561 [email protected]

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ————————————————————————————————————————— The follow ing information is intended for healthcare professionals only:

DARZALEX solution for subcutaneous injection should be administered by a healthcare professional.

To prevent medication errors, it is important to check the vial labels to ensure that the app ropriate formulation (intravenous or subcutaneous formulation) and dose is being given to the patient as prescribed. DARZALEX solution for injection should be given by subcutaneous injection only, using the dose specified. DARZALEX subcutaneous formulation is not intended for intravenous administration.

DARZALEX solution for subcutaneous injection is for single use only and is ready to use.  DARZALEX solution for subcutaneous injection is compatible with polypropylene or polyethylene syringe material; polyp ropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.  DARZALEX solution for subcutaneous injection should be a clear to opalescent and colourless to yellow solution. Do not use i f opaque particles, discolo uration or other foreign particles are present.  Remove the DARZALEX solution for subcutaneous injection vial from refrigerated storage (2°C –8°C) and equilibrate to ambient temperature (15 °C–30°C). The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours in the original carton to protect from light. Keep out of direct sunlight. Do not shake.  Prepare the dosing syringe in controlled and validated aseptic conditions.  To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.

Storage of prepared syringe  If the syringe containing DARZALEX is not used immediately, store the solution of DARZALEX for up to 24hours refrigerated followed by up to 12 hours at 15°C-25°Cand ambient light. If stored in the refrigerator, allow the solution to reach ambient temperature before administration.

Administration  Inject 15 mL DARZALEX solution for subcutaneous injection into the subcutaneous tissue of the abdomen approximately 7.5 cm to the right or left of the navel over approximately 3 – 5minutes. Do not inject DARZALEX solution for subcutaneous injection at other sites of the body as no data are available.  Injection sites should be rotated for successive injections.  DARZALEX solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.  Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.

114 During treatment with DARZALEX solution for subcuta neous injection, do not administer other medicinal products for subcutaneous use at the same site as DARZALEX.  Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Darzalex (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1101).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.