Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - darzalex

Document Subject

Generated Narrative: MedicinalProductDefinition mpd365d405c4186be4b5c62f68568d4862

identifier: http://ema.europa.eu/identifier/EU/1/16/1101/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: DARZALEX 20 mg/mL concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d365d405c4186be4b5c62f68568d4862

identifier: http://ema.europa.eu/identifier/EU/1/16/1101/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - darzalex

Attesters

What is in this leaflet

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

What DARZALEX is DARZALEX is a cancer 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 attach to specific targets in the body. Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer 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.

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 you. 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. Infusion-related reactions DARZALEX is given as an infusion (drip) into a vein. Before and after each infusion of DARZALEX, 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 reactions can happen during the infusion or in the 3 days after the infusion. 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). Some serious allergic reactions and other severe infusion-related reactions have resulted in death. 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, or the infusion may need to be slowed down or stopped. When these reactions go away, or get better, the infusion can be started again. These reactions are most likely to happen with the first infusion. If you have had an infusion-related reaction once it is less likely to happen again. Your doctor may decide not to use DARZALEX if you have a strong infusion reaction. Decreased blood cell counts DARZALEX can decrease white blood cell counts which help fight infections, and blood 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 transfusion, 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 hepatitis B 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 worsening 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 and 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 3 months after treatment. Breast-feeding You and your doctor will decide if the benefit of breast-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. Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines. DARZALEX contains sorbitol Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. You must tell your doctor before receiving this medicine if you have HFI.

How much is given Your doctor will work out your dose and schedule of DARZALEX. The dose of DARZALEX will depend on your body weight. The usual starting dose of DARZALEX is 16 mg per kg of body weight. DARZALEX may be given alone or together with other medicines used to treat multiple myeloma. When given alone, DARZALEX is 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. In the first week your doctor may give you the DARZALEX dose split over two consecutive days. How the medicine is given DARZALEX will be given to you by a doctor or nurse. It is given as a drip into a vein ( intravenous infusion ) over several hours. Medicines given during treatment with DARZALEX You may be given medicines to lower the chance of getting shingles. Before each infusion 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 (corticosteroids)

medicines for fever (such as paracetamol). After each infusion 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). If 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 appointment 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 doctor or nurse.

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 signs of an infusion-related reaction during or in the 3 days after the infusion. You may need other medicines, or the infusion may need to be slowed down or stopped. These reactions include the following symptoms: Very common (may affect more than 1 in 10 people):

chills

sore throat, cough

feeling sick (nausea)

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. Other side effects Very common (may affect more than 1 in 10 people):

fever

feeling very tired

diarrhoea

constipation

decreased appetite

headache

nerve damage that may cause tingling, numbness, or pain

high blood pressure

muscle spasms

swollen hands, ankles or feet

feeling weak

back pain

chills

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)

unusual feeling in the skin (such as a tingling or crawling feeling). Common (may affect up to 1 in 10 people):

irregular heart beat (atrial fibrillation)

build up of fluid in the lungs making you short of breath

flu

urinary tract infection

severe infection throughout the body (sepsis)

dehydration

fainting

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)

inflamed pancreas

type of herpes virus infection (cytomegalovirus infection)

COVID-19. Uncommon (may affect up to 1 in 100 people):

inflamed liver (hepatitis). 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 can help provide more information on the safety of this medicine.

DARZALEX will be stored at the hospital or clinic. 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 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 light. 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.

What DARZALEX contains

The active substance is daratumumab. One mL of concentrate contains 20 mg daratumumab. Each vial of 5 mL concentrate contains 100 mg of daratumumab. Each vial of 20 mL concentrate contains 400 mg of daratumumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol (E420), and water for injections (see DARZALEX contains sorbitol
in section 2). What DARZALEX looks like and contents of the pack DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid. DARZALEX is supplied as a carton pack containing 1 glass vial. DARZALEX is also supplied as an initiation pack containing 11 vials: (6 x 5 mL vials + 5 x 20 mL vials). Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer Janssen Biologics B.V. Einsteinweg NL-2333 CB Leiden The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: 1 800 709 medinfo@its.jnj.com Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 medinfo@its.jnj.com This leaflet was last revised in MM/YYYY. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: