DARZALEX 20 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. DARZALEX 20 mg/mL concentrate for solution for infusion
   1. What is DARZALEX and what is it used for
   2. What you need to know before you use DARZALEX
   3. How to use DARZALEX
   4. Possible side effects
   5. How to store DARZALEX
   6. Package contents and other information
2. DARZALEX 1800 mg injectable solution
   1. What is DARZALEX and what it is used for
   2. What you need to know before you use DARZALEX
   3. How to use DARZALEX
   4. Possible side effects
   5. How to store DARZALEX
   6. Package contents and other information

DARZALEX 20 mg/mL concentrate for solution for infusion

daratumumab

Read this leaflet carefully before you use this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What is DARZALEX and what is it used for

What is DARZALEX
DARZALEX is an anti-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 attack a specific target
in the body. Daratumumab has been designed to attack specific cancer cells
in the body, so that the immune system can destroy the cancer cells.

What is DARZALEX used for
DARZALEX is used in adult patients aged 18 years and over, who have a type of cancer of the
bone marrow called “multiple myeloma”.

2. What you need to know before you use DARZALEX

You must not receive DARZALEX

• if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6). Do not receive DARZALEX if this applies to you. If you are not sure, talk to your doctor or nurse before DARZALEX is given to you.

Warnings and precautions
Before you are given DARZALEX, talk to your doctor or nurse.
Infusion-related reactions
DARZALEX is given as an infusion into a vein (drip). Before and after each infusion of
DARZALEX, you will be given medicines to reduce the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in
section 3). These reactions can happen during the infusion or within 3 days after the
infusion.
In some cases, you may have a serious allergic reaction that can include swelling of the face, lips,
mouth, tongue or throat, difficulty swallowing or breathing, or a skin rash that itches
(hives). Some severe allergic reactions and other reactions associated with the infusion have led to
death.
If you experience any of the infusion-related reactions or symptoms listed in
section 4, tell your doctor or nurse immediately.
If you have infusion-related reactions, you may need to take other medicines, or the infusion may be
slowed down or stopped. When these reactions have gone away, or improved,
the infusion may be restarted.
These reactions are more likely to happen with the first infusion. If you have already 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 severe reaction to the infusion.
Reduction in blood cell numbers
DARZALEX can reduce the number of white blood cells that help fight infections, and
blood cells called platelets that help your blood to clot. Tell your
healthcare provider if you develop symptoms of infection such as fever, or signs of low
platelet count such as bruising (ecchymosis) or bleeding.
Blood transfusions
If you need a blood transfusion, you will first be tested to check your blood group. DARZALEX can affect this type of test. Tell the person doing the test that you are
using DARZALEX.
Hepatitis B
Tell your doctor if you have ever had or currently have a hepatitis B infection, as
DARZALEX may cause the virus to become active again. Your doctor will
check for signs of this infection before, during and for some time after treatment with
DARZALEX. Tell your doctor immediately if you develop worsening fatigue or yellowing of the skin or the whites of your eyes.

Children and adolescents
DARZALEX should not be used in children or adolescents under 18 years of age because
it is not known how the medicine works in these patients.

Other medicines and DARZALEX
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including those you can buy without a prescription, and herbal
remedies.

Pregnancy
If you are pregnant, or think you might be pregnant, or are planning to become pregnant, ask your
doctor for advice before being given DARZALEX.
If you become pregnant during treatment with this medicine, tell your doctor or
nurse immediately. You and your doctor will decide together whether the benefit of receiving the medicine is greater than the
risk to the baby.

Contraception
Women who are receiving DARZALEX must use effective contraception during treatment
and for 3 months afterwards.

Breast-feeding
You and your doctor will decide whether the benefits of breast-feeding are greater than the risk to your baby.
This is because the medicine may pass into breast milk and it is not known how the medicine will act
in the newborn baby.

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

DARZALEX contains sorbitol
Sorbitol is a source of fructose. If you have hereditary fructose intolerance, a rare genetic
illness, you must not take this medicine. Patients with hereditary fructose intolerance
cannot break down fructose, which can build up and cause serious side effects.
If you have hereditary fructose intolerance you must tell your doctor before
taking this medicine.

DARZALEX contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 per mL equivalent to 2.0 mg/vial of
5 mL. Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.
This medicine contains 0.4 mg of polysorbate 20 per mL equivalent to 8.0 mg/vial of
20 mL. Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use DARZALEX

How much will be administered
The doctor will calculate the dose and the administration schedule of DARZALEX. The dose of DARZALEX
will be established in relation to body weight.
The standard initial dose of DARZALEX is 16 mg per kg of body weight. DARZALEX may be
administered alone or together with other medicines used for the treatment of multiple myeloma.
When administered alone, DARZALEX is administered as follows:

• once a week for the first 8 weeks
• then once every 2 weeks for 16 weeks
• then once every 4 weeks as long as health conditions do not worsen.

When DARZALEX is administered together with other medicines, the doctor may modify
the interval between doses as well as the number of treatments received.
In the first week, the doctor may administer the dose of DARZALEX fractionated over two consecutive days.

How the medicine is administered
DARZALEX will be administered to you by the doctor or nurse over several hours, with an
intravenous infusion (“intravenous infusion”).

Medicines administered during treatment with DARZALEX
You may be administered medicines to reduce the probability of developing shingles.
Before each DARZALEX infusion, you will receive medicines to reduce the probability of reactions
related to the infusion. These may include:

• medicines for an allergic reaction (antihistamines)
• medicines for inflammation (corticosteroids)
• medicines for fever (such as paracetamol).

After each DARZALEX infusion, you will receive medicines (such as corticosteroids) to reduce the
probability of reactions related to the infusion.

People with breathing problems
If you have breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD),
you will receive inhaled medicines to help you breathe:

• medicines that help keep the airways open (bronchodilators)
• medicines that reduce inflammation and lung irritation (corticosteroids).

If you take more DARZALEX than you should
This medicine is administered by the doctor or nurse. In the unlikely event that
you are given an excessive amount (overdose), the doctor will monitor for adverse effects.

If you forget your appointment to receive DARZALEX
It is very important to attend all appointments to ensure that the treatment works. If
you miss an appointment, schedule another one as soon as possible.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Infusion-related reactions
Tell your doctor or nurse immediately if you notice any of the following signs of an
infusion-related reaction during or within 3 days after the infusion. You may need to
take 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 pain
• feeling dizzy or lightheaded (hypotension)
• itching
• shortness of breath.

Rare (may affect up to 1 in 1,000):

• a serious allergic reaction that can include swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, or a itchy rash (hives). See section 2
• eye pain
• blurred vision.

If you experience any of these infusion-related reactions, tell your doctor or nurse immediately.

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

• fever
• feeling very tired
• diarrhoea
• abdominal pain
• constipation
• loss of appetite
• difficulty sleeping
• headache
• feeling dizzy
• nerve damage that can cause tingling, numbness or pain
• high blood pressure
• rash
• muscle spasms
• swelling of the hands, ankles or feet
• feeling weak
• muscle and joint pain (including back pain and chest muscle pain)
• lung infection (pneumonia)
• bronchitis
• respiratory tract infections - such as nose, sinuses or throat
• low number of red blood cells that carry oxygen in the blood (anaemia)
• low number of white blood cells that fight infections (neutropenia, lymphopenia, leucopenia)
• low number of platelets that help the blood to clot (thrombocytopenia)
• low levels of potassium in the blood (hypokalaemia)
• unusual sensation on the skin (such as a tingling or prickly feeling)
• COVID-19.

Common(may affect up to 1 in 10 people):

• irregular heartbeat (atrial fibrillation)
• fluid build-up in the lungs causing shortness of breath
• urinary tract infection
• serious infection in any part of the body (sepsis)
• dehydration
• fainting
• chills
• high blood sugar levels (hyperglycaemia)
• low levels of calcium in the blood
• low levels of antibodies, called “immunoglobulins”, in the blood that help fight infections (hypogammaglobulinaemia)
• inflammation of the pancreas
• itching
• a type of herpes virus infection (cytomegalovirus infection).

Uncommon(may affect up to 1 in 100):

• inflammation of the liver (hepatitis).

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 DARZALEX

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 on the vial label after “Exp.”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze.
Keep the vial in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Healthcare professionals will
take care of disposing of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What DARZALEX contains

• The active substance is daratumumab. 1 mL of concentrate contains 20 mg daratumumab. Each vial containing 5 mL of concentrate contains 100 mg of daratumumab. Each vial containing 20 mL of concentrate contains 400 mg of daratumumab.
• The excipients are L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sorbitol (E420) and water for injections (see “DARZALEX contains sorbitol” in section 2).

Description of DARZALEX and package contents
DARZALEX is a concentrate for infusion solution and is a liquid from colourless to yellow.
DARZALEX is supplied in a cardboard box containing 1 glass vial.
DARZALEX is also sold as a starter pack containing 11 vials:
(6 vials x 5 mL + 5 vials x 20 mL).

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
NL-2333 CB Leiden
Netherlands
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън&ДжонсънБългария” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
[email protected]
Tel.: +36 1 884 2858

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson Rom ânia SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor ehf.
Sími: +354 535 7000
[email protected]

Slovenská 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]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
ΒαρνάβαςΧατζηπαναγήςΛτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
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 medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
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The following information is intended exclusively for healthcare professionals:
This medicine is for single use.
Prepare the infusion solution using the following aseptic technique:

• Calculate the dose (mg), the total volume (mL) of DARZALEX solution required and the number of DARZALEX vials required based on the patient's weight.
• Check that the DARZALEX solution is colourless or yellow. Do not use the solution if there are opaque particles, a change in colour or other foreign particles.
• Using aseptic technique, remove from the bag/container for infusion a volume of sodium chloride 9 mg/mL (0.9%) injection solution equal to the volume of DARZALEX solution required.
• Withdraw the required amount of DARZALEX solution and dilute it to the appropriate volume by adding it to a bag/container for infusion containing a sodium chloride 9 mg/mL (0.9%) injection solution. The bags/containers for infusion must be made of polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin mixture (PP+PE). Dilute under appropriate aseptic conditions. Any unused portion remaining in the vial must be discarded.
• Gently invert the bag/container to mix the solution. Do not shake.
• Medicinal products for parenteral use must be visually inspected before administration to check for particles or colour change. Since daratumumab is a protein, the diluted solution may develop very small protein particles, ranging from semi-transparent to white. Do not use the solution if opaque particles, a colour change or foreign particles are visible.
• Since DARZALEX does not contain preservatives, the diluted solution must be used within 15 hours (including infusion time) at room temperature (15 °C-25 °C) and in ambient light.
• If not used immediately, the diluted solution may be stored before administration for up to 24 hours in refrigerated conditions (2 °C-8 °C) and protected from light. Do not freeze.
• Administer the diluted solution by intravenous infusion using an infusion kit equipped with a flow regulator with an in-line filter, sterile, non-pyrogenic, low protein-binding, polyethersulfone (PES) (pore size 0.22 or 0.2 micrometers). Infusion sets made of polyurethane (PU), polybutadiene (PBD), PVC, PP or PE must be used.
• DARZALEX must not be infused with other substances in the same intravenous line.
• Do not save any unused solution from the infusion for later use. Unused medicine and waste materials derived from such medicine must be disposed of in accordance with local regulations.

Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
medicine administered must be clearly recorded.

DARZALEX 1800 mg injectable solution

daratumumab

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is DARZALEX and what it is used for

What is DARZALEX
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 attack a specific target in the body. Daratumumab
has been designed to attack specific abnormal blood cells in the body, so that the immune system
can destroy these cells.

What is DARZALEX used for
DARZALEX is used in adult patients aged 18 years or over, who have a type of bone marrow cancer called “multiple myeloma”.
DARZALEX is used in adult patients aged 18 years or older who have a type of blood and bone marrow disease defined as “indolent or smouldering multiple myeloma” which may transform
into multiple myeloma.
DARZALEX is also used in adults aged 18 years or older who have a type of blood disease called “AL amyloidosis”, in which abnormal blood cells create excessive amounts of
abnormal proteins that deposit in various organs preventing them from functioning correctly.

2. What you need to know before you use DARZALEX

You must not receive DARZALEX

• if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6). Do not receive DARZALEX if this applies to you. If you are not sure, talk to your doctor or nurse before you receive DARZALEX.

Warnings and precautions
Before you receive DARZALEX, talk to your doctor or nurse.
Infusion-related reactions
DARZALEX is given as a subcutaneous injection using a small needle to
inject the medicine under the skin. Before and after each injection, you will be given medicines to try to reduce the chance of infusion-related reactions (see “Medicines
given during treatment with DARZALEX” in section 3). These reactions are more likely to occur with the first injection and most reactions happen on
the day of the injection. If you have had an infusion-related reaction before, it is less
likely to happen again. However, delayed reactions can occur up to 3-4 days after
the injection. Your doctor may decide not to use DARZALEX if you have a severe reaction
to the injection.
In some cases, a serious allergic reaction may occur which can include swelling of the face, lips,
mouth, tongue or throat, difficulty swallowing or breathing, or an itchy skin rash
(hives). See section 4.
If you experience any of the infusion-related reactions or symptoms listed in
section 4, tell your doctor or nurse immediately. If you have infusion-related
reactions, you may need to be given other medicines to treat the symptoms, or to stop
the injection. When these reactions have gone away, or improved, the injection may be restarted.
Decrease in blood cell counts
DARZALEX can reduce the number of white blood cells that help fight infections and
blood cells called platelets that help your blood to clot. Tell your
healthcare provider if you develop any symptoms of infection such as fever or any symptoms of
low platelet counts such as bruising or bleeding.
Blood transfusions
If you need a blood transfusion, you will be tested to check your blood group first. DARZALEX can affect this type of test. Tell the person who is doing the test that you are
using DARZALEX.
Hepatitis B
Tell your doctor if you have ever had or currently have a hepatitis B infection as
DARZALEX may cause the virus to become active again. Your doctor will
check for signs of this infection before, during and for some time after treatment with
DARZALEX. Tell your doctor immediately if you experience worsening of your feeling of
tiredness or yellowing of your skin or the white part of your eyes.

Children and adolescents
DARZALEX should not be used in children or adolescents under 18 years of age because
it is not known how the medicine works in these patients.

Other medicines and DARZALEX
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including those you can buy without a prescription, and herbal remedies.

Pregnancy
If you are pregnant, or think you might be pregnant, ask your doctor for advice before you are given
DARZALEX.
If you become pregnant during treatment with this medicine, tell your doctor or
nurse immediately. You and your doctor will discuss whether the benefit of receiving the medicine is greater than
the risk to the baby.

Contraception
Women receiving DARZALEX must use effective contraception during treatment
and for 3 months afterwards.

Breast-feeding
You and your doctor will decide whether the benefits of breast-feeding are greater than the risk to your baby.
This is because the medicine may pass into breast milk and it is not known how the medicine will affect
your baby.

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

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

DARZALEX solution for subcutaneous injection contains sorbitol
Sorbitol is a source of fructose. If your doctor has told you that you have intolerance to some sugars, or if
you have a diagnosis of hereditary fructose intolerance, a rare genetic disorder where patients are unable to
break down fructose, talk to your doctor before taking this medicine.

DARZALEX solution for subcutaneous injection contains polysorbate
This medicine contains 0.4 mg of polysorbate 20 per mL equivalent to 6.0 mg/15 mL vial. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use DARZALEX

How much is administered
The dose of DARZALEX solution for subcutaneous injection is 1800 mg.
DARZALEX can be administered alone or together with other medicines used for the treatment
of multiple myeloma or with other medicines used to treat AL amyloidosis. DARZALEX is
normally administered as follows:

• once a week for the first 8 weeks
• then once every 2 weeks for 16 weeks
• then once every 4 weeks as long as your health condition does not worsen.

When DARZALEX is administered together with other medicines, the doctor may modify
the interval between doses as well as the number of treatments received.

How the medicine is administered
DARZALEX will be administered to you by a doctor or nurse as an injection under the skin
(subcutaneous injection) over approximately 3-5 minutes. It is administered in the area of the stomach
(abdomen), not in other parts of the body, and not in areas of the abdomen where the skin appears reddened,
shows bruising, is painful or hardened or where there are scars.
If you experience pain during the injection, the doctor or nurse may interrupt the injection and
administer the remaining injection in another area of the abdomen.

Medicines administered during treatment with DARZALEX
You may be administered medicines to reduce the likelihood of developing shingles.
Before each DARZALEX injection you will receive medicines to reduce the likelihood of reactions
related to the infusion. These may include:

• medicines for an allergic reaction (antihistamines)
• medicines for inflammation (corticosteroids)
• medicines for fever (such as paracetamol).

After each DARZALEX injection you will receive medicines (such as corticosteroids) to reduce the
likelihood of reactions related to the infusion.

People with breathing problems
If you have breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD),
you will receive inhaled medicines to help you breathe:

• medicines that help keep your airways open (bronchodilators)
• medicines that reduce inflammation and lung irritation (corticosteroids)

If you use more DARZALEX than you should
This medicine is administered by the doctor or nurse. In the unlikely event that
you are given an excess (overdose) the doctor will monitor for adverse effects.

If you forget your appointment to receive DARZALEX
It is very important to attend all appointments to ensure that the treatment works. If
you miss an appointment, schedule another one as soon as possible.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Infusion-related reactions
Immediately inform your doctor or nurse if you notice any of the following symptoms within
3-4 days after the injection. You may need to receive other medicines, or the injection may need to be
suspended 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 pain
• feeling dizzy or lightheaded (hypotension)
• itching
• shortness of breath.

Rare (may affect up to 1 in 1,000 people):

• a serious allergic reaction that can include swelling of the face, lips, mouth, tongue or throat, difficulty
  swallowing or breathing, or a itchy rash (hives). See section 2
• eye pain
• blurred vision.

If you experience any of these infusion-related reactions, immediately inform your
doctor or nurse.

Reactions at the injection site
With DARZALEX solution for subcutaneous injection, skin reactions may occur at or near the
injection site (local reactions), including injection site reactions. These reactions are very common (may
affect more than 1 in 10 people) and symptoms at the injection site may include:

• redness of the skin
• itching
• swelling, pain, bruising, rash and bleeding.

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

• fever
• feeling very tired
• diarrhoea
• constipation
• abdominal pain
• loss of appetite
• difficulty sleeping
• headache
• nerve damage that can cause tingling, numbness or pain
• rash
• muscle spasms
• muscle and joint pain (including back pain and chest muscle pain)
• swelling of the hands, ankles or feet
• feeling weak
• lung infection (pneumonia)
• bronchitis
• respiratory tract infections - such as nose, sinuses or throat
• low number of red blood cells that carry oxygen in the blood (anaemia)
• low number of white blood cells that fight infections (neutropenia, lymphopenia, leucopenia)
• low number of a type of blood cell called platelets that help the blood to clot (thrombocytopenia)
• low levels of potassium in the blood (hypokalaemia)
• COVID-19.

Common(may affect up to 1 in 10 people):

• irregular heartbeat (atrial fibrillation)
• fluid build-up in the lungs that causes shortness of breath
• urinary tract infection
• severe infection in any part of the body (sepsis)
• dehydration
• high blood sugar levels (hyperglycaemia)
• low levels of calcium in the blood
• low levels of antibodies, called “immunoglobulins”, in the blood that help fight infections (hypogammaglobulinaemia)
• dizziness
• fainting
• chills
• itching
• unusual sensation on the skin (like tingling or prickling)
• inflammation of the pancreas
• high blood pressure.

Uncommon(may affect up to 1 in 100 people):

• inflammation of the liver (hepatitis)
• a 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 side effects not listed in this
leaflet. You can also report side effects directly through 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 DARZALEX

DARZALEX solution for subcutaneous injection will be stored at the hospital or clinic.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the label
vial after “Exp.”. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2° C-8° C). Do not freeze.
Keep the vial in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Healthcare professionals will
take care of disposing of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What DARZALEX contains

• The active substance is daratumumab. 1 mL of solution contains 120 mg of daratumumab. One 15 mL vial of solution for injection contains 1800 mg of daratumumab.
• The excipients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine monohydrate hydrochloride, L-methionine, polysorbate 20 (E432), sorbitol (E420) and water for injections (see “DARZALEX contains sodium and sorbitol” in section 2).

Description of the appearance of DARZALEX and contents of the pack
DARZALEX solution for subcutaneous injection is a liquid from colorless to yellow.
DARZALEX solution for subcutaneous injection is supplied in a cardboard box containing
1 single-use 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
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън&ДжонсънБългария” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
[email protected]
Tel.: +36 1 884 2858

Danmark
Janssen-Cilag A/S
Tlf.: +45 4594 8282
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson Rom ânia SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor ehf.
Sími: +354 535 7000
[email protected]

Slovenská 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]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
ΒαρνάβαςΧατζηπαναγήςΛτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
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.
--------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
DARZALEX solution for subcutaneous injection must be administered by qualified healthcare
personnel.
To prevent medication errors, it is important to check the vial labels to ensure that the patient receives the correct
formulation (intravenous or subcutaneous) and dose as prescribed. DARZALEX injectable solution must be administered
exclusively by subcutaneous injection, using the indicated dose. The subcutaneous formulation of
DARZALEX is not intended for intravenous administration.
DARZALEX solution for subcutaneous injection is for single use only and is ready for use.

• DARZALEX solution for subcutaneous injection is compatible with polypropylene or polyethylene syringes; subcutaneous infusion sets made of polypropylene, polyethylene or polyvinyl chloride (PVC) and stainless steel transfer and injection needles.
• DARZALEX solution for subcutaneous injection should be a transparent to opalescent and colorless to yellow solution. Do not use the solution if opaque particles, color change or other foreign particles are visible.
• Remove the vial of DARZALEX solution for subcutaneous injection from the refrigerator where it is stored (2 °C-8 °C) and allow it to equilibrate to room temperature (15 °C-30 °C). The unopened vial can be stored at room temperature and protected from light for up to 24 hours. Protect from direct sunlight. Do not shake.
• Prepare the administration syringe under controlled and validated aseptic conditions.
• To avoid needle blockage, connect the hypodermic needle for injections or the subcutaneous infusion set to the syringe immediately before injection.

Storage of the prepared syringe

• If the syringe containing DARZALEX is not used immediately, store the DARZALEX solution for a maximum of 24 hours under refrigerated conditions followed by a maximum of 12 hours at 15 °C-25 °C and in light. If stored in the refrigerator, allow the solution to reach room temperature before administration.

Administration

• Inject 15 mL of 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 3-5 minutes. Do not inject DARZALEX solution for subcutaneous injection into other sites, as data are not available at this time.
• Injection sites should be alternated with subsequent injections.
• DARZALEX solution for subcutaneous injection should never be injected into areas where the skin is red, bruised, sensitive or hardened, or into areas where there are scars.
• Suspend or slow down the rate of administration if the patient complains of pain. If the pain is not relieved by slowing the injection, a second injection site on the opposite side of the abdomen can be chosen to administer the remaining dose.
• During treatment with DARZALEX solution for subcutaneous injection, do not administer other medicinal products for subcutaneous use at the same site used for DARZALEX.
• Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.

Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
administered medicine must be clearly recorded.