Prospecto: information for the patient

DARZALEX 20mg/ml concentrate for infusion solution

daratumumab

Read this prospect carefully before starting to receive this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

1.What is DARZALEX and for what it is used

2.What you need to know before starting to receive DARZALEX

3.How DARZALEX is administered

4.Possible adverse effects

5.Storage of DARZALEX

6.Contents of the package and additional information

What is DARZALEX

DARZALEX is a medication for cancer treatment that contains the active ingredient daratumumab. It belongs to a group of medications called “monoclonal antibodies”. Monoclonal antibodies are proteins whose function is to recognize and bind to specific targets in the body. Daratumumab is designed to bind to specific cancer cells in the body, allowing the immune system to destroy them.

How is DARZALEX used

DARZALEX is used in adults aged 18 years or older who suffer from a type of cancer called “multiple myeloma”. It is a cancer of the bone marrow.

You should not receive DARZALEX

• if you are allergic to daratumumab or any of the other ingredients in this medication (listed in section6).

You should not receive DARZALEX if you meet the previous criteria. If you are unsure, consult your doctor or nurse before starting DARZALEX.

Warnings and precautions

Consult your doctor or nurse before starting DARZALEX.

Infusion-related reactions

DARZALEX is administered as an infusion (drip) into a vein. Before and after each infusion of DARZALEX, you will be given medications to help reduce the chances of experiencing infusion-related reactions (see the section «Medications administered during DARZALEX treatment» in section3). These reactions can occur during the infusion or within 3 days after the infusion.

In some cases, you may experience a severe allergic reaction that can include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, or a skin rash with itching (urticaria). Some severe allergic reactions and other severe infusion-related reactions have resulted in death.

Inform your doctor or nurse immediately if you experience any infusion-related reactions or symptoms listed at the beginning of section4.

If you experience infusion-related reactions, you may need other medications or the infusion may need to be slowed down or stopped. The infusion can be resumed when these reactions have resolved or improved.

These reactions occur mainly with the first infusion. If you have already experienced an infusion-related reaction, it is less likely to happen again. If you experience a severe infusion-related reaction, your doctor may decide not to use DARZALEX.

Decreased blood cell count

DARZALEX can reduce the number of white blood cells, which help fight infections, and other blood cells called platelets, which help blood to clot. Inform your healthcare professional if you experience any symptoms of infection such as fever or any symptoms of decreased platelet count such as bruises or bleeding.

Blood transfusions

If you need a blood transfusion, a blood test will be performed first to determine your blood type. DARZALEX may affect the results of this blood test. Inform the person performing the test that you are using DARZALEX.

Hepatitis B

Inform your doctor if you have ever been or may currently be infected with the Hepatitis B virus. This is because DARZALEX could cause the Hepatitis B virus to reactivate again. Your doctor will examine you to detect signs of this infection before, during, and some time after treatment with DARZALEX. Inform your doctor immediately if you experience worsening fatigue or a yellowish discoloration of the skin or the white part of the eyes.

Children and adolescents

Do not administer DARZALEX to children or adolescents under 18years, as its effects on them are unknown.

Other medications and DARZALEX

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription and herbal medications.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

If you become pregnant during treatment with this medication, inform your doctor or nurse immediately. You and your doctor will decide if the benefits of receiving the medication outweigh the risks for the fetus.

Contraception

Women receiving DARZALEX should use an effective contraceptive method during treatment and for 3 months after treatment.

Breastfeeding

You and your doctor will decide if the benefits of breastfeeding outweigh the risks for your baby, as this medication may pass into breast milk and its effects on the baby are unknown.

Driving and operating machinery

You may feel tired after using DARZALEX, which may affect your ability to drive or operate machinery.

DARZALEX contains sorbitol

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you should not receive this medication. Patients with HFI cannot break down fructose, which can cause severe adverse effects.

Consult your doctor before receiving this medication if you have HFI.

Amount Administered

Your doctor will calculate the dose and dosing schedule of DARZALEX. The dose of DARZALEX will depend on your body weight.

The usual initial dose of DARZALEX is 16 mg per kg of body weight. DARZALEX can be administered alone or in combination with other medications used to treat 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
• and then once every 4 weeks as long as the disease does not worsen.

When DARZALEX is administered in combination with other medications, your doctor may modify the time between doses and the number of treatments you receive.

During the first week, your doctor may administer the DARZALEX dose divided over two consecutive days.

How the Medication is Administered

A doctor or nurse will administer DARZALEX. It is administered as an intravenous infusion over several hours.

Medications Administered During DARZALEX Treatment

You may be administered medications to reduce the likelihood of contracting herpes zoster.

Before each DARZALEX infusion, you will be administered medications to help reduce the likelihood of infusion-related reactions. These may include:

• allergy medications (antihistamines)
• inflammation medications (corticosteroids)
• fever medications (such as acetaminophen).

After each DARZALEX infusion, you will be administered medications (such as corticosteroids) to help reduce the likelihood of infusion-related reactions.

Patients with Respiratory Problems

If you have respiratory problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you will be administered inhalation medications to help treat respiratory problems:

• medications to keep airways open in the lungs (bronchodilators)
• medications to reduce inflammation and irritation in the lungs (corticosteroids).

If You Receive More DARZALEX Than You Should

Your doctor or nurse will administer this medication. In the unlikely event that you receive an excessive amount (overdose), your doctor will check if you experience any adverse effects.

If You Miss a DARZALEX Appointment

It is very important that you attend all your appointments to ensure the treatment is effective. If you miss an appointment, please request another one as soon as possible.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Perfusion-related reactions

Inform your doctor or nurse immediately if during the perfusion or within 3 days after it, you experience any of the signs of a perfusion-related reaction listed below. You may need other medicines, or it may be necessary to slow down or stop the perfusion.

These reactions include the following symptoms:

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

• chills
• sore throat, cough
• feeling sick (nausea)
• vomiting
• itching, runny or stuffy nose
• difficulty breathing or other breathing problems.

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

• chest discomfort
• dizziness or vertigo (hypotension)
• itching
• whistling sounds.

Rare (may affect up to 1 in 1000 people):

• severe allergic reaction, which may include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, or a rash with itching (urticaria). See section 2.
• eye pain
• blurred vision.

If you experience any of the perfusion-related reactions mentioned above, inform your doctor or nurse immediately.

Other side effects

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

• fever
• feeling extremely tired
• diarrhea
• constipation
• loss of appetite
• headache
• nervous system damage that can cause tingling, numbness, or pain
• high blood pressure
• muscle spasms
• swollen hands, ankles, or feet
• weakness
• back pain
• chills
• lung infection (pneumonia)
• bronchitis
• infection of the respiratory tract, such as the nose, sinuses, or throat
• low red blood cell count, which transports oxygen in the blood (anemia)
• low white blood cell count, which helps fight infections (neutropenia, lymphopenia, leukopenia)
• low platelet count, which helps blood to clot (thrombocytopenia)
• strange sensation in the skin (such as tingling or prickling).

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

• irregular heartbeat (atrial fibrillation)
• fluid accumulation in the lungs, which can cause difficulty breathing
• flu
• urinary tract infection
• severe infection throughout the body (sepsis)
• dehydration
• syncope
• high blood sugar level
• low calcium level in the blood
• low level of antibodies called 'immunoglobulins' in the blood, which help fight infections (hypogammaglobulinemia)
• pancreatitis
• infection caused by a type of herpes virus (cytomegalovirus infection)
• COVID-19.

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

• inflammation of the liver (hepatitis).

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

DARZALEX will be stored in the hospital or clinic.

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

Do not use this medication after the expiration date that appears on the box and on the vial label after “CAD”. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Your healthcare professional will dispose of unused medications. This will help protect the environment.

Composition of DARZALEX

• The active ingredient is daratumumab. One milliliter of concentrate contains 20 mg of daratumumab. Each vial of 5 ml of concentrate contains 100 mg of daratumumab. Each vial of 20 ml of concentrate contains 400 mg of daratumumab.
• The other components are L-histidine, L-histidine chlorhydrate monohydrate, L-methionine, polisorbate 20, sorbitol (E420), and water for injection (see the section "DARZALEX contains sorbitol" in section 2).

Appearance of the product and contents of the pack

DARZALEX is a concentrate for solution for infusion and is a colorless to yellowish liquid.

DARZALEX is supplied in a box containing 1 vial of glass.

DARZALEX is also available as a starter pack containing 11 vials: (6 vials of 5 ml + 5 vials of 20 ml).

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible Person

Janssen Biologics B.V.

Einsteinweg 101

NL-2333 CB Leiden

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

---------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

This medicine is for single use only.

To prepare the infusion solution using aseptic technique as follows:

• Calculate the dose (mg) and the total volume (ml) of DARZALEX solution required and the number of vials of DARZALEX needed based on the patient's weight.
• Check that the DARZALEX solution is colorless to yellowish. Do not use if it contains visible particles, changes in color, or other types of particles.
• Using aseptic technique, withdraw a volume of sodium chloride 9 mg/ml (0.9%) for injection from the infusion bag/container equivalent 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 an infusion bag/container containing sodium chloride 9 mg/ml (0.9%) for injection. The infusion bags/containers must be made of polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE), or a mixture of polyolefins (PP + PE). Dilute under appropriate aseptic conditions. Discard any unused portion of the solution without using it. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.
• Invert the infusion bag/container gently to mix the solution. Do not shake.
• Before administration, visually inspect the parenteral medications to discard the presence of solid particles and changes in color. The diluted solution may contain very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visible particles are observed, changes in color, or other types of particles.
• Since DARZALEX does not contain any preservative, the diluted solution must be administered within 15 hours (including the infusion time) at room temperature (between 15°C and 25°C) and under ambient light.
• If not used immediately, the diluted solution can be stored before administration for a maximum of 24 hours under refrigeration (between 2°C and 8°C) and protected from light. Do not freeze.
• Administer the diluted solution by intravenous infusion using a sterile infusion set with a flow regulator and a built-in sterile and apyrogenic filter with low protein binding (pore size, 0.22 or 0.2 μm). Use infusion administration equipment made of polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE.
• DARZALEX should not be administered with other medications through the same intravenous route.
• Do not store and re-use any unused portion of the infusion solution. The disposal of unused medication and all materials that have come into contact with it will be carried out 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.