Prospecto: information for the patient

DARZALEX 1800mg injectable 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 possible adverse effects not listed in this prospect. See section4.

1.What DARZALEX is 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 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 abnormal blood cells in the body, allowing the immune system to destroy them.

What is DARZALEX used for

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

DARZALEX is also used in adults aged 18 years or older who suffer from a type of hematological disorder called “AL amyloidosis”. In AL amyloidosis, abnormal blood cells produce excessive amounts of abnormal proteins that deposit in various organs, causing them to function incorrectly.

You should not receive DARZALEX

• if you are allergic to daratumumab or any of the other components of 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 a subcutaneous injection using a small needle to inject the medication under your skin. Before and after each injection, you will be given medications to help reduce the likelihood of experiencing infusion-related reactions (see the section «Medications administered during DARZALEX treatment» in section3). These reactions occur mainly with the first injection and most occur on the day of the injection. If you have already experienced an infusion-related reaction, it is less likely to happen again. However, delayed reactions can occur up to 3‑4days after the injection. If you have a severe reaction after the injection, your doctor may decide not to use DARZALEX.

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 rash with itching (urticaria). See section4.

Immediately inform your doctor or nurse if you experience any of the infusion-related reactions or symptoms listed at the beginning of section4. If you experience infusion-related reactions, you may need other medications to treat your symptoms, or it may be necessary to stop the injections. When these reactions subside or improve, the injection can be administered again.

Decreased number of blood cells

DARZALEX may reduce the number of white blood cells, cells that 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 may 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 your 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 subcutaneous injectable solution contains sodium

This medicationcontains less than 1mmol (23mg) of sodium per 15ml, which is essentially “sodium-free”.

DARZALEX subcutaneous injectable solution 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 been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the person cannot break down fructose, consult your doctor before receiving this medication.

Administered Amount

The dose of DARZALEX subcutaneous injectable solution is 1800mg.

DARZALEX can be administered alone or in combination with other medications used to treat multiple myeloma, or with other medications used to treat AL amyloidosis. DARZALEX is usually administered as follows:

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

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

How the Medication is Administered

A doctor or nurse will administer DARZALEX as a subcutaneous injection under the skin for approximately 3 to 5 minutes. It is administered in the abdominal area, not in other areas of the body, and not in areas of the abdomen where the skin is red, bruised, sensitive, hardened, or has scars.

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

Medications Administered During DARZALEX Treatment

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

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

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

After each DARZALEX injection, you will be administered medications (such as corticosteroids) to reduce the likelihood of experiencing 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).

Receiving More DARZALEX than Prescribed

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

Missing a DARZALEX Appointment

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

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

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

Infusion-related reactions

Inform your doctor or nurse immediately if, within 3-4 days after injection, you experience any of the following symptoms. You may need other medicines, or it may be necessary to interrupt or discontinue injections.

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
• wheezing.

Rare (may affect up to 1 in 1,000 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 infusion-related reactions mentioned above, inform your doctor or nurse immediately.

Injection site reactions

Reactions may occur on the skin at the injection site or nearby (local reactions), including reactions at the injection site, with DARZALEX subcutaneous injection solution. These reactions are common (may affect up to 1 in 10 people). Injection site symptoms may include redness of the skin, itching, swelling, pain, bruising, hives, bleeding.

Other side effects

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

• fever
• feeling extremely tired
• diarrhea
• constipation
• loss of appetite
• difficulty sleeping
• headache
• nervous system disorder that may cause tingling, numbness, or pain
• hives
• muscle spasms
• joint pain
• swollen hands, ankles, or feet
• weakness
• back pain
• lung infection (pneumonia)
• bronchitis
• respiratory tract infection, 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, leucopenia)
• low platelet count, which helps blood to clot (thrombocytopenia).

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

• irregular heartbeat (atrial fibrillation)
• fluid accumulation in the lungs, which may cause difficulty breathing
• urinary tract infection
• severe infection throughout the body (sepsis)
• dehydration
• high blood sugar level
• low calcium level in the blood
• low level of antibodies called ‘immunoglobulins’ in the blood, which help fight infections (hypogammaglobulinemia)
• dizziness
• syncope
• chest muscle pain
• influenza
• chills
• itching
• strange sensations in the skin (such as tingling or numbness)
• pancreatitis
• high blood pressure
• COVID-19.

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

• inflammation of the liver (hepatitis)
• infection caused by a type of herpes virus (cytomegalovirus infection).

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 subcutaneous injectable solution 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 solution contains 120mg of daratumumab. Each vial of 15ml of injectable solution contains 1800mg of daratumumab.
• The other components are human recombinant hyaluronidase (rHuPH20), L‑histidine, L‑histidine hydrochloride monohydrate, L‑methionine, polisorbate 20, sorbitol (E420) and water for injection (see the section “DARZALEX contains sodium and sorbitol” in section2).

Appearance of the product and contents of the pack

DARZALEX subcutaneous injectable solution is a clear or yellowish liquid.

DARZALEX subcutaneous injectable solution is supplied in a pack containing 1vial of glass monodose.

Marketing Authorization Holder

Janssen-CilagInternationalNV

Turnhoutseweg30

B-2340 Beerse

Belgium

Responsible Person

Janssen Biologics B.V.

Einsteinweg 101

NL-2333 CB Leiden

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

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

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This information is intended for healthcare professionals only:

DARZALEX subcutaneous injectable solution should be administered by a healthcare professional.

To avoid medication errors, it is essential to check the labels on the vial to ensure that the correct formulation (intravenous or subcutaneous) is being administered and that the dose is administered to the patient as prescribed. DARZALEX injectable solution should only be administered subcutaneously at the specified dose. DARZALEX subcutaneous formulation is not indicated for intravenous administration.

DARZALEX subcutaneous injectable solution is for single use and is ready to use.

• DARZALEX subcutaneous injectable solution is compatible with polypropylene or polyethylene syringes; with subcutaneous infusion kits made of polypropylene, polyethylene or chlorinated polyvinyl chloride (PVC); and with steel needles for injection and transfer.
• DARZALEX subcutaneous injectable solution should be a clear or yellowish liquid. Do not use if it presents opaque particles, color changes or foreign particles.
• Remove the vial of DARZALEX subcutaneous injectable solution from the refrigerated storage area (2°C – 8°C) and equilibrate to room temperature (15°C–30°C). The unopened vial can be stored at room temperature and light for a maximum of 24hours in the original packaging to protect it from light. Protect from direct sunlight. Do not shake.
• Prepare the syringe for administration in controlled and validated aseptic conditions.
• To avoid clogging the needle, attach the hypodermic needle or subcutaneous infusion kit to the syringe immediately before injection.

Storage of the prepared syringe

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

Administration

• Inject 15ml of DARZALEX subcutaneous injectable solution into the subcutaneous tissue of the abdomen approximately 7.5cm to the right or left of the navel over a period of approximately 3-5minutes. Do not inject DARZALEX subcutaneous injectable solution into other areas of the body as there are no available data.
• In subsequent injections, alternate the administration sites.
• DARZALEX subcutaneous injectable solution should never be injected into areas of the skin that show redness, hematomas, sensitivity, hardening or areas where there are scars.
• Pause or reduce the rate of administration if the patient experiences pain. If the pain does not subside by reducing the injection rate, it may be possible to administer the remaining dose in a second injection site in the opposite area of the abdomen.
• During treatment with DARZALEX subcutaneous injectable solution, do not administer other medications subcutaneously in the same site as DARZALEX.
• 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 medicinal products, the name and batch number of the medicinal product administered must be clearly recorded.