1. Why am I using DARZALEX?

DARZALEX contains the active ingredient daratumumab. DARZALEX is used in adults who have a type of cancer called "multiple myeloma" (cancer of the bone marrow).

For more information, see Section 1. Why am I using DARZALEX? in the full CMI.

2. What should I know before I use DARZALEX?

Do not use if you have ever had an allergic reaction to DARZALEX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use DARZALEX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DARZALEX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How DARZALEX is given?

DARZALEX will be given to you by a doctor or nurse as a solution for infusion over several hours as a drip into a vein ("intravenous infusion"). 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.

More instructions can be found in Section 4. How DARZALEX is given? in the full CMI.

5. What should I know while using DARZALEX?

For more information, see Section 5. What should I know while using DARZALEX? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The most common and serious side effects are infusion-related reactions (chills, sore throat, cough, nausea, vomiting, itchy, runny or blocked nose, feeling short of breath or other breathing problems). For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

DARZALEX®

Active ingredient(s): daratumumab

Consumer Medicine Information (CMI)

This leaflet provides important information about using DARZALEX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using DARZALEX.

Where to find information in this leaflet:

1. Why am I using DARZALEX?

DARZALEX contains the active ingredient daratumumab. DARZALEX is an anti-cancer medicine and belongs to a group of medicines called "monoclonal antibodies". One of the ways monoclonal antibodies work is by attaching themselves to specific abnormal blood cells in your body, so your immune system can destroy them.

DARZALEX is used in adults who have a type of cancer called "multiple myeloma". This is a cancer of your bone marrow.

2. What should I know before I use DARZALEX?

Warnings

Do not use DARZALEX if:

• you are allergic to daratumumab, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions, especially the following:
  • blood disorder with a low level of white blood cells or platelets. This disorder may become worse during treatment with DARZALEX.
  • Hepatitis B infection.

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

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 5 What should I know while using DARZALEX? and 6. Are there any side effects?

Pregnancy and breastfeeding

Talk to your doctor or nurse before you are given DARZALEX if you are pregnant, think you might be pregnant or are planning to have a baby.

If you become pregnant while being treated with this medicine, tell your doctor or nurse right away. You and your doctor will decide if the benefit of having the medicine is greater than the risk to your baby.

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

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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.

Children and adolescents below 18 years of age

DARZALEX should not be given to children or young people below 18 years of age. This is because it is not known how the medicine will affect them.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

These medicines may be affected by DARZALEX or may affect how well DARZALEX works. Your doctor or pharmacist can tell you what to do if you are using any other medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect DARZALEX.

4. How DARZALEX is given?

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.

Ask your doctor if you want to know more about the dose of DARZALEX you receive.

How it is given

DARZALEX will be given to you by a doctor or nurse. It is given over several hours as a drip into a vein ("intravenous infusion").

When it is given:

Your doctor will tell you when DARZALEX will be given. The frequency depends on whether it is given alone or together with other medicines used to treat multiple myeloma.

Medicines given during treatment with DARZALEX:

DARZALEX may be given alone or together with other medicines used to treat multiple myeloma (with bortezomib, thalidomide and dexamethasone, or with bortezomib, melphalan and prednisone, or with lenalidomide and dexamethasone or with bortezomib and dexamethasone, or with carfilzomib and dexamethasone).

Read the Consumer Medicine Information for all medicines you take in combination with DARZALEX.

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 (corticosteroids)
• 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.

You may also be given medicines to lower the chance of getting shingles.

People with breathing problems:

If you have breathing problems, such as asthma or Chronic Obstructive Pulmonary Disease (COPD), you may 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)

What do I do if I receive too much? (overdose)

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.

5. What should I know while using DARZALEX?

Things you should do

• Be sure to keep all your doctor's appointments so your progress can be checked. Your doctor will want to do some blood, urine and other tests from time to time to check on your progress and detect any unwanted side effects.
• Keep follow up appointments with your doctor. It is important to have your follow-up doses of DARZALEX at the appropriate times to get the best effects from your treatment.
• Be sure to follow your doctor's instructions about other medicines you should take, and other things you should do.
• Tell any other doctors, dentists and pharmacists who are treating you that you are using DARZALEX.
• If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are using DARZALEX.
• If you need to have a blood test, tell the person doing the test that you are using DARZALEX.
• If you become pregnant or your partner becomes pregnant while being given DARZALEX, tell your doctor immediately.

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 doctor or nurse if you develop fever or if you have signs of 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

If you have ever had a hepatitis B infection, 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 increasingly tired or get yellowing of your skin or white part of your eyes.

Infusion-related reactions

Before and after each injection of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see "Medicines given during treatment with DARZALEX "). These reactions can happen during the infusion or in the 3 days after the infusion.

Some serious allergic reactions and other severe infusion related reactions have resulted in death.

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 right away if you get any of the infusion-related reactions listed under "Serious side effects" table below.

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 continue DARZALEX if you have a strong infusion-related reaction.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how DARZALEX affects you.

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

Looking after your medicine

DARZALEX is usually stored in the hospital, clinic or at the pharmacy.

Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly.

Unopened vials:

DARZALEX should be stored in a refrigerator (2 to 8 degrees Celsius).

Do not freeze.

Store in the original package to protect from light.

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

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What DARZALEX contains

Do not take this medicine if you are allergic to any of these ingredients.

What DARZALEX looks like

DARZALEX is a colourless to yellow, preservative-free liquid concentrate for intravenous infusion after dilution.

DARZALEX is supplied as a carton pack containing one single use glass vial.

100 mg/5mL Aust R 281842

400mg/20mL Aust R 281843.

Who distributes DARZALEX

JANSSEN-CILAG Pty Ltd

1-5 Khartoum Rd

Macquarie Park NSW 2113 Australia

Telephone: 1800 226 334

This leaflet was prepared 29 November 2024.