Concentrate for solution for infusion
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DARZALEX Concentrate for Solution
for Infusion. It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being
given DARZALEX against the benefits this medicine is expected to have for you.
If you have any concerns about being given DARZALEX ask your doctor.
Keep this leaflet while you are being treated with DARZALEX.
You may need to read it again.
What DARZALEX is used for
DARZALEX is an anti-cancer medicine and contains the active substance daratumumab.
This belongs to a group of medicines called "monoclonal antibodies". One of the ways
monoclonal antibodies work is by attaching themselves to specific cancer cells in
your body, so your immune system can destroy them.
DARZALEX is used to treat adults with multiple myeloma (cancer of the bone marrow).
Your doctor may have prescribed DARZALEX for another reason.
Ask your doctor if you have any questions about why DARZALEX has been prescribed for
This medicine is available only with a doctor's prescription.
Before you are given DARZALEX
When you must not use it:
Do not use DARZALEX if:
you know you are allergic (hypersensitive) to daratumumab or other ingredients of
DARZALEX. See Product Description at the end of this leaflet for a list of ingredients.
Symptoms of an allergic reaction may include rash, itching or hives on the skin, shortness
of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or
other parts of the body.
Do not give DARZALEX to children or young people below 18 years of age. This is because
it is not known how the medicine will affect them.
Before you start to use it:
Tell your doctor if you have or have had any 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.
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, DARZALEX is not recommended for use during
Tell your doctor if you are trying to make your partner pregnant.
Both men and women receiving DARZALEX and their partners must use a reliable method
of contraception during and for 3 months after ceasing treatment with DARZALEX.
Tell your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether DARZALEX passes into breast milk. Therefore there is a possibility
that the breastfed baby may be affected.
If you wish to restart breastfeeding after your DARZALEX treatment, you must discuss
this with your doctor or nurse, who will tell you when it is safe to do so.
If you have not told your doctor about any of the above, tell them before you start
treatment with DARZALEX.
Taking other medicines:
Tell your doctor if you are taking any other medicines, including vitamins and herbal
supplements and including medicines you can buy with or without a prescription from
a 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.
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
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.
DARZALEX will be diluted in sterile normal sodium chloride (salt) solution for injection.
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
Medicines given during treatment with DARZALEX:
DARZALEX may be given alone or together with other medicines used to treat multiple
myeloma (with bortezomib, melphalan and prednisone, or with lenalidomide and dexamethasone
or with bortezomib and dexamethasone).
Read the Consumer Medicine Information for all medicines you take in combination with
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 by mouth (such as corticosteroids)
to lower the chance of infusion 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)
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
While you are using DARZALEX
Things you must 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
If you are about to be started on any new medicines, tell your doctor, dentist or
pharmacist that you are having 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 if you develop fever or if you have signs of bruising or bleeding.
The following precautions should be taken to reduce your risk of infection or bleeding:
Avoid people who have infections. Check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain or find it is painful or difficult to urinate.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist may recommend other ways to clean your teeth and gums. Check
with your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
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.
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"). These reactions can happen during the infusion or in the 3 days after
Tell your doctor or nurse right away if you get any of the infusion-related reactions
listed at the top of the Side Effects section.
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 reaction.
Things to be careful of
Be careful driving or operating machinery until you know how DARZALEX affects you.
DARZALEX may cause tiredness and other effects in some people. Make sure you know
how you react to DARZALEX before you drive a car, operate machinery, or do anything
else that could be dangerous if you have side effects.
Like all medicines, DARZALEX can cause side effects, although not everybody gets them.
Some of these effects may be serious. However, there may be ways to reduce the discomfort
of these effects. You may need medical treatment if you get some of the side effects.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being treated with DARZALEX.
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Below is a list of the more common side effects that you could get while being treated
Tell your doctor or nurse right 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.
sore throat, cough
itchy, runny or blocked nose
feeling short of breath or other breathing problems
dizziness or light-headedness (hypotension)
If you get any of the infusion-related reactions above, tell your doctor or nurse
Other side effects
feeling very tired
nerve damage that may cause tingling, numbness or pain
high blood pressure
swollen hands, ankles or feet
lung infection (pneumonia)
build-up of fluid in the lungs making you short of breath
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)
low number of a type of blood cell called platelets which help to clot blood (thrombocytopenia)
irregular heart beat (atrial fibrillation)
other pain (eg back, joints)
small blisters in clusters on the skin (herpes)
redness of the skin or redness and pain at injection site
If you think you are having an allergic reaction to DARZALEX, tell you doctor immediately
or go to Accident and Emergency at your nearest hospital.
Symptoms usually include some or all of the following:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
Other side effects not listed above may also occur in some people.
Tell your doctor, nurse or pharmacist if you notice any other effect that is making
you feel unwell.
DARZALEX should be stored in a refrigerator (2 degrees 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.
What it looks like:
DARZALEX is available as 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.
daratumumab 100 mg
(for DARZALEX 20mg/mL 5mL vials) OR
daratumumab 400 mg
(for DARZALEX 20mg/mL 20mL vials)
glacial acetic acid
sodium acetate trihydrate
water for injection.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
DARZALEX 100 mg/5mL (AUST R 281842)
DARZALEX 400 mg/20mL (AUST R 281843)
This leaflet was prepared in November 2018.