Solution for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DARZALEX SC Solution for injection.
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 SC against the benefits this medicine is expected to have for you.
If you have any concerns about being given DARZALEX SC ask your doctor.
Keep this leaflet while you are being treated with DARZALEX SC.
You may need to read it again.
What DARZALEX SC is used for
DARZALEX SC 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 abnormal blood cells
in your body, so your immune system can destroy them.
DARZALEX SC is used to treat adults with multiple myeloma (cancer of the bone marrow).
DARZALEX SC is also used to treat adults with AL amyloidosis (also known as light
chain amyloidosis, a type of blood disorder). In AL amyloidosis, abnormal blood cells
make excessive amounts of abnormal proteins that deposit in various organs, causing
these organs to not function properly.
Your doctor may have prescribed DARZALEX SC for another reason.
Ask your doctor if you have any questions about why DARZALEX SC has been prescribed
This medicine is available only with a doctor's prescription.
Before you are given DARZALEX SC
When you must not use it:
Do not use DARZALEX SC if:
you know you are allergic (hypersensitive) to daratumumab or other ingredients of
DARZALEX SC. 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.
DARZALEX SC 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.
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 SC.
Hepatitis B infection
DARZALEX SC 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 SC.
Tell your doctor if you are pregnant or intend to become pregnant.
Like most medicines used to treat cancer, DARZALEX SC is not recommended for use during
Tell your doctor if you are trying to make your partner pregnant.
Both men and women receiving DARZALEX SC and their partners must use a reliable method
of contraception during and for 3 months after ceasing treatment with DARZALEX SC.
Tell your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether DARZALEX SC 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 SC 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 SC.
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 SC or may affect how well DARZALEX SC
works. Your doctor or pharmacist can tell you what to do if you are using any other
How DARZALEX SC is given
How much is given:
Your doctor will work out your dose and schedule of DARZALEX SC. The recommended dose
of DARZALEX SC is 1800 mg.
DARZALEX SC may be given alone or together with other medicines used to treat multiple
myeloma or AL amyloidosis.
Ask your doctor if you want to know more about the dose of DARZALEX SC you receive.
How it is given:
DARZALEX SC will be given to you by a doctor or nurse as an injection under your skin
(subcutaneous injection) over approximately 3 to 5 minutes. It is given in the stomach
area (abdomen), not in other sites of the body, and not into areas of the abdomen
where the skin is red, bruised, tender, hard or where there are scars. If you experience
pain during the injection, the doctor or nurse may interrupt the injection and give
you the remaining injection in another area of your abdomen.
When it is given:
Your doctor will tell you when DARZALEX SC will be given. The frequency depends on
whether it is given alone or together with other medicines used to treat multiple
myeloma or AL amyloidosis.
Medicines given during treatment with DARZALEX SC:
DARZALEX SC 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).
DARZALEX SC may also be given together with other medicines used to treat AL amyloidosis
(with bortezomib, cyclophosphamide and dexamethasone)
Read the Consumer Medicine Information for all medicines you take in combination with
Before each injection of DARZALEX SC 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 SC 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 SC:
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 SC
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 SC 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 SC.
If you are about to be started on any new medicines, tell your doctor, dentist or
pharmacist that you are using DARZALEX SC.
If you become pregnant or your partner becomes pregnant while being given DARZALEX
SC, tell your doctor immediately.
If you need to have a blood test, tell the person doing the test that you are using
Decreased blood cell counts
DARZALEX SC 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 SC can affect the results of this blood test. Tell the person doing
the test that you are using DARZALEX SC.
If you have ever had a hepatitis B infection, DARZALEX SC 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 SC.
Tell your doctor right away if you get increasingly tired or get yellowing of your
skin or white part of your eyes.
Before and after each injection of DARZALEX SC, you will be given medicines which
help to lower the chance of infusion-related reactions (see “Medicines given during
treatment with DARZALEX SC”).
These reactions are most likely to happen with the first injection and most reactions
occur on the day of injection. If you have had an infusion-related reaction once it
is less likely to happen again. However, delayed reactions can happen up to 3-4 days
after the injection. Your doctor may decide not to use DARZALEX SC if you have a strong
reaction after the injection.
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
Tell your doctor or nurse right away if you get any of the infusion-related reactions
or allergic reactions listed in the Side Effects section.
If you get infusion-related reactions, you may need other medicines to treat your
symptoms, or the injections may need to be stopped. When these reactions go away or
get better, the injection can be started again.
Things to be careful of
Be careful driving or operating machinery until you know how DARZALEX SC affects you.
DARZALEX SC may cause tiredness and other effects in some people. Make sure you know
how you react to DARZALEX SC before you drive a car, operate machinery, or do anything
else that could be dangerous if you have side effects.
Like all medicines, DARZALEX SC 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
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being treated with DARZALEX SC.
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
with DARZALEX SC:
Tell your doctor or nurse right away if you get any of the following signs of an infusion-related
reaction up to 3-4 days after the injection. You may need other medicines, or the
injection may need to be interrupted or stopped.
sore throat, cough
feeling sick (nausea)
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
Injection site reactions
Skin reactions at or near the injection site (local), including injection site reactions,
can happen with DARZALEX SC. These reactions may include:
redness of the skin
swelling, pain, bruising, rash, bleeding
Other side effects
feeling very tired
nerve damage that may cause tingling, numbness or pain
swollen hands, ankles or feet
other pain (eg back, joints)
lung infection (pneumonia)
infections of the airways – such as nose, sinuses or throat
build-up of fluid in the lungs making you short of breath
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)
high level of sugar in the blood
low level of calcium in the blood
low level of antibodies called 'immunoglobulins' in the blood which help fight infections
irregular heart beat (atrial fibrillation)
heart disorders (heart failure, heart attack)
urinary tract infection
severe infection throughout the body (sepsis)
high blood pressure
inflamed liver (hepatitis)
small blisters in clusters on the skin (herpes)
a type of herpes virus infection (cytomegalovirus infection)
unusual feeling in the skin (such as tingling or crawling feeling)
If you think you are having an allergic reaction to DARZALEX SC, tell you doctor immediately
or go to Accident and Emergency at your nearest hospital.
Symptoms of allergic reactions 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 SC should be stored in a refrigerator (2 to 8 degrees Celsius) and equilibrated
to ambient temperature (15 to 30 degrees Celsius) before use. The unpunctured vial
may be stored at ambient temperature and ambient light for a maximum of 24 hours.
Do not freeze.
Store in the original package to protect from light. Do not shake.
If the syringe containing DARZALEX SC is not used immediately, it can be stored for
up to 24 hours refrigerated followed by up to 12 hours at 15 to 25 degrees Celsius
and ambient light. The syringe should be discarded if it is not used within 24 hours
of being refrigerated or within 12 hours of being at 15 to 25 degrees Celsius. If
stored in the refrigerator, allow the solution to come to ambient temperature before
Keep this medicine out of the sight and reach of children.
What it looks like:
DARZALEX SC is available as a colourless to yellow, clear to opalescent, preservative-free
solution for subcutaneous administration.
DARZALEX SC is supplied as a carton pack containing one single use glass vial.
daratumumab 1800 mg (120 mg/mL)
histidine hydrochloride monohydrate
water for injections.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
DARZALEX SC 1800 mg/15 mL (AUST R 322685)
This leaflet was prepared 28 October 2022.