Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using DARZALEX SC?
DARZALEX SC contains the active ingredient daratumumab. DARZALEX SC is used in adults
who have a type of cancer called "multiple myeloma" (cancer of the bone marrow). DARZALEX
SC is also used in adults who have a type of blood disorder called "AL amyloidosis".
2. What should I know before I use DARZALEX SC?
Do not use if you have ever had an allergic reaction to DARZALEX SC 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.
3. What if I am taking other medicines?
Some medicines may interfere with DARZALEX SC and affect how it works.
4. How DARZALEX SC is given?
DARZALEX SC will be given to you by a doctor or nurse as an injection under your skin
(subcutaneous injection). 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.
5. What should I know while using DARZALEX SC?
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Things you should do
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Women who are being given DARZALEX SC should use effective contraception during treatment
and for 3 months after treatment. Tell your doctor immediately if you become pregnant
or your partner becomes pregnant while being given DARZALEX SC.
Be sure to keep all your doctor's appointments so your progress can be checked.
If you need to have a blood test, tell the person doing the test that you are using
DARZALEX SC.
Tell any other doctors, dentists and pharmacists who are treating you that you are
using DARZALEX SC.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how DARZALEX
SC affects you. You may feel tired after taking DARZALEX SC which may affect your
ability to drive or use machines.
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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.
Active ingredient(s):
daratumumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DARZALEX SC. 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 SC.
Where to find information in this leaflet:
1. Why am I using DARZALEX SC?
DARZALEX SC contains the active ingredient daratumumab. DARZALEX SC 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 SC is used in adults who have a type of cancer called "multiple myeloma".
This is a cancer of your bone marrow.
DARZALEX SC is also used in adults who have a type of blood disorder called "AL amyloidosis".
In AL amyloidosis, abnormal blood cells make excessive amounts of abnormal proteins
that deposit in various organs, causing these organs to not function properly.
2. What should I know before I use DARZALEX SC?
Warnings
Do not use DARZALEX SC 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 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.
Pregnancy and breastfeeding
Talk to your doctor or nurse before you are given DARZALEX SC 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 SC 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 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.
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 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
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 SC.
4. 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 with other medicines used to treat 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 give:
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 with other medicines used to treat 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,
or with pomalidomide and dexamethasone, or with carfilzomib 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
DARZALEX SC.
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
nurse.
5. What should I know while using DARZALEX SC?
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 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 need to have a blood test, tell the person doing the test that you are using
DARZALEX SC.
If you become pregnant or your partner becomes pregnant while being given DARZALEX
SC, tell your doctor immediately.
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 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 SC can affect the results of this blood test. Tell the person doing
the test that you are using DARZALEX SC.
Hepatitis B
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.
Infusion-related reactions
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
rash (hives).
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 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DARZALEX
SC affects you.
You may feel tired after taking DARZALEX SC which may affect your ability to drive
or use machines.
Looking after your medicine
DARZALEX SC 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 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.
Prepared syringe:
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
administration.
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
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Less serious side effects
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What to do
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Injection site reactions:
redness of the skin
itching
swelling
pain
bruising
rash
bleeding
Stomach or gut related:
constipation
diarrhoea
decreased appetite
Muscle or nerve related:
muscle spasm
back pain
joint pain
chest muscle pain
nerve damage that may cause tingling, numbness or pain
Infection related:
flu
lung infection (pneumonia)
bronchitis
infections of the airways – such as nose, sinuses or throat
COVID-19 infection
urinary tract infection
small blisters in clusters on the skin (herpes)
a type of herpes virus infection (cytomegalovirus infection)
Blood related:
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,
leukopenia)
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
(hypogammaglobulinemia).
Others:
fever
feeling very tired or weak
feeling dizzy
fainting
headache
rash
dehydration
difficulty sleeping
chills
itching
unusual feeling in the skin (such as tingling or crawling feeling)
high blood pressure
swollen hands, ankles or feet
build up of fluid in the lungs making you short of breath
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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 SC contains
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Active ingredient
(main ingredient)
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daratumumab 1800 mg (120 mg/mL)
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Other ingredients
(inactive ingredients)
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vorhyaluronidase alfa
histidine
histidine hydrochloride monohydrate
sorbitol
methionine
polysorbate 20
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What DARZALEX SC looks like
DARZALEX SC is 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. (Aust
R 322685).
Who distributes DARZALEX SC
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
This leaflet was prepared 29 November 2024.