What is DARZALEXÃÂ® (daratumumab)?
DARZALEXÃÂ® is a prescription medicine used to treat adults with multiple myeloma:
In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma
In combination with the medicines bortezomib, melphalan and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
In combination with the medicines bortezomib, thalidomide, and dexamethasone in people with newly diagnosed multiple myeloma who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor
Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent
It is not known if DARZALEXÃÂ® is safe and effective in children.
Important Safety Information for DARZALEXÃÂ® (daratumumab)
Do not receive DARZALEXÃÂ® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEXÃÂ®. See the ingredients for DARZALEXÃÂ® below.
What should I tell my healthcare provider before taking DARZALEXÃÂ®?
Before you receive DARZALEXÃÂ®, tell your healthcare provider about all of your medical conditions, including if you:
have a history of breathing problems
have had shingles (herpes zoster)
have ever had or might now have a hepatitis B infection as DARZALEXÃÂ® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during and for some time after treatment with DARZALEXÃÂ®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes
are pregnant or plan to become pregnant. DARZALEXÃÂ® may harm your unborn baby
Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 3 months after your final dose of DARZALEXÃÂ®. Talk to your healthcare provider about birth control methods that you can use during this time
are breastfeeding or plan to breastfeed. It is not known if DARZALEXÃÂ® passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive DARZALEXÃÂ®?
DARZALEXÃÂ® may be given alone or together with other medicines used to treat multiple myeloma
DARZALEXÃÂ® will be given to you by your healthcare provider by intravenous (IV) infusion into your vein
Your healthcare provider will decide the time between doses as well as how many treatments you will receive
Your healthcare provider will give you medicines before each dose of DARZALEXÃÂ® and after each dose of DARZALEXÃÂ® to help reduce the risk of infusion reactions
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment
What are the possible side effects of DARZALEXÃÂ®?
DARZALEXÃÂ® may cause serious reactions, including:
Infusion reactions. Infusion reactions are common with DARZALEXÃÂ® and can be severe or serious. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEXÃÂ® if you have infusion reactions. Get medical help right away if