Patient information: uses, side effects, how to take - Darzalex Faspro

What is DARZALEX FASPRO?

DARZALEX FASPRO is a prescription medicine used:

to treat adults with multiple myeloma:
- in combination with the medicines bortezomib, lenalidomide, and dexamethasone in newly diagnosed people 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, lenalidomide, and dexamethasone in newly diagnosed people 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, melphalan and prednisone, in newly diagnosed people who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).
- in combination with the medicines lenalidomide and dexamethasone in newly diagnosed people who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine.
- in combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people 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.
- in combination with the medicines pomalidomide and dexamethasone in people who have received at least one prior medicine including lenalidomide and a proteasome inhibitor.
- in combination with the medicines carfilzomib and dexamethasone in people whose multiple myeloma has come back or did not respond to treatment who have received one to three prior medicines.
- 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.
alone to treat adults with high-risk smoldering multiple myeloma (an early form of multiple myeloma that has a higher chance of progressing to active multiple myeloma).
in combination with the medicines bortezomib, cyclophosphamide and dexamethasone to treat adults with newly diagnosed light chain (AL) amyloidosis.

It is not known if DARZALEX FASPRO is safe and effective in children.

Do not receive DARZALEX FASPRO if you have a history of a severe allergic reaction to daratumumab, hyaluronidase or any of the ingredients in DARZALEX FASPRO. See the end of this leaflet for a complete list of ingredients in DARZALEX FASPRO.

Before you receive DARZALEX FASPRO, 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 DARZALEX FASPRO 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 DARZALEX FASPRO. 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. DARZALEX FASPRO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX FASPRO.
- Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of DARZALEX FASPRO. Talk to your healthcare provider about birth control methods that you can use during this time.
- Before starting DARZALEX FASPRO in combination with lenalidomide, thalidomide or pomalidomide, females and males must agree to the instructions in the lenalidomide, thalidomide or pomalidomide REMS program.
  - The lenalidomide, thalidomide and pomalidomide REMS have more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
  - For males who have female partners who can become pregnant, there is information in the lenalidomide, thalidomide and pomalidomide REMS about sperm donation and how lenalidomide, thalidomide and pomalidomide can pass into human semen.
are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO passes into your breast milk. You should not breastfeed during treatment with DARZALEX FASPRO. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX FASPRO.

Before you receive DARZALEX FASPRO for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. DARZALEX FASPRO should not be used in light chain (AL) amyloidosis patients with highly advanced heart disease outside of clinical trials.

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 DARZALEX FASPRO?

DARZALEX FASPRO may be given alone to treat multiple myeloma or high-risk smoldering multiple myeloma or together with other medicines to treat multiple myeloma or light chain (AL) amyloidosis.
DARZALEX FASPRO will be given to you by your healthcare provider as an injection under the skin, in the stomach area (abdomen).
DARZALEX FASPRO is injected over 3 to 5 minutes.
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 DARZALEX FASPRO and after each dose of DARZALEX FASPRO to help reduce the risk of serious allergic reactions and other reactions due to release of certain substances by your body (systemic).

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of DARZALEX FASPRO?

DARZALEX FASPRO may cause serious reactions, including:

Serious allergic reactions and other severe injection-related reactions. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX FASPRO. Your healthcare provider may temporarily stop or completely stop treatment with DARZALEX FASPRO if you have a serious reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of DARZALEX FASPRO.

shortness of breath or trouble breathing
dizziness or lightheadedness (hypotension)
cough
wheezing
heart beating faster than usual
low oxygen in the blood (hypoxia)

throat tightness or irritation
runny or stuffy nose
headache
itching
high blood pressure
eye pain

nausea
vomiting
chills
fever
chest pain
blurred vision

Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO. Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO.
Heart problems in people with light chain (AL) amyloidosis. Heart problems, in some cases fatal, have occurred. Your healthcare provider will monitor you closely during treatment with DARZALEX FASPRO. Call your healthcare provider right away if you get any of the following symptoms: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.
Infections. DARZALEX FASPRO can cause serious life-threatening infections that can lead to death. Tell your healthcare provider right away if you develop a fever, trouble breathing, cough, burning or pain when you urinate, or any other signs and symptoms of infection during treatment.
Decreases in blood cell counts. DARZALEX FASPRO can decrease white blood cell counts which help fight infections and blood cells called platelets which help to clot blood. Decreases in blood cell counts are common with DARZALEX FASPRO and can be severe. Your healthcare provider will check your blood cell counts during treatment with DARZALEX FASPRO. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
Changes in blood tests. DARZALEX FASPRO can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX FASPRO. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX FASPRO. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO before receiving blood transfusions.

The most common side effects of DARZALEX FASPRO when used alone include:

cold-like symptoms (upper respiratory tract infection)
muscle, bone, and joint pain
tiredness
diarrhea
rash

trouble sleeping, including sleep apnea and restless legs
nerve problems, including increased or decreased sensitivity to touch, temperature, or pain; loss of smell; and numbness, tingling, or burning sensations
injection site reactions

The most common side effects of DARZALEX FASPRO when used in combination therapy include:

tiredness
nausea
diarrhea
shortness of breath
trouble sleeping
headache
rash
kidney problems
movement and balance problems, muscle spasms, weakness, and tremors

fever
cough
muscle spasms
back pain
vomiting
high blood pressure
muscle, bone, and joint pain
decreased appetite
urinary tract infection
stomach pain
cold-like symptoms (upper respiratory tract infection)

nerve problems, including increased or decreased sensitivity to touch, temperature, or pain; loss of smell; and numbness, tingling, or burning sensations
constipation
lung infection (pneumonia)
swollen hands, ankles, or feet
feeling dizzy
bruising
COVID-19

The most common severe abnormal blood test results with DARZALEX FASPRO include decreased white blood cells, platelets, and red blood cells.

These are not all of the possible side effects of DARZALEX FASPRO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX FASPRO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DARZALEX FASPRO that is written for health professionals.

What are the ingredients in DARZALEX FASPRO?

Active ingredient: daratumumab and hyaluronidase-fihj

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, and water for injection.

Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA

U.S. License Number 1864

For patent information: www.janssenpatents.com

For more information, call 1-800-526-7736 or go to www.DARZALEXFASPRO.com.

Darzalex Faspro: Uses, Side Effects and Dosage