Darzalex Faspro is an injectable prescription medicine used to treat multiple myeloma and light chain amyloidosis.

Darzalex Faspro is a subcutaneous formulation of Darzalex, an established treatment for multiple myeloma that is given by intravenous infusion over a period of hours. Darzalex Faspro is administered by subcutaneous injection over a much shorter period of approximately three to five minutes.

What is Darzalex Faspro used to treat?

Darzalex Faspro is used to treat adult patients with 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 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 whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma.
• 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 to treat multiple myeloma.
• in combination with the medicines pomalidomide and dexamethasone in people who have received at least one prior medicine including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
• in combination with the medicines carfilzomib and dexamethasone in people who have received one to three prior medicines to treat multiple myeloma.
• 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.

Darzalex Faspro is also used to treat adult patients with newly diagnosed light chain (AL) amyloidosis:

• in combination with the medicines bortezomib, cyclophosphamide and dexamethasone.

It is not known if this medicine is safe and effective in children.

• Darzalex Faspro may be given alone or together with other medicines.
• 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 and after each dose 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.

Usual Adult Dose for Multiple Myeloma:

1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes.

Duration of therapy:
For monotherapy or in combination with lenalidomide/ dexamethasone:
-Weeks 1 to 8: weekly (8 doses)
-Weeks 9 to 24: every 2 weeks
-Week 25 onward until disease progression: every 4 weeks

Comments:
-Consult the manufacturer product information for dosing as part of other combination therapies.
-Premedicate patients with acetaminophen 650 to 1000 mg orally, diphenhydramine 25 to 50 mg (or equivalent) orally or IV, and a corticosteroid (long- or intermediate-acting) such as methylprednisolone 100 mg (or equivalent) oral or IV. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of this drug.
-Post medicate patients with methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of this drug.
-Consult manufacturers prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Uses:
For the treatment of adult patients with multiple myeloma:
-As monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
-In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
-In combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.
-In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.

Usual Adult Dose for Light Chain Amyloidosis:

1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3 to 5 minutes.

Comments:
-Consult the manufacturer product information for dosing as part of other combination therapies.
-Premedicate patients with acetaminophen 650 to 1000 mg orally, diphenhydramine 25 to 50 mg (or equivalent) orally or IV, and a corticosteroid (long- or intermediate-acting) such as methylprednisolone 100 mg (or equivalent) oral or IV. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of this drug.
-Post medicate patients with methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of this drug.
-Consult manufacturers prescribing information for pre-medication and post-medication recommendations when used as part of a combination therapy.

Use:
For the treatment of adult patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

You should not receive this medicine 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 page for a complete list of ingredients.

Before receiving Darzalex Faspro

Before you start treatment, 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. 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.
• 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. 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. Talk to your healthcare provider about the best way to feed your baby during treatment.

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.

Darzalex Faspro may be used with other medicines called lenalidomide, thalidomide or pomalidomide. You should also read the Medication Guide that comes with lenalidomide, thalidomide or pomalidomide if you use Darzalex Faspro with these medicines.

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.

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
• runny or stuffy nose
• headache
• itching
• high blood pressure
• 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. 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.

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. Your healthcare provider will check your blood cell counts during treatment. 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. Your healthcare provider will do blood tests to match your blood type before you start treatment. 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 infection) and decreased red blood cell counts.

The most common side effects of Darzalex Faspro used in combination therapy include:

• tiredness
• nausea
• diarrhea
• shortness of breath
• trouble sleeping
• fever
• cough
• muscle spasms
• back pain
• vomiting
• cold-like symptoms (upper-respiratory infection)
• nerve damage causing tingling, numbness or pain
• constipation
• lung infection (pneumonia)
• swollen hands, ankles, or feet
• headache
• high blood pressure
• decreased red blood cell counts

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.