Darzalex Faspro

Generic name: Daratumumab And Hyaluronidase-fihj
Dosage form: injection, for subcutaneous use
Drug class: CD38 monoclonal antibodies

Usage of Darzalex Faspro

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

Darzalex Faspro is a suBC UTAneous 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.

Darzalex Faspro side effects

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.

Before taking Darzalex Faspro

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.

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How to use Darzalex Faspro

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).

What other drugs will affect Darzalex Faspro

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

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