Daratumumab and hyaluronidase

What is Daratumumab and hyaluronidase?

• Daratumumab and hyaluronidase (Darzalex Faspro) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase used for the treatment of adults with newly diagnosed or relapsed/refractory multiple myeloma.
• Hyaluronidase allows daratumumab to be given by injection under the skin. Daratumumab and hyaluronidase can be given in less time than daratumumab alone, which is given as an infusion.

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What are the uses of this medicine?

Daratumumab and hyaluronidase (Darzalex Faspro) is a prescription medicine 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 Fasprois a prescription medicine also used in combination with the medicines bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain (AL) amyloidosis.

How does this medicine work?

Daratumumab:

• Daratumumab (dar" a toom' ue mab) is human IgG1 monoclonal antibody to CD38, which is a transmembrane glycoprotein that is frequently overexpressed on cancer cells including multiple myeloma cells.
• The monoclonal antibody binds to the CD38 molecule and triggers cell apoptosis, probably as a result of antibody mediated cytotoxicity.
• Daratumumab has been evaluated in heavily pretreated patients with refractory multiple myeloma and shown overall response rates of higher than expected.

Hyaluronidase:

• (HY-al-yoo-RAH-nih-days) is an enzyme that breaks down a substance in the body called hyaluronic acid.
• Hyaluronic acid is found throughout the body in connective tissue, skin, and fluids in the joints and inside the eye.
• It causes fluids to have a jelly-like thickness, which can help moisten and protect tissues and joints.
• In medicine, hyaluronidase is made in the laboratory and given with other drugs by injection under the skin to treat certain conditions.
• Using hyaluronidase to break down hyaluronic acid helps make the fluids and connective tissue thinner so the drugs can move more easily into the tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a history of a severe allergic reaction to daratumumab, hyaluronidase or any of the ingredients in DARZALEX FASPRO.

What drug interactions can this medicine cause?

• Darzalex Fasprocan 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.
• Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test).
• Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein.

Is this medicine FDA approved?

• It was approved for use in the United States in May 2020.

How should this medicine be used?

• Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist.

Recommended dosage:

• The recommended dosage of Darzalex Fasprois (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to recommended schedule.

Administration:

• Darzalex Faspromay be given alone or together with other medicines used to treat multiple myeloma.
• Darzalex Fasprowill be given to you by your healthcare provider as an injection under the skin, in the stomach area (abdomen).
• Darzalex Fasprois 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 Fasproand after each dose of Darzalex Fasproto help reduce the risk of serious allergic reactions and other reactions due to release of certain substances by your body (systemic).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• DARZALEX FASPRO

What side effects can this medication cause?

The most common side effects of Darzalex Fasprowhen used alone include:

• cold-like symptoms (upper respiratory infection) and decreased red blood cell counts.

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

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

Darzalex Faspromay cause serious reactions, including:

• Serious allergic reactions and other severe injection-related reactions
• Injection site reactions
• Heart problems in people with light chain (AL) amyloidosis
• Decreases in blood cell counts
• Changes in blood tests

What special precautions should I follow?

• Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO. Permanently discontinue Darzalex Fasprofor life-threatening reactions.
• Serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received Darzalex Fasproin combination with bortezomib, cyclophosphamide and dexamethasone. Monitor patients with cardiac involvement more frequently for cardiac adverse reactions and administer supportive care as appropriate.
• Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Consider withholding Darzalex Fasproto allow recovery of neutrophils.
• Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment. Consider withholding Darzalex Fasproto allow recovery of platelets.
• Darzalex FasproCan cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception
• Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received DARZALEX FASPRO.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Darzalex Fasprocan cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Darzalex Fasproin pregnant women to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of Darzalex Fasproin pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: daratumumab and hyaluronidase-fihj
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, and water for injection.

Who manufactures and distributes this medicine?

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

What should I know about storage and disposal of this medication?

• Store Darzalex Fasprovials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light.
• Do not freeze or shake.

• Dailymed label info on Daratumumab and hyaluronidase
• FDA Daratumumab and hyaluronidase

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