Daratumumab

What is Daratumumab?

• Daratumumab (Darzalex) is a CD38-directed cytolytic antibody used to treat patients with multiple myeloma who have received at least three prior treatments.

What are the uses of this medicine?

This medicine is 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 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, 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 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 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 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation.

What drug interactions can this medicine cause?

• Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching.
• Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). False positive SPE and IFE assay results may occur for patients with IgG kappa myeloma protein impacting initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• Pre-medicate with corticosteroids, antipyretics and antihistamines.
• Dilute and administer as an intravenous infusion.

Recommended Dosage:

• The recommended dose is 16 mg/kg intravenously every week for 8 to 9 weeks, and then every 2, 3 or 4 weeks based upon indications and other agents being used.

Administration

• Darzalex may be given alone or together with other medicines used to treat multiple myeloma.
• Darzalex 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 Darzalex and after each dose of Darzalex to help reduce the risk of infusion-related reactions.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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

This medicine is available in fallowing doasage form: As Injection:

• 100 mg/5 mL (20 mg/mL) in a single-dose vial.
• 400 mg/20 mL (20 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Darzalex

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness
• nausea
• diarrhea
• shortness of breath
• feeling weak
• fever
• cough
• cold-like symptoms (upper respiratory infection)
• nerve damage causing tingling, numbness or pain
• swollen hands ankles or feet
• constipation

Darzalex may cause serious reactions, including:

• Infusion-related reactions
• Changes in blood tests
• Decreases in blood cell counts

What special precautions should I follow?

• Darzalex can cause severe and/or serious infusion-related reactions including anaphylactic reactions. Interrupt Darzalex infusion for infusion-related reactions of any severity. Permanently discontinue the infusion in case of anaphylactic reactions or life-threatening infusion-related reactions and institute appropriate emergency care.
• Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Type and screen patients prior to starting treatment. Inform blood banks that a patient has received Darzalex.
• Darzalex may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Dose delay may be required to allow recovery of neutrophils.
• Darzalex may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment. Dose delay may be required to allow recovery of platelets.
• Darzalex Can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception.

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 can cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Darzalex in 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 in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: daratumumab
• Inactive ingredients: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, and water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Janssen Biotech, Inc., Horsham

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

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Do not freeze or shake.
• Protect from light.
• This product contains no preservative.

• Dailymed label info on Daratumumab
• FDA Daratumumab

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