Darzalex Faspro
Generic name: daratumumab and hyaluronidase
Drug class: CD38 monoclonal antibodies
Medically reviewed by A Ras MD.
What is Darzalex Faspro?
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.
It is also used in the treatment of 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.
Darzalex Faspro is a prescription medicine also used in combination with the medicines bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain (AL) amyloidosis.
It is not known if Darzalex Faspro is safe and effective in children.
Description
Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody that binds to the CD38 antigen. Daratumumab is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. The molecular weight of daratumumab is approximately 148 kDa.
Hyaluronidase (recombinant human) is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by Chinese Hamster Ovary cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (recombinant human) has a molecular weight of approximately 61 kDa.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) injection is a sterile, preservative-free, colorless to yellow, and clear to opalescent solution supplied in a single-dose vial for subcutaneous administration.
Each DARZALEX FASPRO 15 mL single-dose vial contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase, L-histidine (4.9 mg), L-histidine hydrochloride monohydrate (18.4 mg), L-methionine (13.5 mg), polysorbate 20 (6 mg), sorbitol (735.1 mg), and Water for Injection, USP.
Mechanism of Action
CD38 is a transmembrane glycoprotein (48 kDa) expressed on the surface of hematopoietic cells, including clonal plasma cells in multiple myeloma and light chain (AL) amyloidosis, as well as other cell types. Surface CD38 has multiple functions, including receptor mediated adhesion, signaling, and modulation of cyclase and hydrolase activity. Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP). A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab.
Hyaluronan is a polysaccharide found in the extracellular matrix of the subcutaneous tissue. It is depolymerized by the naturally occurring enzyme hyaluronidase. Unlike the stable structural components of the interstitial matrix, hyaluronan has a half-life of approximately 0.5 days. Hyaluronidase increases permeability of the subcutaneous tissue by depolymerizing hyaluronan. In the doses administered, hyaluronidase in DARZALEX FASPRO acts locally. The effects of hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.
What is the most important information I should know about Darzalex Faspro?
Darzalex Faspro may be used with other medicines called lenalidomide or thalidomide and dexamethasone. You should also read the Medication Guide that comes with lenalidomide or thalidomide if you use Darzalex Faspro with lenalidomide or thalidomide. You can ask your healthcare provider or pharmacist for information about dexamethasone.
Who should not use Darzalex Faspro?
Do not receive Darzalex Faspro if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in Darzalex Faspro. See the end of this guide for a complete list of ingredients in Darzalex Faspro.
What should I tell my healthcare provider before using 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 at least 3 months after your final 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 and dexamethasone, females and males must agree to the instructions in the lenalidomide REMS program.
- The lenalidomide REMS has 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 REMS about sperm donation and how lenalidomide can pass into human semen.
- are breastfeeding or plan to breastfeed. It is not known if Darzalex Faspro passes into your breast milk.
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 should I use Darzalex Faspro?
- Darzalex Faspro may be given alone or together with other medicines used to treat multiple myeloma.
- 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. 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.
- 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.
- 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 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.
- Heart problems in patients 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 any of the following symptoms occur: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.
The most common side effects of Darzalex Faspro when used alone include cold-like symptoms (upper respiratory infection).
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
These are not all 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 guide. 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, water for injection.
Label
PRINCIPAL DISPLAY PANEL – 15 ML VIAL BOX
- NDC 57894-503-01
- DARZALEX Faspro®
(daratumumab and
hyaluronidase-fihj)
Injection - 1,800 mg and
30,000 Units/15 mL
(120 mg and 2,000 Units/mL) - For Subcutaneous Use Only
- Administer subcutaneous
injection over 3 to 5 minutes. - Rx only
- One 15 mL Vial
- Single-dose vial.
Discard unused portion. - janssen
SRC: NLM .