Uses
Darzalex Faspro (daratumumab/hyaluronidase-fihj) is commonly used for treating multiple myeloma and light chain amyloidosis. Multiple myeloma is a type of blood cancer. Light chain amyloidosis is a condition where protein builds up and can damage your tissues and organs.
Darzalex Faspro can be used in certain people who have or have not received prior treatment for their condition and who may or may not qualify for other treatments, such as a stem cell transplant. Depending on the specifics of your condition, Darzalex Faspro may be used by itself or in combination with other medicines.
Darzalex Faspro may also be used for other conditions as determined by your healthcare provider.
Other forms of Darzalex Faspro are available. See Darzalex for more information.
How does Darzalex Faspro work (mechanism of action)?
Darzalex Faspro targets a protein called CD38. CD38 is on the surface of blood and bone marrow cells, including the cells that cause multiple myeloma. Darzalex Faspro attaches itself to CD38 and prevents the cells from growing and eventually making them die. The hyaluronidase helps allow the medicine to reach the cells when it is given as an injection.
How is Darzalex Faspro supplied (dosage forms)?
Darzalex Faspro is available in an injectable form that is given by a healthcare provider.
How should I store Darzalex Faspro?
Darzalex Faspro is given by a healthcare provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Darzalex Faspro?
The most common side effects of Darzalex Faspro are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Constipation
- Nausea and vomiting
- Tiredness
- Fever
- Nerve problems
- Diarrhea
- Cough
- Trouble sleeping
- Back pain
- Muscle spasms
- Pneumonia
- Shortness of breath
- High blood pressure
- Fluid retention
- Headache
- Blood disorders (see below)
There may be other side effects of Darzalex Faspro that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Darzalex Faspro?
While less common, the most serious side effects of Darzalex Faspro are described below, along with what to do if they happen.
Severe Allergic Reactions. Darzalex Faspro may cause allergic reactions, which can be serious. Stop using Darzalex Faspro and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Injection Reactions. Darzalex Faspro can cause severe injection reactions that can be serious and even life-threatening. These reactions can happen immediately after you receive Darzalex Faspro or they can be delayed, happening over 24 hours after your dose. They may occur at the injection site (such as rash or itching, swelling, bruising, pain or redness) or throughout your body (such as having dizziness or trouble breathing). Get help right away if you have any of the following symptoms of injection reactions after your Darzalex Faspro dose.
- Shortness of breath or trouble breathing
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Cough
- Fast or abnormal heartbeat
- Throat tightness or irritation or wheezing
- Runny or stuffy nose
- Headache
- Itching
- Eye pain
- Nausea and vomiting
- Fever or chills
- Discomfort or pain in the chest
- Blurred vision
Changes in Blood Tests. Darzalex Faspro can change certain blood tests to make them match your blood type. These changes can last for up to 6 months after your last dose. Tell all healthcare providers that you are being treated with Darzalex Faspro before you receive a blood transfusion.
Blood Disorders. Darzalex Faspro can cause blood disorders, such as low platelet levels (thrombocytopenia) and low neutrophil levels (neutropenia). Stop using Darzalex Faspro and get help right away if you have any of the following symptoms of blood disorders.
- Fever
- Shortness of breath
- Pale or yellowish skin
- Easy bruising or bleeding
- Frequent infection
- Unusual weakness or tiredness
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Headache
- Fast or abnormal heartbeat
Heart Problems. In people who have light chain amyloidosis, Darzalex Faspro can cause serious heart problems when it is given in combination with medicines known as bortezomib, cyclophosphamide, and dexamethasone. These problems can be very serious and even life-threatening. If you are being treated for light chain amyloidosis, make sure to go to all your appointments so your healthcare provider can monitor your heart function closely. If you have had heart problems in the past, you may be at an even higher risk of having serious heart problems. Be sure to tell your healthcare provider about any heart problems you have had in the past to make sure Darzalex Faspro is safe for you.
Warnings & Precautions
Who should not use Darzalex Faspro?
Allergies to Ingredients. People who are allergic to any of the following should not use Darzalex Faspro.
- Darzalex Faspro
- Daratumumab
- Hyaluronidase
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Darzalex Faspro.
What should I know about Darzalex Faspro before using it?
Do not use Darzalex Faspro unless it has been prescribed by a healthcare provider. Your healthcare provider will store and give you the medicine.
Darzalex Faspro will be given to you by your healthcare provider as an injection under the skin of your stomach area (abdomen). Your healthcare provider may also instruct you to take certain medicines before or after you receive your Darzalex Faspro dose. These medicines can help to prevent infusion-related side effects.
What should I tell my healthcare provider before using Darzalex Faspro?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Darzalex Faspro is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Breathing or lung problems
- Have had shingles (herpes zoster)
- Have had heart problems
- Have ever had or may currently have a hepatitis B infection
- Hereditary fructose intolerance (HFI)
Pregnancy. Darzalex Faspro may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Darzalex Faspro. If you can become pregnant, use effective birth control during treatment with Darzalex Faspro and for 3 months after your last dose.
Breastfeeding. Do not undergo treatment with Darzalex Faspro while you are breastfeeding. It is not known if Darzalex Faspro passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Darzalex Faspro?
For more information about Darzalex Faspro, you can visit the manufacturer’s website at www.darzalex.com or call them at 844-628-1234.
Interactions
Does Darzalex Faspro interact with foods or drinks?
There are no known interactions between Darzalex Faspro and foods or drinks.
It is unknown if drinking alcohol will affect Darzalex Faspro.
Does Darzalex Faspro interact with other medicines (drug interactions)?
There are no known interactions between Darzalex Faspro and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
This may not be a complete list of medicines that can interact with Darzalex Faspro. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Darzalex Faspro?
If you or someone else has used too much Darzalex Faspro, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Darzalex Faspro?
Darzalex Faspro is given by a healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving Darzalex Faspro as scheduled. If you miss an appointment, call your healthcare provider right away to reschedule.