DAR-a-TOOM- ue-mab & HYE-al-ure-ON-i-dase)
Trade Name: DARZALEX FASPRO
Daratumumab and hyaluronidase is the generic name for the trade name drug DARZALEX FASPRO. In some cases, health care professionals may use the trade name DARZALEX FASPRO or the generic name Daratumumab and Hyaluronidase when referring to the drug.
Drug Type: Daratumumab and Hyaluronidase is an anti-cancer (“antineoplastic” or “cytotoxic”) drug. This medication is a monoclonal antibody directed against CD38, a molecule present on myeloma cells (for more detail, see “How Daratumumab and hyaluronidase Works” below).
What Daratumumab and Hyaluronidase Is Used For
- Treatment of newly diagnosed and relapsed/refractory multiple myeloma
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Daratumumab and Hyaluronidase Is Given
- It is administered by a healthcare provider as an injection under the skin (in the abdomen) over 3-5 minutes
- It may be given alone or together with other medications used to treat multiple myeloma
- Medications will be given before each dose of daratumumab and hyaluronidase to reduce the occurrence of infusion-related symptoms
- Other medications requiring injections into the skin should not be given at the same site
- There is no pill form of daratumumab and hyaluronidase
The schedule of daratumumab and hyaluronidase will be determined by your doctor.
Important things to remember about the side effects of Daratumumab and Hyaluronidase
- Most people will not experience all of the side effects listed
- Daratumumab and hyaluronidase side effects are often predictable in terms of their onset, duration, and severity
- Daratumumab and hyaluronidase side effects will improve after therapy is complete
- There are things your treatment team can do to minimize or prevent side effects
The following side effects are common (occurring in greater than 30%) for patients taking Daratumumab and Hyaluronidase:
These are less common side effects (occurring in 10-29%) for patients receiving Daratumumab and Hyaluronidase:
These are rare serious side effects for patients receiving Daratumumab and Hyaluronidase:
Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24 hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in your stools
- Blood in the urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
Always inform your health care provider if you experience any unusual symptoms.
- Do not receive Daratumumab and Hyaluronidase, if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in Daratumumab and Hyaluronidase.
- This drug may affect the results of your blood test to match your blood type. These changes can last for up to 6 months after your final dose. Your doctor will do tests to match your blood type before you start treatment with daratumumab and hyaluronidase. Inform your healthcare provider that you are being treated with Daratumumab and Hyaluronidase before receiving blood transfusion.
- Before starting Daratumumab and Hyaluronidase: treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Before starting Daratumumab and Hyaluronidase, inform your doctor if you had shingles (herpes zoster).
- Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Daratumumab and Hyaluronidase.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If you become pregnant while taking Daratumumab and Hyaluronidase, stop taking the medication immediately and call your doctor for further instructions.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking Daratumumab and Hyaluronidase. Barrier methods of contraception, such as condoms, are recommended for up to 3 months after last dose of Daratumumab and Hyaluronidase.
- Do not breast feed while taking Daratumumab and Hyaluronidase.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing While Taking Daratumumab and Hyaluronidase
You will be checked regularly by your doctor while you are taking Daratumumab and Hyaluronidase, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
A type and screen blood test should be done before you start daratumumab. If you require a blood transfusion after starting daratumumab, the blood bank should be informed that you are receiving this medication as it masks antibody detection to minor antigens in your blood. Your ABO and Rh blood type are not affected.
This treatment may affect some of the blood work your provider used previously to monitor your multiple myeloma. Your provider may monitor your myeloma in a different way after starting this therapy.
How Daratumumab and Hyaluronidase Works
Cancer is a disease caused by changes, also known as mutations, in DNA that change the way cells grow and divide. Cancer cells can be destroyed using many different types of medications that work in very different ways. Examples of medications that destroy cancer cells include cytotoxic chemotherapy, targeted therapy, immunotherapy, and antibody-drug conjugates.
The immune system uses antibodies to protect the body against foreign substances. An antibody is a protein that sticks to a specific type of protein called an antigen. When an antibody finds an antigen, it triggers the immune system to destroy the cells that have the antigen. Researchers can create antibodies in a lab that target specific antigens like ones found on cancer cells. These antibodies created in a lab are called monoclonal antibodies.
Monoclonal antibodies target specific differences in the cancer cells than normal cells. Since monoclonal antibodies have a specific target on cancer cells, they may cause less toxicity to healthy cells. Each type of monoclonal antibody works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
Daratumumab and hyaluronidase is a targeted therapy (IgG1k human monoclonal antibody) that targets CD38. CD38 is a cell surface glycoprotein which is highly expressed on myeloma cells. It is expressed at low levels on normal myeloid and lymphoid (normal) type of white blood cells. When daratumumab binds to CD38, it inhibitors the growth of CD38 myeloma cells and causes cell death. The addition of hyaluronidase to the daratumumab allows daratumumab to be absorbed more readily into the bloodstream. It does not have any anti-cancer effects.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.