Is Darzalex Faspro approved by the FDA?
Yes, Darzalex Faspro, a combination of daratumumab and hyaluronidase, is FDA approved. The FDA approved Darzalex Faspro for the treatment of multiple myeloma and light chain amyloidosis in adults on May 1, 2020.
What is Darzalex Faspro?
Darzalex Faspro is a combination of daratumumab, a CD38 monoclonal antibody, and hyaluronidase, an enzyme that facilitates the absorption of the medication when injected subcutaneously. It is used to treat:
- Multiple myeloma
- Light chain amyloidosis
Darzalex Faspro can be used as a monotherapy or in combination with other medications.
How Does Darzalex Faspro Work?
Daratumumab targets the CD38 protein, which is present on the surface of multiple myeloma cells, leading to the destruction of these cancer cells. Hyaluronidase helps the absorption of daratumumab when administered subcutaneously, allowing for quicker and easier administration compared to intravenous infusions.
Dosage and Administration
Darzalex Faspro is administered as a subcutaneous injection into the abdomen. The typical dosing schedule varies from weekly to monthly, depending on the treatment regimen and response:
- It is usually given every 1 to 4 weeks.
- The injection is administered by a healthcare professional.
Side Effects
Common side effects of Darzalex Faspro include:
- Swollen hands, ankles, or feet
- Itching, swelling, bruising, or redness at the injection site
- Nausea, vomiting, diarrhea, constipation
- Fever, low blood cell counts
- Severe headache, blurred vision
- Trouble breathing, lung infection
- Numbness or tingling in hands or feet
- Tiredness
- Cold symptoms (stuffy nose, sneezing, sore throat)
- Muscle spasm, back pain
- Sleep problems (insomnia)
Serious side effects can also occur, and patients should seek immediate medical help if they experience symptoms such as:
- Allergic reactions (itching, hives, runny or stuffy nose, fever, chills)
- Light-headedness or feeling faint
- Unusual bleeding or bruising
- Liver problems (right-sided upper stomach pain, loss of appetite, jaundice)
- Heart problems (abnormal heart rhythm, chest pain, shortness of breath)
- Lung infection (fever, chills, cough with mucus, chest pain)
Warnings and Precautions
- Darzalex Faspro may harm an unborn baby, so effective birth control should be used during treatment and for at least 3 months after the last dose.
- The drug should not be used if there is a known allergy to daratumumab or hyaluronidase.
- Patients with heart problems, breathing issues, hepatitis B, or herpes zoster should inform their doctor before starting treatment.
- Breastfeeding is not recommended during treatment.
Conclusion
Darzalex Faspro is a significant advancement in the treatment of multiple myeloma and light chain amyloidosis, offering a more convenient subcutaneous administration compared to intravenous infusions. Approved by the FDA on May 1, 2020, it provides an effective treatment option with a manageable side effect profile. Patients should follow their healthcare provider's instructions and report any adverse reactions promptly to ensure the best outcomes.
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