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DARZALEX FASPRO
Daratumumab (with Hyaluronidase)
$3090.00
400mg · 400 vial
BrandBranded medicine· By Janssen
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About DARZALEX FASPRO
Overview
DARZALEX FASPRO contains daratumumab and hyaluronidase and is given as an injection under the skin. It treats adults with multiple myeloma, either with other medicines or on its own in certain previously treated patients, and is also used alone for high-risk smoldering multiple myeloma. It is used with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis, but is not recommended for certain advanced stages of heart involvement outside controlled clinical trials. Daratumumab attaches to a protein called CD38 on cancer cells and helps destroy them, while hyaluronidase helps the medicine spread and be absorbed under the skin.
What it treats
Multiple myeloma in adults, in combination with other medicines or, in certain previously treated patients, alone. Use depends on previous treatment and eligibility for an autologous stem cell transplant. High-risk smoldering multiple myeloma in adults, used alone. Newly diagnosed light chain (AL) amyloidosis in adults, with bortezomib, cyclophosphamide and dexamethasone. It is not indicated or recommended outside controlled clinical trials for patients with NYHA Class IIIB or IV cardiac disease or Mayo Stage IIIB disease.
Safety information
Side effects
Common side effects vary depending on the condition being treated and whether DARZALEX FASPRO is used alone or with other medicines. They include upper respiratory tract infections, tiredness, diarrhea, constipation, muscle, bone or back pain, nerve problems affecting sensation or movement, trouble sleeping, rash, swelling, fever, nausea, cough and shortness of breath. Injection-site reactions are also common in people treated for high-risk smoldering multiple myeloma. Blood tests may show reduced white blood cells, platelets and hemoglobin. Contact your doctor promptly if you develop signs of infection, bruising, shortness of breath, or a suspected allergic or administration-related reaction. DARZALEX FASPRO can cause serious and fatal infections, including pneumonia. Allergic and administration-related reactions can be life-threatening; seek emergency medical help for a severe reaction. Serious heart-related side effects can occur in people with light chain (AL) amyloidosis, and those with heart involvement need closer monitoring. Low neutrophils, a type of white blood cell, and low platelets require regular blood-count checks and may lead your prescriber to pause treatment.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use DARZALEX FASPRO if you have had a severe allergic reaction to daratumumab, hyaluronidase or any other ingredient in the medicine. Treatment must be permanently stopped if a life-threatening reaction occurs. Particular caution and monitoring are needed for: • Light chain (AL) amyloidosis with heart involvement, because of the risk of heart-related adverse reactions. • Infections, which can be serious or fatal. • Low neutrophil counts (a type of white blood cell) or low platelet counts. Blood counts should be checked periodically, and treatment may need to be withheld until counts recover. DARZALEX FASPRO can harm an unborn baby. Women who could become pregnant should use effective contraception. DARZALEX FASPRO can interfere with blood compatibility tests. Blood typing and antibody screening should be done before treatment, and the blood bank must be told if you have received this medicine.
Using DARZALEX FASPRO
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)) INJECTION [JANSSEN BIOTECH, INC.] (DailyMed, retrieved 19 September 2026).
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