• Darzalex Faspro is a brand (trade) name for a subcutaneous (under the skin) injection that contains daratumumab combined with hyaluronidase-fihj. Darzalex Faspro may be used to treat adults with multiple myeloma who meet certain criteria and adults with Light Chain (AL) amyloidosis. It is usually used in combination with other medications but may be used alone.
• The active ingredient in Darzalex Faspro, daratumumab works by targeting a specific transmembrane protein, called CD38, that exists on the surface of hematopoietic cells (these are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets), including multiple myeloma and other cell types and tissues. CD38 has multiple functions, such as adhesion, signaling, and modulation of enzyme activity. When Darzalex Faspro binds to this protein, it causes CD38-expressing tumor cells to self-destruct or disintegrate.
• The other ingredient in Darzalex Faspro, hyaluronidase-fihj is a man-made form of the naturally occurring human enzyme, hyaluronidase, which hydrolyzes hyaluronic acid, increasing the permeability of subcutaneous tissue, which increases the dispersion of daratumumab, and allows it to be given subcutaneously.
• Darzalex Faspro belongs to the class of medicines called CD38 monoclonal antibodies. It may also be called a targeted treatment, a biologic, or a monoclonal antibody.

• Darzalex Faspro may be used in combination with other treatments to treat adults with multiple myeloma (MM) who are newly diagnosed and can or cannot have an autologous stem cell transplant; and in those with MM (including relapsed or refractory MM) who have received at least one prior therapy.
• It can be used as single therapy in adults with MM who have received at least three prior medical treatments including a proteasome inhibitor (PI) and an immunomodulatory agent that they have not responded to.
• Darzalex Faspro may also be used to treat Light Chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone in newly diagnosed patients (FDA Accelerated Approval Program).
• Given subcutaneously (under the skin) usually into the stomach area (abdomen).
• Can be given over 3 to 5 minutes, which is quicker than Darzalex, which is given by intravenous infusion and takes over 7 hours for the first infusion.
• Less likely than Darzalex to cause infusion-related reactions.
• Available in one strength: 1,800mg daratumumab/30,000 units hyaluronidase per 15 mL (equivalent to 120mg daratumumab and 2,000 units hyaluronidase per mL) in a single-dose vial.
• Darzalex Faspro is not chemotherapy, it is a targeted treatment that works by binding to a protein called CD38 that is present on the surface of hematopoietic cells, including MM cells. When Darzalex Faspro binds to this protein, it causes cells that carry this protein to self-destruct or disintegrate.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Upper respiratory tract infections, constipation, nausea, fatigue, fever, neuropathy (damage to the nerves in the hands and feet), diarrhea, cough, insomnia, vomiting, back pain, muscle spasms, edema, pneumonia, and shortness of breath. The most common laboratory abnormalities reported were decreased leukocytes, lymphocytes, neutrophils, platelets, and hemoglobin.
• Should not be used in people with a history of severe allergic reactions to daratumumab, hyaluronidase, or any of the components of the formulation.
• Systemic administration-related reactions, such as hypoxia, shortness of breath, high blood pressure, fast heart rate, and ocular effects have been reported in 8% of patients with the first injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The average time to onset was 3.2 hours (range 4 minutes to 3.5 days). Monitor and pause the injection. Discontinue if anaphylaxis occurs.
• May increase the risk of cardiac toxicity in patients with Light Chain Amyloidosis. Monitor for cardiac adverse reactions and treat as necessary.
• Darzalex Faspro may interfere with cross-matching and red blood cell antibody screening. Always type and screen before starting treatment and blood banks should be told the patient has received Darzalex Faspro.
• Complete blood counts require monitoring periodically throughout treatment. Patients with neutropenia should be monitored for signs of infection. The next dose of Darzalex Faspro may need to be delayed to allow neutrophil or platelet recovery.
• There is a potential for immunogenicity and the development of treatment-emergent anti-daratumumab antibodies.
• Must be administered via subcutaneous injection into the abdomen approximately 3 inches (7.5cm) to the right or left of the navel over 3 to 5 minutes by a healthcare professional. Rotate injection sites for successive injections. Do not inject into skin that is hard, red, bruised, tender, or scarred. Slow down the rate of injection if the patient experiences pain. Do not administer other medications for subcutaneous use at the same site.
• Patients need to be premedicated 1 to 3 hours before every Darzalex Faspro injection with a long or intermediate-acting corticosteroid (such as methylprednisolone 100mg IV for the initial injection; methylprednisolone 60mg oral/IV may be considered for subsequent injections), oral acetaminophen 650mg to 1000mg, and an antihistamine (such as diphenhydramine 25mg to 50mg oral/IV) to reduce the risk of administration-related reactions.
• After the injection, consider an oral intermediate- or long-acting corticosteroid (such as methylprednisolone 20mg) for 2 days starting the day after the Darzalex Faspro injection, particularly in those with a medical history of reactions. Antiviral prophylaxis to prevent herpes zoster reactivation should be started 1 week after the Darzalex Faspro injection and continued for 3 months following the end of treatment.
• Darzalex Faspro can cause fetal harm if administered to pregnant women, including depletion of fetal immune cells and decreased bone density. Those of childbearing potential should use effective contraception while receiving Darzalex Faspro and for 3 months after the last dose. If a woman becomes inadvertently pregnant she should advise her doctor immediately. Women should not breastfeed during treatment with Darzalex Faspro.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before starting treatment with Darzalex Faspro, tell your health care provider if you think you have an infection or have symptoms of an infection such as a fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. Also, let them know if you have infections that keep coming back.
• Some vaccinations may need to be avoided during treatment with Darzalex Faspro and for a few months after stopping it. Take care to avoid people who are unwell and protect yourself from injury.
• Your actual appointment time to get your injection of Darzalex Faspro will be longer because premedication with a corticosteroid, acetaminophen, and an antihistamine needs to be administered 1 to 3 hours before giving Darzalex Faspro, to lessen the risk of administration reactions happening.
• Administration reactions, some serious, may occur while you are having a Darzalex Faspro injection, although the likelihood of these is much less than with a Darzalex infusion. Symptoms may include itchy skin, a rash, hives, skin redness, bronchospasm, throat irritation, oropharyngeal pain, shortness of breath, throat edema, flushing, low blood pressure, fever, fatigue, headache, dizziness, nausea, a fast heartbeat, and anaphylaxis. These may occur up to 3.5 days after the injection. Tell your doctor immediately if you experience symptoms of a reaction.
• Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding before being administered Darzalex Faspro as it is not suitable during pregnancy and breastfeeding. Use effective contraception while receiving Darzalex Faspro and for 3 months after the last injection. If you inadvertently become pregnant, see your doctor immediately.

• An overall response rate of 88% (95% CI 78% to 95%) was reported when Darzalex Faspro was administered in combination with bortezomib, melphalan, and prednisone to 67 patients with newly diagnosed MM.
• An overall response rate of 91% (95% CI 81% to 97%) was reported when Darzalex Faspro was administered in combination with lenalidomide and dexamethasone to 65 patients with relapsed/refractory MM.
• Similar efficacy results were seen with other treatments in Multiple Myeloma populations. Refer to the prescribing information for the full details.
• ANDROMEDA, an open-label randomized controlled trial reported a 42% complete response rate in those patients administered Darzalex Faspro in combination with bortezomib, cyclophosphamide, and dexamethasone, compared with 13% in those just administered bortezomib, cyclophosphamide, and dexamethasone.

Medicines that interact with Darzalex Faspro may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Darzalex Faspro. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Darzalex Faspro include:

• antineoplastics, such as capecitabine or cyclophosphamide
• antipsychotics, such as clozapine
• biologics, such as adalimumab, etanercept, golimumab, or infliximab
• fingolimod or golimumab
• HIV medications, such as zidovudine
• immunosuppressants such as azathioprine, cyclosporine, or tacrolimus
• interferon
• live vaccines and some other vaccines, such as BCG, cholera, Covid-19 vaccines, measles, hepatitis b vaccines, yellow fever, or live influenza vaccines (Darzalex Faspro may reduce the immune response to vaccination)
• probiotics, such as bifidobacterium or lactobacillus.

Darzalex Faspro interferes with antibody screening and cross-matching tests because it binds to CD38 on RBCs. Perform type and matching tests before treatment. Daratumumab may also be detected on serum protein electrophoresis and immunofixation assays used for monitoring disease monoclonal immunoglobulins (M protein).

Darzalex Faspro may have additive immune-suppressing effects when given with any other medications such as anticancer drugs, immune-modulating, or immunosuppressive therapies, which may increase a person's risk for infection. Take this into account when switching from drugs with prolonged immune effects.

Note that this list is not all-inclusive and includes only common medications that may interact with Darzalex Faspro. You should refer to the prescribing information for Darzalex Faspro for a complete list of interactions.