Daratumumab and Hyaluronidase-fihj Injection
Daratumumab and hyaluronidase-fihj is a targeted antibody combination used to treat multiple myeloma, high-risk smoldering multiple myeloma, and light chain (AL) amyloidosis in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Daratumumab and Hyaluronidase-fihj Injection: Patient Information Guide
A plain-language walkthrough of Daratumumab and Hyaluronidase-fihj Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Darzalex Faspro (daratumumab and hyaluronidase-fihj) is approved for several conditions involving abnormal plasma cells in adults:
- Newly diagnosed multiple myeloma — transplant eligible: Darzalex Faspro combined with bortezomib, lenalidomide, and dexamethasone for induction and consolidation, or combined with bortezomib, thalidomide, and dexamethasone
- Newly diagnosed multiple myeloma — transplant ineligible: Darzalex Faspro combined with bortezomib, lenalidomide, and dexamethasone; or with bortezomib, melphalan, and prednisone; or with lenalidomide and dexamethasone
- Relapsed or refractory multiple myeloma: Darzalex Faspro combined with lenalidomide and dexamethasone (after at least one prior therapy); with bortezomib and dexamethasone (after at least one prior therapy); with pomalidomide and dexamethasone (after at least one prior line including lenalidomide and a proteasome inhibitor); with carfilzomib and dexamethasone (after one to three prior lines); or as monotherapy (after at least three prior lines, or double-refractory to a proteasome inhibitor and an immunomodulatory agent)
- High-risk smoldering multiple myeloma: Darzalex Faspro as monotherapy
- Newly diagnosed light chain (AL) amyloidosis: Darzalex Faspro combined with bortezomib, cyclophosphamide, and dexamethasone — not for patients with NYHA Class IIIB or IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials
⚙️How it works▾
Daratumumab is a monoclonal antibody that targets a protein called CD38, which is found in high amounts on the surface of cancerous plasma cells in multiple myeloma and AL amyloidosis. When daratumumab binds to CD38, it kills those cells in several ways: it can directly trigger the cancer cell to self-destruct (apoptosis), and it signals the immune system to attack the cells through multiple pathways, including complement activation, antibody-dependent cellular toxicity, and cellular phagocytosis (engulfing and destroying cells). It also reduces certain immune-suppressing cells that carry CD38, which may help restore a more effective immune response against the cancer.
Hyaluronidase, the second component, works locally at the injection site. It temporarily breaks down hyaluronan — a gel-like substance in the tissue under the skin — which creates more space for the medicine to spread and be absorbed after the subcutaneous injection. This effect is reversible, with normal tissue permeability restored within 24 to 48 hours.
💊How it's taken▾
Darzalex Faspro is given by a healthcare professional as a subcutaneous injection (under the skin, into the abdomen) over approximately 3 to 5 minutes. It is not taken by mouth and is not self-injected at home. Dosing frequency starts out more intensive — typically weekly for the first weeks — then gradually shifts to every 2 weeks, and eventually every 4 weeks, based on which treatment regimen you are on and which condition is being treated. The schedule also varies depending on whether Darzalex Faspro is used alone or in combination with other medicines.
- Pre-medications (acetaminophen, an antihistamine, and a corticosteroid) are required before each dose to lower the chance of a reaction
- Additional medications may be given after the injection to further reduce delayed reactions
- If a dose is missed, take it as soon as possible and adjust the schedule to keep the correct interval between doses
- Follow your care team's specific instructions — schedules differ by indication and regimen
🤒Side effects — in detail▾
The most commonly reported side effects with Darzalex Faspro vary somewhat by treatment regimen, but across studies include:
- Upper respiratory tract infections (such as colds or sinus infections)
- Fatigue
- Diarrhea or constipation
- Peripheral neuropathy (numbness, tingling, or weakness in the hands or feet)
- Nausea
- Musculoskeletal pain (muscle aches, back pain)
- Swelling (edema)
- Injection site reactions (redness, rash at the injection spot)
- Insomnia
- Rash
- Decreased blood cell counts (low white cells, low platelets, low red cells) seen on lab tests
Serious reactions to watch for and report immediately include signs of a severe allergic reaction (difficulty breathing, chest tightness, very low blood pressure), eye problems (sudden vision changes, eye pain), symptoms of serious infection (high fever, chills, worsening cough), and signs of bleeding or severe bruising.
⚠️Warnings & precautions▾
- Administration-related reactions: Serious and even fatal reactions to the injection can occur, including difficulty breathing, dangerously low blood pressure, rapid heart rate, and eye complications such as sudden vision changes or acute glaucoma. These are most likely with the first and second injections. Pre-medications are required, and patients are monitored closely. Life-threatening reactions require permanently stopping the medicine.
- Cardiac toxicity in AL amyloidosis: Serious and fatal heart problems occurred in patients with AL amyloidosis receiving Darzalex Faspro. Patients with significant heart involvement need more frequent cardiac monitoring.
- Serious infections: Darzalex Faspro can cause life-threatening infections, including pneumonia. About 1 in 4 patients in clinical trials had a serious infection. Preventive antimicrobials may be recommended.
- Low blood cell counts: Both neutropenia (low infection-fighting white blood cells) and thrombocytopenia (low platelets, increasing bleeding risk) can occur. Regular blood count monitoring is required throughout treatment.
- Fetal harm: This medicine can harm an unborn baby. Effective contraception is required during treatment and for 3 months after the last dose. Pregnancy must be avoided, especially when combined with lenalidomide, thalidomide, or pomalidomide.
- Laboratory test interference: Daratumumab can produce false positive results on blood compatibility tests and on tests used to monitor myeloma response. Inform blood banks and your care team at every visit.
🔀What it interacts with▾
Darzalex Faspro has several important interactions and laboratory interferences to be aware of:
- Blood bank compatibility testing: Daratumumab binds to a protein on red blood cells, causing false positive results on antibody screening and cross-matching tests. Blood banks must be told before any blood typing or transfusion — the effect can last up to 6 months after the last dose.
- Lenalidomide, thalidomide, or pomalidomide in pregnancy: When Darzalex Faspro is combined with any of these drugs, use in pregnant women is contraindicated due to the severe risk of birth defects and fetal death from those partner medicines.
- Myeloma monitoring labs (SPE/IFE tests): Daratumumab can appear as a false band on serum protein electrophoresis and immunofixation tests used to track your myeloma, which can make it difficult to confirm a complete response. A special daratumumab-specific test may be needed to sort this out.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Severe allergic history: Do not use Darzalex Faspro if you have had a severe hypersensitivity reaction to daratumumab, hyaluronidase, or any component of the formulation.
- Heart disease: If you have AL amyloidosis with serious heart disease (NYHA Class IIIB or IV, or Mayo Stage IIIB), Darzalex Faspro is not recommended outside of a clinical trial setting.
- Pregnancy: Darzalex Faspro can harm a fetus, including depleting the baby's immune cells and reducing bone density. Effective contraception is required during treatment and for 3 months after the final dose.
- Breastfeeding: Women should not breastfeed while receiving Darzalex Faspro, especially when used with lenalidomide, thalidomide, or pomalidomide.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Kidney or mild liver impairment: Mild-to-moderate kidney impairment and mild liver impairment do not meaningfully affect how the body handles daratumumab. The effect of moderate or severe liver impairment is not known.
- Low body weight: Patients with lower body weight may have a higher risk of severe low white blood cell counts (neutropenia).
- Blood transfusions: Always tell your blood bank or transfusion team that you are receiving Darzalex Faspro before any blood typing or transfusion.
📡Pharmacodynamics — effects in the body▾
Daratumumab acts on NK cells (natural killer cells), which also carry the CD38 protein. As a result, treatment with Darzalex Faspro reduces the number of NK cells circulating in the blood and in the bone marrow. Darzalex Faspro is a large protein molecule and is not expected to directly interfere with the heart's electrical system; there is no evidence that it delays the heart's electrical recovery (ventricular repolarization).
🔬Pharmacokinetics — how your body processes it▾
After subcutaneous injection, daratumumab is absorbed gradually, with peak blood levels typically reached around 3 days in multiple myeloma patients and around 4 days in AL amyloidosis patients. The absolute bioavailability (the fraction that actually reaches the bloodstream) is about 69%. Drug levels build up over the first several weeks of weekly dosing. The estimated half-life — the time it takes the body to clear half of the drug — is around 20 days in multiple myeloma and about 28 days in AL amyloidosis. Daratumumab is cleared through two parallel processes: a slower, constant linear clearance and a faster, saturable process that depends on how much CD38-expressing tissue is present. Age, sex, mild-to-moderate kidney impairment, and mild liver impairment do not meaningfully change how the body handles daratumumab.
📦How to store it▾
Store DARZALEX FASPRO vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
📄 Written from Daratumumab and Hyaluronidase-fihj Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Daratumumab and Hyaluronidase-fihj Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Darzalex Faspro and what is it treating? ▾
How is this medicine given — do I inject it myself at home? ▾
What side effects should I expect, and which ones mean I need to call someone right away? ▾
I'm scheduled for a blood transfusion — does this medicine affect blood tests? ▾
Is it safe to get pregnant or breastfeed while on this treatment? ▾
I have AL amyloidosis with heart problems — can I still take this? ▾
Is Daratumumab and Hyaluronidase-fihj Injection available over the counter? ▾
When was Daratumumab and Hyaluronidase-fihj Injection first available? ▾
💬 Answers drafted from Daratumumab and Hyaluronidase-fihj Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Daratumumab and Hyaluronidase-fihj Injection comes
Daratumumab and Hyaluronidase-fihj Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Darzalex Faspro is used to treat multiple myeloma in adults — alone or in combination with other medicines — for both newly diagnosed and previously treated patients
- Darzalex Faspro is used as monotherapy for adults with high-risk smoldering multiple myeloma
- Darzalex Faspro is used in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain (AL) amyloidosis in adults
- Darzalex Faspro is not recommended for AL amyloidosis patients with NYHA Class IIIB or IV cardiac disease or Mayo Stage IIIB outside of clinical trials
- Darzalex Faspro is given by subcutaneous injection into the abdomen by a healthcare professional over approximately 3 to 5 minutes
- Darzalex Faspro is given weekly at first, then spaced to every 2 weeks, and then every 4 weeks — the exact schedule depends on which condition is being treated and which combination regimen is used
- Darzalex Faspro requires pre-medications (acetaminophen, an antihistamine, and a corticosteroid) given 1 to 3 hours before each dose to reduce the risk of reactions
- If a dose of Darzalex Faspro is missed, it should be given as soon as possible and the dosing schedule adjusted to maintain the proper interval
📊 Daratumumab and Hyaluronidase-fihj Injection across the U.S. market
How Daratumumab and Hyaluronidase-fihj Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Daratumumab and Hyaluronidase-fihj Injection is used
A general measure of how commonly Daratumumab and Hyaluronidase-fihj Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Daratumumab and Hyaluronidase-fihj Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Daratumumab and Hyaluronidase-fihj Injection prescribed? Of the 1,594 medications we measure, Daratumumab and Hyaluronidase-fihj Injection ranks #767 by Medicaid prescriptions — more than 52% of them.
Utilization by Daratumumab and Hyaluronidase-fihj Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Daratumumab and Hyaluronidase-fihj Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 1 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Daratumumab and Hyaluronidase-fihj Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Daratumumab and Hyaluronidase-fihj Injection NDCs with Medicaid activity.
🔍 Compare Daratumumab and Hyaluronidase-fihj Injection products
A representative set of FDA-listed product records for Daratumumab and Hyaluronidase-fihj Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| DARATUMUMAB 1800 mg/15 mL; HYALURONIDASE (HUMAN RECOMBINANT) 30000 U/15 mL | Subcutaneous | Janssen Biotech, Inc. × 2 listings | BLA | View NDC → |
| 1800; 30000 mg/15 mL; U/15 mL | Subcutaneous | Janssen Biotech, Inc. × 2 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Daratumumab and Hyaluronidase-fihj Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Daratumumab and Hyaluronidase-fihj Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Daratumumab and Hyaluronidase-fihj Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Daratumumab and Hyaluronidase-fihj Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Daratumumab and Hyaluronidase-fihj Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Daratumumab and Hyaluronidase-fihj Injection belongs to the Endoglycosidase class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.