Daratumumab Injection
Daratumumab injection (Darzalex) is a targeted antibody therapy used to treat multiple myeloma — a cancer of plasma cells in the bone marrow — either alone or in combination with other cancer medicines.
🧬 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 Injection: Patient Information Guide
A plain-language walkthrough of Daratumumab 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 (daratumumab) is approved for adult patients with multiple myeloma across multiple settings and combination regimens.
- Newly diagnosed, transplant-ineligible: Darzalex is used in combination with lenalidomide and dexamethasone, or with bortezomib, melphalan, and prednisone.
- Newly diagnosed, transplant-eligible: Darzalex is used in combination with bortezomib, thalidomide, and dexamethasone.
- Relapsed or refractory myeloma (1+ prior therapies): Darzalex is used with lenalidomide and dexamethasone, or with bortezomib and dexamethasone.
- Relapsed or refractory myeloma (1–3 prior lines): Darzalex is used in combination with carfilzomib and dexamethasone.
- Relapsed or refractory myeloma (2+ prior therapies including lenalidomide and a proteasome inhibitor): Darzalex is used with pomalidomide and dexamethasone.
- Heavily pretreated myeloma (3+ prior lines, or double-refractory): Darzalex may be used as a single agent (monotherapy).
⚙️How it works▾
Darzalex is a monoclonal antibody — a precisely engineered protein — that targets a molecule called CD38, found in high amounts on the surface of multiple myeloma cells. When Darzalex binds to CD38, it kills cancer cells through multiple pathways: it activates the immune system's complement proteins to punch holes in cancer cells (complement-dependent cytotoxicity), recruits immune cells to attack and engulf them (antibody-dependent cell-mediated cytotoxicity and phagocytosis), and directly triggers myeloma cells to undergo apoptosis (programmed cell death). It also reduces populations of immune-suppressing cells — certain regulatory T cells, B cells, and myeloid-derived suppressor cells — that normally help cancer evade the immune system.
Because Darzalex targets CD38, it also affects some normal immune cells (like NK cells) that carry CD38. This is why the drug can suppress parts of the immune system, increasing the risk of infection during treatment.
💊How it's taken▾
Darzalex is given as an intravenous (IV) infusion by a healthcare provider in a clinical setting. The dosing schedule depends on which regimen is being used, but in general, infusions start out weekly (for the first 8–9 weeks), then shift to every two or three weeks, and eventually to every four weeks — continuing until the disease progresses or the treatment plan changes. A healthcare provider administers pre-medications (a steroid, acetaminophen, and an antihistamine) before each infusion to reduce reaction risk, and additional medications are given afterward as well.
- Infusions typically take several hours, especially the first one; later infusions may be shorter if earlier ones were well tolerated.
- If a scheduled dose is missed, it should be given as soon as possible, with the schedule adjusted to preserve the intended interval.
- Herpes zoster (shingles) antiviral prophylaxis is recommended during treatment.
🤒Side effects — in detail▾
The most commonly reported side effects (occurring in 20% or more of patients) include:
- Upper respiratory infections (colds, bronchitis)
- Neutropenia (low white blood cell count, raising infection risk)
- Infusion-related reactions (during or shortly after the IV infusion)
- Thrombocytopenia (low platelet count, raising bleeding risk)
- Anemia (low red blood cell count)
- Diarrhea and constipation
- Fatigue and weakness (asthenia)
- Nausea, cough, fever, and shortness of breath
- Swelling in the limbs (peripheral edema) and nerve-related tingling or numbness (peripheral sensory neuropathy)
Serious reactions — including life-threatening infusion reactions, severe infections, and dangerously low blood counts — require prompt medical attention. Contact your care team right away if you develop a high fever, trouble breathing, unusual bleeding, or severe fatigue.
⚠️Warnings & precautions▾
- Infusion-related reactions: Reactions occur in about 37% of patients during the first infusion and can be severe or life-threatening (including anaphylaxis, throat swelling, bronchospasm, and dangerously low blood pressure). Darzalex is always given in a monitored medical setting with emergency equipment available. Pre- and post-infusion medications are required. Infusion is stopped immediately if a reaction occurs, and permanently discontinued for life-threatening reactions.
- Serious infections: Darzalex can cause serious and fatal infections. Patients should be monitored for signs of infection throughout treatment. Antiviral prophylaxis against shingles is recommended.
- Low blood counts: Neutropenia (low white cells) and thrombocytopenia (low platelets) are common and can be severe. Regular blood count monitoring is required; dose delays may be needed to allow recovery.
- Embryo-fetal toxicity: Darzalex can harm an unborn baby. Women of childbearing potential must use effective contraception during treatment and for 3 months after the last dose. Some combination partner drugs (lenalidomide, pomalidomide, thalidomide) carry additional severe birth defect risks.
- Lab test interference: Darzalex binds to red blood cells and can make standard blood bank typing tests unreliable. Blood banks and all treating providers must be informed before any transfusion or surgery.
🔀What it interacts with▾
Darzalex has important effects on laboratory tests and specific risks when combined with certain partner drugs — here's what to know:
- Blood bank typing tests (indirect Coombs/cross-match): Darzalex binds to CD38 on red blood cells and can make standard blood compatibility testing unreliable. Always inform blood bank staff you are receiving this drug.
- Serum protein electrophoresis (SPE) and immunofixation (IFE) tests: Darzalex can show up as a false-positive M protein on these tests, which are used to monitor myeloma. Your oncologist must account for this when interpreting results; a special daratumumab-specific test may be needed.
- Lenalidomide, pomalidomide, and thalidomide (combination partners): These drugs are teratogenic (cause severe birth defects) and must never be used during pregnancy. They are only available through restricted safety programs. Additional contraception and pregnancy testing requirements apply when Darzalex is combined with any of these agents.
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 allergy to daratumumab: Darzalex is contraindicated (must not be used) if you have ever had a severe allergic or anaphylactic reaction to daratumumab or any ingredient in the formulation.
- Pregnancy: Darzalex can harm a fetus. Inform your doctor immediately if you are pregnant or become pregnant during treatment. Effective contraception is required during treatment and for 3 months after the final dose.
- Breastfeeding: Women should not breastfeed while taking Darzalex, particularly when it is combined with lenalidomide, pomalidomide, or thalidomide, due to potential serious harm to the nursing infant.
- COPD (chronic obstructive pulmonary disease): Patients with COPD may need additional breathing medications (short- and long-acting bronchodilators, inhaled corticosteroids) around infusion days.
- Children: Safety and effectiveness have not been established in pediatric patients.
- Infants exposed in the womb: Neonates or infants whose mothers received Darzalex during pregnancy should have a blood evaluation completed before receiving any live vaccines.
- Severe liver impairment: The effect of severe hepatic impairment on daratumumab levels in the body is not known.
📡Pharmacodynamics — effects in the body▾
Darzalex reduces the number of NK cells (natural killer cells) — a type of immune cell that also carries CD38 — in the blood and bone marrow, since those cells are susceptible to the same killing mechanism that targets myeloma cells. It also decreases certain immune-suppressing cell populations, including CD38-positive regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells. There is no evidence that Darzalex affects heart electrical conduction (no risk of prolonging the heart's repolarization interval).
🔬Pharmacokinetics — how your body processes it▾
After IV infusion, daratumumab distributes into a relatively small volume, consistent with staying mostly in the bloodstream rather than spreading widely into body tissues. Drug levels build up with repeated weekly dosing — peak concentrations are about 2.7 to 3 times higher by the end of the weekly dosing phase compared to the first dose. When given as monotherapy, steady-state levels are reached around 5 months into treatment. The estimated half-life (how long it takes the body to clear half the drug) is approximately 18 days, meaning daratumumab stays active in the body for weeks after a dose. Clearance decreases with higher doses and with multiple dosing. No clinically meaningful differences in drug levels were seen based on age (31–93 years), sex, mild-to-moderate liver impairment, or moderate kidney impairment.
📦How to store it▾
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
📄 Written from Daratumumab 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 Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Darzalex and what is it supposed to do for my myeloma? ▾
How will I get this medication — do I take it at home? ▾
What side effects should I expect, and which ones mean I need to call someone right away? ▾
What happens during an infusion reaction — and how will I know if I'm having one? ▾
Can Darzalex cause problems with my blood type tests or other lab work? ▾
Is Darzalex safe if I'm pregnant or thinking about having a baby? ▾
Is Daratumumab Injection available over the counter? ▾
When was Daratumumab Injection first available? ▾
💬 Answers drafted from Daratumumab 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 Injection comes
Daratumumab 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 is used intravenously to treat adult patients with multiple myeloma — either newly diagnosed or relapsed/refractory — in multiple combination regimens or as a single agent.
- Darzalex IV is used as part of combination regimens including lenalidomide, bortezomib, thalidomide, carfilzomib, melphalan, pomalidomide, and dexamethasone, depending on the patient's treatment history.
- Darzalex is used as monotherapy for patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to both.
- Darzalex is used in newly diagnosed patients eligible for autologous stem cell transplant when given in combination with bortezomib, thalidomide, and dexamethasone.
- Darzalex is administered only as an intravenous infusion by a healthcare provider; it must be diluted before infusion and is never self-administered at home.
- Darzalex requires pre-infusion medications (a steroid, acetaminophen, and an antihistamine) given 1 to 3 hours before each infusion to reduce infusion reaction risk; post-infusion medications are also required.
- Darzalex infusion frequency starts weekly, then shifts to every two or three weeks, then every four weeks — the specific schedule depends on which combination regimen is being used.
- Darzalex must be administered in a setting with immediate access to emergency equipment and medical support in case of infusion-related reactions.
📊 Daratumumab Injection across the U.S. market
How Daratumumab 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 Injection is used
A general measure of how commonly Daratumumab 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 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 Injection prescribed? Of the 1,596 medications we measure, Daratumumab Injection ranks #1,255 by Medicaid prescriptions — more than 21% of them.
Utilization by Daratumumab 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.
20 ML daratumumab 20 MG/ML Injection Most dispensed
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1726439
5 ML daratumumab 20 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1721951
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 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 2 of 4 listed Daratumumab Injection NDCs with Medicaid activity.
🔍 Compare Daratumumab Injection products
A representative set of FDA-listed product records for Daratumumab 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 | ||||
| 100 mg/5 mL | Intravenous | Janssen Biotech, Inc. × 8 listings | BLA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Daratumumab 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 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 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 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.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1721947 1 dose form · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1721950In current FDA listingsClinical drug / strength (SCD) 5 ML daratumumab 20 MG/MLRxCUI 172195120 ML daratumumab 20 MG/MLRxCUI 1726439
Look up RxCUI 1721947 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Daratumumab 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 Injection belongs to the CD38-directed Cytolytic Antibody 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.