Daratumumab: uses, dosing, side effects & brands

How daratumumab is dosed

From the FDA label for Darzalex (application BLA761036). Other daratumumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Pre-medicate with corticosteroids, antipyretics and antihistamines. ( 2.3 ) Dilute and administer as an intravenous infusion. ( 2.5 ) Recommended dose is 16 mg/kg actual body weight. See full prescribing information for drugs used in combination and schedule. ( 2.2 ) Administer post-infusion medications. ( 2.3 ) 2.1 Important Dosing Information Administer pre-infusion and post-infusion medications [see Dosage and Administration (2.3) ] . Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.5) ]. DARZALEX should be administered by a healthcare provider, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur [see Warnings and Precautions (5.1) ]. Type and screen patients prior to starting DARZALEX [see Warnings and Precautions (5.2) ] . 2.2 Recommended Dosage Monotherapy and In Combination with Lenalidomide (D-Rd) or Pomalidomide (D-Pd) and Dexamethasone The DARZALEX dosing schedule in Table 1 is for combination therapy (4-week cycle regimens) and monotherapy as follows: - combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed/refractory multiple myeloma - combination therapy with pomalidomide and low-dose…

Daratumumab side effects

Who shouldn’t take daratumumab

Daratumumab drug interactions

Combination products containing daratumumab

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

• Darzalex Faspro

Can you crush or split daratumumab?

The daratumumab labels that address it permit crushing or splitting in the terms they state — quoted per product, because the instruction belongs to the form.

Daratumumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No information is available on the clinical use of daratumumab during breastfeeding. Because daratumumab is a large protein molecule with a molecular weight of 148,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant. However, daratumumab is administered with lenalidomide, pomalidomide, or thalidomide, three drugs that have no information on use in nursing mothers. For this reason, the manufacturer recommends that women receiving daratumumab should not breastfeed.

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about daratumumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 17,311 reports naming daratumumab, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

• plasma cell myeloma1,691 reports
• pneumonia1,140 reports
• neutropenia1,127 reports
• thrombocytopenia759 reports
• diarrhoea676 reports
• pyrexia662 reports
• fatigue652 reports
• anaemia639 reports

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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