Datopotamab deruxtecan
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Handling and access
NIOSH hazardous drug
Table 1NIOSH lists datopotamab deruxtecan as a hazardous drug. AHFS class: 10:00 antineoplastic agents.
- The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.
- Added to the list by NIOSH on 2025-07-17 after the 2024 publication.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Dosing in kidney impairment
Renal Impairment Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. A higher incidence of ILD/pneumonitis has been observed in patients with creatinine clearance (CLcr) 30 to <90 mL/min (estimated by Cockcroft Gault) [see Warnings and Precautions ]. No dosage adjustment is recommended in patients with CLcr 30 to <90 mL/min [see Clinical Pharmacology ] .
The pharmacokinetics of datopotamab deruxtecan-dlnk or DXd in patients with CLcr <30 mL/min is unknown.
Dosing in liver impairment
Hepatic Impairment Monitor patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST) for increased adverse reactions [see Dosage and Administration ] . Limited data are available in patients with moderate hepatic impairment. No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST).
The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST) [see Clinical Pharmacology ].
Preparation and administration
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Preparation and Administration Reconstitute and further dilute DATROWAY prior to intravenous infusion. Use appropriate aseptic technique. DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Reconstitution Reconstitute immediately before dilution. More than one vial may be needed for a full dose.
Calculate the dose (mg), the total volume of reconstituted DATROWAY solution required, and the number of vial(s) of DATROWAY needed [see Dosage and Administration ]. Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of Sterile Water for Injection into each vial to obtain a final concentration of 20 mg/mL.
Swirl the vial gently until completely dissolved. Do not shake. If not used immediately, refrigerate the reconstituted DATROWAY solution in the original vial at 2°C to 8°C (36°F to 46°F) for up to 48 hours from the time of reconstitution. Protect the vial from light. Do not freeze. The product does not contain a preservative.
Discard unused reconstituted DATROWAY after 48 hours of refrigeration. Dilution Withdraw the calculated amount from the vial(s) using a sterile syringe. Inspect for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colorless to light yellow. Do not use if visible particles are observed or if the solution is cloudy or discolored.
Dilute the calculated volume of reconstituted DATROWAY in an infusion bag containing 100 mL of 5% Dextrose Injection. DO NOT use Sodium Chloride Injection. DATROWAY is compatible with an infusion bag made of polyvinylchloride or polyolefin (polypropylene or copolymer of ethylene and propylene). Gently invert the infusion bag to thoroughly mix the solution.
Do not shake. Cover the infusion bag to protect from light. If not used immediately, store at room temperature at up to 25°C (77°F) for up to 4 hours including preparation or in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Do not freeze. Discard any unused portion left in the vial. Administration The maximum time from reconstitution of the vial through the end of administration should not exceed 48 hours.
Discard if storage time exceeds these limits. If the prepared infusion solution was stored refrigerated at 2°C to 8°C (36°F to 46°F), allow the solution to reach room temperature prior to administration, protected from light. Inspect for particulate matter and discoloration prior to administration. Administer DATROWAY as an intravenous infusion only with an infusion line and tubing set made of polyvinyl chloride, polybutadiene or low-density polyethylene.
Administer DATROWAY with a 0.2-micron in-line polytetrafluoroethylene, polyethersulfone or nylon 66 filter. Do NOT administer as an intravenous push or bolus. Cover the infusion bag to protect from light during administration. Do not mix DATROWAY with other drugs or administer other drugs through the same intravenous line.
Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY. First infusion: Administer infusion over 90 minutes. Observe patients during the infusion and for at least 1 hour following the initial dose for signs or symptoms of infusion-related reactions. Second Infusion: If first infusion was tolerated, administer second infusion over 30 minutes.
Observe patients during the infusion and for at least 1 hour after infusion. Subsequent Infusions: Administer infusion over 30 minutes if prior infusions were tolerated. Observe patients during the infusion and for at least 30 min after infusion.
| PremedicationWith or without systemic corticosteroid | Examples (or equivalent) | Timing of Treatment/Duration |
|---|---|---|
| Eye drops [see Warnings and Precautions (5.2)] | Preservative-free lubricant eye drops | Administer at least four times daily and as needed |
| Mouthwash [see Warnings and Precautions (5.3)] | Steroid-containing mouthwash (dexamethasone oral solution 0.1 mg/mL) | Administer four times daily and as needed |
| Antihistamine [see Adverse Reactions (6.1)] | Diphenhydramine (25 to 50 mg) administered intravenously or orally | Administer 30-60 minutes prior to each infusion |
| Antipyretic [see Adverse Reactions (6.1)] | Acetaminophen (650 to 1,000 mg) administered intravenously or orally | Administer 30-60 minutes prior to each infusion |
| Antiemetics [see Adverse Reactions (6.1)] | 5-HT3 serotonin receptor antagonist or appropriate alternatives intravenously or oral | Prior to each infusion and thereafter as needed |
| Adverse Reaction | Severity Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | Dosage Modifications |
|---|---|---|
| Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.1)] | Asymptomatic ILD/pneumonitis Grade 1 | Withhold DATROWAY until ILD/pneumonitis is completely resolved, then:if resolved in ≤28 days, maintain current dose.if resolved in >28 days, reduce one dose level (see Table 2).Consider corticosteroids as soon as ILD/pneumonitis is suspected. |
| Symptomatic ILD/pneumonitis Grade 2 or greater | Permanently discontinue DATROWAY.Administer corticosteroids as soon as ILD/pneumonitis is suspected. | |
| Keratitis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] | Nonconfluent superficial keratitis | Monitor.Continue DATROWAY at current dose. |
| Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity | Withhold DATROWAY until improved or resolvedRestart DATROWAY at the same dose level or consider dose reduction (see Table 2). | |
| Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse | Withhold DATROWAY until improved or resolvedRestart DATROWAY at reduced dose level (see Table 2). | |
| Corneal perforation | Permanently discontinue DATROWAY. | |
| Stomatitis [see Warnings and Precautions (5.3)] | Grade 1 | Optimize prophylactic and supportive medications.Continue DATROWAY at current dose. |
| Grade 2 | Withhold DATROWAY until resolved to ≤Grade 1.Restart DATROWAY at the same dose level for first occurrence.Recurrence: consider restarting at reduced dose level (see Table 2). | |
| Grade 3 | Withhold DATROWAY until resolved to ≤Grade 1. Restart DATROWAY at reduced dose level (see Table 2). | |
| Grade 4 | Permanently discontinue DATROWAY. | |
| Infusion-Related Reactions (IRR) [see Adverse Reactions (6.1)] | Grade 1 | Reduce DATROWAY infusion rate by 50% if IRR is suspected and monitor patient closely. |
| Grade 2 | Interrupt DATROWAY infusion and administer supportive care medications.If the event resolves or improves to Grade 1, restart the infusion at 50% rate.Administer all subsequent infusions at the reduced rate. | |
| Grade 3 or 4 including anaphylactic reactions | Permanently discontinue DATROWAY. | |
| Other Non-Hematologic Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 | Withhold dose until resolved to ≤Grade 1 or baselineRestart DATROWAY at reduced dose level (see Table 2). |
| Grade 4 | Permanently discontinue DATROWAY. |
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for datopotamab deruxtecan. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells [see Clinical Pharmacology (12.1) , Nonclinical Toxicology (13.1) ] . There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data There were no animal reproductive or developmental toxicity studies conducted with datopotamab deruxtecan-dlnk.
Breastfeeding (LactMed)
No information is available on the clinical use of datopotamab deruxtecan during breastfeeding. Because datopotamab is a large protein molecule, 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. However, datopotamab is conjugated with the small-molecule topoisomerase I inhibitor, deruxtecan, which might be excreted into milk and absorbed by the infant. Because of the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued during therapy and for 1 month after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.