Datopotamab Deruxtecan-Dlnk: uses, dosing, side effects & brands
Datopotamab Deruxtecan-Dlnk is a medicine sold in the U.S. under one brand, for breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Breast Neoplasms
- Available as
- Injectable
- Sold as
- Datroway
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How datopotamab deruxtecan-dlnk is dosed
From the FDA label for Datroway (application BLA761394). Other datopotamab deruxtecan-dlnk products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Reconstitute DATROWAY with Sterile Water for Injection. ( 2.5 ) Dilute with 5% Dextrose Injection. ( 2.5 ) For intravenous infusion only. Do not administer as an intravenous push or bolus. DO NOT use Sodium Chloride Injection, USP. ( 2.5 ) Premedicate to reduce the risk of infusion reactions and nausea and vomiting. ( 2.3 ) The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. ( 2.3 , 2.4 ) 2.1 Patient Selection Select patients with locally advanced or metastatic NSCLC for treatment with DATROWAY based on the presence of epidermal growth factor receptor (EGFR) mutations in tumor or plasma specimens [see Clinical Studies (14.1) ] . Testing may be performed at any time from initial diagnosis and does not need to be repeated once EGFR mutation status has been established. 2.2 Recommended Dosage The recommended dosage of DATROWAY is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. If a planned dose is delayed or missed, administer as soon as possible; do not wait until the next planned cycle. Adjust the schedule of administration to maintain a 3-week interval between doses. 2.3 Premedication,…
Datopotamab Deruxtecan-Dlnk side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Ocular Adverse Reactions [see Warnings and Precautions (5.2) ] Stomatitis [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash. ( 6.1 ) TNBC were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased ALT, increased AST, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium, and increased blood alkaline phosphatase. ( 6.1 ) HR-positive, HER2-negative breast cancer were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,…
Who shouldn’t take datopotamab deruxtecan-dlnk
None. None. ( 4 )
Every datopotamab deruxtecan-dlnk product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Datroway.
Related calculators
Frequently asked questions
What is datopotamab deruxtecan-dlnk?
Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody and topoisomerase inhibitor conjugate.
Can you take datopotamab deruxtecan-dlnk with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run datopotamab deruxtecan-dlnk against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does datopotamab deruxtecan-dlnk come in?
Across the brands we track, datopotamab deruxtecan-dlnk is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic datopotamab deruxtecan-dlnk?
We do not currently list a generic-labelled datopotamab deruxtecan-dlnk product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Datopotamab Deruxtecan-Dlnk: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/datopotamab-deruxtecan-dlnk
- MLA
- “Datopotamab Deruxtecan-Dlnk: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/datopotamab-deruxtecan-dlnk.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for datopotamab deruxtecan-dlnk on DailyMed (NIH) ↗.