Datroway Dosage

Generic name: DATOPOTAMAB DERUXTECAN 100mg in 5mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Jan 28, 2025.

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.

Premedication, Concomitant Medications, and Required Eye Care

Administer DATROWAY in a setting where cardiopulmonary resuscitation medication and equipment are available.

Conduct an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at initiation of DATROWAY, annually while on treatment, at end of treatment, and as clinically indicated.

Administer DATROWAY with the premedication and concomitant medications described in Table 1.

Monitor patients for infusion-related reactions for at least 1 hour for the first 2 cycles of DATROWAY infusions. If there are no infusion-related reactions observed, monitor patients for at least 30 minutes for all subsequent cycles of infusions.

Table 1: Premedication and Concomitant Medications
Premedication *	Examples (or equivalent)	Timing of Treatment/Duration
* With or without systemic corticosteroids.
Eye drops	Preservative-free lubricant eye drops	Administer at least four times daily and as needed
Mouthwash	Steroid-containing mouthwash (dexamethasone oral solution 0.1 mg/mL)	Administer four times daily and as needed
Antihistamine	Diphenhydramine (25 to 50 mg) administered intravenously or orally	Administer 30-60 minutes prior to each infusion
Antipyretic	Acetaminophen (650 to 1,000 mg) administered intravenously or orally	Administer 30-60 minutes prior to each infusion
Antiemetics	5-HT3 serotonin receptor antagonist or appropriate alternatives intravenously or oral	Prior to each infusion and thereafter as needed

Dosage Modifications

Dosage Modifications for Adverse Reactions

The recommended dose reduction levels for adverse reactions are described in Table 2.

Table 2: Recommended Dosage Reductions of DATROWAY for Adverse Reactions
Dose Reductions	Recommended Dose
First	4 mg/kg (up to a maximum of 360 mg for patients ≥90 kg)
Second	3 mg/kg (up to a maximum of 270 mg for patients ≥90 kg)
Third	Permanently discontinue

Do not re-escalate the DATROWAY dose after a dose reduction. Permanently discontinue DATROWAY in patients who are unable to tolerate 3 mg/kg intravenously once every 3 weeks.

The recommended dosage modifications for adverse reactions of DATROWAY are described in Table 3.

Table 3: Dosage Modifications of DATROWAY for Adverse Reactions
Adverse Reaction	Severity *	Dosage Modifications
* Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Interstitial Lung Disease (ILD)/Pneumonitis	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.
Interstitial Lung Disease (ILD)/Pneumonitis	Symptomatic ILD/pneumonitis Grade 2 or greater	Permanently discontinue. Administer corticosteroids as soon as ILD/pneumonitis is suspected.
Keratitis	Nonconfluent superficial keratitis	Monitor.
	Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity	Withhold until improved or resolved, then maintain at same dose level or consider dose reduction.
	Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse	Withhold until improved or resolved, then reduce by one dose level.
	Corneal perforation	Permanently discontinue.
Stomatitis	Grade 1	Optimize prophylactic and supportive medications.
	Grade 2	Withhold until resolved to < Grade 1. Restart at the same dose level for first occurrence. Consider restarting at reduced dose level (see Table 2) if recurrent.
	Grade 3	Withhold until resolved to ≤Grade 1. Restart at reduced dose level (see Table 2).
	Grade 4	Permanently discontinue.
Infusion-Related Reactions (IRR)	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	Permanently discontinue DATROWAY.
Other Non-Hematologic Adverse Reactions	Grade 3	Withhold dose until resolved to ≤Grade 1 or baseline Restart at reduced dose level (see Table 2).
	Grade 4	Permanently discontinue DATROWAY.

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.
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 2ºC to 8ºC (36°F to 46°F) for up to 24 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 24 hours refrigerated.

Dilution

Withdraw the calculated amount from the vial(s) using a sterile syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 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 25ºC (77°F) for up to 4 hours including preparation or in a refrigerator at 2ºC to 8ºC (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 24 hours. Discard if storage time exceeds these limits.
If the prepared infusion solution was stored refrigerated at 2ºC to 8ºC (36°F to 46°F), allow the solution to reach room temperature prior to administration, protected from light.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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.