DOSING
Jump To Section:
DATROWAY is the first and only Trop-2-directed ADC with Q3W dosing1-4
The recommended dose of DATROWAY is 6 mg/kga until disease progression or unacceptable toxicity1
21-DAY CYCLE
FIRST INFUSION
SUBSEQUENT INFUSIONS
aUp to a maximum of 540 mg for patients ≥90 kg.1
- Premedication is recommended to help reduce the risk and severity of infusion-related
reactions, nausea, and vomiting1
Click here for premedication information
- Monitor patients for infusion-related reactions for at least 1 hour for the first 2 cycles of DATROWAY1
- If there are no infusion-related reactions observed, monitor patients for at least 30 minutes for all subsequent cycles of infusions
Missed or delayed infusion?1
- If a planned dose is missed or delayed, administer as soon as possible, without waiting for the next cycle
- Adjust the schedule of administration to maintain a 3-week interval between doses
Dosage forms & strengths1
- Strength: 100 mg per vial
- Dosage form: White to yellowish white lyophilized powder in a single-dose vial for reconstitution and further dilution
Dosage reduction schedule for DATROWAY1
Adverse reactions with DATROWAY may require dose delays, reductions, or discontinuations, if needed
RECOMMENDED
STARTING DOSE
FIRST DOSE REDUCTION
Up to a maximum of 360 mg for patients ≥90 kg
SECOND DOSE REDUCTION
Up to a maximum of 270 mg for patients ≥90 kg
Third dose reduction: Permanently discontinue.
Do not re-escalate the dose of DATROWAY after a dose reduction.
Permanently discontinue DATROWAY in patients who are unable to tolerate 3 mg/kg intravenously once every 3 weeks.
Preparation and administration of DATROWAY1
Reconstitute and further dilute DATROWAY prior to intravenous infusion. Use appropriate aseptic technique.
-
Reconstitution1
-
Reconstitute immediately before dilution. More than one vial may be needed for a full dose
IMPORTANT: Calculate the dose (mg), the total volume of reconstituted DATROWAY solution required, and the number of vial(s) of DATROWAY needed
-
IMPORTANT: 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
-
-
Dilution1
-
Withdraw the calculated amount from the vial(s) using a sterile syringe
IMPORTANT: 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
IMPORTANT: DO NOT use Sodium Chloride Injection. DATROWAY is compatible with an infusion bag made of polyvinyl chloride 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 2ºC to 8ºC (36°F to 46°F) for up to 24 hours. Do not freeze. Discard any unused portion left in the vial
-
-
Administration1
-
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
IMPORTANT: 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 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
-
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.1
DATROWAY (datopotamab deruxtecan-dlnk) is a hazardous drug. Follow applicable special handling and disposal procedures.1
Request a rep
Request that a representative contact you with more information about DATROWAY
Adverse reaction management
Learn about prophylactic regimens and management guidance for select adverse reactions