- Approval Id
- 8f01908b9a1aba37
- Drug Name
- DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
- Product Name
- DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
- Approval Number
- SIN17234P
- Approval Date
- 2025-05-10
- Registrant
- ASTRAZENECA SINGAPORE PTE LTD
- Licence Holder
- ASTRAZENECA SINGAPORE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- <p><strong>4.2. Posology and Method of Administration</strong></p>
<p><strong>Premedication and Prophylactic Medications</strong></p>
<p>Prior to each infusion of DATROWAY, a premedication regimen for the prevention of infusion-related reactions that consists of an antihistamine agent and acetaminophen (with or without glucocorticoids) should be considered.</p>
<p>It is also recommended that patients receive prophylactic antiemetic agents (dexamethasone with 5-HT3 antagonists as well as other medicinal products, such as NK1 receptor antagonists), prior to infusion of DATROWAY and on subsequent days as needed.</p>
<p>For prophylactic treatment for keratitis and stomatitis, please refer to Special Warnings and Precautions for Use (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Posology</strong></p>
<p>The recommended dose of DATROWAY is 6 mg/kg given as an intravenous infusion once every three weeks (21-day cycle) until disease progression or unacceptable toxicity.</p>
<p>First infusion: Administer infusion over 90 minutes. Observe patients during the infusion and for at least 30 minutes following the initial dose, for signs or symptoms of infusion-related reactions.</p>
<p>Subsequent infusions: Administer infusion over 30 minutes if prior infusions were tolerated. Observe patients during the infusion and for at least 30 minutes after infusion.</p>
<p><strong>Dose Modifications</strong></p>
<p><strong><u>Dose modifications for infusion-related reactions</u></strong></p>
<p>Slow or interrupt the infusion rate if the patient develops an infusion-related reaction. Permanently discontinue DATROWAY for life-threatening infusion-related reactions.</p>
<p><strong><u>Dose modifications for adverse reactions</u></strong></p>
<p>Management of adverse reactions may require dose delay, dose reduction, or treatment discontinuation per guidelines provided in Tables 1 and 2.</p>
<p>Do not re-escalate the DATROWAY dose after a dose reduction is made. After the dose reductions, if further toxicity meeting the requirement for dose reduction occurred, permanently discontinue DATROWAY.</p>
<p>Permanently discontinue for corneal perforation.</p>
<img src="/TGIF/Datroway-Table1.png" alt="Datroway Dosage Table 1" /><br><br>
<img src="/TGIF/Datroway-Table2.png" alt="Datroway Dosage Table 2" /><br><br>
<p><strong>Delayed or Missed Dose</strong></p>
<p>If a planned dose is delayed or missed, it should be administered as soon as possible without waiting until the next planned cycle. The schedule of administration should be adjusted to maintain a 3-week interval between doses.</p>
<p><strong>Special Populations</strong></p>
<p><strong><u>Geriatrics</u></strong></p>
<p>No dose adjustment of DATROWAY is required in patients aged 65 years or older.</p>
<p>Of 365 patients in TROPION-Breast01 randomized to DATROWAY 6 mg/kg, 24.9% were 65 years of age or older. No overall differences in efficacy were observed between patients ≥65 years of age and younger patients.</p>
<p>Of the 927 patients treated with DATROWAY 6 mg/kg in the clinical studies, 32.8% were 65 years of age or older. No clinically meaningful differences in safety were observed between patients ≥65 years of age and younger patients.</p>
<p>Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of datopotamab deruxtecan.</p>
<p><strong><u>Pediatrics</u></strong></p>
<p>The safety and efficacy in children and adolescents below 18 years of age have not been established.</p>
<p><strong><u>Renal Impairment</u></strong></p>
<p>No dose adjustment is required in patients with mild to moderate (creatinine clearance [CLcr] 30 to <90 ml/min) renal impairment. There are limited data to make a recommendation on dose adjustment in patients with severe renal impairment.</p>
<p><strong><u>Hepatic Impairment</u></strong></p>
<p>No dose adjustment is required in patients with mild (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST) hepatic impairment. There are limited data to make a recommendation on dose adjustment in patients with moderate (total bilirubin >1.5 to 3 times ULN and any AST) and severe (total bilirubin >3 times ULN and any AST) hepatic impairment.</p>
<p><strong>Method of Administration</strong></p>
<p>DATROWAY is for intravenous use. It must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. DATROWAY must not be administered as an intravenous push or bolus.</p>
<p>For instructions on reconstitution and dilution of DATROWAY before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1. Therapeutic Indications</strong></p>
<p><strong>Breast Cancer</strong></p>
<p>DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH−) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>None.</p>
- Atc Code
- Pending
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
