Enhertu Dosage/Direction for Use


Daiichi Sankyo




Daiichi Sankyo
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Full Prescribing Info
Dosage/Direction for Use
Enhertu should be prescribed by a physician and administered under the supervision of a healthcare professional experienced in the use of anticancer medicinal products. In order to prevent medicinal product errors, it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Enhertu (trastuzumab deruxtecan) and not trastuzumab or trastuzumab emtansine.
Enhertu should not be substituted with trastuzumab or trastuzumab emtansine.
Patients treated with trastuzumab deruxtecan should have documented HER2-positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked in vitro diagnostic (IVD) medical device. If a CE-marked IVD is not available, the HER2 status should be assessed by an alternate validated test.
Posology: The recommended dose of Enhertu is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.
The initial dose should be administered as a 90-minute intravenous infusion. If the prior infusion was well tolerated, subsequent doses of Enhertu may be administered as 30-minute infusions. Antiemetics may be administered in accordance with local medical practice as per patient tolerance for prophylaxis or management.
The infusion rate of Enhertu should be slowed or interrupted if the patient develops infusion-related symptoms. Enhertu should be permanently discontinued in case of severe infusion reactions.
Dose modifications: Management of adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of Enhertu per guidelines provided in Tables 2 and 3. (See Tables 2 and 3.)
Enhertu dose should not be re-escalated after a dose reduction is made.

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Delayed or missed dose: 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. The infusion should be administered at the dose and rate the patient tolerated in the most recent infusion.
Special populations: Elderly: No dose adjustment of Enhertu is required in patients aged 65 years or older. Limited data are available in patients ≥ 75 years of age.
Renal impairment: No dose adjustment is required in patients with mild (creatinine clearance [CLcr] ≥ 60 and < 90 mL/min) or moderate (CLcr ≥ 30 and < 60 mL/min) renal impairment (see Pharmacology: Pharmacokinetics under Actions). The potential need for dose adjustment in patients with severe renal impairment cannot be determined due to insufficient data. A higher incidence of Grade 1 and 2 ILD has been observed in patients with moderate renal impairment. Patients with moderate or severe renal impairment should be monitored carefully (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with total bilirubin ≤ 1.5 times upper limit of normal (ULN), irrespective of aspartate transaminase (AST) value. The potential need for dose adjustment in patients with total bilirubin > 1.5 times ULN, irrespective of AST value, cannot be determined due to insufficient data; therefore, these patients should be monitored carefully (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Enhertu in children and adolescents below the age of 18 years have not been established. No data are available.
Method of administration: Enhertu is for intravenous use. It must be reconstituted and diluted by a healthcare professional and administered as an intravenous infusion. Enhertu must not be administered as an intravenous push or bolus.
For instructions on reconstitution and dilution of the medicinal product before administration, see Cautions for Usage.
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