National Comprehensive Cancer Network (NCCN). ENHERTU is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior anti-HER2 breast cancer treatments. Cancer Guidelines and Drugs and Biologics Compendium. The median duration of treatment was 7 months (range: 0.7 to 31).In the pooled 234 patients, the median age was 56 years (range: 28-96), 74% of patients were <65 years, 99.6% of patients were female, and the majority were White (51%) or Asian (42%).
Median time to first onset was 1.4 months (range: 0.3 to 18.2). 3. Monitor patients for signs and symptoms of ILD. Clinical Pharmacology Elsevier Gold Standard. Sign Up for Updates
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Manage LVEF decrease through treatment interruption.
Following binding to HER2 on tumor cells, fam-trastuzumab deruxtecan-nxki undergoes internalization and intracellular linker cleavage by lysosomal enzymes.
There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged 65 years or older (53%) as compared to younger patients (42%).No dose adjustment of Enhertu is required in patients with mild (creatinine clearance (CLcr) ≥60 and <90 mL/min) or moderate (CLcr ≥30 and <60 mL/min) renal impairment No dose adjustment of Enhertu 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) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment.
PP-US-ENB-0225 08/20To contact us with questions or concerns 2020.
ENHERTU is a prescription medicine used in adults to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received two or more prior Reconstitute immediately before dilution. Based on the severity of neutropenia, Enhertu may require dose interruption or reduction Patients treated with Enhertu may be at increased risk of developing left ventricular dysfunction. ENHERTU was administered by intravenous infusion once every three weeks. For asymptomatic (Grade 1) ILD, consider corticosteroid treatment (e.g., ≥0.5 mg/kg prednisolone or equivalent). AHFS Drug Information.
It is not known if ENHERTU is safe and effective in children. NCCN Guidelines. Withhold Enhertu until recovery Severe neutropenia, including febrile neutropenia, can occur in patients treated with Enhertu. Your healthcare Tell your healthcare provider about all the medicines you take, Ninety-two percent had visceral disease, 29% had bone metastases, and 13% had brain metastases. lqfrruglqdwlrq dqg ru jdvwurlqwhvwlqdo vljqv dqg v\pswrpv h j qdxvhd yrplwlqj glduukhd 7kh rqvhw ri v\pswrpv xvxdoo\ rffxuv zlwklq plqxwhv wr krxuv ri uhfhlylqj d qhz ru d juhdwhu grvh ri d vhurwrqhujlf phglfdwlrq 'lvfrqwlqxh AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 5. American Cancer Society.
No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. Support and Resources
Sum of diameters of target lesions were < 5 cm in 42%, and ≥ 5 cm in 50% (not evaluable by central review in 8% of patients).The median number of prior cancer regimens in the locally advanced/metastatic setting was 5 (range: 2-17).All patients received prior trastuzumab, ado-trastuzumab emtansine, and 66% had prior pertuzumab.Enhertu (fam-trastuzumab deruxtecan-nxki) for injection is a white to yellowish white lyophilized powder supplied as:Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Enhertu and for at least 4 months after the last dose of Enhertu The following clinically significant adverse reactions are described elsewhere in the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety of Enhertu was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of Enhertu 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101 (NCT02564900).
Approximately 8 molecules of deruxtecan are attached to each antibody molecule. Calculate the dose (mg), the total volume of reconstituted ENHERTU solution required, and the number of vial(s) of ENHERTU needed [see Dosage and … Before you receive ENHERTU, tell your healthcare provider about all of your medical conditions, including if you: HER2 expression was based on archival tissue tested at a central laboratory prior to enrollment with HER2 positivity defined as HER2 IHC 3+ or ISH positive.Patients received Enhertu 5.4 mg/kg by intravenous infusion every 3 weeks until unacceptable toxicity or disease progression.
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