近日，美国食品和药物管理局（FDA）已批准Herceptin Hylecta（trastuzumab and hyaluronidase-oysk，曲妥珠单抗和透明质酸酶）皮下注射液，用于：（1）联合化疗用于治疗HER2阳性早期乳腺癌（淋巴结阳性，或淋巴结阳性且ER/PR阴性，或具有一个高危特征）患者；（2）单独或联合紫杉醇用于既往已接受一种或多种化疗方案治疗转移性疾病的HER2阳性转移性乳腺癌患者。
Herceptin Hylecta是一种皮下注射剂型的赫赛汀（Hercepin，通用名：trastuzumab，曲妥珠单抗），由与静脉注射剂型赫赛汀相同的单克隆抗体曲妥珠单抗和重组人透明质酸酶PH20组成，该酶可帮助在皮下递送曲妥珠单抗。Herceptin Hylecta是一种即用型制剂，可在2-5分钟内完成给药，而静脉输注剂型赫赛汀则需要30-90分钟。
Herceptin Hylecta(trastuzumab and hyaluronidase-oysk)
HERCEPTIN HYLECTA Rx
Generic Name and Formulations:
Trastuzumab 600mg, hyaluronidase-oysk 10,000 Units; per 5mL; soln for SC inj; preservative-free.
Company:
Genentech, Inc.
Breast cancer:
Recent Updates:
Monograph added.
Indications for HERCEPTIN HYLECTA:
Adjuvant treatment in HER2-overexpressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin). HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel for first line treatment.
Adult:
Do not substitute for or with ado-trastuzumab emtansine. Give as SC inj in left or right thigh; rotate inj sites. 600mg/10,000 Units over 2–5mins once every 3 weeks. Adjuvant treatment: treat for 52 weeks or until disease recurrence, whichever occurs first; extending treatment beyond 1year: not recommended. Metastatic treatment: treat until disease progression. Dose modification for cardiomyopathy: see full labeling.
Children:
Not established.
Boxed Warning:
Cardiomyopathy. Pulmonary toxicity. Embryo-fetal toxicity.
Warnings/Precautions:
Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy or every 6 months for ≥2yrs after therapy (if adjuvant); repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Discontinue if anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome occurs. Monitor for hypersensitivity reactions; permanently discontinue if occur. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests specific for breast cancer. Embryo-fetal toxicity (eg, oligohydramnios); monitor during pregnancy or within 7 months prior to conception. Advise females of reproductive potential to use effective contraception during and for 7 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Pharmacologic Class:
Human epidermal growth factor receptor (HER2) inhibitor + endoglycosidase.
Interactions:
Increased cardiomyopathy with anthracycline-based chemotherapy; if possible, avoid for up to 7 months after discontinuing Herceptin Hylecta; if used, monitor carefully.
Adverse Reactions:
Fatigue, arthralgia, diarrhea, inj site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, pain in extremity; cardiac dysfunction, exacerbation of chemotherapy-induced neutropenia, pulmonary toxicity, hypersensitivity.
Note:
Report pregnant women with breast cancer exposed to Herceptin Hylecta in the pharmacovigilance program (888) 835-2555.
Testing considerations: HER2 protein overexpression or HER2 gene amplification
Generic Availability:
NO
How Supplied:
Single-dose vial—1 |
