In the SafeHER trial, 2 patients required permanent treatment discontinuation with HERCEPTIN HYLECTA; 1 patient due to a hypersensitivity reaction and 1 patient due to anaphylaxis. As a result, it can be administered more quickly. • Prepare the dosing syringe in controlled and validated aseptic conditions 121 patients in arm A received 4 cycles of Herceptin HYLECTA followed by 4 cycles of IV trastuzumab and 119 patients in arm B received 4 cycles of IV trastuzumab followed by 4 cycles of Herceptin HYLECTA. Herceptin may be resumed if, within 4 8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is 15%. Found inside – Page iIn this practice-oriented handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists ... Subcutaneous Hereceptin. from $4,890.45 for 5 milliliters. Quantity. J9356 Injection, trastuzumab, 10 mg and Hyaluronidase -oysk: 1 billable unit = 10 mg NDC : y Herceptin Hylecta 600 mg/10,000 units (providing 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL) single -dose vials : 50242- 0 077- xx VII. This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of ... Do not administer intravenously. About Herceptin Hylecta. Herceptin Hylecta Generic Name: Trastuzumab and Hyaluronidase-oysk Dosage Form Name: INJECTION, SOLUTION Administration Route: Subcutaneous Substances: Name: HYALURONIDASE Strength: 10000.0 Unit: U/5mL Name: TRASTUZUMAB Strength: 600.0 Unit: mg/5mL . Back to top. *High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. HannaH demonstrated comparability between Herceptin Hylecta and intravenous trastuzumab based on co-primary endpoints of pathologic complete response and pharmacokinetics. The NDC Code 50242-077-01 is assigned to a package of 1 vial, single-dose in 1 carton > 6 ml in 1 vial, single-dose of Herceptin Hylecta, a human prescription drug labeled by Genentech, Inc.. The Biology of Hyaluronan Chairman: T. C. Laurent 1989 Hyaluronan is a unique linear polysaccharide found in cartilage and in soft connective tissues such as synovial fluid and skin. A Subcutaneous Option. Trastuzumab belongs to a class of medications known as monoclonal antibodies. Warning. Do not substitute HERCEPTIN HYLECTA for or with ado-trastuzumab emtansine. The recommended Herceptin Hylecta dose is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks. Herceptin Hylecta is a combination of Herceptin and hyaluronidase, an enzyme that helps your body use the Herceptin. Patients received a fixed dose of 600 mg/10,000 units Herceptin HYLECTA every 3 weeks for 18 cycles, The most common adverse reactions of Herceptin HYLECTA observed in at least 10% of patients were fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity, Most common reason cited for preference of Herceptin HYLECTA, 77% (179/231) of patients reported that subcutaneous administration required less time (~2-5 minutes), Most common reason cited for preference of IV trastuzumab, 13% (29/231) of patients reported fewer local injection reactions with IV administration, 3.8% (9/240) of patients withdrew from treatment prior to completion and did not complete the post-study preference questionnaire, As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel, As a single agent following multi-modality anthracycline-based therapy, In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer, As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease, HERCEPTIN HYLECTA can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death, HERCEPTIN HYLECTA can also cause asymptomatic decline in LVEF, Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan, Monitor frequently for decreased left ventricular function during and after HERCEPTIN HYLECTA treatment, Monitor more frequently if HERCEPTIN HYLECTA is withheld for significant left ventricular cardiac dysfunction, Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCEPTIN HYLECTA, Advise pregnant women and females of reproductive potential that exposure to HERCEPTIN HYLECTA during pregnancy or within 7 months prior to conception can result in fetal harm, Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCEPTIN HYLECTA, Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for HERCEPTIN HYLECTA treatment and any potential adverse effects on the breastfed child from HERCEPTIN HYLECTA or from the underlying maternal condition, If HERCEPTIN HYLECTA is administered during pregnancy, or if a patient becomes pregnant while receiving HERCEPTIN HYLECTA or within 7 months following the last dose of HERCEPTIN HYLECTA, health care providers and patients should immediately report HERCEPTIN HYLECTA exposure to Genentech at, Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity, Discontinue HERCEPTIN HYLECTA in patients experiencing pulmonary toxicity, In randomized, controlled clinical trials with intravenous trastuzumab, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. 328 0 obj <> endobj Herceptin is used to treat the following types of cancer: early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. Herceptin Hylecta should be administered by a health care . Herceptin SC is given as a subcutaneous injection (under the skin) over 2 to 5 minutes every three weeks. Both arms received a total of 18 cycles. This is the standard reference for prescribing and dispensing drugs. This site is intended for US residents only. Trastuzumab is the same monoclonal antibody in intravenous Herceptin that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive . Herceptin Hylecta (subcutaneous Herceptin) is a combination of trastuzumab and Halozyme Therapeutics' Enhanze ® drug delivery technology. Trastuzumab may cause serious heart problems, including heart failure. Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS. 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