• medical citation needed] Hyaluronidase is available in some fixed-dose combination drug products in the United States: rituximab/hyaluronidase (Rituxan Hycela), trastuzumab/hyaluronidase-oysk (Herceptin Hylecta), daratumumab/hyaluronidase-fihj (Darzalex Faspro), and pertuzumab/trastuzumab/hyaluronidase-zzxf (Phesgo). (wikipedia.org)
  • What it Treats PHESGO ™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a prescription medicine approved for use in combination with chemotherapy for: use prior to surgery (neoadjuvant treatment) in adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumor is greater than 2 cm in diameter or node-positive). (oncopeutic.com)
  • It is a dual vial unit with one vial of immune globulin infusion 10% (human) and one vial of recombinant human hyaluronidase. (wikipedia.org)
  • It is an immune globulin with a recombinant human hyaluronidase indicated in the United States for the treatment of primary immunodeficiency in adults. (wikipedia.org)
  • The company's products are based on the patented recombinant human hyaluronidase enzyme (rHuPH20) that enables delivery of injectable biologics, such as monoclonal antibodies and other therapeutic molecules, as well as small molecules and fluids. (yahoo.com)
  • The fixed-dose combination of pertuzumab and trastuzumab uses recombinant human hyaluronidase PH20 enzyme (rHuPH20), which is proprietary technology from Halozyme, to degrade hyaluronan in human tissue. (cancertherapyadvisor.com)
  • Talk to your doctor about the risks of receiving trastuzumab and hyaluronidase-oysk injection. (medlineplus.gov)
  • Do not substitute for or with pertuzumab, trastuzumab, ado-trastuzumab emtansine, or fam-trastuzumab deruxtecan. (empr.com)
  • To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment. (karmanos.org)
  • Trastuzumab and hyaluronidase-oysk injection is used along with other medications or after other medications have already been used to treat a certain type of breast cancer that has spread to other parts of the body. (medlineplus.gov)
  • Trastuzumab and hyaluronidase-oysk injection is also used during and after treatment with other medications to decrease the chance that a certain type of breast cancer will return. (medlineplus.gov)
  • Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. (ascopost.com)
  • The drug is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer. (ons.org)
  • In HannaH, 596 patients with HER2-positive operable or locally advanced breast cancer, including inflammatory breast cancer, were randomized to receive eight cycles of either the trastuzumab and hyaluronidase-oysk injection or IV trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either the trastuzumab and hyaluronidase-oysk injection or IV trastuzumab, for an additional 10 cycles. (ons.org)
  • SafeHER was a prospective, two-cohort, nonrandomized, multinational, open-label trial assessing the overall safety and tolerability of the trastuzumab and hyaluronidase-oysk injection with chemotherapy in 1,864 patients with HER2-positive breast cancer. (ons.org)
  • Neratinib: A tyrosine kinase inhibitor approved for the extended adjuvant treatment of patients with early-stage Her2Neu-positive breast cancer, following adjuvant trastuzumab-based therapy. (medscape.com)
  • On 28 February 2019, the US Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer. (esmo.org)
  • Sandrine Richard 1, Frédéric Selle 1, Jean-Pierre Lotz 1 2, Ahmed Khalil 1, Joseph Gligorov 1 2, Daniele G Soares 1 Affiliations expand PMID: 27275646 DOI: 10.1590/0001-3765201620150178 Free article Abstract It has now been 15 years since the HER2-targeted monoclonal antibody trastuzumab was introduced in clinical and revolutionized the treatment of HER2-positive breast cancer patients. (oncopeutic.com)
  • Mehmet A N Şendur, Sercan Aksoy, Nurullah Zengin PMID: 22475602 DOI: 10.1056/NEJMc1201462 Comment on Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. (oncopeutic.com)
  • IV pertuzumab in combination with IV trastuzumab and chemotherapy has demonstrated improved outcomes for patients with HER2-positive breast cancer compared with IV trastuzumab and chemotherapy alone. (onclive.com)
  • Trastuzumab is FDA-approved and can be considered to combat early-stage as well as advanced breast cancer. (indianpharmanetwork.in)
  • In case of neoadjuvant or adjuvant surgery to treat early breast cancer, Trastuzumab is usually prescribed for 6 to 12 months. (indianpharmanetwork.in)
  • This HER2 monoclonal antibody is used with trastuzumab and chemotherapy, either prior to or following surgery to tackle early-stage breast cancer, or to combat advanced breast cancer. (indianpharmanetwork.in)
  • Findings from modeling studies support adjuvant continuation of pertuzumab plus trastuzumab for patients achieving pathologic complete response among patients with high-risk, HER2 -positive early breast cancer. (jons-online.com)
  • A fixed-dose combination of subcutaneous pertuzumab and trastuzumab was found to be noninferior for patients with HER2-positive breast cancer. (cancertherapyadvisor.com)
  • In combination with neoadjuvant chemotherapy, a fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously appeared to be noninferior to intravenous administration of these drugs in patients with HER2-positive breast cancer, potentially offering patients a more convenient administration option. (cancertherapyadvisor.com)
  • For instance, in the single area of the metastatic breast cancer treatment, one can find sub-cutaneous formulations of trastuzumab including hyaluronidase, that represent a major advance with respect to IV solutions in terms of comfort for the patients. (bnlf-crs.org)
  • Learn about Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk), a subcutaneous trastuzumab treatment option for eligible HER2+ patients. (herceptin.com)
  • HannaH demonstrated comparability between Herceptin Hylecta and intravenous trastuzumab based on co-primary endpoints of pathologic complete response (pCR) and pharmacokinetics. (esmo.org)
  • Herceptin Hylecta was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab. (esmo.org)
  • In the phase 1b dose-finding HannaH trial, the appropriate dose of trastuzumab and hyluronidase-oysk (Herceptin Hylecta) was identified. (onclive.com)
  • The company is exploring a number of alternative delivery systems for some of its core products, such as its partnership with Halozyme for Herceptin Hylecta ​ ​ (trastuzumab and hyaluronidase-oysk). (biopharma-reporter.com)
  • The recommended trastuzumab and hyaluronidase-oysk injection dose is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately two to five minutes once every three weeks. (ons.org)
  • Acts as a HER2-directed antibody-drug conjugate composed of a humanized IgG1 monoclonal antibody (which has the same amino acid sequence as trastuzumab [and targets HER2]), a cleavable linker, and a topoisomerase I inhibitor (DXd) (the cytotoxic component which causes DNA damage and apoptosis). (unboundmedicine.com)
  • Effective July 1, 2020, ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has a permanent j-code: J9358. (accc-cancer.org)
  • Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive trastuzumab and hyaluronidase-oysk injection. (medlineplus.gov)
  • Your doctor will watch you carefully when you receive trastuzumab and hyaluronidase-oysk injection so that your treatment can be interrupted if you experience a serious reaction. (medlineplus.gov)
  • With a new administration route, [this triplet] offers an outpatient option for patients to receive trastuzumab and pertuzumab," said Richard Pazdur, MD , Director of the FDA's Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. (ascopost.com)
  • Your doctor will need to monitor you closely if you receive these medications during your treatment with trastuzumab and hyaluronidase-oysk injection and for up to 7 months after your final dose. (medlineplus.gov)
  • Trastuzumab and hyaluronidase-oysk injection may cause serious or life-threatening reactions that may occur while the medication is being given or up to 24 hours after a dose. (medlineplus.gov)
  • The recommended initial dose of pertuzumab/trastuzumab/hyaluronidase-zzxf is 1,200 mg of pertuzumab, 600 mg of trastuzumab, and 30,000 units of hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg of pertuzumab, 600 mg of trastuzumab, and 20,000 units of hyaluronidase administered subcutaneously over approximately 5 minutes. (ascopost.com)
  • Patients received a fixed dose of 600 mg of the trastuzumab and hyaluronidase-oysk injection every three weeks for 18 cycles. (ons.org)
  • Moreover, data from the trial showed noninferiority for the predose cycle 8 serum C trough for the trastuzumab component of the fixed-dose combination versus with IV trastuzumab, at 62.9 µg/mL versus 48.1 µg/mL, respectively. (onclive.com)
  • 252 patients were randomly assigned to receive neoadjuvant chemotherapy plus pertuzumab and trastuzumab intravenously and 248 patients were assigned to receive neoadjuvant chemotherapy plus a fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously into the thigh. (cancertherapyadvisor.com)
  • The fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously after chemotherapy led to a noninferior serum trough concentration of pertuzumab compared with intravenous administration, meaning the study met its primary endpoint. (cancertherapyadvisor.com)
  • The primary endpoint of FeDeriCa was noninferiority of cycle 7 pertuzumab serum trough concentration comparing pertuzumab/trastuzumab/hyaluronidase-zzxf to intravenous pertuzumab. (ascopost.com)
  • Secondary endpoints included cycle 7 trastuzumab serum trough concentration, pathologic complete response, and safety. (ascopost.com)
  • The serum trough concentration of trastuzumab after subcutaneous administration was also found to be noninferior. (cancertherapyadvisor.com)
  • trastuzumab, brexucabtagene autoleucel. (medscape.com)
  • rituximab-hyaluronidase, brexucabtagene autoleucel. (medscape.com)
  • The pathologic complete response rate was 59.7% (95% confidence interval [CI] = 53.3%-65.8%) in the pertuzumab/trastuzumab/hyaluronidase-zzxf arm and 59.5% (95% CI = 53.2%-65.6%) in the intravenous pertuzumab and intravenous trastuzumab arm. (ascopost.com)
  • HannaH demonstrated comparability between the trastuzumab and hyaluronidase-oysk injection and IV trastuzumab based on co-primary endpoints of pathologic complete response and pharmacokinetics. (ons.org)
  • Patients were randomized to receive 4 cycles of doxorubicin and cyclophosphamide chemotherapy followed by 4 cycles of docetaxel given with randomized therapy: IV pertuzumab and trastuzumab or the SC FDC. (onclive.com)
  • After undergoing surgery, patients were administered adjuvant therapy with the same pertuzumab/trastuzumab formulation that they had received in the neoadjuvant setting. (onclive.com)
  • By catalyzing the hydrolysis of hyaluronan, a constituent of the extracellular matrix, hyaluronidase lowers the viscosity of hyaluronan, thereby increasing tissue permeability. (wikipedia.org)
  • Pertuzumab/trastuzumab/hyaluronidase-zzxf showed noninferior pertuzumab and trastuzumab serum trough concentrations compared to intravenous pertuzumab and trastuzumab. (ascopost.com)
  • The comparison of predose cycle 8 C trough values for IV pertuzumab and trastuzumab and the individual components of the FDC resulted in GMRs that fell within the 90% confidence intervals for noninferiority. (onclive.com)
  • Trastuzumab and hyaluronidase-oysk injection is in a class of medications called monoclonal antibodies. (medlineplus.gov)
  • Human recombinant hyaluronidase (Hylenex)-approved for use in the United States in December 2005-corresponds to the soluble fragment of human HYAL5 (PH20) produced in culture by genetically engineered Chinese hamster ovary cells containing a DNA plasmid encoding the enzyme. (wikipedia.org)
  • This product also contains hyaluronidase, which helps your body absorb pertuzumab and trastuzumab given by injection under the skin. (alberta.ca)
  • The drug Trastuzumab can be administered into a vein (IV) or as an injection under the skin (subcutaneous). (indianpharmanetwork.in)
  • The three main types of hyaluronidases are two classes of eukaryotic endoglycosidase hydrolases and a prokaryotic lyase-type of glycosidase. (wikipedia.org)
  • Patients were randomly assigned to receive neoadjuvant chemotherapy with concurrent administration of either the triplet combination or intravenous pertuzumab and intravenous trastuzumab during the neoadjuvant and adjuvant therapies. (ascopost.com)
  • The safety profile of pertuzumab/trastuzumab/hyaluronidase-zzxf is comparable to intravenous pertuzumab and trastuzumab, except for increased administration-related reactions. (ascopost.com)
  • When applied as an adjuvant, hyaluronidase enhances the diffusion capacity and bioavailability of injected drugs. (biomedcentral.com)
  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously received a trastuzumab-based regimen. (unboundmedicine.com)
  • As testicular tissue is a physiological source of bioactive hyaluronidase, bovine hyaluronidase can be extracted from bovine testes. (biomedcentral.com)
  • If you become pregnant during your treatment with trastuzumab and hyaluronidase-oysk injection, call your doctor immediately. (medlineplus.gov)
  • Hyaluronidase can be injected to dissolve hyaluronic acid type dermal fillers and is the best treatment option for those looking at dissolving lip filler or dealing with related complications. (wikipedia.org)
  • Pertuzumab and trastuzumab belong to a class of medications known as monoclonal antibodies. (alberta.ca)
  • The trastuzumab and hyaluronidase-oysk injection was initiated either sequentially with chemotherapy, concurrently with chemotherapy, or without adjuvant chemotherapy, or in combination with neoadjuvant chemotherapy followed by trastuzumab. (ons.org)
  • The three naturally-sourced hyaluronidases are orthologs of human HYAL5 (PH20) obtained from testicular preparations. (wikipedia.org)
  • A human recombinant hyaluronidase kit, HyQvia, was approved for use in the European Union in May 2013, and in the United States in September 2014. (wikipedia.org)