Reconstitute each 35 mg vial of fabrazyme by slowly injecting 7. This enzyme normally breaks down a fatty substance called globotriaosylceramide gl3. The objective of this document is to provide patients with guidance on how to receive fabrazyme agalsidase beta at home. Refrigerate vials of fabrazyme at 2c to 8c 36f to 46f. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Fabrazyme agalsidase 5, 35 mg singleuse vials 5846800401 5846800411 j0180. Winrho sdf for the treatment of immune thrombocytopenic. Fabrazyme agalsidase beta overrides approval duration prior authorization 1 year medications dosing limit fabrazyme agalsidase beta 5 mg, 35 mg vial 1 mgkg every two weeks approval criteria requests for fabrazyme agalsidase beta may be approved when the following criteria are met. Fabrazyme should not be infused in the same intravenous line with other products. Cerezyme is an enzyme replacement therapy ert, that treats pediatric and adult patients with gaucher disease type 1. Patients should receive antipyretics prior to infusion. Fabrazyme agalsidase 5, 35 mg singleuse vials 5846800401 5846800411 j0180 6. Fabrazyme helps people affected by fabry disease by replacing a missing enzyme.
Fabrazyme is a fully functional enzyme, with an amino acid sequence identical to the bodys own native enzyme. A deficiency of this enzyme is called fabry disease. Fabrazyme is used to treat patients who have fabry disease, a rare inherited disorder. Follow applicable special handling and disposal procedures. Package carton principal display panel 5 mg carton. Applicable procedure codes j0180 injection, agalsidase beta, 1 mg. Agalsidase beta powder for concentrate for solution for. Highlights of prescribing information initial dose of. In patients 16 months to 5 years old, elaprase did not show improvement in diseaserelated symptoms or long term clinical result. Download leaflet view the patient leaflet in pdf format.
Winrho sdf is a rh o d immune globulin intravenous human product indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of nonsplenectomized, rh o dpositive. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Do not use fabrazyme after the expiration date on the vial. Patients who have had a positive skin test to fabrazyme or who have tested positive for anti fabrazyme ige may be successfully rechallenged with fabrazyme. Fabrazyme reduces globotriaosyl ceramide gl3 deposition in capillary endothelium of the kidney and certain other cell types. Highlights of prescribing information these highlights do not. Fabrazyme agalsidase beta mb9300 this policy is specific. Elaprase has been shown to improve walking ability in patients 5 years and older. If anaphylactic or other severe hypersensitivity reactions occur, immediately discontinue. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions.
Fabrazyme dosage and administration recommended dosage. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Fabrazyme, innagalsidase beta european medicines agency. And documented diagnosis of fabry disease with biochemicalgenetic confirmation by one of the following. Prior approval is required to ensure the safe, clinically appropriate and cost effective use of fabrazyme while maintaining optimal therapeutic outcomes. Fabrazyme 5 mg powder for concentrate for solution for infusion prior to adding the reconstituted volume of fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0. In clinical studies, moms who took zulresso experienced a greater improvement in symptoms of postpartum depression vs placebo in 2. It is supplied as a sterile, nonpyrogenic, preservativefree, white to offwhite, lyophilized cake or powder for reconstitution with sterile water for injection, usp. The reconstituted solution must be diluted further see section 6. Highlights of prescribing information these highlights do. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. Onpattro patisiran and investigational alnttrsc02 for. Warnings and precautions talk to your doctor or pharmacist before using fabrazyme. Nov 01, 2019 fabrazyme agalsidase beta for injection is supplied as a sterile, nonpyrogenic, white to offwhite lyophilized cake or powder in singledose vials.
Fabrazyme agalsidase beta treatment option for fabry. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. The infusion nurse will strictly follow the prescribed dose and infusion rate of fabrazyme as stated in the logbook appendix 3. Risk minimisation information for healthcare professionals. Fabrazyme reduces globotriaosylceramide gl fabrazyme reduces globotriaosylceramide gl 3 deposition in capillary endothelium of the kidney and certain other cell types. Fabrazyme agalsidase beta home infusion patient manual risk minimisation information for patients. Fabrazyme 35 mg powder for concentrate for solution for infusion each vial of fabrazyme contains a nominal value of 35 mg of agalsidase beta. Fabrazyme agalsidase beta prior auth criteria proprietary information. The infusion rate may be slowed in the event of infusion reactions. The recommended dosage of fabrazyme is 1 mgkg body weight infused every two weeks as an intravenous infusion. Fabrazyme agalsidase beta home infusion patient manual. Agalsidase beta powder for concentrate for solution for infusion. Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
Appropriate medical support and monitoring measures should be readily available when aldurazyme is administered. Fabrazyme is considered investigational when used for any indication not listed above. Arzerra ofatumumab injection, for intravenous use initial u. Please see the full prescribing information including boxed warning pdf. Fabry disease is a rare genetic disorder caused by mutations in the alpha galactosidase a gla gene located on the x chromosome. Nov 11, 2019 the reduction in plasma gl3 levels in the fabrazyme group compared to the placebo group was significant at one year p fabrazyme treated and 6 in placebo had skin biopsies at first infusion and final visit.
Fabrazyme has been used to treat people with fabry disease for over 15 years and is backed by the safety and effectiveness shown in clinical studies. If severe infusion or allergic reactions occur, immediate discontinuation of the administration of lumizyme should be considered, and appropriate medical treatment should be initiated. Thymoglobulin antithymocyte globulin rabbit sanofi. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Each vial of fabrazyme contains a nominal value of 35 mg of agalsidase beta. Symptoms were measured at the beginning of treatment using a standard depression scale and again at the end of treatment. The recommended dosage of fabrazyme is 1 mgkg body weight infused. Fabrazyme package insert guideline initial approval criteria coverage is provided in the following conditions. The total volume of infusion is determined by the patients body weight and should be administered over approximately 4 hours. Fabrazyme 35 mg pregnancy, breastfeeding and fertility. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred. Fabry disease alphagalactosidase a deficiency patient is 8 years of age or older.
The infusion nurse records each administration of fabrazyme in the logbook appendix 3. Patients with fabry disease do not have enough of an enzyme called alphagalactosidase a. The mature protein is comprised of two subunits of 398 amino acids. Lifethreatening anaphylactic reactions have been observed in some patients during aldurazyme infusion and up to 3 hours after infusion. The recommended dosage of fabrazyme is 1 mgkg body weight infused every two weeks as an intravenous iv infusion. Initial approval criteria 1,2,3,4,5,6 site of care specialty infusion program requirements are met refer to moda site of care policy. Policy history date action march 2010 age updated to current package insert recommendations. For the full list of all side effects reported with fabrazyme, see the package leaflet. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Fabrazyme for intravenous infusion genzyme, drug reference. Cerezyme is the only ert enzyme replacement therapy that has shown longterm efficacy and safety in multiple studies over 10 years and has been prescribed for over 20 years learn more about cerezyme and talk to your doctor to see if cerezyme is right for you. Etopophos solutions may be administered at infusion rates up to 3.
Fabrazyme agalsidase beta page 3 select a combination of 35 mg and 5 mg vials so that the total number of mg is equal to or greater than the patients number of kg of body weight. Thymoglobulin antithymocyte globulin rabbit is a purified, pasteurized, gamma immune globulin obtained by immunization of rabbits with human thymocytes. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a classical hemophilia. See important safety including boxed warnings for more information. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kd. Fabrazyme 35 mg powder for concentrate for solution for infusion.
Fabrazyme fda prescribing information, side effects and uses. Highlights of prescribing information infusionassociated. Rituxan rituximab for ra, nhl, cll, gpa, mpa, and pv. And baseline value for plasma gl3 andor gl3 inclusions. Fabrazyme reduces globotriaosylceramide gl3 deposition in capillary endothelium of the kidney and certain other cell types. Resources and support aldurazyme healthcare professional. The safety and efficacy of fabrazyme were assessed in a multinational, multicenter, uncontrolled, openlabel study in 16 pediatric patients with fabry disease. Vpriv should be administered under the supervision of a healthcare professional. It results from a buildup of fat called globotriaosylceramide gl 3 in blood vessels, kidneys, the heart, the nerves, and oth er organs. Restricted access do not disseminate or copy without approval. Fabrazyme is indicated for use in patients with fabry disease. Fabrazyme agalsidase beta for injection is intended for intravenous infusion. Fabrazyme should not be used in people who may be hypersensitive allergic to agalsidase beta or any of the other ingredients.
View important safety information, including risk of anaphylaxis. Page 1 of 2 commercialhealthcare exchange pa criteria. It is the responsibility of the treating physician to supply this material to patients only if the treating physician. What you need to know before you use fabrazyme do not use fabrazyme if you are allergic to agalsidase beta or any of the other ingredients of this medicine listed in section 6. Learn about cerezyme diagnosis, dosing, safety and support resources.
Severe infusionassociated reactions experienced by more than one patient in clinical studies with fabrazyme. The number of 35 mg and 5 mg vials needed is based on the patients body weight kg and the recommended dose of 1 mgkg. The diluted solution may be filtered through an inline low proteinbinding 0. Fabrazyme agalsidase beta is a manmade form of the naturallyoccurring alphagalactosidase a enzyme. Highlights of prescribing information extended treatment in. Mar 07, 2019 fabrazyme agalsidase beta is a manmade form of the naturallyoccurring alphagalactosidase a enzyme. Fabrazyme prior approval request the information provided on this form will be used to determine the provision of healthcare benefits under a u. Because of the potential for severe infusion reactions, appropriate medical support measures should be readily available when fabrazyme is administered. Patients who receive fabrazyme can develop antibodies proteins that are produced in response to fabrazyme and can affect treatment. Storage store fabrazyme under refrigeration between 28c 3646f. January 28, 2019 this document is confidential and proprietary to emblemhealth.
Find information about rituxan rituximab, a possible treatment for ra, nhl, cll, gpa, mpa, and pv. Medication guide remicade remeh kaid infliximab lyophilized concentrate for injection, for intravenous use read the medication guide that comes with remicade before you receive the first treatment, and before each time you get. Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for fabry disease who are responding to therapy e. Dailymed fabrazyme agalsidase beta injection, powder. In clinical trials with fabrazyme, 59% of patients experienced infusionassociated reactions during fabrazyme administration, some of which were severe see warnings and precautions 5. Agalsidase beta reduces deposits of globotriaosylceramide gl3 in the kidneys and certain other cells in the body. Tegsedi is a drug for the treatment of nerve damage in adult patients with hereditary transthyretinmediated amyloidosis. Fabrazyme will not be used in combination with galafold. The initial iv infusion rate should be no more than 0.
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