The information in this policy is used by wellmark to make determinations whether medical treatment is covered under the terms of a wellmark members health benefit plan. This is a multidose vial which contains a total of 22. Cerezyme rx only imiglucerase for injection description cerezyme imiglucerase for injection is an analogue of the human enzyme. Vpriv should be administered under the supervision. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Highlights of prescribing information these highlights do not. Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Please click here for full prescribing information. Patients should always ask their doctors for medical advice about adverse events.
Zavesca fda prescribing information, side effects and uses. Consensus statement by the international collaborative gaucher. Elelyso taliglucerase alfa for injection is indicated for the treatment of patients with a confirmed diagnosis of type 1 gaucher disease. The efficacy of enzyme replacement therapy in patients with chronic neuronopathic gauchers disease.
The efficacy of enzyme replacement therapy in patients with chronic neuronopathic. Lifethreatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema including tongue or lip swelling, periorbital edema, and face edema, and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and. Serratrice c, carballo s, serratrice j, stirnemann j. Jun 01, 2019 zavesca miglustat capsules, 100 mg is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Open the mix2vial transfer set package by peeling away the lid figure 1. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of. Cerezyme fda prescribing information, side effects and uses. In clinical trials, cerezyme improved anemia and thrombocytopenia, reduced spleen and liver size, and decreased cachexia 2. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Highlights of prescribing information infusionassociated. Injectafer ferric carboxymaltose injection, for intravenous use initial u. Elelyso taliglucerase alfa for injection risk info.
Cerezyme is administered by intravenous infusion over 12 hours. Actemra subcutaneous formulation is not intended for intravenous. Grip the mix2vial transfer set together with the clear package and push the plastic spike at the blue end of the mix2vial transfer set firmly through the center of the stopper of the diluent vial figure 2. Furthermore, these data indicate no malformative toxicity for the foetus. Place the diluent vial on a flat surface and hold the vial tightly. Cerezyme imiglucerase for injection is indicated for longterm enzyme replacement therapy for pediatric and adult. Reconstituted vials may be stored either refrigerated at 2 to 8 c 36 to 46 f, or at controlled room temperature 20 to 25 c 68 to 77 f.
Medicare coverage for outpatient part b drugs is outlined in the medicare benefit policy manual. Zavesca is an nalkylated imino sugar, a synthetic analog of d. Fabrazyme helps people affected by fabry disease by replacing a missing enzyme. Dailymed corvert ibutilide fumarate injection, solution. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Elstein d, abrahamov a, oz a, arbel n, baris h, zimran a. Leave the mix2vial transfer set in the clear package.
A range of dosage regimens has proven effective towards some or all of the nonneurological. Corvert injection prolongs action potential duration in isolated adult cardiac myocytes and increases both atrial and ventricular refractoriness in vivo, ie, class iii. In clinical trials, cerezyme improved anemia and thrombocytopenia, reduced spleen and liver size, and decreased cachexia 1. Actemra subcutaneous formulation is not intended for. Zavesca miglustat capsules, 100mg is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Multiple sclerosis ms only prescribers registered in the ms touch prescribing program may prescribe tysabri for multiple sclerosis see warnings and precautions 5. Mar 30, 2020 cerezyme imiglucerase for injection is an analogue of the human enzyme. Cerezyme imiglucerase is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of nonneuronopathic type 1 or chronic neuronopathic type 3 gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. Erikson a, forsberg h, nilsson m, astrom m, mansson je. Cerezyme imiglucerase for injection prescribing information. Highlights of prescribing information for intravenous. It is recommended that due to the heterogeneity and the multisystemic nature of gaucher disease, dosage should be individualised for each patient based on a.
Manual for patients with gaucher disease who receive home infusion. Cerezyme is the only ert enzyme replacement therapy that. 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. You are encouraged to report an adverse event related to pfizer. Package insert zavesca miglustat capsules, 100mg description zavesca miglustat capsules, 100mg is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis. Vpriv velaglucerase alfa for injection is a prescription medication indicated for longterm enzyme replacement therapy ert for patients with type 1 gaucher disease. Furthermore, these data indicate no malformative toxicity for the foetus by cerezyme, although the statistical evidence is low. Zavesca is an nalkylated imino sugar, a synthetic analog of dglucose. Cerezyme 400 units powder for concentrate for solution for infusion. Use of cerezyme in these age groups is supported by.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. The information in this policy is used by wellmark. The recommended dosage of hycamtin for injection is 0. 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. Hypersensitivity reactions, including serious allergic reactions anaphylaxis have occurred. Zavesca is an nalkylated imino sugar, a synthetic analogue of dglucose.
Cerezyme imiglucerase for injection is an analogue of the human enzyme. Cerezyme imiglucerase for injection catalyzes the hydrolysis of glucocerebroside to glucose and ceramide. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsing. Higher than recommended doses or more frequent dosing of. Nulojix is contraindicated in patients who are ebv seronegative or with unknown serostatus because the risk of ptld is particularly increased in patients who are ebv seronegative. Cerezyme imiglucerase for injection product monograph page 4 of 34 pediatrics 2 16 years of age. Cerezyme imiglucerase for injection is indicated for. Fabrazyme lowers the amount of a substance called globotriaosylceramide gl3, which builds up in cells lining the blood. Aseptically transfer the required dose of reconstituted dalbavancin solution. The safety and effectiveness of cerezyme have been established in children and adolescents from 2 up to 16 years of age. Injection, usp, the imiglucerase concentration is 40 uml see dosage and. Cerezyme has no or negligible influence on the ability to drive and use machines. Cerezyme imiglucerase for injection is indicated for long term enzyme replacement therapy for pediatric and adult.
Ciq41114 cinqair full pi and patient information 8. Carefully remove the clear package from the mix2vial transfer set. Nonfda approved indications, which are not addressed in this policy. The safety and effectiveness of cerezyme imiglucerase for injection have been established in patients between 2 and 16 years of age. 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. Use of cerezyme in this age group is supported by evidence from adequate and wellcontrolled studies of cerezyme and ceredase alglucerase. Elelyso, cerdelga, cerezyme, vpriv, and zavesca notice this policy contains information which is clinical in nature. Dosage adjustments should be made on an individual basis and may.
Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab. Lifethreatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness. In clinical trials, cerezyme improved anemia and thrombocytopenia, reduced spleen and. Cerezyme imiglucerase for injection product monograph page 7 of 34 dxa lumbar spine and femoral neck pulmonary recommended every 1224 months for patients with borderline or above normal pulmonary pressures at baseline ecg, chest xray, and. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour. January 1, 2020 page 3 of 3 applicable procedure codes j1786 injection, imiglucerase, 10 units applicable ndcs 584681983xx cerezyme 200 unit injection 584684663xx cerezyme 400 unit injection applicable diagnosis codes e75. Serious infections leading to hospitalization or death including. Risk of serious infections see full prescribing information for complete boxed warning. Cerezyme 200 u powder for concentrate for solution for infusion.
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