Consider additional monitoring in patients with medical conditions which predispose them to cardiovascular or pulmonary compromise. Alemtuzumab is a genetically engineered humanised igg1 kappa monoclonal. Dose modifications for vectibix concerning dermatologic toxicity are provided see dosage and administration 2. Highlights of prescribing information for intravenous. The official hcp site for lemtrada for relapsing multiple sclerosis ms. See full prescribing information for complete boxed warning. Monitor for fever and other signs of infection and treat promptly. Alemtuzumab is also approved as brand name campath, a medicine approved to treat a type of cancer called bcell chronic lymphocytic leukemia bcll. Cd52 is a glycosylphosphatidylinositol gpianchored protein consisting of 12 amino acids expressed at high. The associated longterm risks of infection remain poorl. At this time there are no fdaapproved alternate ways of administering epoprostenol as flolan. Lemtrada alemtuzumab injection, for intravenous use initial u. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma.
Left ventricular dysfunction and embryofetal toxicity see full prescribing information for complete boxed warning. Restricted access do not disseminate or copy without approval. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. Alemtuzumab was detected in the milk of lactating hucd52 transgenic mice following intravenous administration of alemtuzumab at a dose of 10 mgkg on postpartum days 812. Fda warns about rare but serious risks of stroke and blood. Refer todoxorubicin prescribing information for dosing, and dose modifications. Summary of product characteristics spc and package leaflet and labelling. Arzerra ofatumumab injection, for intravenous use initial u. Cd52 is expressed on the surface of normal and malignant b and t lymphocytes, nk cells, monocytes, macrophages, and tissues of the male reproductive system.
Lemtrada alemtuzumab 10mgml injection concentrated. Amikacin is rapidly absorbed after intramuscular administration. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission cr or complete remission with. Lemtrada alemtuzumab 10mgml injection concentrated cas registry number not applicable description alemtuzumab rch is a recombinant dnaderived humanized monoclonal antibody directed against the 2128 kd cell surface glycoprotein, cd52. Highlights of prescribing information these highlights do. Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. Perjeta can result in subclinical and clinical cardiac failure manifesting as decreased lvef and chf. Disclaimer the authors make no claims of the accuracy of the information contained herein. Jul 01, 2018 amikacin is rapidly absorbed after intramuscular administration. Full prescribing information 1 indications and usage avonex is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Highlights of prescribing information extended treatment in.
Taxane should be administered after perjeta and trastuzumab. The proposed mechanism of action for alemtuzumab is antibodydependent lysis of leukemic cells following cell surface binding. Includes dosages for multiple sclerosis and chronic lymphocytic leukemia. Highlights of prescribing information these highlights do not. See full prescribing information, including boxed warning. Tecfidera dimethyl fumarate prescribing information and.
Fludarabine phosphate injection, usp is a sterile solution intended for intravenous administration. It is a humanized antibody with a ratderived antigenspecific, highly variable fab region and an fc region of human origin 4,5. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. In normal adult volunteers, average peak serum concentrations of about 12, 16 and 21 mcgml are obtained 1 hour after intramuscular administration of 250 mg 3. Perjeta pertuzumab injection, for intravenous use initial u. These highlights do not include all the information needed to use mavenclad safely and effectively. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults primary progressive ms, in adults 2 dosage and administration. Multiple sclerosis ms only prescribers registered in the ms touch prescribing program may prescribe tysabri for multiple sclerosis see warnings and precautions 5.
Guide and package leaflet, and be informed about the risks of lemtrada. Thiotepa is a synthetic product with antitumor activity. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine. Lemtrada alemtuzumab injection, for intravenous use. This leaflet is part iii of a threepart product monograph. Autoimmunity, infusion reactions, stroke, and malignancies see full prescribing information for complete boxed warning. Alemtuzumab campath1h is a monoclonal igg1 antibody binding to the human cd52 protein. Campath alemtuzumab is a recombinant dnaderived humanized monoclonal antibody campath1h that is directed against the 2128 kd cell surface. Lemtrada causes serious, sometimes fatal, autoimmune. Serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum day and were associated with evidence of pharmacological activity decrease in. Single doses of campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia see package insert for warnings and precautions 5. Libtayo, a programmed death receptor1 pd1 inhibitor, is the first and only fdaapproved therapy indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma cscc or locally advanced cscc who are not candidates for curative surgery or curative radiation 1.
Thus, alemtuzumab has a potential broad application across a spectrum of b and tcell malignancies. Highlights of prescribing information these highlights do not include all the information needed to use arzerra safely and effectively. For the first cycle, the recommended total dose of besponsa for all patients is 1. Highlights of prescribing information these highlights. Lemtrada alemtuzumab injection for intravenous use prescribing information. Dec 03, 2019 alemtuzumab was detected in the milk of lactating hucd52 transgenic mice following intravenous administration of alemtuzumab at a dose of 10 mgkg on postpartum days 812. Alemtuzumab rch is a sterile, clear, colorless to slightly yellow, injection concentrate with ph 7. The data from the 27 alemtuzumab recipients in this series show a wide variety of infectious complications. Infusion reactions and cardiopulmonary arrest 1 indications and usage 1. Pulmonary toxicity in a clinical investigation using fludarabine phosphate injection in combination with pentostatin deoxycoformycin for the treatment of refractory chronic lymphocytic leukemia cll in adults, there was an unacceptably high incidence of fatal pulmonary toxicity. Food and drug administration fda in november 2014, alemtuzumab is approved in over 30 countries for the therapy of relapsingremitting multiple. Jul 01, 2006 patients receiving alemtuzumab in clinical practice thus far are typically pretreated with multiple regimens of other chemotherapeutic agents, adding to an alreadyincreased risk for significant infection. Jul 20, 2015 alemtuzumab is a humanized monoclonal antibody targeting cd52, a surface molecule with largely unknown function and which is predominantly expressed on b and t cells.
Full prescribing information 1 indications and usage tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Lemtrada is a cd52directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis ms, to include relapsing remitting disease and active secondary progressive disease, in adults. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Please see package insert for full details no medications are prohibited with the use of epoprostenol. Alemtuzumab for the treatment of multiple sclerosis. Mabcampath, innalemtuzumab european medicines agency.
Pulmonary toxicity in a clinical investigation using fludarabine phosphate injection in combination with pentostatin deoxycoformycin for the treatment of refractory chronic lymphocytic leukemia cll in adults, there was an unacceptably high incidence of fatal pulmonary. Multiple sclerosis ms is a common inflammatory, demyelinating disease of the central nervous system cns1 with a worldwide prevalence of approximately 2. Dosage and administration campath package insert related medical guideline lemtrada package insert guideline. Infectious complications associated with alemtuzumab use. Mild to moderate decreases in platelet counts, starting at the time of alemtuzumab infusion have been reported. Dec 03, 2019 detailed alemtuzumab dosage information for adults and children. Lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include relapsingremitting disease and active secondary progressive disease, in adults.
Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. Please see indication and important safety information. Mabcampath alemtuzumab is indicated for the treatment of patients with previously untreated progressive. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Infectious complications associated with alemtuzumab use for. Highlights of prescribing information these highlights do not include all the information needed to usegilenya safely and effectively.
Because of its safety profile, the use of lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the. Campath alemtuzumab is a recombinant dnaderived humanized monoclonal antibody campath1h that is directed against the 2128 kd cell surface glycoprotein, cd52. Physicians should alert patients that an infusion reaction could occur within 48 hours of infusion. Alemtuzumab for patients with relapsing multiple sclerosis after diseasemodifying therapy. Alemtuzumab is an emerging therapy for refractory lymphoproliferative disorders. 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.
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