Patients treated with gattex have a potential increased risk of. Alternation of sites for subcutaneous injection is recommended, and can include the thighs, arms, and the quadrants of the abdomen. Arava may cause fetal harm when administered to a pregnant woman. Commercialhealthcare exchange pa criteria effective. Gattex is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome sbs who are dependent on parenteral support. May 31st, 2019 this document is confidential and proprietary to emblemhealth. Use your other hand to insert the needle straight down into the middle of the gray rubber seal on the gattex vial see figure m. Gattex teduglutide gattex fep clinical rationale rationale for inclusion in pa program background gattex is used to treat patients with short bowel syndrome sbs who need additional nutrition. Short bowel syndrome sbs authorizations of 6 months may be granted to member who has required parenteral support for at least 3 times a week for a period of at least 12 continuous months prior to gattex therapy initiation. If there is a conflict between the medical policy statement and the plan contract i. For those medications having an indefinite duration of use e.
This medicinal product is subject to additional monitoring. Each singledose vial of gattex contains 5 mg of teduglutide as a white lyophilized powder for reconstitution and administration by subcutaneous injection. Gattex teduglutide for injection support with onepath. Gammaplex 10% immune globulin intravenous human, 10% liquid. Gilenyafingolimod capsules, for oral use initial u. Administration kit for use with brineura package 2 of 2 see how suppliedstorage and handling 16 syringe pump not supplied. Teduglutide reduces need for parenteral support among. You may feel some resistance as the needle passes through the rubber seal. Colorectal polyps were identified during clinical trials. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, xlinked agammaglobulinemia, congenital. Use the syringes and needles provided in the gattex kit. See full prescribing information for risk and benefit considerations. Arava is contraindicated for use in pregnant women see contraindications 4. List of approved drugs containing teduglutide listed with health canada in the drug product database dpd.
Gattex is the only glucagonlike peptide2 glp2 analog approved that improves intestinal absorption in patients with sbs who are dependent on parenteral support ps 1. Highlights of prescribing information these highlights do not include all the information needed to use mavyret safely and effectively. Please see important safety information on pages 7 and 8, click for full prescribing information and medication guide, and discuss any questions with your doctor. Estimates of annual perpatient expenditures for 150 specialty medications. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gattex teduglutide for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome sbs who are dependent on parenteral support important safety information warnings and precautions acceleration of neoplastic growth. Gattex teduglutide for subcutaneous injection is a prescription medicine used in adults and children 1 year of age and older with short bowel syndrome sbs who need additional nutrition or fluids from intravenous iv feeding parenteral support. Fda approves gattex teduglutide for children 1 year of. Revestive, innteduglutide european medicines agency.
Plaquenil hydroxychloroquine sulfate tablets is indicated for the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, in patients who have not responded satisfactorily to drugs with less potential for serious side effects. Gattex is used to treat patients with short bowel syndrome sbs who need additional nutrition from intravenous. Do not use a gattex vial more than 1 time, even if there is medicine left in the vial. Gattex has been shown to reduce ps volume and to help some children with sbs wean off of intravenous nutrition over time during clinical studies 1. Dosage and administration approvals may be subject to dosing limits in accordance with fdaapproved labeling, accepted compendia, andor evidencebased practice guidelines. Gattex is indicated for the treatment of adult patients with short bowel syndrome sbs who are dependent on parenteral support. Gattex injection fda prescribing information, side.
Short bowel syndrome sbs is a condition that results from partial or complete surgical resection of the small. Give gattex within 3 hours after you mix the powder with the diluent sterile water for injection. Gattex is indicated for the treatment of adult patients with short bowel syndrome sbs who are dependent on. Gattex teduglutide is a glucagonlike peptide2 glp2 analog indicated for the treatment of adults and pediatric patients 1 year of age and older with short bowel syndrome sbs who are dependent on parenteral support. Teduglutide drug substance is a clear, colorless to lightstrawcolored liquid. Gattex was studied in a 6month clinical trial of 86 adult sbs patients who needed to use ps at least 3 times a week for at least 1 year. Refer to the product package insert for dosing, administration and safety guidelines. If the service, product, or procedure requires prior approval, the fact that the beneficiary is under 21 years of age does not. Teratogenicity and embryolethality occurred in animal reproduction studies with leflunomide at doses lower than the human exposure level see use in specific populations 8. Teduglutide has a molecular weight of 3752 daltons. Inject all of the medication by pushing in the plunger all the way until the plunger head is completely between the needle guard activation. Teduglutide gattex medical clinical policy bulletins aetna. Gattex injection dosage and administration important administration information gattex is for adult selfadministration or caregiver administration.
Gattex teduglutide for injection, for subcutaneous use. Andexxa coagulation factor xa recombinant, inactivatedzhzo is a recombinant modified human factor xa fxa protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to lifethreatening or uncontrolled bleeding. Gattex is indicated for use in the treatment of adult patients with short bowel syndrome sbs who are dependent on parenteral support. In a 24week pediatric study, gattex helped reduce the volume of daily ps. Mulpleta is a thrombopoietin receptor agonist for the treatment of thrombocytopenia in. Gattex teduglutide rdna origin overrides approval duration prior authorization 1 year medications gattex teduglutide rdna origin approval criteria requests for gattex teduglutide rdna origin may be approved if the following criteria are met. Gattex is a prescription medicine for adults with short bowel syndrome sbs who need additional nutrition or fluids from intravenous iv feeding, also known as parenteral support ps. However, endogenous glp2 is rapidly degraded by dipeptidyl peptidaseiv ddpiv resulting in a halflife of only 7 minutes. 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. Teduglutide gattex is indicated for the treatment of adult patients with short bowel. Teduglutide health canada drug product database dpd. Gammaplex 10% immune globulin intravenous human, 10% liquid is indicated for replacement therapy in primary humoral immunodeficiency pi in adults and pediatric patients 2 years of age and older. It is not known if gattex is safe and effective in children under 1 year of age.
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