This is a phase iii, prospective, multicenter study with two study parts epochs to evaluate the efficacy, safety, and tolerability of hyqviahyqvia igi, 10% with recombinant human hyaluronidase rhuph20 administered subcutaneously for maintenance therapy to prevent relapse epoch 1 and gammagard liquidkiovig immunoglobulin g intravenous igiv 10% administered. Ideally, you have access to an experienced infusion center where the nurses are trained, gentle and proficient. Gammagard sd is an immune globulin intravenous human, indicated for. Part d is only available through private companies. Gammagard sd discontinuation immune deficiency foundation. As needed for iv access, administration and appropriateclinical monitoring. Pdr provides the following fdaapproved services, including full prescribing information, drug summaries, fda early warning communications, fda drug safety communications, pdr drug alerts, medication guides and free continuing medical education cme course credits. Immune globulin intravenous human, 10% solution tradename. Gammagard liquid j1569 is added to the external infusion pump lcd as covered subcutaneous immune globulin effective for dates of service on or after july 22, 2011. Phase iii efficacy, safety, and tolerability study of. We are committed to providing immunoglobulin ig therapy for both children and adult patients with various chronic autoimmune, neuromuscular and immune deficiency disorders. Gammagard liquid is a clear or slightly opalescent, colorless or pale yellow solution. Gammagard 10% liquid 10gm 100ml ivig solution ref wide neck vial 24cs. Immune globulin intravenous and subcutaneous for injection into a vein or under the skin is used to treat primary immunodeficiency pi, idiopathic thrombocytopenic purpura itp.
Gammagard liquid is a readytouse liquid medicine that is given in a vein intravenously or under the skin subcutaneously to treat primary immunodeficiency pi in people 2 years and older and given in a vein to treat multifocal motor neuropathy mmn in adults. Gammagard liquid fda prescribing information, side effects and. A 62 kg patient is to receive 60g of gammagard liquid. Dosage is based on your medical condition, weight, and. Nov 14, 2018 gammagard sd is made from human blood, it may carry a risk of transmitting infectious agents, e. J1569 is a valid 2020 hcpcs code for injection, immune globulin, gammagard liquid, nonlyophilized, e. Immune globulin intravenous human, 10% liquid privigen. Gammagard sd can be given via cvc, picc or peripheral venous line. Part b part d is the outpatient prescription drug benefit for anyone with medicare. An excellent reference source is the association for the advancement of medical instrumentation web site at. Do not mix immune globulin intravenous human products of differing formulations or brands. Apr 14, 2020 if stored in a refrigerator, let gammagard immune globulin injection subcutaneous or iv come to room temperature before using it. Sep 04, 2019 gammagard liquid immune globulin intravenous human 10% is a preparation of highly purified and concentrated immunoglobulin g antibodies used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia. Allow the gammagard liquid, gammaked, or gamunexc brand to reach room temperature before using it.
Gammagard is a preparation of pooled human plasma antibodies from blood donations. Prior authorization approval criteria fallon health. Injection, immune globulin, gammagard liquid, nonlyophilized, e. Gammagard sd information, side effects, warnings and recalls. Two products, gammaked and gamunexc, are approved for use in patients with chronic inflammatory demyelinating polyneuropathy iv only. Dailymed gammagard sd immune globulin intravenous human kit. Overall, gammagard liquid is a valuable addition to available therapies that has utility in lifethreatening and complicated diseases, and its use will continue to grow. An initial dose of 10 mgkg iv should be followed by two iv doses of 5 mgkg each, after 24 and 48 hours. Having a better understanding of your condition is an. Gammagard sd immune globulin intravenous human solvent detergent treated description gammagard sd, immune globulin intravenous human igiv is a solventdetergent treated, sterile, freezedried preparation of highly purified immunoglobulin g igg derived from large pools of human plasma. Gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid preparation of highly puri. Allow ivig time to come to room temperature where possible.
The quantity and refills for pretreatment and flushing protocol medications will match the immune globulin administration requirements. Instructions for administration are unique and specific to this product. Gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency pi in adult and pediatric patients two years of age or older. Read enclosed directions for use, including information on compatibility. See full prescribing information for gammagard sd gammagard sd, immune. The safety of gammagard liquid intravenous infusion was evaluated in 61. Any vial that has been entered should be used promptly. You must have either part a or part b to be eligible for part d. Although nordion compiles this information, we do not verify radiation compatibility of the products listed.
Gammagard liquid contains a broad spectrum of igg antibodies against bacterial and. Administration procedures to be followed per pharmacy protocol. Discard product if it contains particulate matter, is cloudy, or discolored discard unused portion. Immune globulin is a sterilized solution made from human plasma. To use gammagard liquid, gammaked, gamunexc, or hizentra. Bioavailability trough levels of igg after administration of igiv, 10% given via iv or sc with rhuph20 in participants aged 2 to human, 10% is a readyforuse sterile, liquid preparation of highly puri. Bioavailability trough levels of igg after administration of igiv, 10% given via iv or sc with rhuph20 in participants aged 2 to iv and sc except during rampup for sc and at end of study visit. Per statespecific law, prescriptions will be dispensed as generic, if applicable, unless notated otherwise. Gammagard liquid immune globulin intravenous human 10%.
Mar 20, 2015 preventive strategies always check for compatibility standardize protocol for drug preparation check for alternative modes of administration separation of drug doses by time and place usage of multilumen catheters use inline filters 18. Tips to make infusion days easier by jennifer richlin, rn, msn, pnp photos by can turkyilmaz. The iv route was generally tolerated by most patients, and larger doses could be given, with resulting improvements in the patients. Gammagard liquid, gammaked, gamunexc immune globulin. Many patients form a bond with the nurses whom they trust to get their iv access, and that relationship is a blessing. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation. Gammagard liquid can be given via cvc, picc or peripheral venous line. Gammagard has been used offlabel for the treatment of a small number of alzheimers disease patients for years. Do not use if the solution is cloudy, leaking, or has particles. Wash your hands with soap and water before and after using this.
It has an established safety record from human use in immunodeficiency and certain autoimmune conditions. First, gather the items you will need on a clean, flat surface using a cloth or towel in a welllighted area. Mmn is a rare disease that causes muscle weakness that worsens over time. Feb 07, 2020 gammagard is also used as maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy mmn. It is recommended that all materials should be tested thoroughly to verify the compounds performance after irradiation. Immunoglobulin therapy, also known as normal human immunoglobulin nhig, is the use of a mixture of antibodies immunoglobulins to treat a number of health conditions. Gammagard liquid immune globulin infusion human dose. Compare prices, print coupons and get savings tips for gammagard and other immunodeficiency drugs at cvs, walgreens, and other pharmacies. Injection, immune globulin privigen, intravenous, nonlyophilized e. Gammagard immune globulin is a sterilized solution made from human plasma. Do not heat gammagard immune globulin injection subcutaneous or iv. Gammagard sd is lyophilized and should only be given using a vented 15 micron filtered set. Discard product if it contains particulate matter, is cloudy, or discolored.
It contains the antibodies to help your body protect itself against infection from various diseases. Sep 04, 2019 gammagard immune globulin sd contains all of the igg antibody activities which are present in the donor population. Do not use if the solution is cloudy, turbid, or if it contains particulates. If stored in a refrigerator, let gammagard immune globulin injection subcutaneous or iv come to room temperature before using it. It is a sugar and sodiumfree product with improved safety, tolerability and convenience. Administer using an infusion pump and compatible syringes.
Gammagard liquid immune globulin infusion human 10%. Gammagard sd, carimune nf immune globulin iv igiv dosing. Gammagard liquid is an immune globulin infusion human indicated as. This document applies to all gammagard sd immune globulin. Gammagard sd is made from human blood, it may carry a risk of transmitting infectious agents, e. Second or third doses should be held if patients become anuric or have. This medication is used to strengthen the bodys natural defense system immune system to lower the risk of infection in persons with a weakened immune system. Preventive strategies always check for compatibility standardize protocol for drug preparation check for alternative modes of administration separation of drug doses by time and place usage of multilumen catheters use inline filters 18.
The starting infusion rate is the starting infusion rate is 0. On the average, the distribution of igg subclasses present in this product is similar to that in normal plasma. Baxter has made the decision to discontinue manufacturing gammagard sd immune globulin intravenous human effective december 2012. Can i take gammagard together with immunoglobulins intravenous. This medication is usually given by slow injection infusion into a vein by a health care professional. Gammagard liquid j1569 added as covered subcutaneous immune globulin. Intravenous immune globulin enrollment form a division of health care service corporation, a mutual legal reserve company, an independent licensee of the blue cross and blue shield association scp909917 2012 txa0006 02012 fax completed form to. Gammagard liquid should be given using a vented and unfiltered set. Worsening weakness includes an increase in any of the following symptoms. The overall pharmacokinetic characteristics of immune globulin intravenous. Gammagard sd immune globulin intravenous human solvent. Gammagard is used to treat primary immunodeficiency diseases pi in adults and children two years of age or older gammagard is also used as maintenance therapy to improve muscle strength and. Asceniv, bivigam, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunexc, octagam, panzyga, privigen ivig fep clinical criteria. Do not freeze store reconstituted product in accordance with package insert instructions store unreconstituted product at or below 77 degrees f gammaked.
Gammagard liquid and rhuph20 in pid full text view. This document applies to all gammagard liquid ivig 10%. Immunoglobulin therapy is used in a variety of conditions, many of which involve decreased or abolished antibody production capabilities, which range from a complete absence of multiple types of antibodies, to igg subclass deficiencies usually involving igg2 or igg3, to other disorders in which antibodies are within a normal quantitative range, but lacking in quality unable. The distribution of the igg subclasses is similar to that of normal plasma. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 3 version 10. Once the vial has been entered under aseptic conditions, its contents should be used promptly. Treatment of primary immunodeficiency pi in adults and pediatric patients two years of age or older. See important safety information, including warning about blood clots, decreased kidney function, and kidney failure. Premier infusion care is an industry leader in immunoglobulin ig infusion both intravenous ivig and subcutaneous scig. Gammaked is an immune globulin ig injection approved to treat chronic inflammatory demyelinating polyneuropathy cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse, primary humoral immunodeficiency pi in patients 2 years of age and older, and idiopathic thrombocytopenic purpura itp in adults and children to raise platelet. The following side effects may generally occur after treatment with intravenous human immunoglobulins medicines like gammagard sd common or. Gammagard sd 10gm 5% low iga ivig vial immune globulin intravenous human iga less than.
Gammagard liquid j1569 added as covered subcutaneous. Intravenous immune globulin ivig or subcutaneous immune globulin scig is considered medically. Does gammagard contain immunoglobulins intravenous. Gammagard sd is indicated for the treatment of primary immunodeficient states, such as.
129 810 1359 1319 1406 215 1492 354 729 466 761 1283 1194 52 793 249 381 1473 1282 199 1371 967 372 975 572 186 50 540 608 1138 604 418 946 1134 1420 440 1063 1368 1406 530 1338