Treatment of primary immunodeficiency pi in adults and pediatric patients two years of age or older. Do not use if the solution is cloudy, turbid, or if it contains particulates. You must have either part a or part b to be eligible for part d. Gammagard sd information, side effects, warnings and recalls. Immune globulin is a sterilized solution made from human plasma. 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. Gammagard sd is lyophilized and should only be given using a vented 15 micron filtered set. Gammagard liquid fda prescribing information, side effects and. An excellent reference source is the association for the advancement of medical instrumentation web site at. 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.
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. Two products, gammaked and gamunexc, are approved for use in patients with chronic inflammatory demyelinating polyneuropathy iv only. 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. Read enclosed directions for use, including information on compatibility. Worsening weakness includes an increase in any of the following symptoms. 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. 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. Administration procedures to be followed per pharmacy protocol. Asceniv, bivigam, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunexc, octagam, panzyga, privigen ivig fep clinical criteria. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation. J1569 is a valid 2020 hcpcs code for injection, immune globulin, gammagard liquid, nonlyophilized, e. Gammagard liquid should be given using a vented and unfiltered set.
As needed for iv access, administration and appropriateclinical monitoring. See full prescribing information for gammagard sd gammagard sd, immune. 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. Dosage is based on your medical condition, weight, and. Premier infusion care is an industry leader in immunoglobulin ig infusion both intravenous ivig and subcutaneous scig.
Dailymed gammagard sd immune globulin intravenous human kit. Gammagard liquid is an immune globulin infusion human indicated as. Per statespecific law, prescriptions will be dispensed as generic, if applicable, unless notated otherwise. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 3 version 10. Feb 07, 2020 gammagard is also used as maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy mmn. Injection, immune globulin privigen, intravenous, nonlyophilized e. Baxter has made the decision to discontinue manufacturing gammagard sd immune globulin intravenous human effective december 2012. Ideally, you have access to an experienced infusion center where the nurses are trained, gentle and proficient. It contains the antibodies to help your body protect itself against infection from various diseases. Gammagard sd immune globulin intravenous human solvent. Once the vial has been entered under aseptic conditions, its contents should be used promptly. Gammagard liquid, gammaked, gamunexc immune globulin.
Gammagard sd is indicated for the treatment of primary immunodeficient states, such as. To use gammagard liquid, gammaked, gamunexc, or hizentra. Immune globulin intravenous human, 10% liquid privigen. Part d is only available through private companies. This document applies to all gammagard sd immune globulin.
Administer using an infusion pump and compatible syringes. On the average, the distribution of igg subclasses present in this product is similar to that in normal plasma. Tips to make infusion days easier by jennifer richlin, rn, msn, pnp photos by can turkyilmaz. See important safety information, including warning about blood clots, decreased kidney function, and kidney failure. Gammagard 10% liquid 10gm 100ml ivig solution ref wide neck vial 24cs. Gammagard liquid immune globulin infusion human dose. Gammagard liquid and rhuph20 in pid full text view. Prior authorization approval criteria fallon health. Gammagard sd is an immune globulin intravenous human, indicated for. 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. Second or third doses should be held if patients become anuric or have.
Compare prices, print coupons and get savings tips for gammagard and other immunodeficiency drugs at cvs, walgreens, and other pharmacies. 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. It has an established safety record from human use in immunodeficiency and certain autoimmune conditions. Do not mix immune globulin intravenous human products of differing formulations or brands. 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. 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. Discard product if it contains particulate matter, is cloudy, or discolored discard unused portion. Gammagard liquid contains a broad spectrum of igg antibodies against bacterial and. 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 j1569 added as covered subcutaneous. The overall pharmacokinetic characteristics of immune globulin intravenous.
Gammagard liquid immune globulin intravenous human 10%. Gammagard liquid can be given via cvc, picc or peripheral venous line. Do not heat gammagard immune globulin injection subcutaneous or iv. Gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid preparation of highly puri. Part b part d is the outpatient prescription drug benefit for anyone with medicare. The following side effects may generally occur after treatment with intravenous human immunoglobulins medicines like gammagard sd common or. Do not freeze store reconstituted product in accordance with package insert instructions store unreconstituted product at or below 77 degrees f gammaked. Wash your hands with soap and water before and after using this. Phase iii efficacy, safety, and tolerability study of.
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. Allow the gammagard liquid, gammaked, or gamunexc brand to reach room temperature before using it. Injection, immune globulin, gammagard liquid, nonlyophilized, e. 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. An initial dose of 10 mgkg iv should be followed by two iv doses of 5 mgkg each, after 24 and 48 hours. Discard product if it contains particulate matter, is cloudy, or discolored. Gammagard sd discontinuation immune deficiency foundation. Gammagard immune globulin is a sterilized solution made from human plasma. Gammagard is a preparation of pooled human plasma antibodies from blood donations. The starting infusion rate is the starting infusion rate is 0. The quantity and refills for pretreatment and flushing protocol medications will match the immune globulin administration requirements. Gammagard sd, carimune nf immune globulin iv igiv dosing. Many patients form a bond with the nurses whom they trust to get their iv access, and that relationship is a blessing.
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, leaking, or has particles. 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. A 62 kg patient is to receive 60g of gammagard liquid. Having a better understanding of your condition is an. 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.
Although nordion compiles this information, we do not verify radiation compatibility of the products listed. This medication is usually given by slow injection infusion into a vein by a health care professional. Mmn is a rare disease that causes muscle weakness that worsens over time. Gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency pi in adult and pediatric patients two years of age or older. Gammagard sd can be given via cvc, picc or peripheral venous line. We are committed to providing immunoglobulin ig therapy for both children and adult patients with various chronic autoimmune, neuromuscular and immune deficiency disorders. It is recommended that all materials should be tested thoroughly to verify the compounds performance after irradiation. The iv route was generally tolerated by most patients, and larger doses could be given, with resulting improvements in the patients. Gammagard liquid immune globulin infusion human 10%.
Gammagard has been used offlabel for the treatment of a small number of alzheimers disease patients for years. If stored in a refrigerator, let gammagard immune globulin injection subcutaneous or iv come to room temperature before using it. Nov 14, 2018 gammagard sd is made from human blood, it may carry a risk of transmitting infectious agents, e. Can i take gammagard together with immunoglobulins intravenous. Instructions for administration are unique and specific to this product. 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.
Gammagard sd immune globulin contains only trace amounts of iga. 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. It is a sugar and sodiumfree product with improved safety, tolerability and convenience. Gammagard sd 10gm 5% low iga ivig vial immune globulin intravenous human iga less than.
Any vial that has been entered should be used promptly. The safety of gammagard liquid intravenous infusion was evaluated in 61. Gammagard liquid is a clear or slightly opalescent, colorless or pale yellow solution. This document applies to all gammagard liquid ivig 10%. Immune globulin intravenous human, 10% solution tradename. Gammagard sd is made from human blood, it may carry a risk of transmitting infectious agents, e. Apr 14, 2020 if stored in a refrigerator, let gammagard immune globulin injection subcutaneous or iv come to room temperature before using it. Intravenous immune globulin ivig or subcutaneous immune globulin scig is considered medically. The distribution of the igg subclasses is similar to that of normal plasma. Does gammagard contain immunoglobulins intravenous. Gammagard liquid j1569 added as covered subcutaneous immune globulin. First, gather the items you will need on a clean, flat surface using a cloth or towel in a welllighted area. Allow ivig time to come to room temperature where possible.
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