Cardiovascular risk associated with rapid infusion rates see full prescribing information for complete boxed warning the rate of intravenous cerebyx administration should not exceed 150 mg phenytoin sodium equivalents pe per minute in adults and 2 mg pekgmin or 150 mg pemin, whichever is slower in pediatric patients because of. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab. The package insert is currently being revised to incorporate the cidp indication and supporting information. Packaging and storage gamunexc immune globulin injection. Jul 28, 2010 we are receiving inconsistent information about the administration of gamunex infusions. It is not known if gattex is safe and effective in children under 1 year of age. Immune globulin may be administered simultaneously with hepatitis a vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, in older adults, immunocompromised patients, and patients with chronic liver disease or other chronic medical. Use sterile technique for all handling and administration of omnipaque for intravascular, intrathecal, intraarticular, and body cavity administration. Dec 10, 2018 phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0. Immune globulin is a sterilized solution made from human plasma.
Gamunexc is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. If you have questions about how to store gamunexc immune globulin injection subcutaneous or iv, talk with your pharmacist. Immune globulin intravenous human, 10% liquid privigen. Gamunex 10% summary of product characteristics smpc. Gamunexc thrombotic events have occurred in patients. Patient resources gamunexc immune globulin injection. Read the package insert that comes with gamunexc immune globulin injection subcutaneous or iv. If you have questions about how to store gamunex c immune globulin injection subcutaneous or iv, talk with your pharmacist. Flolan is a potent pulmonary and systemic vasodilator and can cause hypotension and other. For additional information about gamunex, please see for full prescribing information. Uncover the difference gamunexc immune globulin injection.
For patients at risk of renal dysfunction or failure, administer gamunexc at the minimum concentration available and the minimum infusion rate practicable. Some centers say hydrate with saline using a bag of solution, they then use new tubing prior to administering the gamunex. Find out about the patient resources related to gamunex c. 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, or chronic inflammatory. The recommended dose of gammaplex 10% for patients with pi is 300 to 800 mgkg 3 to 8 mlkg, administered every 3 to 4 weeks. There have been reports of noncardiogenic pulmonary edema transfusionrelated acute lung injury trali in patients administered igiv 33. For complete product information please refer to product insert. For immediate release talecris biotherapeutics helps patients. This medication is also used to improve muscle strength in adults with multifocal motor neuropathy. September 2011 line extension of gammaked, fda approved 832011, for the treatment of. Do not, repeat do not, flush with iv saline if using gamunex.
The gamunex c infusion line can be flushed with 5% dextrose in water d5w or 0. For patients at risk of renal dysfunction or failure, administer gamunex c at the minimum concentration available and the minimum infusion rate practicable. Gamunex c immune globulin injection human, 10% caprylatechromatography purified. Gammagard sd, carimune nf immune globulin iv igiv dosing. If dilution is required, gamunexc may be diluted with 5% dextrose in water d5w.
What is the most important information i need to know about cuvitru. Ashp commission on therapeutics, ashp therapeutic guidelines for intravenous immune globulin, am j hosp pharm, 1992, 493. Gamunex c immune globulin injection human 10% caprylatechromatography purified is a form of immunoglobulin therapy and is used to treat people with chronic inflammatory demyelinating polyneuropathy cidp, primary immunodeficiency pi, and idiopathic thrombocytopenic purpura. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab skip to. Covered icd codes for gamunexc immune globulin injection human, 10% caprylatechromatography purified copay assistance icd9 279. Infuse gamunex c using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. 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, or chronic inflammatory demyelinating polyneuropathy cidp. Gamunex is the best, and most physiologically well tolerated, but if you read the insert, it forms precipitates when it comes into contact with saline.
This medicine is collected from the pooled blood of many donors. Since gamunex 10% has a low buffering capacity, it is rapidly neutralised by the blood during the infusion. The package insert is currently being revised to incorporate information regarding. Infusion rate mlkgmin x pt wt kg x 60 min infusion rate mlhr 0. This medication may cause serious rarely fatal kidney problems. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Transfusion medicinelab will provide gamunex to the nearest 5 gram increment if prescriber omits this step. Gamunex c is contraindicated in individuals with acute severe hypersensitivity reactions to immune globulin human. Ivig specialty pharmacy clinical policy bulletins aetna. For immediate release talecris biotherapeutics helps. Gamunex c is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. How does ivig work for both autoimmune and immune deficiencies. Immune globulin memorial sloan kettering cancer center. Gamunexc may be stored for 36 months at 28c 3646f, and product may be stored at temperatures not to exceed 25c 77f for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded.
Before sharing sensitive information, make sure youre on a federal government site. Jan 14, 2020 refer to package insert for dosage and administration and compatibility with other solutions. Gamunex c immune globulin injection human, 10% caprylatechromatography purified is approved to treat primary humoral immunodeficiency disease pidd in patients 2 years of age and older. Gamunexc medicare coverage and copay details goodrx. Some patients who have immune globulin therapy for the first time or who have not had it within the past 8 weeks may have a risk for certain side effects. All manuscripts should be submitted in ms word, in arial font. Store in the original container to protect from light. Grifols introduces new 40g ivig vial size for gamunexc. Pk, safety and tolerability of scadministered gamunexc in pediatric pi subjects ages 2 16.
Gamunex c immune globulin helps to prevent or reduce the severity of certain infections in patients who are at risk. If you have pidd, you may take gamunex c under the skin subcutaneously or in a vein intravenously. Dosage is based on your medical condition, weight, and response. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10. If you must hydrate with iv saline youll have to completely change your line before infusing with gamunex. Page 1 of 3 grifols introduces new 40g ivig vial size for gamunexc the widest range of vial sizes expands convenience options for ig therapy rtp, nc november 6, 2014.
All gamunex doses should be rounded up or down to nearest 5 gram increment at time of ordering. Gamunex 10% summary of product characteristics smpc emc. Grifols, a leading provider of plasmaderived therapies, announced. Cipro iv ciprofloxacin is a synthetic broadspectrum antimicrobial agent for intravenous iv.
Learn more about medicare prescription drug plans and savings with goodrx. Read the package insert that comes with gamunex c immune globulin injection subcutaneous or iv. Please see adjacent page for brief summary of gamunexc full prescribing information. For patients at risk of thrombosis, administer gamunexc at the minimum dose and infusion rate practicable. Gammagard liquid, gammaked, gamunexc immune globulin. Pi the most common adverse reactions 5% with intravenous use of. Jeffrey modell foundation medical advisory board, 20. Up to 6 months at any time during 36month shelf life. This medication is usually given by slow injection infusion into a vein by a health care professional. Gamunex is the only one that is approved for neurological disorders, and the only one that i will use. Xgevadenosumab injection, for subcutaneous use initial usapproval.
Gamunex c is also approved to treat idiopathic thrombocytopenic purpura itp in adults and. Globulin subcutaneous igsc product have not been studied. Medicare coverage and pricing details for gamunexc. The gamunexc infusion line can be flushed with 5% dextrose in water d5w or 0.
Phenytoin sodium is related to the barbiturates in chemical structure, but has a fivemembered ring. Ensure the correct dosage has been ordered as per product monograph. Panzyga immunoglobulin intravenous human, 10% is a sterile liquid preparation of highly purified immunoglobulin g igg derived from large pools of human plasma. Quarterly accepts manuscript submissions in ms word between 600 and 2,500 words in length. Dosage requirements for patients switching to gamunexc from another immune. If a patient routinely receives a dose of less than 400 mgkg of. Prior authorization protocol bivigam, carimune nf, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunex, octagam, privigen immune globulin intravenous, ivig. For additional information about gamunex, please see. If dilution is required, gamunex c may be diluted with 5% dextrose in water d5w. Type your drug name like atorvastatin, sildenafil, etc. It contains the antibodies to help your body protect itself against infection from various diseases. Even after administration of high doses of gamunex 10%, no change in the ph of the blood was recorded.
Gamunexc is contraindicated in individuals with acute severe hypersensitivity reactions to immune globulin human. Under some plans, including plans that use an open or closed formulary, intravenous immunoglobulins ivig and adagen are subject to precertification. Side effects of gamunexc immune globulin injection human. Omnipaque oral solution 9 and 12 are indicated for oral use only see. Gamunex immune globulin intravenous human, 10% is indicated in. Chronic inflammatory demyelinating polyneuropathy cidp. The treatment of patients with primary immune deficiency pid and secondary immune deficiency sid. We are receiving inconsistent information about the administration of gamunex infusions. Pharmacokinetics, safety, and tolerability of subcutaneous. Gamunexc is an immune globulin injection human 10% liquid indicated for. Oct 15, 2008 for additional information about gamunex, please see. Gamunex immune globulin intravenous human, 10% does not contain sucrose. This document applies to all gamunex immune globulin 10%. Cuvitru is a readytouse liquid medicine that is given under the skin subcutaneously to treat primary immunodeficiency pi in people.
Gammaked, immune globulin injection human, 10% caprylatechromatography purified initial u. Hepatitis a vaccine is preferred to immune globulin for all susceptible persons. Gamunex immune globulin intravenous human 10% consists of 9%11% protein in 0. The same iv port is used and the vein is flushed with dextrose prior to administering the gamunex. Following 60minute intravenous infusions of 200 mg and 400 mg ciprofloxacin to normal volunteers, the mean maximum serum concentrations achieved were 2. 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. What gamunex 10% is and what it is used for what gamunex 10% is this medicine is an unmodified human immunoglobulin g igg with a broad spectrum of antibodies to various infectious agents. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. If precertification requirements apply aetna considers these medications to be medically necessary for those members who meet the following precertification criteria. Mar 08, 2016 gamunex is the best, and most physiologically well tolerated, but if you read the insert, it forms precipitates when it comes into contact with saline. Tell the doctor right away if any of these side effects occur. Indications and clinical use panzyga is indicated for.
Enterococcus faecalis vancomycin susceptible isolates only. Refer to package insert for dosage and administration and compatibility with other solutions. Please see adjacent page for brief summary of gamunex c full prescribing information. Gamunex c immune globulin subcutaneous 10%, hizentra immune globulin subcutaneous 20%, hyqvia immune globulin infusion 10% with. If side effects occur, the infusion should be slowed or stopped until the symptoms subside. Side effects of gamunexc immune globulin injection. Osmolality is 258 mosmolkg solution and thus approximates to the normal range 285295. Gamunex immune globulin intravenous human 10% contains trace levels of fragments, iga average 0. Talecris biotherapeutics receives fda approval for gamunexc. Phenytoin sodium injection, usp is a sterile solution containing in each ml phenytoin sodium 50 mg, propylene glycol 0. Indicated as replacement therapy for primary humoral immunodeficiency pi. September 2011 line extension of gamunex c, fda approved 10142011, for primary immunodeficiency. Gamunexc immune globulin helps to prevent or reduce the severity of certain infections in patients who are at risk. In clinical trials, one class iii patients death was judged attributable to the interruption of flolan.
Gamunexc immune globulin injection official site for. Infuse gamunexc using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. This document applies to all covenant and ahs sites. These highlights do not include all the information needed to use gammaked safely and effectively. Patient education is vital to treatment success in cidp, pidd, and itp. Gamunexc immune globulin injection human 10% caprylatechromatography purified is a form of immunoglobulin therapy and is used to treat people with chronic inflammatory demyelinating polyneuropathy cidp, primary immunodeficiency pi, and idiopathic thrombocytopenic purpura.