33% of reviewers reported a positive effect, while 33% reported a negative effect. Pharmacists also advise. Aim: To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving Octagam ® 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP). . Corporate news. Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) ( 1 ). DM - The most common adverse reactions reported in >5% of study subjects were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions. Available Brand Names of OCTAPHARMA: Octagam 5%, Octagam 5%, Octagam 5%, Octagam 5%, Octagam 10%, Octagam 10%, Octagam 10%, Octagam 10%. En una dosis en asociación con el ácido acetilsalicílico. First 30 min. In some blood disorders (aplastic anemia, Myelodysplastic Syndromes [MDS]), T. 0 incubation, SD Octagam 10% Octapharma USA Customer service: (866) 766-4860 Chronic ITP 106 mcg/mL 4. Octagam® 10% is a ready-to-use solution available in Australia as a 10% concentration. It has fewer side effects than steroids or immunosuppressive agents. Rate of administration. A total of 664 infusion cycles with Octagam 10% were administered during the entire study. Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 1 gram protein/10 mL bottle, NDC 00944-2700-02. It is composed of the. Each center focuses on providing top quality care to all patients in search of professional infusion therapy treatment. 5 mg/kg/min and a 3. This medication. Trasplante de médula ósea alogénico: - Tratamiento de infecciones y profilaxis de injerto contra enfermedad del huésped. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. Option Two: If you are receiving home infusions the home infusion company may be able to offer assistance. . " Intravenous immune globulin (IVIg) is a blood product prepared from the pooled plasma of donors. 4. You may be shown how to use an IV at home. 4)Renal dysfunction, acute renal failure, osmotic nephropathy, and Ensure that patients are not volume depleted prior to the initiation of the infusion days following rapid infusion with Octagam treatment. Option Three: There are many other programs and organizations that can help you with access to IVIG and/or other medications. Administration. For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 5%liquid at the minimum dose and infusion rate practicable. Intravenous immunoglobulin (IVIG) therapy is a treatment for people with weakened immune systems. Individual has antibodies to IgA, or a history of hypersensitivity to any product containing a higher content of IgA HyQvia (immune globulin infusion [human] 10% with recombinantDosing recommendation. I have more strength. 33 mg/kg/minCertain severe adverse drug reactions may be related to the rate of infusion. 06ml/kg/min, if no abnormal sign appears from patients. Octagam 5% liquid is a solution for infusion which must be administered intravenously. Humans have five primary types of immunoglobulins, IgG, IgM,. 0. 5 mL/kg/hrThe information provided in Name of the medicinal product of Octagam. The figure above depicts total infusion time based on the infusion rates and ramp-up schedule for octagam 10%. If you experience drowsiness, dizziness, hypotension or a headache as side-effects when using Octagam Infusion medicine then it may not be safe to drive a vehicle or operate heavy machinery. 0g, 2. , hemoglobin, kidney and liver function tests, platelet count, serum IgG level). OCTAGAM® is a prescription infusion medication used to treat adult patients with chronic immune thrombocytopenic purpura (cITP) to raise platelet counts and control bleeding. 1 Octagam® 10% is supplied in 2 g, 5 g, 10 g and 20 g single-use bottles. Octagam (immune globulin intravenous) "Octagam 10 for Myasthenia Gravis , #1 I had a headache and chills the next day. Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. (USA) 20/07/2021. The rate can then be increased based on the tolerability of the patient. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer octagam 10% at the minimum dose and infusion rate practicable. All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for. Confound the results of serological testing (7). The pooled plasma samples are purified before administration. It has been used to treat a variety of autoimmune diseases, including mucocutaneous blistering diseases. and/or Infusion Precertification Request Page 1 of 3 For Medicare Advantage Part B: FAX: 1-844-268-7263 . The cost for Octagam intravenous solution 10% is around $403 for a supply. 2 g/kg. Your doctor will give you OCTAGAM® as an infusion, that is, an injection given slowly into the vein. Some side effects may occur during the injection. Idiopathic Thrombocytopenic Purpura is a systemic illness characterized by ecchymoses (extensive purplish patchs caused by extravasation of blood into the skin) and hemorrhages from mucous membranes and very low platelet counts. 10% IVIG products: If no reaction to first infusion, Intragam® 10, Privigen®, Flebogamma® 10%, Kiovig® Octagam® 10% should be infused at a rate of 0. Patients predisposed to. Severe muscle, joint, or bone pain. Uncommon (0. Refer to the Criteria for the clinical use of immunoglobulin in Australia for specific indications and product information sheet for further information. Subjects who were on the 4-week infusion sched-The NDC code 68982-840 is assigned by the FDA to the product Octagam Immune Globulin (human) which is a plasma derivative product labeled by Octapharma Usa Inc. death may occur with the administration of Immune Globulin . Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases. Initial Infusion Rate: 0. Mecanismo de acción: es un medicamento derivado de la sangre humana, inyectable estéril y no piretógeno, conteniendo los anticuerpos normales de la población o inmunoglobulina tipo G (IgG) polivalente, en sus diferentes subclases IgG1, IgG2, IgG3 e IgG4, semejante al suero o plasma de partida. Product. Hyperproteinemia, increased serum viscosity, and hyponatremia occur in patients receiving lglV therapy. 2, 5. Home Infusion Administration . Octagam 5% liquid contains maltose, a disaccharide which is derived from corn. This medicine is collected from the pooled blood of many donors. For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer octagam 10% at the minimum dose and infusion rate practicable. Ensure adequate. 5915 Landerbrook Dr, Suite 110 | Mayfield Heights, OH44124 | Phone: 216-381-3333 | Fax: 440-443-0700 | [email protected]. Nplate has an average rating of 7. Indications and Limitations of Coverage. 1. Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 5 grams protein/100 mL vial, NDC 61953-0004-03. Sensitivity to these reactions is usually related to the infusion rate. 2–200 microns; Administer octagam 10%, which is to be at room temperature, only by the intravenous route; Rate of administration mg/kg/min (mg/kg/hour) mL/kg/min; First 30 min: 1 (60) 0. Mitä valmiste on ja mihin sitä käytetään. We currently offer IVIG, Gammagard, Gammunex, Octagam, Nulojix, and IV Steroids for autoimmune treatment. Injection. 0 out of 10 from a total of 3 ratings on Drugs. DOB Address Cell Phone . Octagam 5% liquid is a solution for infusion which must be administered intravenously. 01: Next 30 min: 2 (120) 0. Patients predisposed to. Initial infusion rate: 0. Revised: April 2022 . Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 10% liquid. PI : 300 to 600 mg/kg every 3 to 4 weeks based on clinical response. congenital AIDS and HSCT) 0. Int Immunopharmacol . Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions. Dizziness. (Patients with renal failure or diabetes require daily U&Es during course of infusions, on day of completing infusion and 3 days after completion of course). Primary immune thrombocytopenia. Octagam (J1568) Gammagard liquid (J1569) Flebogamma (J1572) Immune globulin drugs covered under Part B for administration in the home for patients with PIDD are subject to change. The kit is available on the Blood transfusions page, or for printed copies contact BloodSafe. Initially infuse Octagam 5% liquid at infusion rates stated below, at least until the physician has had adequate experience with a given patient. Privigen(R): 1 gram/kg, IV, daily for 2 consecutive days (total dose of 2. For any signs of infusion reaction: STOP infusion. PARAMUS, N. Note: Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma, Gammagard, Gammaked, Gammaplex, Gamunex-C, Hyqvia, Octagam, Panzyga, and Xembify are non-preferred. 9 g/kg/course; Table 1). Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated. Octagam 10% (PDF 56KB) Privigen and Privigen AU 10% (PDF 51KB) Paediatric transfusion information kit. Caution should be exercised in the administration of intravenous immune globulin; reactions may cause a rapid fall in blood pressure and clinical anaphylaxis. 1% to 1%): Infusion site inflammation, injection site edema, injection site pruritus, injection site swelling, migration. Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin; in IgA-deficient patients with antibodies against IgA and history of hypersensitivity; in patients with acute hypersensitivity reaction to corn. 3 Contraindications Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see Sections 4. Octagam 5% liquid is a solution for infusion which must be administered intravenously. 3 Contraindications Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see Sections 4. octagam 10% was well tolerated and effective in this population representative of adult patients with ITP, even at the maximum infusion rate of 0·12 ml/kg/minute, without unexpected safety issues. Precertification of intravenous immunoglobulins (IVIG) [Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, and Privigen] and subcutaneous immunoglobulins (SCIG) [Cutaquig, Cuvitru, Hizentra, HyQvia, and. Indications. Octagam 5% liquid at the minimum rate of infusion practicable (less than patients before administration. I had Octagam yesterday and today and have no symptoms except feel very tired. QUALITATIVE AND QUANTITATIVE COMPOSITION . Octagam 10% is not supplied with an infusion set. 4 g/kg every 3–4 weeks. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Place this label in your treatment diary or log book. S. Octagam 10% contains not more than 3% aggregates, not less than 94% monomers and dimers and not more than 3% fragments. 3Administration • Administer Octagam 10%, which is to be at room temperature, only by the intravenous route. 07 mL/kg/min (3. To book your first appointment, please call 954-248-3422. ). injection, immune globulin, (octagam), intravenous. Insert needle only once, within the stopper area delineated (by. Octagam® 5% Immune Globulin Intravenous (Human) 5% Liquid Preparation Octapharma USA Inc. The dermatology infusion nursing team at IV Infusion Treatment Center has experience with many of these conditions, and we administer the IV medications Remicade, Stelara, and Simponi Aria. S. Octagam 5% 50mg/ml Infusion manufactured by OCTAPHARMA. . Maintenance infusion rate: If the infusion is well tolerated, the rate can be increased every 30 minutes up to 5 ml/kg/hr (8 mg/kg/min). Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Office. Indicated for treatment of dermatomyositis; 2 g/kg IV divided in equal doses over 2-5 consecutive days q4Weeks ; Guillain-Barre; Lambert-Eaton Myasthenic; Stiffman Syndrome (Off-label)Octagam ® 5% and Octagam ® 10% do not contain sucrose. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Its generic name is Immunoglobulin-gamma (human, normal). During the study no patient met the criteria for intravascular haemolysis. 302. ³˒⁴. Animal studies have not been performed. Confound the results of serological testing (7). The product's dosage form is solution and is administered via intravenous form. 2–0. 5 mL/kg/hour for the first 15 minutes. 5ml/kg/hr x 62 kg x 1hr = 31ml/hr (for 30 minutes), then gradually increase subsequent infusion rates every fifteen minutes as the patient can tolerate. Contents of the pack and other information 1 What Octagam 10% is and what it is used for What Octagam 10% is Octagam 10% is a human normal immunoglobulin (IgG) solution (i. infusion of Octagam 5% liquid with some glucometer and test strip systems. A dermatology infusion center can often use IV therapy to treat conditions such as psoriasis, atopic dermatitis, lupus, or pemphigus. 5 mg/kg/min 3. Gammagard Liquid 2. OCTAGAM. 0 US source and recovered plasma from FDA-registered sites 40 Cold ethanol, pH 4. Privigen 5. Example: A 62 kg patient is to receive 55g of Octagam. 759. Use is not recommended unless clearly needed. On July 15, the U. com. It is characterized by . Results:. 8–1. ¹˒². 02: Next 30 min:The manufacturing process for octagam 10% therapy for adult dermatomyositis has been validated for its capacity to remove and inactivate both enveloped and nonenveloped viruses. 2 micron filters may be used. 2% of. Popularity arrow_drop_down. IndicationDose Initial Infusion rateMaintenance infusion rate (if tolerated) PI 300-600 mg/kgEvery 3-4 weeks0. This preparation contains approximately 100 mg of protein per mL (10%) of which not less than 96% is normal human immunoglobulin G. User Reviews for Immune globulin intravenous to treat Myasthenia Gravis. g. Octagam Interactions. Maximum infusion rate is 4 mg/kg/min. The FDA granted a new indication to Immune Globulin Intravenous (Human) (Octagam 10%, Octapharma USA), for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. Octagam 5% and 10% liquid preparations do not contain sucrose. OCTAGAM®. 3 mg/kg/min)This section addresses coverage of drugs and biologicals. Ensure adequate hydration in patients before administration.