Third, recombinant monoclonal antibody drugs: 3 1 Ilaris (canakinumab) approval date: June 17, U.S. FDA, 2009 年 10 月 29 EU EMEA approval; Company:. Novartis AG General Description: Canakinumab is a recombinant, human anti- - human-IL-1β monoclonal antibody is IgG1 / κ isotype subclass. Expression of the murine cell line Sp2/0-Ag14 by two 447 - (or 448 -) and two heavy chain residues 214 - residue light chains, when the deglycosylated molecular weight of 145,157 Er Dayton. Canakinumab inclusive of two heavy chain oligosaccharide chains attached to the protein backbone iss group asparagine 298 (Asn 298). Indications: ILARIS interleukin-1β blocker for the treatment of adults and children 4 years old and over implicit thermal protein (cryopyrin) - associated periodic syndrome (CAPS), including: familial cold spontaneous inflammatory syndrome iss group (Familial Cold Autoinflammatory Syndrome, FCAS Note: rare inflammation, characterized by a general exposure iss group to the cold temperature, fever, rash and joint pain); Mu - Weier Shi syndrome (Muckle-Wells Syndrome, MWS, Note: characterized by familial amyloidosis involving kidneys, nerves and unexplained progressive deafness, limb and joint and muscle pain with fever urticaria; autosomal dominant inheritance). DOSAGE AND ADMINISTRATION: weight> 40 kg CAPS patients iss group were treated with 150 mg and weight 15 kg and 40 kg CAPS patients were treated iss group with 2 mg / kg. 15 至 40 kg, the dose for children of poor response may be increased to 3 mg / kg. Contraindications: None. Adverse reactions: CAPS patients reported using this treatment the most common adverse reactions iss group were nasopharyngitis, diarrhea, influenza, headache iss group and nausea. 2 Stelara (ustekinumab) Injection FDA Approval Date: September 25, 2009, the Company: Centocor Ortho Biotech Inc General Description:. STELARA is IL-12 and IL-23 cytokine IgG1κ p40 subunit of human monoclonal antibodies?. Characterized by recombinant DNA technology in the production of recombinant cells is well established, iss group and with the standard bio - technology purification. Manufacturing process includes a variety of steps to clear the virus. STELARA? 1326 by the amino acid composition and molecular weight estimates ranging from 148,079 to 149,690 Daltons. Indications:? STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of adult (18 years or older), moderate to severe plaque psoriasis, phototherapy or systemic iss group therapy in patients iss group candidate. Dosage and Administration: subcutaneous administration. Body weight <100 kg (220 lbs) patient, the recommended iss group dose, 45 mg and 4 weeks after the start, and then 45 mg every 12 weeks. On body weight> 100 kg the recommended dose patients and 4 weeks after the initial 90 mg, then 90 mg every 12 weeks. Contraindications: None. Adverse reactions: The most common adverse reactions (incidence> 3% and> iss group placebo): nasopharyngitis, iss group upper respiratory tract infection, headache and fatigue. 3 Arzerra iss group (ofatumumab) Injection Approval Date: U.S. FDA, 2009 年 10 月 26 February; Company: KLS company GlaxoSmithKline (GSK) and Genmab General Description: ARZERRA (ofatumumab) is a human monoclonal IgG1 molecular weight of about 149 kDa. Transgenic mice generated antibodies and recombinant hybridoma technology and murine cell lines (NS0) using standard mammalian cell culture and purification techniques units produced. Indications: ARZERRATM (ofatumumab) is a targeted cytotoxic-CD20 monoclonal antibody for the treatment of fludarabine (fludarabine) iss group and alemtuzumab (alemtuzumab) iss group in refractory chronic lymphocytic leukemia (CLL) patients. Its effectiveness is based on objective response lasting display. No data confirmed ARZERRA can improve disease-related symptoms or increased survival. DOSAGE AND ADMINISTRATION: dilution and intravenous infusion, not intravenous injection. The recommended dose is 12 administration and processes: the initial amount of 300 mg followed by one week after 2,000 mg of 7 times per week, followed by 2,000 mg every 4 weeks for a total of four times after 4 weeks. Advance to the oral or intravenous iss group acetaminophen intravenous antihistamines and corticosteroids. Contraindications: None. Adverse reactions: The most common adverse reactions (10%) is leukopenia, pneumonia, fever, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis and upper respiratory tract infections. 4 Simponi (golimumab) Injection Approval Date: April 24, 2009 the U.S. FDA, 2009 年 10 月 1 EU EMEA; Company:. Centocor General Description: SIMPONI (golimumab) is a human tumor necrosis iss group factor α (TNFα)-specific human IgG1 monoclonal iss group antibody, showing various glycoforms (multiple glycoforms) a molecular weight of about 150 to 151 kDa. TNF immune employing genetically engineered mice to build SIMPONI, get someone antibody iss group variable region iss group and a constant region of the antibody. SIMPONI purified by continuous perfusion culture production of recombinant cell lines and a series of steps, iss group including viral inactivation and removal steps. Indications: SIMPONI is the inhibition of tumor necrosis factor blockers for: (1) and in combination with methotrexate treatment of moderate to severe rheumatoid arthritis in adult (RA). 2 alone or in combination with methotrexate treatment of adult active psoriatic arthritis (PsA). 3. Treatment of adult active ankylosing arthritis (AS). DOSAGE AND ADMINISTRATION: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis 50 mg subcutaneous injection once a month. Contraindications: None. Adverse reactions: The most common adverse reactions iss group (incidence> 5%) are: upper respiratory tract infection, iss group nasopharyngitis. Boxed Warning: Severe infections: leading to hospitalization or death, have occurred in patients with an acceptable SIMPONI2 iss group including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and other opportunistic infections. 2 If a serious infection or sepsis patients should be interrupted medication. (3) to test for latent TB; such a positive start TB treatment. 4 even begin treatment of latent TB, such as testing negative, OMV all patients during treatment with active iss group TB. Child and adolescent patients reported with TNF blockers had malignant lymphoma and other malignancies, some fatal, SIMPONI is one of the members. Fourth, the new recombinant protein drugs a Atryn (antithrombin (recombinant), Antithrombin (Recombinant)) Approval Date: February 6,2009 U.S. FDA, July 28, 2006 EU EMEA; Company: iss group British GTC Biotherapeutics, Limited. General Description: Injection Atryn are nanometer filtration, disinfection of the bacteria viruses, terminally heat treated, lyophilized formulations. Antithrombin iss group (recombinant), Atryn activity of the active ingredient is a recombinant human antithrombin is a 432 amino acid glycoprotein with a molecular weight of approximately 57,215 daltons. MF: C2191H3457N583O656S18. By recombinant DNA technology using genetic engineering techniques thrombin mammary DNA coding sequence is introduced into the DNA sequence together iss group with the production of anti-thrombin (recombinant) goat anti-thrombin which may be oriented iss group in milk expression. Production of antithrombin (recombinant) goat by the United States iss group Department of Agriculture iss group U.S. Department of Agriculture (USDA) proved no scrapie (scrapie-free, Note: It is a fatal disease in sheep and goats, manifestations iss group of chronic itching, muscle iss group ataxia and degeneration of the central nervous system), and the control of specific pathogens. Antithrombin (recombinant) and human plasma - the same amino acid sequence sources antithrombin. Antithrombin (recombinant) and plasma-derived antithrombin both contain six cysteine residues forming three disulphide iss group bridges and 3-4 N-linked carbohydrate portion. Antithrombin (recombinant) glycosylation differs from plasma-derived antithrombin graphics, resulting in increased affinity for heparin. When analyzing the presence of excess heparin and recombinant products no different plasma-derived products. iss group Indications: For the prevention of hereditary antithrombin deficiency in patients with perioperative and perinatal perinatal thromboembolic events. Does not apply to the treatment iss group of patients with hereditary antithrombin deficiency thromboembolic events. DOSAGE AND ADMINISTRATION: after preparation for intravenous use only. Atryn dose for each patient individualized. The purpose is to restore and maintain the therapeutic functionality of antithrombin (AT) activity level in the normal 80% - 120% (0.8 - 1.2 IU / mL). Given load capacity of 15 - minute intravenous infusion, followed by a maintenance dose infusion to continue. Contraindications: Known for goats and goat's egg Baichao Min patients. Adverse reactions: clinical trials, the frequency of 5% of the most commonly reported adverse reactions are hemorrhage and infusion site reactions. .. References 1 http://www.drugs.com/ 2 http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ iss group 3 http://www.fda.gov/ 4 http: / / www.emea.europa.eu / htms / human / epar / a.htm 5 http://www.sfda.gov.cn/ 6 Niemann H, Kues WATransgenic farm animals:.. an update Reprod Fertil Dev.. 2007;.. iss group 19 (6) :762-70 .. 7 Dixon MB, Lien YH Tolvaptan and its potential in the treatment of hyponatremia.Ther Clin Risk Manag 2008 Dec;.. 4 (6) :1149-55 8 Berntorp. .. E, Windyga J; European Wilate Study Group Treatment and prevention of acute bleedings in von Willebrand disease-efficacy and safety of Wilate, a new generation von Willebrand factor / factor VIII concentrate.Haemophilia 2009 Jan; 15 (1): 122 - . 30 9 Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, Tanaka KA Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level:... a pilot study Br J Anaesth 2009. Jun;..... 102 (6) :785-92 Epub 2009 May 2 10 Keating GM Human C1-esterase inhibitor concentrate (Berinert) BioDrugs 2009;.. 23 (6) :399-406 11 Statkute L, Ruderman. . EM Novel TNF antagonists for the treatment of rheumatoid arthritis Expert Opin Investig Drugs 2010 Jan;.. 19 (1) :105-15.
Instructions [154] Pharmaceutical Affairs [17] to treat gout medicine [2] anticoagulants [2] anti-infective drugs [6] Clinical studies of drugs [19] dipeptidyl peptidase -4 (DPP-4) inhibitors [ 2] vaccines [4] clinical studies important findings [16] multiple myeloma [1] incretin therapy in type 2 diabetes [3] clinical study drug treatment progress [8] cancer treatment drugs [1] pharmacokinetics [4 ] treatment with peptides [1] Symposium [1] monoclonal antibody therapeutic agents [9] drug research new technologies [6] FDA approved drugs [185] clinical trials [10] orphans iss group (orphan) drugs [12] new ideas or new methods of drug research design [15] drug research new technologies and new methods [4] Basics [20] kinase inhibitor [13]
There are cases in patients with CLL and coexistence iss group Obinutuzumab plus chlorambucil TAFINLAR (dabrafenib) Instructions January 2014 edition Mekinist (trametinib) Instructions 2014
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