Adalimumab

Adalimumab C화학적 특성, 용도, 생산

용도

Treatment of rheumatoid arthritis and other chronic inflammatory diseases (monoclonal antibody).

Indications

Adalimumab has been evaluated in a number of clinical trials for RA, Crohn's disease,ankylosing spondylitis,and psoriatic arthritis. Initially evaluated as adjunctive therapy to RA patients on methotrexate, adalimumab demonstrated rapid improvement in American College of Rheumatology 20 scores at 1 week of administration. The PREMIER trial compared combination adalimumab plus methotrexate therapy with either medication given alone and found that the combination of adalimumab plus methotrexate was superior to adalimumab or methotrexate monotherapy.

Pharmacology

Adalimumab is a fully human, anti-TNF-α IgG1 monoclonal antibody, which blocks the interaction of TNF-α with p55 and p75 cell surface receptors.
Adalimumab is typically administered as a 20-or 40-mg dose via subcutaneous injection either weekly or every other week. The subcutaneous route of administration may be favorable to infliximab, which requires an intravenous infusion.
The terminal half-life of adalimumab ranges from 15 to 19 days and early phase I trials demonstrated no significant pharmacokinetic advantage to weight-based dosing strategies.

Clinical Use

Adalimumab is supplied in single-use, prefilled, glass syringes as a sterile, preservative-free, colorless solution for subcutaneous administration. The pharmacokinetics of adalimumab were linear over the dose range of 0.5 to 10.0 mg/kg following a single IV dose. The mean elimination half-life was approximately 2 weeks.

부작용

Injection site reactions appear to be the most commonly reported adverse event and occur in up to 10% of patients treated. In an efficacy and safety study of adalimumab for ankylosing spondylitis, the number of adverse events was higher in patients receiving subcutaneous adalimumab 40 every other week than in those receiving placebo. The percentage of patients who experienced infectious complications was higher in the patients receiving adalimumab, but this finding was not statistically significant. No occurrences of latent tuberculosis reactivation, lupus-like syndromes, congestive heart failure, or secondary malignancies were reported.In a postmarketing surveillance study of RA patients, Schiff et al.reported that adalimumab appeared to be relatively safe and well tolerated. In their study, safety data from randomized clinical trials, open-label extensions, phase IIIb trials, and postmarketing reporting of adverse events in the USA were collected. Reported adverse events included serious infections (5.1 events/100 patient-years (PYs)), lymphoma (0.12/100 PYs), tuberculosis (0.27/100 PYs), opportunistic infections (0.08 events/100 PYs), demyelinating diseases (0.08/100 PYs), systemic lupus erythematosis/lupus-like syndrome (0.10/100 PYs), and congestive heart failure (0.28/100 PYs). The incidence of lymphoma did not appear to be significantly higher in patients treated with adalimumab than in RA patients who were naïve to anti-TNF-α therapy; however, the rate of lymphoma may be higher in RA patients compared to the general population, particularly in patients with severe RA. Adverse events reported in patients with ophthalmic inflammatory disease treated with adalimumab have included injection site reactions, herpes simplex keratitis, and elevation of liver enzymes requiring cessation of therapy.

Drug interactions

Adalimumab is currently approved for RA and psoriatic arthritis in combination with methotrexate and low-dose prednisone. Live viruses should be avoided in patients on adalimumab and its use may decrease the immunologic protection conferred by live attenuated vaccines. No clear data are available for its use in combination with other biologic agents, so this combination should be avoided until further studies have demonstrated efficacy and safety.

주의 사항

Adalimumab is contraindicated in patients with known hypersensitivity to the medication or any of its components and in patients at risk for sepsis. In addition, the medication should be avoided in patients with a history of multiple sclerosis, active infection, or malignancy.

Adalimumab 준비 용품 및 원자재

원자재

준비 용품

Adalimumab 공급 업체

공급자	전화	이메일	국가	제품 수	이점
Shanghai Minbiotech Co., Ltd.	+8617315815539	sales@minbiotech.com	CHINA	129	58
Henan Tianfu Chemical Co.,Ltd.	+86-0371-55170693 +86-19937530512	info@tianfuchem.com	China	21691	55
Hubei xin bonus chemical co. LTD	86-13657291602	linda@hubeijusheng.com	CHINA	22968	58
TopScience Biochemical	00852-68527855	info@itopbiochem.com	China Hong Kong	902	58
career henan chemical co	+86-0371-86658258 15093356674;	factory@coreychem.com	China	29826	58
Shaanxi Dideu Medichem Co. Ltd	+86-29-87569265 +86-18612256290	1056@dideu.com	China	3632	58
Hubei Ipure Biology Co., Ltd	+8613367258412	ada@ipurechemical.com	China	10326	58
HONG KONG IPURE BIOLOGY CO.,LIMITED	86 18062405514 18062405514	ada@ipurechemical.com	CHINA	3465	58
Shanghai UCHEM Inc.	+862156762820 +86-13564624040	sales@myuchem.com	China	6710	58
Dideu Industries Group Limited	+86-29-89586680 +86-15129568250	1026@dideu.com	China	29271	58

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