FDA批准巯基嘌呤混悬液便于儿童用药

美国食品药品管理局（FDA）在巯基嘌呤50 mg片剂上市60多年后，批准了该药物的口服混悬液。

据FDA声明，巯基嘌呤口服混悬液（20 mg/mL）已于4月28日获准用于急性淋巴细胞性白血病（ALL）患者的联合治疗。该制剂的获批，使得ALL儿童患者用药剂量更为准确成为可能。

FDA声明指出，巯基嘌呤是一种核苷代谢抑制剂，最初于1953年获准上市，为50 mg片剂，这是迄今为止唯一获准上市的剂型，但对于6岁以下儿童而言并非理想剂型。有些药店提供复方制剂或将50 mg片剂掰开后用于儿童给药，对于采取同一给药方案的不同体重儿童，混悬剂的优势在于可提供更为准确的所需剂量，并且更加便于调整给药剂量。

该批准令是基于一项临床药理学研究结果，该研究评价了健康成人巯基嘌呤混悬液与片剂的生物等效性。在多药物联合化疗维持方案中巯基嘌呤起始剂量为1.5 ~2.5 mg/kg （50~75 mg/m2），每日1次。

该混悬液由英国NOVA Laboratories公司生产，将以商品名Purixan由Rare Disease Therapeutics公司负责在美国的销售。

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By: ELIZABETH MECHCATIE, Oncology Practice Digital Network

More than 60 years after it first became available as a 50-mg tablet, an oral suspension formulation of mercaptopurine has been approved by the Food and Drug Administration.

The oral suspension formulation (20 mg/mL) – approved on April 28 for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen – will make it possible to more accurately dose pediatric patients with ALL, according to the FDA announcement of the approval.

Mercaptopurine, a nucleoside metabolic inhibitor, was initially approved in 1953, in a 50-mg tablet formulation. Until now, this has been the only formulation available, which the FDA statement points out is not an ideal dosage form for children under age 6. Compounded formulations provided by local pharmacies or splitting the 50-mg tablets have been used to dose children, but "a suspension offers the advantage of more accurately delivering the desired dose to children with a wide range of weights using a consistent administration schedule," and will make it possible to be more flexible in adjusting the dose, the FDA statement said.

Approval of the suspension was based on a clinical pharmacology study that evaluated the bioequivalence of mercaptopurine tablets with the oral suspension in healthy adults. The starting dose of mercaptopurine in multiagent combination chemotherapy maintenance regimens is 1.5 to 2.5 mg/kg (50-75 mg/m2) as a single daily dose.

The suspension is manufactured by NOVA Laboratories in the United Kingdom, and it will be distributed in the United States by Rare Disease Therapeutics under the trade name Purixan. The prescribing information is available here.

Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.