L-谷氨酰胺口服粉末Endari (L-glutamine oral powder)
近日，FDA批准Endari（L- 谷酰胺口服粉[L-glutamine]）用于5岁及以上年龄患有镰状细胞疾病的患者，用以减轻与该血液疾病相关的严重并发症。Endari是近20年来获批用于镰状细胞疾病患者的首个治疗药物，
一般信息
Endari（L-谷氨酰胺口服粉末）通过改善烟酰胺腺嘌呤二核苷酸（NAD）的氧化还原电位来减少氧化剂对红细胞的损伤，烟酰胺腺嘌呤二核苷酸（NAD）是已被确定为氧化的主要调节剂的辅酶。
Endari专门用于减少5岁及以上成人和儿科患者的镰状细胞病（SCD）的严重并发症。
Endari是作为口服给药的粉末提供的。
临床结果
FDA批准
Endari的FDA批准得到了一项48周随机，双盲，安慰剂对照，多中心III期临床试验的疗效数据的支持，该试验评估Endari，处方级L-谷氨酰胺与安慰剂相比对230名成人和儿童的影响与SCD。结果显示，Endari将镰状红细胞危象的发生率降低了25％，住院率降低了33％。其他研究结果显示，累计住院天数减少41％，ACS发生率降低60％以上。
副作用
与使用Endari相关的不利影响可能包括但不限于以下内容：
•便秘
•恶心
•头痛
•腹痛
•咳嗽
•肢体疼痛
•背疼
•胸痛（非心脏）
作用机制
Endari（L-谷氨酰胺口服粉末）通过改善烟酰胺腺嘌呤二核苷酸（NAD）的氧化还原电位来减少氧化剂对红细胞的损伤，烟酰胺腺嘌呤二核苷酸（NAD）是已被确定为氧化的主要调节剂的辅酶。
Endari (L-glutamine oral powder)
VERZENIO Rx
Generic Name and Formulations:
Abemaciclib 50mg, 100mg, 150mg, 200mg; tabs.
Company:
Lilly, Eli and Company
Indications for VERZENIO:
In combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. As monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Adult:
Swallow whole. Take at the same time every day. Combination with fulvestrant (see full labeling): initially 150mg twice daily; in pre/perimenopausal women: also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: initially 200mg twice daily. Both: continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant strong CYP3A4 inhibitors: see full labeling. Severe hepatic impairment: reduce frequency to once daily.
Children:
Not established.
Warnings/Precautions:
Advise patients to initiate antidiarrheal (eg, loperamide) and increase fluids at first sign of loose stools; discontinue if Grade 3/4 diarrhea occurs or hospitalization required, until resolves to ≤Grade 1, then resume at next lower dose. Monitor CBCs and LFTs prior to initiation and every 2 weeks for the first 2 months, then monthly for the next 2 months, and as clinically indicated. Dose interruption/reduction/discontinuation or delay in starting treatment cycles if Grade 3/4 neutropenia, recurrent Grade 2 or Grade 3/4 transaminase elevation occurs. Monitor for signs/symptoms of venous thromboembolic events; treat appropriately. Severe hepatic impairment (Child-Pugh C). Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 3 weeks after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 3 weeks after the last dose).
Interactions:
Avoid concomitant ketoconazole, grapefruit products. Concomitant other strong CYP3A inhibitors: reduce abemaciclib dose. Avoid concomitant strong CYP3A inducers (eg, rifampin): consider alternative agents.
Pharmacological Class:
Kinase inhibitor.
Adverse Reactions:
Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, thrombocytopenia; venous thromboembolic events, hepatotoxicity.
Generic Availability:
NO
How Supplied:
Blister pack—14