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Duopa(Carbidopa and Levodopa Enteral Suspension)为晚期帕金森症患者的长效新药物
DUOPA (carbidopa and levodopa) enteral suspension is a treatment for motor fluctuations in patients with advanced Parkinson’s disease.
Important Safety Information about DUOPA (carbidopa and levodopa) enteral suspension
DUOPA (carbidopa and levodopa) enteral suspension is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains 2 medicines: carbidopa and levodopa.
DUOPA is given over a period of 16 hours by a pump through a tube that requires a small hole (stoma) into the stomach. Before the procedure, a discussion with a healthcare provider about any previous procedures or problems with the abdomen area is required. Risks of the procedure may result in blockage of the stomach or intestine, stopping of movement through the intestine, infection, inflammation of the pancreas, stomach pain, gas, stomach and intestinal ulcers or bleeding, nausea, blocking of the tube, or other serious outcomes that may lead to surgery or be fatal.
DUOPA should not be taken by people who are currently taking or have recently taken (within 2 weeks) a medicine called a nonselective monoamine oxidase (MAO) inhibitor. Serious side effects of medicines that contain carbidopa and levodopa, including DUOPA, include sleepiness or suddenly falling asleep without warning during daily activities. Patients should not drive or operate heavy machinery until they are sure how DUOPA affects them. Some patients taking Parkinson's disease medications, including DUOPA, can experience low blood pressure; fast, irregular heartbeat or chest pain; dizziness or fainting; hallucinations or confusion; intense urges they are unable to control, including the urge to gamble, spend money, or overeat; increased sexual urges; and other intense urges. DUOPA can cause or worsen depression. Patients should be counseled to report symptoms of depression or thoughts of suicide. Suddenly stopping DUOPA or rapid dose reduction can result in fever and confusion. Taper dose and monitor patients for fever, confusion, or severe muscle stiffness. Progressive weakness or loss of sensation in the fingers or feet may occur. People with Parkinson's disease have a greater risk of melanoma than the general population and should be monitored while on DUOPA. Worsening of glaucoma may occur. The most common adverse reactions (>7% and greater than carbidopa and levodopa immediate release) were complication of device insertion, nausea, constipation, incision site erythema, dyskinesia, depression, post procedural discharge, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, confusional state, anxiety, dizziness, and hiatal hernia.
DUOPA Rx
Pharmacological Class:
Dopa-decarboxylase inhibitor + dopamine precursor.
Active Ingredient(s):
Carbidopa 4.63mg (as 5mg of monohydrate), levodopa 20mg; per mL; enteral susp; use with CADD-Legacy 1400 pump.
Company
AbbVie
Indication(s):
Treatment of motor fluctuations in advanced Parkinson’s disease.
Pharmacology:
Carbidopa inhibits the decarboxylation of peripheral levodopa, making more levodopa available for delivery to the brain. Levodopa is the metabolic precursor of dopamine, which crosses the blood-brain barrier, and presumably is converted to dopamine in the brain.
Clinical Trials:
The efficacy of Duopa was established in a randomized, double-blind, double-dummy, active-controlled, parallel group, 12-week study in patients with advanced Parkinson’s disease who were levodopa-responsive and had persistent motor fluctuations while on treatment with oral immediate-release (IR) carbidopa-levodopa and other Parkinson’s disease medications.
Patients (n=71) were randomized to either Duopa + placebo capsules or placebo suspension + IR carbidopa-levodopa 25mg/100mg capsules; all patients had a PEG-J device placement. The clinical outcome measure was the mean change from baseline to Week 12 in the total daily mean “Off” time, based on a Parkinson’s disease diary. The mean score decrease in “Off” time from baseline to Week 12 for Duopa was significantly greater (−4.0 vs. −2.1 hours; P=0.0015) than for oral IR carbidopa-levodopa. Also, the mean score increase in “On” time without troublesome dyskinesia from baseline to Week 12 was significantly greater (4.1 vs. 2.2 hours; P=0.0059) for Duopa than for oral IR carbidopa-levodopa.
Legal Classification:
Rx
Adults:
See full labeling. Prior to initiation, convert all other forms of levodopa to oral (IR) carbidopa-levodopa tabs (1:4 ratio). Give by infusion over 16 hours through an NJ tube (optional: short-term) or PEG-J tube (long-term). Individualize. Day 1: calculate and administer initial daily (Morning Dose + Continuous Dose); titrate subsequent doses based on response. Max daily dose: 2000mg of levodopa (1 cassette) over 16 hours. May give extra doses to manage acute “Off” symptoms uncontrolled by the Morning Dose + Continuous Dose over 16 hours. Treatment discontinuation: taper dose or switch to oral IR carbidopa-levodopa tabs.
Children:
Not established.
Contraindication(s):
During or within 2 weeks of nonselective MAOIs (eg, phenelzine, tranylcypromine).
Warnings/Precautions:
Risk of GI or GI procedure-related complications (may result in the need for surgery or death). Sleep disorders: consider discontinuing if significant daytime sleepiness occurs. Monitor for orthostatic hypotension. Depression. Suicidal tendencies. Major psychotic disorder: not recommended. Impulse control disorders: consider reducing dose or discontinuing if occurs. Monitor for signs/symptoms of neuropathy. History of MI or arrhythmias. Glaucoma: monitor intraocular pressure. Perform skin exams to monitor for melanoma. Withdrawal-emergent hyperpyrexia or confusion: avoid sudden discontinuation or rapid dose reduction. Elderly. Pregnancy (Category C). Nursing mothers.
Interaction(s)
See Contraindications. Orthostatic hypotension with MAO-B inhibitors (eg, rasagiline, selegiline), antihypertensives; may need to adjust dose of antihypertensive. Increased somnolence with sedatives, alcohol, or other CNS depressants (eg, benzodiazepines, antipsychotics, antidepressants). Antagonized by phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine, isoniazid, iron salts, high protein diets. May interfere with lab tests.
Adverse Reaction(s)
Device insertion complication, nausea, depression, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, incision site erythema; dyskinesia (reduce doses), CNS disturbances (eg, hallucinations, confusion, somnolence).
How Supplied:
Single-use cassettes (100mL)—7
LAST UPDATED:
1/26/2015
Duopa(Carbidopa and Levodopa Enteral Suspension)被FDA批准为帕金森症长效上市
2015年1月14日，艾伯维宣布公司开发的用于治疗晚期帕金森症患者运动波动的药物DUOPA获得FDA的上市批准，这一利好消息无疑对今后生物医药产业界更好地开发这类药物打了一针强心剂。
DUOPA是目前市面上第一种畅销治疗帕金森症患者运动波动的药物。它主要是通过一个小型药物泵将卡比多巴和左旋多巴注入人体，以达到治疗效果。这种疗法的持续时间可以长达16个小时，极大程度上降低了患者的负担和痛苦。与传统的口服卡比多巴和左旋多巴不同，DUOPA是将药物直接泵入到小肠部位，避过了患者的胃部，从而避免了胃部的酸性环境和酶类对药物的破坏，保证药效。
此次FDA批准DUOPA作为罕见病药物上市。研究人员称，这一决定将在很大程度上缓解目前重度帕金森症患者对治疗运动波动的疗法的需求。临床三期研究显示，使用了DUOPA的患者临床症状获得了明显缓解。
所谓帕金森症，是一种神经退行性疾病，它可以造成患者出现震颤、肌肉僵硬、动作缓慢等等症状，这主要是与大脑中一种分泌多巴胺的细胞数量减少直接相关。目前，科学家们尚没有办法治愈这种疾病，仅能通过药物缓解这种疾病的症状。据估计，美国目前有一百万人患有这种疾病，而每年还有6万例新增病例出现。
http://www.multivu.com/players/English/7132951-abbvie-fda-approval-duopa/
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