|
部分中文Prezista处方资料（仅供参考）
艾滋病上市新药- Prezista 达如那韦（darunavir）
美国食品和药物管理局日前批准一种新药，用于治疗艾滋病。
这种药属于艾滋病病毒蛋白酶抑制剂类药物，通过抑制蛋白酶的作用，来阻碍艾滋病病毒的自我复制。
这种药名为“Prezista”，适用于感染了艾滋病病毒、但服用现有抗逆转录病毒药物未见疗效的成年人，至于那些感染艾滋病病毒、但从未接受过任何药物治疗的成年人及儿童是否也适用，目前还不清楚。
药管局批准这种新药可以和低剂量的另一种艾滋病药物“Norvir”同时用药，以提高药效。用药后的主要副作用表现为头痛、恶心、腹泻等。另外临床试验显示，7％的患者用药后还会出现不同程度的皮疹。
这一艾滋病新药由美国强生公司在比利时的一家医药子公司研制开发。据公司方面介绍，患者需每天两次、每次两片服用，每天用药需花费25美元。
达如那韦片
蒂泊特克制药（Tibotec Pharmaceuticals）公司的抗HIV药达如那韦（darunavir）薄膜包衣片（商品名：Prezista，原先称为TMC114），剂量规格：达如那韦300 mg/片。
达如那韦是一种新的HIV-1蛋白酶抑制药，其作用机制是选择性抑制感染细胞内的编码Gag-Pol多蛋白HIV卵裂，继而抑制形成成熟的病毒粒。
达如那韦适用于与小剂量利托那韦或其它抗HIV药合用治疗用其它抗HIV药治疗无效的成人HIV感染。利托那韦也是一种蛋白酶抑制药，可减缓达如那韦体内代谢，联合用药能使达如那韦血药浓度增加。推荐剂量：进食后服用达如那韦600 mg一日2次，加服利托那韦100 mg一日2次。
美国FDA加速批准了TibotecPharmaceuticals公司的抗HIV药达如那韦薄膜包衣片（darunavir，Prezista，原先称为TMC114）上市，商品名为本品剂量规格：达如那韦300mg/片。
达如那韦是一种新的HIV-1蛋白酶抑制药，其作用机制是选择性抑制感染细胞内的编码Gag-Pol多蛋白HIV卵裂，继而抑制形成成熟的病毒粒。
达如那韦适用于与小剂量利托那韦或其它抗HIV药合用治疗用其它抗HIV药治疗无效的成人HIV感染。利托那韦也是一种蛋白酶抑制药，可减缓达如那韦体内代谢，联合用药使达如那韦血药浓度增加。推荐剂量：进食后服用达如那韦600mg一日2次，加服利托那韦100mg一日2次。达如那韦最常见的不良反应为腹泻、恶心和头痛。
Generic Name for PREZISTA
Darunavir (as ethanolate) 75mg, 150mg, 400mg, 600mg; tabs.
Legal Classification:
Rx
Pharmacological Class for PREZISTA
Protease inhibitor.
Manufacturer of PREZISTA
Tibotec, Inc.
Indications for PREZISTA
Treatment of HIV infection in combination with ritonavir and with other antiretroviral agents.
Adult dose for PREZISTA
Take with food. ≥18yrs: Treatment-naive and treatment-experienced with no darunavir resistance associated substitutions: 800mg once daily with ritonavir 100mg once daily. Treatment-experienced with at least one darunavir resistance associated substitution: 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended.
Children's dosing for PREZISTA
<6yrs: not recommended. Take with food. Treatment-experienced: ≥6yrs to <18yrs: ≥20kg–<30kg: 375mg twice daily with ritonavir 50mg twice daily; ≥30kg–<40kg: 450mg twice daily with ritonavir 60mg twice daily; ≥40kg: 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended.
Contraindications for PREZISTA
Concomitant rifampin, alfuzosin, ergots, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, oral midazolam, triazolam, sildenafil (Revatio; only when used to treat PAH).
Warnings/Precautions for PREZISTA
Children <3yrs old: do not use. Sulfonamide allergy. Hepatic impairment (eg, chronic hepatitis, cirrhosis, pre-treatment elevated transaminases): monitor liver enzymes; interrupt or discontinue therapy if liver dysfunction occurs or worsens. Severe renal impairment. Diabetes (may need insulin or oral hypoglycemics dose adjusted). Hemophilia: monitor for spontaneous bleeding. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for PREZISTA
See Contraindications. Voriconazole, salmeterol: not recommended. Avoid protease inhibitors other than those studied (lopinavir/ritonavir, saquinavir, indinavir, atazanavir), dexamethasone, fluticasone. Potentiates carbamazepine, risperidone, thioridazine, trazodone, desipramine, IV midazolam, rifabutin, digoxin, atorvastatin, pravastatin, rosuvastatin, sildenafil, vardenafil, tadalafil (reduce their doses). Potentiates, and is potentiated by, indinavir, ketoconazole, itraconazole. Increases bosentan (see literature), maraviroc, nevirapine, tenofovir, efavirenz, colchicine (dose adjustments: see literature) levels. Antagonizes sertraline, paroxetine (monitor levels), ethinyl estradiol, norethindrone (use backup contraception). Antagonizes and antagonized by other CYP3A4 substrates (eg, carbamazepine, phenobarbital, phenytoin). Antagonized by efavirenz. Monitor antiarrhythmics (eg, bepridil, systemic lidocaine, quinidine, amiodarone, flecainide, propafenone), calcium channel blockers, β-blockers, warfarin, digoxin, immunosuppressants (eg, tacrolimus, sirolimus, cyclosporine), methadone (possible opiate withdrawal syndrome). Reduce concomitant clarithromycin dose in renal impairment. Separate dosing of didanosine. Others.
Adverse Reactions fr PREZISTA
GI upset, abdominal pain, headache; rash (may be severe; discontinue if occurs), drug-induced hepatitis, new onset diabetes, hyperglycemia, fat redistribution, immune reconstitution syndrome, others.
Notes for PREZISTA
See Norvir entry for more information on ritonavir. To register pregnant patients exposed to darunavir/ritonavir call (800) 258-4263.
How is PREZISTA supplied?
Tabs 75mg—480; 150mg—240; 400mg, 600mg—60
darunavir（Prezista）-艾滋病新药
一项新的、重要的抗逆转录病毒药物已被批准使用，该药用于治疗对其他蛋白酶抑制剂耐药的患者。与一线药物比较，目前尚无该药利弊的信息。Tibotec公司开发该药，并限制药价。 Prezista是一种新的蛋白酶抑制剂，具有抗耐其他蛋白酶抑制剂病毒的活性，２００６年６月２３日被FDA批准用于治疗成人HIV感染，特别是耐其他蛋白酶抑制剂的HIV-1病毒株。治疗高度耐药的患者十分困难，根据FDA的分析，服用Prezista与其他抗逆转录病毒药物，７０％的患者治疗２４周有效；用其他治疗仅２１％的患者有病毒学反应。 Prezista须与小剂量ritonavir及食物一起服用。否则血中Prezista的含量太低，增加了病毒耐药的危险。Prezista片剂，300mg／片；成人剂量为２片加100mg ritonavir与食物一起服用，２次／日。 Prezista具有克服对其他蛋白酶抑制剂耐药病毒的能力。一些患者亦可出现对Prezista的交叉耐药，这种耐药可随用药而加重。Prezista显示出较多抗逆转录病毒活性，期待在治疗方面有一定进展。
About PREZISTA
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
PREZISTA is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.
The use of other medicines active against HIV in combination with PREZISTA/ritonavir (Norvir®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines
It is important that you remain under the care of your healthcare professional during treatment with PREZISTA
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA?
PREZISTA, together with Norvir®, has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare professional should do blood tests prior to starting combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
Talk to your healthcare professional about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs
In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare professional immediately if you develop a rash
Can PREZISTA be taken with other medications?
Taking PREZISTA with certain medicines could cause serious and/or life-threatening side effects or may result in loss of its effectiveness. Do not take PREZISTA if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Migranal®), ergonovine, ergotamine (Wigraine®, Ergostat®, Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), rifampin (Rifadin®, Rifater®, Rifamate®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), lovastatin (Mevacor®, Altoprev®, Advicor®), pravastatin (Pravachol®), simvastatin (Zocor®, Simcor®, Vytorin®), salmeterol (Serevent®), or products containing St. John's wort
Before taking PREZISTA, tell your healthcare professional if you are taking sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), atorvastatin/amlodipine (Caduet®), rosuvastatin (Crestor®), or colchicine (Colcrys®). This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements
Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
What should I tell my healthcare professional before I take PREZISTA?
Before taking PREZISTA, tell your healthcare professional if you have any medical conditions, including allergy to sulfa medicines, diabetes, liver problems (including hepatitis B or C), or hemophilia
Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA is right for you
Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby
What are the possible side effects of PREZISTA?
High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA
Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA. The cause and long-term health effects of these conditions are not known at this time
As with other protease inhibitors, taking PREZISTA may strengthen the body's immune response, enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness
The most common side effects related to taking PREZISTA include diarrhea, nausea, rash, headache, stomach pain, and vomiting. Other important severe side effects include inflammation of the liver or pancreas and increased blood fat levels
This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA or any other medicines without first talking to your healthcare professional
---------------------------------------------------------------
注：以下产品不同规格和不同价格，购买力时请以电话咨询为准！
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
PREZISTA 600MG/TAB 60TABS/BOTTLE
原产地英文药品名:
DARUNAVIR ETHANOLATE
中文参考商品译名:
PREZISTA 600毫克/片 60片/瓶
中文参考药品译名:
达如那韦
生产厂家中文参考译名:
TIBOTEC
生产厂家英文名:
TIBOTEC
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
PREZISTA 400MG/TAB 60TABS/BOTTLE
原产地英文药品名:
DARUNAVIR ETHANOLATE
中文参考商品译名:
PREZISTA 400毫克/片 60片/瓶
中文参考药品译名:
达如那韦
生产厂家中文参考译名:
TIBOTEC
生产厂家英文名:
TIBOTEC
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
PREZISTA 75MG/TAB 480TABS/BOTTLE
原产地英文药品名:
DARUNAVIR ETHANOLATE
中文参考商品译名:
PREZISTA 75毫克/片 480片/瓶
中文参考药品译名:
达如那韦
生产厂家中文参考译名:
TIBOTEC
生产厂家英文名:
TIBOTEC
--------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
PREZISTA 300MG/TAB 120TABS/BOTTLE
原产地英文药品名:
DARUNAVIR ETHANOLATE
中文参考商品译名:
PREZISTA 300毫克/片 120片/瓶
中文参考药品译名:
达如那韦
生产厂家中文参考译名:
TIBOTEC
生产厂家英文名:
TIBOTEC
--------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
PREZISTA 150MG/TAB 240TABS/BOTTLE
原产地英文药品名:
DARUNAVIR ETHANOLATE
中文参考商品译名:
PREZISTA 150毫克/片 240片/瓶
中文参考药品译名:
达如那韦
生产厂家中文参考译名:
TIBOTEC
生产厂家英文名:
TIBOTEC
|
