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英文药名: Pulmozyme(Doranase Alfa)
中文药名: 百慕时(阿法链道酶)雾化吸入剂
生产厂家: Roche Pharmaceuticals
药品说明
药物名称: 阿法链道酶
药物别名: 阿法链道酶、阿法脱氧核糖核酸酶, Pulmozyme
英文名称: Dornase Alfa
适应症
本品适用于与常规治疗方法结合在一起治疗肺囊性纤维化。单纯本品不能代替常规的抗菌治疗，但在许多病人中，本品能减少应用抗菌素的次数并减轻呼吸道感染，从而减少抗菌素用量，减少住院和其它有关的卫生保健服务的花费。
用法用量
本品溶液经压缩空气驱动的雾化器产生气溶胶，大多数病人每日吸人1次(2.5mg)。一些研究提示，本品对较大年龄(20岁以上)的病人疗效比年龄小的差，较大年龄的病人每天须要两倍的剂量，而另一些研究认为，1天大于2.5mg两倍的剂量并无任何益处。
[制剂与规格]安瓿剂：2.5mg/2.5ml
[贮藏]本品须在冷藏条件下运输和保存，不可暴露于室温中达24小时。
*囊性纤维化(CF)是一种累及遍及全身的腺体的遗传状态。因此CF可侵犯许多不同器官。其症状常累及肺和消化系统。肺中的阻塞、感染是CF中最常见的特征。
在CF中，肺中浓厚的粘液阻塞呼吸道并使细菌感染和发生炎症。白细胞，中性粒细胞被送至肺与这些感染斗争。当中性粒细胞死亡时，释放DNA和弹性酶，时粘液进一步变脓稠，并加重呼吸道的阻塞、感染和炎症。Pulmozyme是人工制备的天然存在物质被称为脱氧核糖核酸酶DNase。尽管不能治愈CF，但是Pulmozyme可能有助于治疗这种情况。酶将中性粒细胞释放的DNA "切割"。Pulmozyme在1994年已经推向失常，是30多年来第一个处理CF的新治疗药物。
1993年12月30日美国FDA批准Genentech公司的Pulmozyme(dornase alpha)吸入溶液与标准治疗联用适用于处理囊性纤维化病人以改善肺功能。病人用力肺活量(FVC)≥40%预期值，每天给予Pulmozyme也曾显示减低需肠道外抗生素的呼吸道感染的危险。尚未证实病人每天给药治疗12个月以上的安全性和有效性。
规格：2.5mg 30 (支) x 2.5ml
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Pulmozyme® (dornase alfa) Inhalation Solution is a sterile, clear, colorless, highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA.
Pulmozyme is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer system.
Launched in 1994, Pulmozyme was the first new therapeutic drug for the management of cystic fibrosis in over 30 years.
Status
Daily administration of Pulmozyme in conjunction with standard therapies is indicated in the management of cystic fibrosis patients to improve pulmonary function. In patients with an FVC ≥40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.
Important Safety Information
Pulmozyme should not be used in patients who are allergic to any of its ingredients. Pulmozyme should be used along with standard therapies for cystic fibrosis. When starting Pulmozyme therapy, patients may experience change in or loss of their voice, discomfort in the throat, chest pain, red watery eyes, rash, dizziness, fever, or runny nose. These side effects are usually mild and short-lived.
There is a limited amount of information available concerning the usage of Pulmozyme in patients who are younger than 5 years. The decision to use Pulmozyme in these patients is made after considering the potential for a benefit in lung function or in decreasing the risk of respiratory tract exacerbations.
The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to ≤10 years (older group). The PARI BABY™ reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. There were more reports of cough, moderate to severe cough, runny nose, and rash in the younger group of patients. Other reported events tended to be of mild to moderate severity. The kind of side effects reported was similar to that of Pulmozyme when used in the larger trials that studied older patients.
Proposed Mechanism of Action
In vitro, Pulmozyme cleaves extracellular DNA in mucus of cystic fibrosis patients, reducing the adhesiveness and viscoelasticity of the mucus.
Disease Education
Cystic fibrosis is a life-threatening disease involving a genetic mutation that disrupts the cystic fibrosis transmembrane regulator protein. This protein acts on an ion-specific channel that modulates salt and water transport. This ion-channel defect leads to poorly hydrated, thick, mucous secretions in the airways and severely impaired mucociliary clearance. Impairments in these vital lung defense mechanisms typically begin in early childhood. Chronic secondary infections invariably occur, resulting in progressive lung dysfunction and deterioration. Cystic fibrosis affects other organ systems as well, especially the digestive tract and reproductive organs. Respiratory failure accounts for approximately 90% of deaths in patients with cystic fibrosis.
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PulmozymeGeneric Name: dornase alfa (Inhalation route)
DOR-nase AL-fa
Commonly used brand name(s):
In the U.S.
Pulmozyme
Available Dosage Forms:
Solution
Therapeutic Class: Mucolytic
Pharmacologic Class: Mucolytic Enzyme
Uses For Pulmozyme
Dornase alfa is used in the management of cystic fibrosis. It is used every day with other cystic fibrosis medicines, especially antibiotics, bronchodilators (medicines that open up narrowed breathing passages), and corticosteroids (cortisone-like medicines).
Cystic fibrosis is a condition in which thick mucus is formed in the lungs and breathing passages. The mucus blocks the airways and increases the chance of lung infections. The infections then cause the mucus to become even thicker, making it more difficult to breathe.
Dornase alfa will not cure cystic fibrosis. However, when it is used every day, it helps make breathing easier and reduces the number of serious lung infections that require treatment with antibiotics.
Dornase alfa is available only with your doctor's prescription.
Before Using Pulmozyme
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Dornase alfa has been studied in children 3 months of age and older and has not been shown to cause different side effects or problems in children than it does in adults, although coughing, runny or stuffy nose, and skin rashes were more common in children 3 months to 5 years of age than in other age groups.
Geriatric
Dornase alfa has not been tested on enough patients 65 years and older. Cystic fibrosis is a disease that usually affects children and young adults. Although there is no specific information comparing use of dornase alfa in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use of Pulmozyme
Dornase alfa usually comes with patient instructions. Read them carefully before using this medicine.
Dornase alfa is packaged in small plastic containers called ampules. Each ampule contains one full dose of dornase alfa. Do not use an ampule that has already been opened. Also, do not use an ampule of this medicine after the expiration date printed on the package.
Do not use dornase alfa solution if it is cloudy or discolored.
Dornase alfa must be used in a nebulizer with a compressor . Only the following nebulizers and compressors should be used with this medicine:
Hudson T Up-draft II disposable jet nebulizer used with the Pulmo-Aide compressor
Marquest Acorn II disposable jet nebulizer used with the Pulmo-Aide compressor
Reusable PARI LC Jet+ nebulizer used with the PARI PRONEB compressor
Reusable PARI BABY nebulizer used with the PARI PRONEB compressor
Reusable Durable Sidestream jet nebulizer with the MOBILAIRE or the Porta-Neb compressor
Your health care professional will help you decide which nebulizer and compressor to use.
It is very important that you use dornase alfa only as directed. Use the mouthpiece provided with the nebulizer. Do not use a face mask with the nebulizer because less medicine will get into your lungs. Patients who are unable to inhale and exhale through the mouth for the entire nebulizer treatment may use the PARI BABY nebulizer with the supplied face mask. Make sure you understand exactly how to use this medicine in the nebulizer.
In order to receive the full effects of this medicine, you must use it every day as ordered by your doctor. If possible, dornase alfa should be used at about the same time each day. You may notice some improvement in your condition within the first week of treatment. However, some patients may not feel the full effects of this medicine for weeks or months.
If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using dornase alfa, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use dornase alfa. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with dornase alfa.
To prepare the nebulizer for use:
Wash your hands well with soap and water before putting the nebulizer together and preparing the medicine. This will help prevent infection.
Put the nebulizer together only on a clean surface. If dirt or germs get on the nebulizer or in the medicine, they may cause infection.
After you put the nebulizer together, test the compressor (following the manufacturer's directions) to make sure it works properly. If you have any questions about this, ask your health care professional.
If you are using the Durable Sidestream jet nebulizer with the MOBILAIRE compressor, turn the compressor control knob all the way to the right and then turn on the compressor. The needle on the gauge vibrates between 35 and 45, which is the highest amount of pressure.
To prepare the medicine for use in the nebulizer:
Remove one ampule of dornase alfa from the refrigerator. Squeeze the ampule before opening to make sure there are no leaks. Hold the tab at the base of the ampule firmly. Twist off the top of the ampule, but do not squeeze the body of the ampule while doing so.
Take the cap off the nebulizer cup. Turn the opened ampule upside down over the cup. Squeeze the ampule gently until all the contents are emptied into the cup. It is very important that you use the full dose of this medicine.
Replace the cap on the nebulizer cup. Connect the nebulizer and compressor, following the manufacturer's directions.
Turn on the compressor. Make sure there is mist coming from the nebulizer.
To use the medicine in the nebulizer:
Place the mouthpiece between your teeth and on top of your tongue. Close your lips around the mouthpiece. Be sure that you do not block the air flow with your tongue or teeth.
Breathe normally, in and out, through your mouth. Do not breathe through your nose. If you have trouble breathing only through your mouth, use a nose clip.
During treatment, moisture may collect in the long connecting tube of the nebulizer. This should be expected. However, if you notice a leak or feel moisture coming from the nebulizer during the treatment, turn off the compressor. Then check to make sure the nebulizer cap is sealed correctly before you continue the treatment.
When the nebulizer begins 'spitting' gently tap the nebulizer cup. Continue breathing until the cup is empty or no more mist comes from the nebulizer.
If you have to stop the treatment for some reason or if you start coughing during the treatment, turn off the compressor. To begin the treatment again, turn on the compressor and continue as before.
The complete treatment usually takes 10 to 15 minutes. Be sure to inhale the full dose of dornase alfa.
After using dornase alfa:
Turn off the compressor. Then take apart the nebulizer system.
Follow the manufacturer's directions for care and cleaning of your nebulizer and compressor.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For inhalation dosage form (inhalation solution):
For cystic fibrosis:
Adults and children 5 years of age and older—The usual dose is 2.5 milligrams (mg) (one ampule), used in a nebulizer once a day for about 10 to 15 minutes. However, your doctor may want you to use this medicine two times a day at regularly spaced times.
Children 3 months to 5 years of age—The usual dose is 2.5 milligrams (mg) (one ampule), used in a nebulizer once a day for about 10 to 15 minutes.
Children up to 3 months of age—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Store the medicine in the refrigerator in the foil pouches. However, keep the medicine from freezing. Do not leave this medicine out of the refrigerator for longer than 24 hours. If an ampule of medicine is left out for longer than this, it should be thrown away and a new ampule should be used.
Precautions While Using Pulmozyme
If your condition becomes worse while you are using this medicine, check with your doctor.
Pulmozyme Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Rare
Hives or welts
itching
redness of skin
skin rash
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Chest pain or discomfort
hoarseness
sore throat
Less common
Difficulty breathing
fever
redness, itching, pain, swelling, or other irritation of eyes
runny or stuffy nose
upset stomach
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. | 
