Noxafil,posaconazole,泊沙康唑,抗真菌药
   
美国FDA近日已批准Noxafil (posaconazole，泊沙康唑) 口服混悬剂上市，用于治疗13岁以上人群的曲霉菌、假丝酵母菌的入侵性感染。入侵性真菌感染能威胁生命，通常发生在免疫力受抑制的病人中，如：器官移植病人，干细胞移植及接受化疗的癌症患者。

Noxafil是FDA首次批准用于治疗由曲霉菌引起的入侵性真菌感染的抗真菌药物。Noxafil由先灵葆雅公司研发，在2005年10月已欧洲获得批准用于成人严重入侵性真菌感染。

美国FDA于2006年9月18日批准先灵-葆雅公司（Schering Corporation）抗真菌新药Noxafil（口服混悬液，40mg／mL），主要用于那些因骨髓移植后免疫力减弱和白细胞计数减少的患者，以防止某些霉菌和酵母样真菌（如曲霉菌和念珠菌）71起的感染。这些患者的身体在接受癌症化疗后难以抵抗上述感染。

Noxafil

Generic Name: posaconazole (poe sa KONE a zole)
Brand Names: Noxafil

What is Noxafil?
Noxafil (posaconazole) is an antifungal medication that fights certain infections caused by fungus.

Noxafil is used to prevent fungal infections in people with weak immune systems resulting from chemotherapy or stem cell transplantation.

Noxafil may also be used for other purposes not listed in this medication guide.

Important information about Noxafil
Do not use Noxafil if you are allergic to posaconazole, or if you are using any of the following drugs:
halofantrine (Halfan);
pimozide (Orap);
quinidine (Cardioquin, Quinidex, Quinaglute); or
ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine).

Take Noxafil for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Noxafil will not treat a viral infection such as the common cold or flu. Call your doctor if you have ongoing vomiting or diarrhea. Noxafil may not work as well while during this time.

What should I discuss with my healthcare provider before using Noxafil?
Do not use Noxafil if you are allergic to posaconazole, or if you are using any of the following drugs:
halofantrine (Halfan);
pimozide (Orap);
quinidine (Cardioquin, Quinidex, Quinaglute); or

sirolimus (Rapamune) or tacrolimus (Prograf);
ergot medicine such as ergotamine (Ergomar), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine);

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Noxafil:
a personal or family history of "Long QT syndrome";
a history of allergy to antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
liver disease; ora heart rhythm disorder.

FDA pregnancy category C. It is not known whether Noxafil is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether posaconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give Noxafil to a child younger than 13 years old.

How should I take Noxafil?
Take Noxafil exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Noxafil works best if you take it within 20 minutes after a full meal or a nutritional supplement (such as Ensure). Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if you have ongoing vomiting or diarrhea. Noxafil may not work as well while during this time.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Noxafil will not treat a viral infection such as the common cold or flu. Store Noxafil at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Noxafil overdose are not known.

What should I avoid while taking Noxafil?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Noxafil side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Noxafil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
pale skin, easy bruising or bleeding, unusual weakness;
fever, chills, cough, body aches, flu symptoms;
slow, fast, or pounding heartbeats;
feeling light-headed, fainting;
numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;
swelling of your ankles or feet;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Noxafil side effects may include:
mild headache, tired feeling;
joint or muscle pain;
sleep problems (insomnia);
mild nausea, vomiting, diarrhea, constipation, or stomach pain; or
skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Noxafil?
Many drugs can interact with Noxafil. Below is just a partial list. Tell your doctor if you are using:
arsenic trioxide (Trisenox);
cimetidine (Tagamet);
cyclosporine (Neoral, Sandimmune, Gengraf);
digoxin (digitalis, Lanoxin);
droperidol (Inapsine);
esomeprazole (Nexium);
midazolam (Versed);
phenytoin (Dilantin);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), or rifabutin (Mycobutin);
an antidepressant;
anti-malaria medications;
a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), nicardipine (Cardene), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), or others;
cancer medicines such as vinblastine (Velban) or vincristine (Oncovin, Vincasar), vindesine (Eldisine), or vinorelbine (Navelbine);
cholesterol-lowering medicines such as simvastatin (Zocor);
heart rhythm medication;
HIV medication such as atazanavir (Reyataz), efavirenz (Sustiva), or ritonavir (Norvir, Kaletra);
medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan) or ondansetron (Zofran);
medicines to treat psychiatric disorders;
migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); ornarcotic medication.

This list is not complete and there are many other medicines that can interact with Noxafil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?
Your pharmacist can provide more information about Noxafil.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

【原产地英文商品名】:NOXAFIL ORAL SUSPENSION 40mg/ml 105mls/bottle
【原产地英文药品名】:POSACONAZOLE
【中文参考商品译名】:NOXAFIL口服混悬剂 40毫克/毫升 105毫升/瓶
【中文参考药品译名】:泊沙康唑
【生产厂家中文参考译名】:先灵
【生产厂家英文名】:SCHERING