Viread (tenofovir disoproxil) 40 mg

Viread (tenofovir disoproxil) 300 mg 

原廠中文介紹:http://www.viread.com/ch-t/learn_about_viread.aspx

Black Box Warnings

Lactic Acidosis/Severe Hepatomegaly

lactic acidosis and severe hepatomegaly w/ steatosis, incl. fatal cases, associated w/ nucleoside analogue use alone or in combination; suspend tx if clinical or laboratory findings suggest lactic acidosis or hepatotoxicity

Hepatitis B Exacerbation

severe acute exacerbations of hepatitis may occur in HBV-infected patients when D/C tenofovir; monitor hepatic fxn closely for at least several months after D/C tenofovir; initiate anti-HBV tx if needed

VIREAD 可能導致如下的嚴重副作用:

  • 一種酸累積在血液中(乳酸酸中毒):乳酸酸中毒可能發生在某些服用 VIREAD 或類似(核苷類)藥物的人身上。乳酸酸中毒是一種可能導致死亡的嚴重醫療急症。乳酸酸中毒的症狀看起來像是其他健康問題的症狀,因此早期可能難以識別。如果您出現以下可能是乳酸酸中毒跡象的症狀,請立即致電您的醫護人員: 感覺虛弱無力或異常疲倦、肌肉異常疼痛、呼吸困難、胃痛伴隨著噁心和嘔吐、身上發冷(特別是四肢)、覺得頭昏目眩或眩暈、心跳得很快或心律不整。
  • 嚴重的肝臟疾病:服用 VIREAD 或類似藥物的人可能會發生嚴重的肝臟問題。在某些情況下,這些肝臟疾病可能導致死亡。當您服用 VIREAD 時,您的肝臟有可能擴大(肝腫大),而且您的肝臟可能產生脂肪(脂肪病變)。如果您有以下任何肝臟疾病的症狀,請立即致電您的醫護人員: 您的皮膚或眼白變黃(黃疸)、暗「茶色」尿液、淺色糞便、食慾不振數天或更長時間、噁心和胃痛。您的 B 型肝炎感染惡化:如果您在服用 VIREAD 之後又停止服用,您的 B 型肝炎病毒 (HBV) 感染可能會惡化(再度突然發作)。「再度突然發作」是指您的 B 型肝炎病毒 (HBV) 感染以惡化的方式突然復發。不要把 VIREAD 全部吃完。在與您的醫護人員商討之前,請勿停止服用 VIREAD。一旦您停止服用 VIREAD,您的醫護人員就需要經常檢查您的健康狀況,並且為您進行常規血液檢驗以檢查您的 B 型肝炎病毒 (HBV) 感染情況。請告知您的醫護人員,在您停止服用 VIREAD 之後,是否注意到任何新的或是不尋常的症狀。
    • 如果您是女性、體重過份超重(肥胖)或已經服用 VIREAD 或類似的藥物很長一段時間的話,可能更容易乳酸酸中毒或罹患嚴重的肝臟疾病

服用惠立妥的感染者,有被報告發生骨質缺乏與骨質流失,會需要醫師留意這方面的風險。目前不清楚服用鈣質和補充維生素D是否能預防這項副作用的產生。此外,少數服用惠立妥的感染者,有發生腎臟病變,而惠立妥也需要根據腎臟功能調整劑量,因此會建議醫師在使用惠立妥前,幫患者驗尿和抽血檢驗腎功能,以評估是否適合用藥。目前第一線藥物中,只有惠立妥可能影響腎臟

Adult Dosing .

Dosage forms:  300; 40 mg/scoop pwdr

HIV infxn

[300 mg PO qd]
Info: give oral pwdr w/ food

hepatitis B infxn, chronic

[300 mg PO qd]
Info: give oral pwdr w/ food

renal dosing

[adjust dose frequency]
CrCl 30-49: give q48h; CrCl 10-29: give q72-96h; CrCl <10: not defined; HD: give q7 days after HD

Peds Dosing .

Dosage forms:  150,200,250,300; 40 mg/scoop pwdr

HIV infxn

[>2 yo, 10-16 kg]
Dose: 8 mg/kg PO qd; Info: give oral pwdr w/ food
[>2 yo, 17-21 kg]
Dose: 8 mg/kg PO qd; Alt: 150 mg tab PO qd; Info: give oral pwdr w/ food
[>2 yo, 22-27 kg]
Dose: 8 mg/kg PO qd; Alt: 200 mg tab PO qd; Info: give oral pwdr w/ food
[>2 yo, 28-34 kg]
Dose: 8 mg/kg PO qd; Alt: 250 mg tab PO qd; Info: give oral pwdr w/ food
[>2 yo, >35 kg]
Dose: 8 mg/kg PO qd; Max: 300 mg/day; Alt: 300 mg tab PO qd; Info: give oral pwdr w/ food

hepatitis B infxn, chronic

[>12 yo, >35 kg]
Dose: 300 mg PO qd; Info: give oral pwdr w/ food

Drug Interactions

Viread1

Viread2

Safety/Monitoring .

Pregnancy: B

Lactation: Safety Conditional

Monitoring Parameters
Adolescent/Adult Pts: Cr, phosphorus at baseline, 2-8wk after tx start or change, then q3-6mo; LFTs at baseline, 2-8wk after tx start or change, then q3-6mo, then if HBV infxn, cont. for several mo after D/C; HBsAg at baseline in HIV pts; consider BMD if bone fracture hx or osteopenia risk


Peds Pts: Cr, phosphorus at baseline, then q3-6mo; LFTs at baseline, 1-2wk after tx start, 4-8wk after tx start, then q3-6mo, then if HBV infxn, cont. for several mo after D/C; HBsAg at baseline in HIV pts; consider BMD if bone fracture hx or osteopenia risk

Pharmacology .

Metabolism: intracellular; CYP450: none; Info: prodrug converted to tenofovir

Excretion: urine primarily (32% unchanged); Half-life: 17h

Subclass: HIV 1: NRTIs

Mechanism of Action
inhibits reverse transcriptase; incorporates into viral DNA (nucleotide reverse transcriptase inhibitor)

Patient Education - English

What is the most important information I should know about tenofovir?

 

Do not take tenofovir together with adefovir (Hepsera), or with combination medicines that contain tenofovir (Atripla, Complera, or Truvada).

Some people develop lactic acidosis while taking tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Tenofovir can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have any of these symptoms while taking tenofovir: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using tenofovir. Visit your doctor regularly.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

What is tenofovir?

Tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) or hepatitis B virus cells from multiplying in your body.

Tenofovir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Tenofovir is not a cure for HIV or AIDS. Tenofovir is also used to treat chronic hepatitis B.

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

What should I discuss with my healthcare provider before taking tenofovir?

 

Do not use this medication if you have ever had an allergic reaction to a medicine containing tenofovir, including Atripla, Complera, or Truvada.

Do not take tenofovir together with adefovir (Hepsera), or with combination medicines that contain tenofovir (Atripla, Complera, or Truvada).

To make sure you can safely take tenofovir, tell your doctor if you have any of these other conditions:

  • liver disease (especially hepatitis B if you also have HIV);
  • kidney disease; or
  • bone problems (such as osteopenia).

Some people develop a life-threatening condition called lactic acidosis while taking tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tenofovir on the baby.

Tenofovir can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using tenofovir to treat hepatitis B. Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Tenofovir should not be given to a child younger than 2 years old. Tenofovir is for use in children with HIV. This medication should not be used to treat hepatitis in anyone younger than 18 years old.

How should I take tenofovir?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start treatment with tenofovir, your doctor may perform tests to make sure you do not have HIV (if you are being treated for hepatitis B) or hepatitis B (if you are being treated for HIV).

Tenofovir tablets may be taken with or without food.

Tenofovir oral powder should be taken with food. Mix the powder with soft food such as applesauce, yogurt, or baby food. Do not mix tenofovir oral powder with liquid.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using tenofovir. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tenofovir?

Avoid drinking alcohol. It may increase your risk of liver damage.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of tenofovir?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have a serious side effect such as:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems - increased thirst and urination, loss of appetite, weakness, constipation, urinating less than usual or not at all;
  • signs of a new infection such as fever, chills, sore throat, flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;
  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • problems with walking, breathing, speech, swallowing, or eye movement; or
  • severe lower back pain, loss of bladder or bowel control.

Less serious side effects may include:

  • mild nausea or diarrhea;
  • depression, headache, dizziness, mild weakness;
  • mild itching or rash;
  • sleep problems (insomnia); or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 tenofovir?

Tell your doctor about all other medicines you use, especially:

  • other HIV or AIDS medications such as atazanavir (Reyataz), didanosine (Videx), lopinavir and ritonavir (Kaletra);
  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;
  • medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
  • IV antibiotics such as amphotericin B (AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), foscarnet (Foscavir), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte); or
  • injectable medications to treat osteoporosis or Paget's disease of the bones, such as etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), or zoledronic acid (Zometa, Reclast).

This list is not complete and other drugs may interact with tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

 

快樂小藥師 發表在 痞客邦 留言(1) 人氣()