Darunavir Side Effects
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Darunavir Safety Reports submitted to FDA
Total Darunavir reports: 9.Darunavir FDA safety alerts: 2008 .
Reported deaths: 2 Reported hospitalizations: 5.
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Reported Darunavir Side Effects: diarrhoea, rash, pyrexia, death, hepatic necrosis, hepatic fibrosis, fatigue, dysgeusia, blood bilirubin increased, aspartate aminotransferase increased, anorexia.
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Darunavir Side Effects Report #5235230-2
Physician from UNITED STATES reported DARUNAVIR problem on Feb 08, 2007. Male patient, 62 years of age, was diagnosed with hiv infection and was treated with DARUNAVIR. DARUNAVIR dosage: unknown. During the same period patient was treated with RITONAVIR, EPZICOM, TENOFOVIR, INSULIN, GLUCERNA, CARTIA XT. Patient died on 02/05/2007.
Darunavir Side Effects Report #5235845-1
DARUNAVIR problem was reported by a Physician from UNITED STATES on Feb 06, 2007. Male patient, 30 years of age, was diagnosed with hiv infection and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: progressive multifocal leukoencephalopathy. DARUNAVIR dosage: unknown. During the same period patient was treated with NORVIR, DARAPRIM, CLINDAMYCIN, VIREAD, ZIAGEN. Patient was hospitalized. Patient recovered.
Darunavir Side Effects Report #5241052-9
Pharmacist from UNITED STATES reported DARUNAVIR problem on Feb 14, 2007. Male patient, 31 years of age, weighting 169.1 lb, was diagnosed with acquired immunodeficiency syndrome, hiv infection and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: pyrexia, rash. DARUNAVIR dosage: 600 MG PO BID. During the same period patient was treated with AZITHROMYCIN, DAPSONE, FLUCONAZOLE, ACETAMINOPHEN, LOPERAMIDE, NEUTRA, PROMETHAZINE. Patient was hospitalized. Patient recovered.
Darunavir Side Effects Report #5235230-2
DARUNAVIR problem was reported by a Physician from UNITED STATES on Feb 08, 2007. Male patient, 62 years of age, was diagnosed with hiv infection and was treated with DARUNAVIR. DARUNAVIR dosage: unknown. During the same period patient was treated with RITONAVIR, EPZICOM, TENOFOVIR, INSULIN, GLUCERNA, CARTIA XT. Patient died on 02/05/2007.
Darunavir Side Effects Report #5298042-X
Physician from UNITED STATES reported DARUNAVIR problem on Apr 04, 2007. Male patient, 50 years of age, was diagnosed with hiv infection and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: cerebral infarction, haemorrhage intracranial. DARUNAVIR dosage: unknown. During the same period patient was treated with RITONAVIR, TRUVADA. Patient was hospitalized and became disabled. Patient recovered.
Darunavir Side Effects Report #5308705-5
DARUNAVIR problem was reported by a Physician from CANADA on Apr 20, 2007. Male patient, 57 years of age, weighting 180.8 lb, was diagnosed with hiv infection, diabetes mellitus and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, haemodialysis, hyperkalaemia, lactic acidosis, malaise, renal failure acute, urine output decreased. DARUNAVIR dosage: 600MG TWICE PER DAY. During the same period patient was treated with RITONAVIR, TENOFOVIR, METFORMIN, ABACAVIR SULPHATE, ENFUVIRTIDE, BACTRIM, FENOFIBRATE, TRAZODONE. Patient was hospitalized. Patient recovered.
Darunavir Side Effects Report #5108225-7
Pharmacist from UNITED STATES reported DARUNAVIR problem on Sept 14, 2006. Male patient, 49 years of age, weighting 171.0 lb, was diagnosed with hiv infection, bipolar disorder and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, diarrhoea, liver function test abnormal, pyrexia, rash. DARUNAVIR dosage: 600MG DAILY PO. During the same period patient was treated with LAMOTRIGINE. Patient was hospitalized. Patient recovered.
Darunavir Side Effects Report #5418338-8
DARUNAVIR problem was reported by a Physician from THAILAND on Aug 07, 2007. Female patient, weighting 105.8 lb, was diagnosed with hiv infection and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: lip swelling, rash maculo-papular. DARUNAVIR dosage: unknown. Patient recovered.
Darunavir Side Effects Report #5466669-8
Physician from UNITED STATES reported DARUNAVIR problem on Sept 24, 2007. Male patient, 56 years of age, was diagnosed with hiv infection, candidiasis and was treated with DARUNAVIR. After drug was administered, patient experienced the following problems/side effects: acidosis, alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, blood bilirubin increased, dysgeusia, fatigue, hepatic fibrosis, hepatic necrosis. DARUNAVIR dosage: 600 MG PO BID. During the same period patient was treated with EPZICOM, VIDEX, FLUCONAZOLE, BACTRIM, MEGACE, PLETAL, NAPROXAN, RITONAVIR. Patient recovered.
Drug Information: Darunavir
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a607042.html
(da roon' a veer)IMPORTANT WARNING:
| [Posted 03/12/2008] FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for darunavir (Prezista) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with darunavir/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with darunavir/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/ritonavir treatment. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista, http://www.fda.gov/medwatch/safety/2008/prezista_DHCP.pdf and http://www.fda.gov/cder/foi/label/2008/021976s003s004lbl.pdf. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Darunavir is used with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) in people who have already been treated for HIV. Darunavir is in a class of medications called protease inhibitors. It works by slowing the spread of HIV in the body. Darunavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Darunavir does not prevent you from spreading HIV to other people.
How should this medicine be used?
Darunavir comes as a tablet to take by mouth. It is usually taken with food and with ritonavir twice a day. Take darunavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take darunavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not take darunavir without ritonavir.
Swallow the tablets whole with a drink such as water or milk. Do not chew the tablets.
Darunavir controls HIV but does not cure it. Continue to take darunavir even if you feel well. Do not stop taking darunavir without talking to your doctor. If you stop taking darunavir or skip doses, your condition may become more difficult to treat. When your supply of darunavir starts to run low, get more from your doctor or pharmacist.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking darunavir,
- tell your doctor and pharmacist if you are allergic to darunavir, ritonavir, sulfa medications, or any other medications. Ask your pharmacist if you are unsure if a medication you are allergic to is a sulfa medication.
- tell your doctor if you are taking any of the following medications: astemizole (Hismanal) (not available in the U.S.); cisapride (Propulsid); ergot-type medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), and methylergonovine (Methergine); midazolam (Versed); pimozide (Orap); terfenadine (Seldane) (not available in the U.S.); or triazolam (Halcion). Your doctor will probably tell you not to take darunavir
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); calcium-channel blockers such as felodipine (in Lexxel, Plendil), nicardipine (Cardene), and nifedipine (Adalat, Procardia); cholesterol-lowering medications (statins) such as atorvastatin (in Caduet, Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); dexamethasone (Decadron, Dexone); fluticasone (in Advair, Flonase, Flovent); certain phosphodiesterase inhibitors (PDE-5 inhibitors)such as sildenafil (Revatio, Viagra), tadalafil (Cialis), and vardenafil (Levitra); other medications for HIV including efavirenz (Sustiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), and saquinavir (Invirase); medications for irregular heartbeat including amiodarone (Cordarone, Pacerone), bepridil (Vascor) (no longer available in the U.S.), and quinidine; certain medications for seizures such as carbamazepine (Equetro, Carbatrol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); certain medications that suppress the immune system such as cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); methadone (Dolophine, Methadose); rifabutin (Mycobutin); rifampin (Rimactane, Rifadin);certain selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and sertraline (Zoloft); and trazodone. Many other medications may also interact with darunavir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking didanosine (Videx), take it 1 hour before or 2 hours after you take darunavir.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had diabetes or high blood sugar; hemophilia (bleeding disorder in which the blood does not clot properly); hepatitis (swelling of the liver caused by a virus) or any other liver disease; or an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking darunavir, call your doctor. Do not breastfeed if you are infected with HIV or are taking darunavir.
- you should know that darunavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, or implants). Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
- you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back, neck, chest, and stomach area. Loss of fat from the legs, arms, and face can also happen.
What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
What should I do if I forget a dose?
If you miss a dose by less than 6 hours, take the missed dose as soon as you remember it and then take the next dose at the scheduled time. However, if you miss a dose by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Darunavir may cause hyperglycemia (high blood sugar). Call your doctor if you have any of the following symptoms of hyperglycemia:
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:
- dry mouth
- nausea and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
Darunavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- diarrhea
- nausea
- stomach pain
- constipation
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- rash
- blisters
- fever
- swelling, tenderness, redness, or other signs of infection
Darunavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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