Viramune


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Related to Viramune: nevirapine, Truvada

nevirapine

Viramune, Viramune XR

Pharmacologic class: Nonnucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category C

FDA Box Warning

Drug has caused severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in first 18 weeks. In some cases, patients had nonspecific, prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are commonly associated with rash. Women and patients with higher CD4+ cell counts at initiation of therapy are at increased risk. Women with CD4+ cell counts greater than 250/mm3, including pregnant women receiving nevirapine in combination with other antiretrovirals for treatment of HIV-1 infection, are at greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both men and women, and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for postexposure prophylaxis (PEP). Use of nevirapine for occupational and nonoccupational PEP is contraindicated. Patients must discontinue drug and seek immediate medical help if they develop hepatitis signs or symptoms or have increased transaminase levels along with rash or other systemic symptoms.

Severe, life-threatening skin reactions (including fatal cases) have occurred; these have included Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Patients who develop signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue drug and seek immediate medical help.

Monitor patients intensively during first 18 weeks of therapy. Be especially vigilant during first 6 weeks. Don't restart drug in patient who has had clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms, or after severe rash, or hypersensitivity reaction.

Action

Inhibits human immunodeficiency virus (HIV) nonnucleoside reverse transcriptase by binding directly to reverse transcriptase and blocking RNA-dependent and DNA-dependent polymerase activity

Availability

Oral suspension: 50 mg/5 ml

Tablets: 200 mg

Tablets (extended-release): 400 mg

Indications and dosages

Treatment of HIV-1 infection

Adults: 200 mg P.O. daily for 14 days, then 200 mg (immediate-release) P.O. b.i.d., given in combination with other antiretrovirals; 400 mg (extended-release) P.O. daily after either a 14-day 200-mg lead-in regimen or after switching from a 200-mg b.i.d. regimen.

Children ages 15 days and older: 150 mg/m2 (immediate-release tablet or oral suspension) P.O. once daily for 14 days, followed by 150 mg/m2 b.i.d. thereafter. Total daily dosage shouldn't exceed 400 mg for any patient.

Dosage adjustment

• Chronic hemodialysis

Off-label uses

• Prophylaxis of maternal-fetal HIV transmission

Contraindications

• Hypersensitivity to drug or its components

• Moderate or severe hepatic impairment (Child-Pugh Class B or C, respectively)

• Use as part of occupational and nonoccupational postexposure prophylaxis regimens

Precautions

Use cautiously in:

• impaired renal or hepatic function

• pregnant or breastfeeding patients

• children.

Administration

• Be aware that drug should be given alone for first 14 days to reduce incidence of rash.

• If patient experiences rash during 14-day lead-in period with immediate-release form, don't initiate extended-release form until rash has resolved.

• Don't continue immediate-release lead-in dosing regimen beyond

28 days. If immediate-release dosing is interrupted for more than 7 days, restart recommended dosing, including 14-day lead-in dosing.

• For patients who interrupt extended-release dosing for more than 7 days, restart recommended lead-in dosing with immediate-release form using one 200-mg tablet daily for first 14 days.

• Be aware that drug shouldn't be started in adult females with CD4+ cell counts greater than 250/mm3 or in adult males with CD4+ cell counts greater than 400/mm3 because of serious and life-threatening hepatotoxicity, unless benefit outweighs risk.

• Give with or without food.

Adverse reactions

CNS: paresthesia, headache, malaise, fatigue

GI: nausea, diarrhea, abdominal pain

Hematologic: agranulocytosis

Hepatic: hepatitis, hepatotoxicity, hepatic failure

Musculoskeletal: myalgia, pain

Skin: rash, blistering, toxic epidermal necrolysis, Stevens-Johnson syndrome

Other: fever

Interactions

Drug-drug. Antiarrhythmics, antifungals, calcium channel blockers, cancer chemotherapy, ergot alkaloids, immunosuppressants, motility agents, opiate agonists: possible decreased plasma concentrations of these drugs

Anticoagulants: possible increased or decreased anticoagulant plasma concentrations

Clarithromycin, efavirenz, indinavir, ketoconazole, methadone: decreased activity of these drugs

Ethinyl estradiol, norethindrone: decreased contraceptive plasma levels Fluconazole: increased nevirapine level Lopinavir/ritonavir: decreased lopinavir activity

Nelfinavir: decreased nelfinavir active metabolite, minimum nelfinavir concentration

Rifabutin: increased rifabutin level

Drug-diagnostic tests. Alanine amino-transferase, aspartate aminotransferase, bilirubin, gamma-glutamyltransferase: increased levels

Hemoglobin, neutrophils: decreased levels

Drug-herbs. St. John's wort: decreased nevirapine blood level

Patient monitoring

Check closely for rash (which may be first sign of Stevens-Johnson syndrome), especially during first 6 months of therapy.

• Monitor patient's weight, temperature, and chest X-ray periodically.

• Assess patient's appetite and energy and physical activity levels.

• Monitor liver function tests and CBC with white cell differential.

Patient teaching

• Tell patient he may take with or without food.

• Tell patient or caregiver to shake suspension gently before use and that it's important to take the entire measured dose of suspension by using an oral dosing syringe or dosing cup.

• Tell patient or caregiver that the extended-release tablet must be swallowed whole and must not be chewed, crushed, or divided.

• Instruct patient to take missed dose as soon as he remembers. But if it's almost time for next dose, tell him to skip missed dose. Caution him not to double the dose.

• Inform female patient that hormonal contraceptives, implants, or shots may be ineffective during nevirapine therapy. Urge her to use alternative birth-control method.

Teach patient to recognize and immediately report rash, easy bruising or bleeding, and signs and symptoms of hepatotoxicity.

• Inform patient that nevirapine won't cure HIV or prevent its transmission.

• Caution female not to breastfeed, because breast milk may transfer HIV to infant.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

Viramune

(vîr′ə-myo͞on′)
A trademark for the drug nevirapine.

Viramune®

Nevirapine, see there.
References in periodicals archive ?
Now in its tenth year of use, Viramune has been used as a treatment in more than 800,000 patient-years worldwide."
The study finds that a single dose of nevirapine (Viramune) taken orally by the mother while in labor, followed by a dose for the baby 3 days after birth, reduces the HIV transmission rate by half compared to a similar short course of zidovudine (Retrovir, AZT).
He cited rash and hepatic toxicity with nevirapine (Viramune), hyperglycemia with protease inhibitors, and mitochondrial toxicity with nucleoside analogs.
(56.) See Press Release, BOEHRINGER INGELHEIM, Forty-four Countries Have Taken Up Boehringer Ingelheim's Viramune Donation (August 6, 2003), available at http://www.boehringeringelheim.com/corporate/asp/news/ndetail.asp?ID=1054 (last visited Jan.
Nevirapine (VIRAMUNE, NCP) and ethinyl estradiol/norethindrone (ORTHO-NOVUM 1/35 [21 pack] EE/NET) interaction study in HIV-1 infected women.
The FDA and Boehringer Ingelheim announced new safety information regarding use of Viramune (nevirapine), which is indicated for treatment of HIV infection in both children and adults.
In another study (known as the 2NN study because it compared and combined 2 non-nucs, Sustiva and Viramune), the regimens containing either Sustiva or Viramune were similar in their ability to control the virus, but they had different side effects.
This ad, one of a series for the AIDS drug Crixivan, advises: "Remember to ask your doctor about Crixivan." Warnings about side effects such as swollen organs, kidney stones, respiratory infections, pneumonia, muscle pain, blood in the urine, abdominal swelling, cirrhosis and liver failure and confined to a page of small print which also states that the clinical significance of the drug's supposed benefits "has not been established." Like a series of Viramune ads depicting HIV-positive Odysseans crossing the Pacific, this ad reinforces the image of gay men as dutifylly enduring their regimen of drugs.
Editorial Note: Severe, life-threatening, and fatal cases of hepatotoxicity and skin reactions have occurred among HIV-infected patients treated with NVP [2,3] and are described in a box warning on the NVP label (Viramune [TM] [package insert], [+] Boehringer Ingelheim/Roxane Laboratories, Inc., Ridgefield, Connecticut, 1998).
"The major clinical toxicity of Viramune (another name for Nevirapine] is rash, occurring in 16% of patients; [in one study as much as] 35% of patients experienced rash...
* HIV non-nucleoside reverse transcriptase inhibitors like delaviridine (Rescriptor) and nevirapine (Viramune).
* Nevirapine (Viramune, BI-RG-587), Boehringer Ingelheim Pharmaceuticals, Inc.