Nevirapox is a potent inducer of CYP3A4, resulting in significantly reduced plasma methadone concentrations and consequent opioid withdrawal symptoms, requiring an increase in methadone dose.
Several FDA-approved drug labels may be available for Nevirapox. AIDSinfo provides the following drug label solely as an example of the labels available for Nevirapox. Inclusion or absence of a drug label on the AIDSinfo site does not imply endorsement or lack thereof by AIDSinfo. Search Drugs@FDA to access more information on Nevirapox, including additional drug labels and any generic equivalents.
Co-administration of VIRAMUNE can alter the concentrations of other drugs and other drugs may alter the concentration of Nevirapox. The potential for drug interactions must be considered prior to and during therapy. (5.4, 7, 12.3)
As with all other anti-HIV drugs, strains of HIV that are resistant to Nevirapox (Viramune) may emerge after a period of treatment. The emergence of drug-resistant strains coincides with a fall in the effectiveness of the drug.
A single mutation in the reverse transcriptase gene is sufficient to bring about resistance to Nevirapox. The commonest Nevirapox-associated mutations are K103N, Y181C, G190A and Y188L. Other Nevirapox-associated mutations include V106A, Y188C, G190S and M230L.
Once resistance to Nevirapox has developed, it is very likely that the virus will also be resistant to the NNRTI efavirenz (Sustiva). Conversely, previous exposure to an NNRTI may predispose a person to fail a Nevirapox-based regimen, even where standard resistance tests indicate that no NNRTI resistance is present.
Oral route (Tablet; Tablet, Extended Release; Suspension)
Severe, life-threatening, in some cases fatal, hepatotoxicity and skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction) have been reported. Women, including pregnant women, or patients with higher CD4+ cell counts are at higher risk of hepatotoxicity. Permanently discontinue Nevirapox following severe hepatic, skin, or hypersensitivity reactions. Check transaminase levels immediately for all patients who develop a rash during the first 18 weeks of treatment. Monitor patients intensively during the first 18 weeks of therapy with Nevirapox to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk for adverse events. Strictly follow the 14-day lead-in period with immediate-release Nevirapox 200 mg daily dosing.
Along with its needed effects, Nevirapox 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 immediately if any of the following side effects occur while taking Nevirapox:
- Decreased appetite
- swelling of the feet or lower legs
- Pain, numbness, or tingling of the hands, arms, legs, or feet
- sleepiness or unusual drowsiness
- stomach pain
- tingling, burning, or prickly sensations
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- bone pain
- chest pain
- clay-colored stools
- dark urine
- difficulty swallowing
- fast heartbeat
- general tiredness and weakness
- hives, itching, skin rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- lower back or side pain
- muscle cramps, spasms, pain, or stiffness
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain, continuing
- swollen glands
- tightness in the chest
- trouble breathing
- troubled breathing with exertion
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking Nevirapox:
Symptoms of overdose
- Chest pain
- decrease in weight
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- pain in the ankles or knees
- painful, red lumps under the skin, mostly on the legs
- sensation of spinning
- trouble sleeping
Some side effects of Nevirapox 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:
- Difficulty with moving
- pain in the joints
VIRAMUNE must not be used as a single agent to treat HIV-1 or added on as a sole agent to a failing regimen. Resistant virus emerges rapidly when Nevirapox is administered as monotherapy. The choice of new antiretroviral agents to be used in combination with Nevirapox should take into consideration the potential for cross resistance. When discontinuing an antiretroviral regimen containing VIRAMUNE, the long half-life of Nevirapox should be taken into account; if antiretrovirals with shorter half-lives than VIRAMUNE are stopped concurrently, low plasma concentrations of Nevirapox alone may persist for a week or longer and virus resistance may subsequently develop .
Other uses for this medicine
Nevirapox is also sometimes used to prevent unborn babies whose mothers have HIV or AIDS from becoming infected with HIV during birth.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.