In case of signs or symptoms of hepatitis, serious skin reactions or hypersensitivity reactions, patients should stop taking the drug and immediately go to a medical facility for examination.
VIRAMOUN can not be re-administered to patients who have experienced severe liver, skin, or hypersensitivity reactions when taking this medication.
Monotherapy with the drug VIRAMUN is accompanied by the development of resistance to non-nucleoside analogues of reverse transcriptase inhibitors. In women who previously received a single dose of VIRAMUN drug in order to prevent the transmission of HIV-1 from mother to child, the effectiveness of VIRAMUN drug used in combination therapy may be reduced.Where other antiretroviral drugs are available, the single-dose regimen of VIRAMUN should be combined with additional effective antiretroviral drugs (in accordance with existing international guidelines).
It is necessary to adhere strictly to the recommended dosage regimen.
Reactions from the skin:
VIRAMOUN should be withdrawn from any patient if a severe rash or rash develops, accompanied by common symptoms (fever, blistering, changes in the oral mucosa, conjunctivitis, facial skin, joint and muscle pain, general malaise), with Stevens-Johnson syndrome or toxic epidermal necrolysis. VIRAMOUN should be withdrawn and should not be administered again to any patient if hypersensitivity reactions characterized by a rash and general symptoms of internal organ damage such as hepatitis, eosinophilia, granulocytopenia and renal dysfunction, as well as other changes in the function of the internal organs, develop.
Patients should be informed,that the main manifestation of the toxicity of the drug VIRAMUN is a rash. To reduce the incidence of rash, an initial initial treatment period should be used. In most cases, the rash associated with taking the drug occurs in the first six weeks of therapy, so it is during this period that patients should be closely monitored for dermatological reactions. Patients should be informed that if any rash develops during the initial treatment start-up period, the dose should not be increased to two times a day until the rash disappears. The dosage regimen using 200 mg of the drug once a day should not last more than 28 days, at which point a different regimen should be developed.
In rare cases, in patients with skin and liver reactions associated with the use of nevirapine, rhabdomyolysis was observed.
It was shown that simultaneous application of prednisone (40 mg / day, during the first 14 days of taking nevirapine) does not reduce the incidence of rash, but, on the contrary, may increase the frequency of dermatological reactions during the first 6 weeks of therapy.
Among the risk factors for the development of serious skin reactions is a violation of the recommendation on the use of the drug at a dose of 200 mg per day during the introductory initial treatment period. The risk of serious complications of dermatological reactions increases in the event of delay in seeking medical advice after the onset of symptoms. The risk of developing rash in women is higher than that of men, as in the case of nevirapine, and in the case of therapy that does not contain nevirapine.
Reactions from the liver:
It is necessary to inform the patient that reactions from the liver are the main manifestation of the toxicity of the drug VIRAMUN. Patients who are symptomatic of hepatitis should stop taking the drug and immediately go to a medical facility for examination, which should include an assessment of liver function.
Postexposure prophylaxis of people who have not been infected with HIV is not considered an approved indication for the use of the drug and is therefore strongly discouraged. With repeated use of the drug VIRAMUN for the purpose of postexposure prophylaxis of persons who were not infected with HIV, serious manifestations of hepatotoxicity, incl.on the development of liver failure, requiring liver transplantation.
A high risk of adverse reactions from the liver during any antiretroviral therapy (including during therapy including nevirapine) is noted with an initial increase in the activity of LST or ALT enzymes by more than 2.5 times in comparison with the upper limit of the norm, and / or in the presence of hepatitis B and / or C.
Monitoring the liver
The asymptomatic increase in the activity of liver enzymes and gamma-glutamyl-triphosphase (GGT) is often described and nc is an unconditional contraindication for the use of VIRAMUN.
Strict monitoring of liver function indicators at short intervals is recommended, depending on the clinical condition of the patient, especially during the first 18 weeks of treatment. Clinical and laboratory monitoring should continue throughout the treatment period. Doctors and patients should be wary of such prodromal signs or symptoms of hepatitis such as anorexia, nausea, jaundice, bilirubinemia, fecal staining, hepatomegaly or liver soreness.Patients should be informed of the need to seek medical advice in such cases.
In the case of increased activity of enzymes ACT or ALT more than 2.5 times the upper limit of the norm before or during treatment, liver function indicators should be monitored more often during regular examinations. VIRAMOUN should not be administered to patients with initial activity ACT or ALT is more than 5 times higher than the upper limit of the norm (until it steadily decreases to a level less than 5 times the upper limit of the norm).
If the activity of enzymes ACT or ALT rises more than 5-fold compared with the upper limit of the norm during treatment, VIRAMOON should be immediately withdrawn. If the activity of enzymes ACT and ALT returns to the baseline values and if the patient does not have any symptoms of hepatitis or general symptoms or other phenomena indicative of abnormalities in the function of the internal organs, the use of the drug VIRAMUN can be resumed (if there is a clinical need). The decision on this should be taken in each individual case, based on clinical necessity.The repeated administration of VIRAMUN should be performed under conditions of increased clinical and laboratory alertness, at an initial dose of 200 mg / day (for 14 days), followed by an increase to 400 mg / day. If violations of the liver function are resumed, VIRAMUN should be finally canceled.
In the case of hepatitis, accompanied by clinical manifestations such as anorexia, nausea, vomiting, jaundice, and changes in laboratory indicators (moderate or significant changes in liver function, without taking into account the activity of gamma-glutamyltransferase), nevirapine must be canceled finally. VIRAMOUN should not be given again to those patients who required its withdrawal because of the development of clinically expressed hepatitis caused by nevirapine.
Other caveats
In the use of nevirapine in combination with other antiretroviral drugs, adverse events such as pancreatitis, peripheral neuropathy, and thrombocytopenia have been reported. These phenomena are often associated with the use of other antiretroviral drugs.These conditions can develop with the use of nevirapine in combination with other drugs; The likelihood of the connection of these reactions with the use of the drug VIRAMUN is low.
Patients receiving VIRAMUN or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection. Therefore, such patients should remain under the close supervision of a physician with experience in the treatment of diseases associated with HIV infection. Information on the ability of nevirapine to reduce the risk of horizontal transmission of HIV-1 to others is not available.
Despite the fact that the ability of VIRAMUN to prevent the transmission of HIV-1 infection from the mother, who had previously received other antiretroviral drugs, the child is established, in order to minimize the possibility of HIV-1 transmission to the baby, it is recommended that the mother be more intensively treated before the birth with antiretroviral drug combinations this is possible).
In women who previously received a single dose of nevirapine in order to prevent the transmission of HIV-1 from mother to child, the effectiveness of the drug VIRAMUN, used in combination therapy,which these women receive for treatment, may be reduced.
In women receiving nevirapine, oral contraceptives and other hormonal methods should not be used as the main contraceptive method, since nevirapine can reduce their concentration. In addition, when using oral contraceptives during therapy with nevirapine for the purpose of hormonal regulation, it is necessary to monitor the therapeutic effects of hormonal treatment.
Osteonecrosis:
The etiology of osteonecrosis is multifactorial (use of glucocorticosteroids, alcohol consumption, severe immunosuppression, increase in body mass index), cases of osteonecrosis have been observed in patients with developed stage of HIV infection and / or long-term combined antiretroviral therapy. Patients should be warned about the need to consult a doctor in case of aches and pains in the joints, the hunger of the joints or the difficulty in moving.
Immunodeficiency Syndrome:
In patients infected with HIV-1, in the presence of significant immunodeficiency during the onset of combined antiretroviral therapy, (or intensify)inflammatory response to asymptomatically existing or residual opportunistic infectious microorganisms, leading to severe clinical conditions. Typically, such reactions are observed during the first few weeks or months after the onset of combined antiretroviral therapy. Typical examples are cytomegalovirus retinitis, generalized and / or local infections caused by mycobacteria, and pneumonia caused by Pncumocystic. Autoimmune diseases (eg, Based's disease) can also be noted in the case of immune reconstitution syndrome. However, such diseases can occur several months after the start of treatment. You should analyze any symptoms of inflammation and, if necessary, conduct appropriate treatment.
It is not recommended to use VIRAMUN together with efavirenz, rifampicin, ketoconazole, delavirdine, etravirine, rilpivirin, elvitegravir (in combination with cobicystate), boceprevir; if not simultaneously applies ritonavir in a small dose: with fosamprenavir, saquinavir, atazanavir.