Truvada, 245 mg+200 mg 30 pcs

Treatment of HIV-1 infection in adults in combination with other antiretroviral drugs (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors)

Active ingredient

Composition

1 film-coated tablet contains:
active ingredients: emtricitabine 200 mg, tenofovir 300 mg.

How to take, the dosage

Treatment should be initiated by a physician experienced in treating HIV infection. The recommended dose of Truvad is 1 tablet taken orally once a day; to optimize absorption it is recommended to take it with food.
Elderly patients: The dose for elderly patients should be adjusted with caution given the greater incidence of hepatic, renal or cardiac impairment as well as co-morbidities or taking other medications.

Interaction

The co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been shown to potentiate the systemic effects of didanosine. Patients using tenofovir disoproxil fumarate and didanosine concomitantly should be closely monitored for side effects associated with didanosine (pancreatitis, lactocidosis). Suppression of CD4 lymphocytes was observed in patients who received tenofovir disoproxil fumarate with didanosine at a dose of 400 mg per day. In adult patients with body weight over 60 kg, the dose of didanosine should be reduced to 250 mg per day. There is no information about recommendations on dosage adjustment of didanosine for patients with body weight less than 60 kg.

TRAVADA should be coadministered with didanosine with caution.
Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations. Patients receiving atazanavir and lopinavir/ritonavir together with Truvada should be monitored closely.

Tenofovir decreases the AUC (area under the pharmacokinetic curve) and Cmin (minimum plasma concentration) of atazanavir. When concomitantly administered with Truvada, atazanavir 300 mg together with ritonavir 100 mg is recommended. Atazanavir and Truvada should not be taken simultaneously without ritonavir.
Emtricitabine and tenofovir are mainly excreted by the kidneys. concomitant use of Truvada with drugs that impair renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine, tenofovir and/or other drugs that are excreted by the kidneys. Examples include acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, and valganciclovir.

The likelihood of CYP450 interactions of emtricitabine and tenofovir with other drugs is low.
No clinically significant drug interactions have been observed between emtricitabine and famcyclovir, indinavir, stavudine, tenofovir disoproxil fumarate, zidovudine. No clinically significant drug interactions have been observed between tenofovir disoproxil fumarate and abacavir, adefovir dipivoxil, ifavirenz, emtricitabine, indinavir, lamivudine, lopinavir/ritonavir, methadone, nelfinavir, oral contraceptives, ribavirin, saquinavir/ritonavir.

Special Instructions

Truvada is not recommended as part of a three-component nucleoside treatment regimen.
Truvada should not be administered concomitantly with Atripla, Emtriva or Viread. Because of the similarities between emtricitabine and lamivudine, Truvada should not be administered concomitantly with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzik (abacavir sulfate/lamivudine/zidovudine). Truvada cannot be administered with Hepsera (adenovira dipivoxil).

Clinical studies in HIV-infected patients have shown that certain regimens containing only three nucleoside reverse transcriptase inhibitors (NRTIs) are generally less effective than triple drug regimens containing two NRTIs in combination with a non-nucleoside reverse transcriptase inhibitor or HIV-1 protease inhibitor. In particular, early viral ineffectiveness and a high rate of resistance replacement have been reported. Therefore, triple nucleoside regimens should be used with caution. Patients treated with triple nucleoside regimens should be closely monitored by a physician and a change in treatment should be considered.

Lactate acidosis/extreme liver enlargement with steatosis.
When using nucleoside analogues as monotherapy or in combination with other antiretrovirals, there have been reports of lactate acidosis and marked liver enlargement with steatosis, including death. Most of these cases have occurred in women. Obesity and use of long-acting nucleosides may be risk factors. Caution should be exercised when using nucleoside analogues in patients with known risk factors for liver disease, but cases have been reported in patients without known risk factors. If clinical or laboratory signs of lactate acidosis or avalanche hepatotoxicity (which may include liver enlargement and steatosis with no marked increase in transaminases) are present, treatment with the drug should be discontinued.

Patients concurrently infected with HIV and hepatitis B virus.
All HIV-infected patients should be tested for chronic hepatitis B before initiation of antiretroviral therapy. Truvada is not approved to treat chronic hepatitis B virus (HBV) infection. Although the safety and efficacy of Truvada have not been established in patients co-infected with hepatitis B virus and HIV, a marked acute exacerbation of hepatitis B has been reported in patients co-infected with HIV and HBV who discontinue emtricitabine or tenofovir disoproxil fumarate.

In some patients who were treated with emtricitabine, exacerbation of hepatitis B was accompanied by hepatic decompensation and liver damage. In patients co-infected with HIV and HBV who have discontinued Truvad, liver function should be monitored by clinical and laboratory methods for at least several months. Hepatitis B treatment should be started if necessary.
Renal disorders.

Emtricitabine and tenofovir disoproxil fumarate are eliminated mainly by kidneys. Renal disorders including cases of acute renal failure and Fanconi syndrome (renal tubular damage with severe hypophosphatemia) which are associated with tenofovir disoproxil fumarate use have been reported. It is recommended that all patients be determined clearancecreatinine prior to initiating treatment and as clinically necessary during therapy with the drug. Serum creatinine and phosphorus clearance levels should be monitored continuously in patients with threatened renal failure.

In all patients with a creatinine clearance of 30-49 mL/min, correction of the interval between doses of Truvada and close monitoring of liver function is recommended. Truvada should not be administered to patients who require hemodialysis. Administration should be avoided concomitantly or after recent use of nephrotoxic active ingredients.

The effect on the bone system.
A decrease in bone mineral density in the lumbar and femoral bones during treatment with Truvada has been observed relative to the initial level. Most decreases in bone mineral density were observed during the first 24-48 weeks and persisted through the 144 weeks of the study. In HIV-infected patients with a history of spatologic bone fractures or with an increased risk of osteopenia, the bone condition should be monitored.
Lipodystrophy

In patients who received antiretroviral therapy, redistribution of body fat (lipodystrophy) has been observed, including fat deposition in the abdomen, dorsocervical fat deposition (“bison hump”), loss of fat tissue in the extremities, face, breast enlargement and “cushingoid appearance”. The mechanism and long-term consequences of these phenomena are unknown. High risk of lipodystrophy is associated with individual factors such as advanced age, long-term antiretroviral therapy and associated metabolic disturbances.

The immune reconstitution syndrome.
In the initial phase of combination antiretroviral treatment, patients whose immune systems respond to treatment may develop an inflammatory response to delayed or residual opportunistic infections (infections caused by Mycobacterium avium, cytomegalovirus infection, pneumonia caused by Pneumocystis jirovecii (PCP), or tuberculosis), which may require further evaluation and treatment.

Contraindications

Side effects

Because Truvada contains emtricitabine and tenofovir disoproxil fumarate, adverse reactions similar in nature and severity to those of these antiretroviral drugs may occur when taking it.

With the blood system and hematopoietic organs: neutropenia, anemia.

Immune system disorders: allergic reactions, including angioedema.

Metabolism disorders: hypophosphatemia, hyperglycemia, lactate acidosis, hyperglyceridemia, hypokalemia.

Nervous system disorders: dizziness, headache, insomnia, depression. Respiratory system: shortness of breath.

Gastrointestinal tract: diarrhea, vomiting, nausea, flatulence, increased amylase activity, abdominal pain, bloating, pancreatitis, dyspepsia, increased lipase activity. Liver and biliary tract: hyperbilirubinemia, hepatitis, fatty liver dystrophy, increased activity of liver transaminases (most often aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltranspeptidase).

Skin and subcutaneous fat: skin rash, sometimes accompanied by itching (maculopapular rash, urticaria, vesicular-bulp, pustular rash), skin color changes (mainly on the palms and/or soles of the feet).

Musculoskeletal system disorders: increase in creatine kinase level, rhabdomyolysis, osteomalacia (manifested by bone pain, occasionally leads to fractures), muscle weakness, myopathy.

Urinary system disorders: renal dysfunction, including acute, renal failure, acute renal tubular necrosis, Fanconi syndrome, renal tubulopathy of proximal type, intraregional nephritis, nephrogenic nonscholar diabetes, increased concentration of creatinine, proteinuria, polyuria.

Others: asthenia, fatigue.

Overdose

Symptoms: intensification of side effects.
Treatment: standard maintenance therapy should be followed. Hemodialysis eliminates up to 30% of the emtricitabine dose and 10% of the dose of emtrenofovir.