Truvada pills 245mg+200mg, 30pcs

Composition

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

Indications

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

Contraindications

• hypersensitivity to any component of the drug
• lactation period
• renal failure with creatinine clearance less than 30 ml / min
• children and adolescents under 18 years of age

Side effects

Since Truvada contains emtricitabine and tenofovir disoproxil fumarate, it may cause side effects similar in nature and severity to those that occur when taking these antiretroviral drugs.

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

Immune system disorders: allergic reactions, including angioedema.

From the side of metabolism: hypophosphatemia, hyperglycemia, lactate acidosis, hypergriglyceridemia, hypokalemia.

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

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

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

From the musculoskeletal system: increased creatine kinase, rhabdomyolysis, osteomalacia (manifested by bone pain, occasionally leads to fractures), muscle weakness, myopathy.

From the urinary system: renal dysfunction, including acute, renal failure, acute necrosis of the renal tubules, Fanconi syndrome, renal tubulopathy of the proximal type, intersregial nephritis, nephrogenic diabetes insipidus, increased creatinine concentration, proteinuria, polyuria.

Other: asthenia, fatigue.

Interaction

Concomitant use of tenofovir disoproxil ididanosine fumarate at a dose of 400 mg per day leads to increased systemic action of ididanosine. Patients receiving concomitant use of tenofovir disoproxil fumarate and didanosine should be closely monitored for didanosine-related side effects (pancreatitis, lactic acidosis). Suppression of CD4 lymphocyte count was observed in patients who received tenofovir disoproxil fumarate with didanosine at a dose of 400 mg daily. In adult patients weighing more than 60 kg, the dose of didanosine should be reduced to 250 mg per day. There is no information on recommendations for correcting the dose of didanosine for patients with a body weight of less than 60 kg.

Caution should be exercised when prescribing TRUVADA together with didanosine. Atazanavir and lopinavir / ritonavir showed the ability to increase the concentration of tenofovir. Patients receiving atazanavir and lopinavir/ ritonavir together with Truvada should be carefully monitored. Patients who have developed side effects associated with Truvada should stop using the drug.

Tenofovir reduces the AUC (area under the pharmacokinetic curve) and Cmin (minimum plasma concentration) of atazanavir. When co-administered with Truvada, it is recommended to take atazanavir 300 mg together with ritonavir 100 mg. Do not take atazanavir iTruvada without ritonavir at the same time. Emtricitabine and tenofovir are mainly excreted by the kidneys. Concomitant use of Truvada with drugs that weaken 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 between emtricitabine and tenofovir with other drugs is low. There were no clinically significant drug interactions between emtricitabine and famciclovir, indinavir, stavudine, tenofovir disoproxil fumarate, and zidovudine. No clinically significant drug interactions were observed between tenofovir disoproxil fumarate and abacavir, adefovir dipivoxil, ifavirenz, emtricitabine, indinavir, lamivudine, lopinavir/ritonavir, methadone, nelfinavir, oral contraceptives, ribavirin, saquinavir/ritonavir.

How to take, course of use and dosage

Treatment should be initiated by a doctor who has experience in the treatment of HIV infection. The recommended dose of Truvada is 1 tablet, which is taken orally once a day, to optimize absorption, it is recommended to take with food. Elderly patients: the dose should be selected with caution for elderly patients, given the high frequency of impaired liver, kidney or heart function, as well as concomitant diseases or taking other medications.

Overdose

Symptoms: increased side effects. Treatment: Follow standard maintenance therapy. Up to 30% of the emtricitabine dose and 10% of the tenofovir dose are eliminated by hemodialysis.

Special instructions

The use of Truvada as a component of a three-component nucleoside treatment regimen is not recommended. Truvada should not be administered simultaneously with Atripla, Emtriva, or Viread. Due to the similarity of emtricitabine and lamivudine, Truvada should not be administered concomitantly with other lamivudine-containing medications, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzik (abacavir sulfate/ lamivudine/zidovudine). Truvada should not be administered with Hepera (adenovir dipivoxil).

Clinical studies in patients infected with HIV have shown that certain regimens containing only three nucleoside reverse transcriptase inhibitors (NRTIs) are usually less effective than triple drug regimens containing two NRTIs in combination with a non-nucleoside reverse transcriptase inhibitor or an HIV-1 protease inhibitor. In particular, early viral inefficiency and a high rate of replacement of resistance were reported. Therefore, triple nucleoside schemes should be used with caution. Patients receiving treatment with tri-nucleoside regimens should be under close medical supervision and consideration should be given to changing the treatment.

Lactate acidosis / severe liver enlargement with steatosis. When using nucleoside analogues as monotherapy or in combination with other antiretroviral drugs, there have been reports of lactate acidosis and severe liver enlargement with steatosis, including fatal cases. Most of these cases were observed in women. Obesity and the use of long-acting nucleosides may be risk factors. Nucleoside analogues should be used with extreme caution in patients with known risk factors for liver disease, but such cases have been reported in patients without known risk factors. If the patient shows clinical or laboratory signs of lactate acidosis or apparent hepatotoxicity (which may include enlarged liver and steatosis even in the absence of a marked increase in transaminase levels), treatment with the drug should be discontinued.

Patients who are simultaneously infected with HIV and hepatitis B virus. All HIV-infected patients should be tested for chronic hepatitis B before starting antiretroviral therapy. Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Although the safety and efficacy of Truvada have not been established for patients co-infected with hepatitis B virus and HIV, severe acute exacerbation of hepatitis B has been reported in patients co-infected with HIV and HBV who have stopped using emtricitabine or tenofovir disoproxil fumarate.

In some patients treated with emtricitabine, exacerbation of hepatitis B was accompanied by hepatic decompensation and liver damage. Liver function should be monitored by clinical and laboratory methods for at least several months in patients who are simultaneously infected with HIV and HBV who have stopped using Truvad. If necessary, treatment for hepatitis B should be initiated.

Emtricitabine and tenofovir disoproxil fumarate are mainly excreted by the kidneys. Renal disorders have been reported, including cases of acute renal failure and Fanconi syndrome (severe hypophosphatemia in the renal tubules), which are associated with the use of tenofoviradisoproxil fumarate. All patients are recommended to determine creatinine clearance before starting treatment, as well as if clinically necessary during drug therapy. In patients at risk of renal failure, it is necessary to constantly monitor the levels of creatinine and phosphorus clearance in the blood serum.

All patients with a creatinine clearance of 30-49 ml/min are recommended to adjust the interval between doses of Truvad and carefully monitor the function of the stoves. Truvada should not be prescribed to patients who need hemodialysis. It is necessary to avoid prescribing the drug simultaneously or after the recent use of nephrotoxic active substances.

Effect on the bone system.There was a decrease relative to the initial level of lateral bone density in the lumbar and femoral bones during treatment with Truvada. The majority of cases of reduced bone mineral density were observed during the first 24-48 weeks and persisted for 144 weeks of the study. In HIV-infected patients with a history of spathological bone fractures or who have an increased risk of osteopenia, the condition of bone tissue should be monitored. Lipodystrophy

Patients treated with antiretroviral therapy have been observed to have body fat over-distribution (lipodystrophy), including abdominal fat deposition, dorsocervical fat deposition (“bison hump”), loss of fat tissue on the limbs, face, breast enlargement, and”kushingoid appearance”. The mechanism and long-term consequences of these phenomena are not known. A high risk of lipodystrophy is associated with individual factors, such as old age, long-term treatment with antiretroviral drugs, and associated metabolic disorders.

Immune recovery syndrome. In the initial phase of combined antiretroviral treatment, patients whose immune system responds to treatment may develop an inflammatory reaction to delayed or residual opportunistic infections (Mycobacterium avium infections, cytomegalovirus infection, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis), which may require further examination and treatment.

Form of production

film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 30 °C

Shelf life

4 years

Active ingredient

Tenofovir, Emtricitabine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

HIV infection