Tenofovir TL, 300 mg 30 pcs

Hepatitis, HIV infection

Treatment of HIV-1 infection as part of combination antiretroviral therapy in adults.

Active ingredient

Composition

Active components:

Tenofovir disoproxil fumarate 300.0 mg

How to take, the dosage

Ingestion, regardless of meals. Recommended dose for treatment of HIV-1 infection: 300 mg once daily.

Recommended dosing regimen for Tenofovir in renal failure: Creatinine clearance 30-49 ml/min: 300 mg every 48 hours. Creatinine clearance 10-29 mL/min: 300 mg every 72-96 hr. Hemodialysis: 300 mg every 7 days after completion of a dialysis session.

There are no dosing recommendations for patients with creatinine clearance less than 10 ml/min (without hemodialysis).

Interaction

Didanosine:Elevated concentrations of didanosine when used together; they should be used with caution and the manifestations of didanosine toxicity (e.g., pancreatitis, neuropathy) should be controlled. Combination of tenofovir with didanosine is not recommended; if warranted, a dose reduction or discontinuation of didanosine therapy should be considered. Tenofovir is combined with reduced doses of didanosine (e.g., patients with a body weight of > 60 kg are prescribed didanosine 250 mg once daily; < 60 kg, 200 mg once daily). On the other hand, such low-dose combination may be characterized by low antiviral activity and insufficient growth of C04-lymphocytes number, which is indicated by high frequency of ineffective therapy when this combination is used with addition of efavirenz or nevirapine.

Atazanavir: Decrease atazanavir concentrations when used together and increase tenofovir concentrations. Tenofovir should be used with atazanavir only with additional enhancement of the action of the latter by ritonavir.

Lopinavir/ritonavir: Increased concentrations of tenofovir when used together.

Darunavir:increases tenofovir concentrations by 20-25%. The drugs should be used in standard doses, and the nephrotoxic effect of tenofovir should be closely monitored. Tenofovir is mainly excreted from the body through the kidneys, co-administration of tenofovir with drugs that reduce renal function or reduce/eliminate active tubular secretion may increase the serum concentration of tenofovir and/or increase concentrations of other drugs excreted through the kidneys.

Ganciclovir, valganciclovir and cidofovir compete with tenofovir for active tubular secretion by the kidneys, resulting in increased levels of tenofovir or a concomitant drug; caution is required for possible side effects. Nephrotoxic drugs may also increase tenofovir serum concentrations.

Contraindications

Tenofovir is contraindicated in patients with hypersensitivity to any component of the drug.

Cautions

Renal failure with creatinine clearance less than 50 ml/min, including patients on hemodialysis. When creatinine clearance is less than 30 mL/min, use of the drug should be avoided; if no other treatment is available, renal function should be monitored carefully and the interval between doses of the drug should be adjusted.

Side effects

The following are the adverse reactions with a suspected (possible) association with the drug, which are listed by system-organ class in descending order of severity, with the following frequency: very common (>1/10) and common (>1/100, <1/10), rare (>1/10000, <1/1000), very rare

Metabolic and nutritional disorders: very often hypophosphatemia.

Nervous system disorders: very often – dizziness.

Gastrointestinal tract: very often – diarrhea, vomiting, nausea; often – flatulence.

Combination retroviral therapy has been associated with metabolic disorders such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, and hyperlactatemia; redistribution of subcutaneous tissue (lipodystrophy).

Cases of osteonecrosis have been reported, especially in patients with risk factors or during long-term combination antiviral therapy. The frequency is unknown.

Postmarketing experience

Metabolic and nutritional disorders: rare – lactate acidosis, frequency unknown – hypokalemia

Respiratory, thoracic and mediastinal disorders: very rare – dyspnea.

Gastrointestinal tract: rarely – pancreatitis.

Hepatobiliary system: rare – increased transaminase activity; very rare – hepatitis, frequency unknown – hepatic steatosis.

Skin and subcutaneous tissue: rare – rash.

Musculoskeletal system: incidence unknown – rhabdomyolysis, osteomalacia, muscle weakness, myopathy.

In the urinary system: rare – acute renal failure, proximal renal tubulopathy (including Fanconi syndrome), hypercreatininemia; very rare – acute tubular necrosis; frequency unknown – nephritis (including acute interstitial), nephrogenic nonscholar diabetes.

General disorders and changes at the site of administration: very rare – asthenia.

Overdose

In case of overdose, the patient should be examined for possible signs of intoxication. If necessary, standard supportive therapy is used.

Tenofovir is effectively removed by hemodialysis with an extraction rate of approximately 54%. After taking 300 mg of tenofovir, a 4-hour hemodialysis procedure results in removal of approximately 10% of the tenofovir dose taken.