Tenohop tablets are used for the indications listed below.
HIV-1 infection
Treatment of HIV-1-infected patients, in combination with other antiretroviral drugs.
The drug is prescribed for the treatment of HIV-1-infected adolescents with resistance to nucleoside reverse transcriptase inhibitors (NRTIs) or toxicity that precludes the use of first-line drugs in patients aged 12 to <18 years.
The choice of Tenofovir for the treatment of HIV-1 infected patients who have been treated with antiretroviral drugs should be based on the individual patient's resistance testing history and/or treatment history.
Hepatitis B
The drug is intended for the treatment of chronic hepatitis B in adults with:
compensated liver disease, evidence of active viral replication, persistent elevation of serum alanine aminotransferase (ALT) and histological evidence of active inflammation and/or fibrosis; confirmed lamivudine-resistant hepatitis B; decompensated liver disease.
Tenohop is indicated for the treatment of chronic hepatitis B in adolescents aged 12 to <18 years with compensated liver disease, evidence of active immune system disease, i.e. active viral replication, persistent elevation of serum alanine aminotransferase (ALT) and histological evidence of active inflammation and/or fibrosis.
Composition
The active substance is tenofovir (one film-coated tablet contains tenofovir disoproxil fumarate 300 mg).
Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, Opadry II Blue 30K505002: lactose, hypromellose, titanium dioxide (E 171), triacetin, indigo carmine (E 132).
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Age up to 12 years.
Method of application
Treatment should be initiated by a physician experienced in the treatment of HIV infection and/or chronic hepatitis B.
Adults
The choice of Tenofovir disoproxil fumarate for the treatment of HIV-infected patients who have already undergone antiretroviral therapy should be based on the results of testing individual viral resistance and/or the patient's treatment history.
The recommended dose for the treatment of HIV or for the treatment of chronic hepatitis B is one tablet once daily, taken with food.
Chronic hepatitis B. The optimal duration of treatment is unknown.
Treatment of patients with a positive reaction to hepatitis B virus antigen (HBeAg) without cirrhosis should continue for at least 6-12 months after confirmation of HBe seroconversion (disappearance of hepatitis B virus antigens and hepatitis B virus DNA with detection of anti-HBe) or until HBs seroconversion or until loss of efficacy. After discontinuation of treatment, serum ALT and hepatitis B virus DNA levels should be monitored regularly to detect any late recurrence of viremia.
Treatment of hepatitis B antigen-negative patients without cirrhosis should be continued at least until HBs seroconversion or until signs of loss of efficacy appear. In the case of prolonged treatment lasting more than 2 years, regular review of treatment is recommended to confirm that continuation of the chosen therapy is appropriate for the patient.
Children
HIV-1: for adolescents aged 12 to <18 years, whose body weight is ≥ 35 kg, it is recommended to take one tablet of the drug orally with food once a day.
Chronic hepatitis B: For adolescents aged 12 to <18 years, weighing ≥35 kg, the recommended dose is one tablet orally once daily with food. The optimal duration of treatment is currently unknown.
Method of use
Tenohop tablets should be taken orally once a day with food.
If patients have difficulty swallowing, Tenohop tablets can be crushed and dissolved in approximately 100 ml of water, orange or grape juice and drunk immediately.
An introductory part of the instructions is provided, read the full instructions inside the package.
Application features
Pregnant women
The use of tenofovir disoproxil fumarate is possible during pregnancy if necessary.
Tenofovir has been shown to pass into breast milk. There is insufficient information on the effects of tenofovir on newborns/infants. Therefore, Tenofovir should not be used during breast-feeding.
There are limited clinical data on the effects of tenofovir disoproxil fumarate on fertility. Animal studies have not shown any adverse effects of tenofovir disoproxil fumarate on fertility.
Drivers
No studies on the effects on the ability to drive or use machines have been performed. However, patients should be informed that dizziness may occur during treatment with tenofovir disoproxil fumarate.
Overdose
In the event of overdose, the patient should be observed for signs of toxicity and, if necessary, standard supportive therapy should be administered.
Tenofovir can be removed by hemodialysis, with a median tenofovir clearance of 134 mL/minute. Removal of tenofovir by peritoneal dialysis has not been studied.
Adverse reactions with a potential (at least possible) relationship to treatment are listed below (most frequent).
Metabolic disorders: very common (≥ 1/10) - hypophosphatemia.
From the nervous system: very often (≥ 1/10) - dizziness.
Gastrointestinal tract: very often (≥ 1/10) - diarrhea, nausea, vomiting.
Skin and subcutaneous tissue disorders: very common (≥ 1/10) - rash.
Systemic disorders and disorders related to the route of administration: very common (≥ 1/10) - asthenia.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 2 years.
