Viread ® tablets are used for the indications listed below.
HIV-1 infection
Viread ® tablets are prescribed in combination with other antiretroviral drugs for the treatment of HIV-1-infected patients.
Viread ® tablets are indicated for the treatment of HIV-1-infected adolescents aged 12 to <18 years with resistance to nucleoside reverse transcriptase inhibitors (NRTIs) or toxicity that precludes the use of first-line drugs.
The choice of Viread ® for the treatment of HIV-1 infected patients who have been treated with antiretroviral drugs should be based on individual viral resistance testing data and/or the patients' treatment history.
Hepatitis B
The drug "Viread ®" is intended for the treatment of chronic hepatitis B in adults with:
compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) and histological evidence of active inflammation and/or fibrosis; confirmed lamivudine-resistant hepatitis B; decompensated liver disease.
Viread® 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 disoproxil fumarate (one film-coated tablet contains 300 mg of tenofovir disoproxil fumarate, equivalent to 245 mg of tenofovir disoproxil).
Excipients: pregelatinized starch; croscarmellose sodium; lactose, monohydrate; microcrystalline cellulose; magnesium stearate; Opadry II White 32K18425 (lactose, monohydrate; hypromellose 2910, titanium dioxide (E 171); triacetin).
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 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. Conditions for discontinuation of treatment may include:
Treatment of patients with a positive reaction to the 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 stopping treatment, serum ALT and hepatitis B virus DNA levels should be regularly monitored to detect any late recurrence of viremia; treatment of patients with a negative reaction to the hepatitis B virus antigen without cirrhosis should continue at least until HBs seroconversion or signs of loss of efficacy of treatment appear; in the case of prolonged treatment lasting more than 2 years, regular re-review of treatment is recommended to confirm that the chosen therapy remains suitable for the patient.
Children
HIV-1. For adolescents aged 12 to <18 years, weighing ≥35 kg, the recommended dose of Viread® is one tablet once daily, taken with food.
Chronic hepatitis B. For adolescents aged 12 to <18 years and weighing ≥35 kg, the recommended dose of Viread® is one tablet once daily taken with food. The optimal duration of treatment is currently unknown.
Method of use
Viread® tablets should be taken once daily orally with food.
If patients have difficulty swallowing, Viread ® tablets can be crushed and dissolved in approximately 100 mL of water, orange or grape juice and drunk immediately.
Application features
Pregnant women
The use of tenofovir disoproxil fumarate is possible during pregnancy if necessary.
Tenofovir has been shown to pass into human breast milk. There is insufficient information on the effects of tenofovir on newborns/infants. Therefore, Viread ® should not be used during breastfeeding. In general, HIV- and HBV-infected women are advised not to breastfeed to avoid transmission of HIV or HBV infection to the infant.
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 and use machines have been performed. Patients should be informed that dizziness may occur during treatment with tenofovir disoproxil fumarate.
Overdose
Symptoms: In case of overdose, the patient should be observed for signs of toxicity and, if necessary, standard supportive therapy should be administered.
Treatment: Tenofovir can be removed by hemodialysis, the median clearance of tenofovir is 134 mL/minute. The removal of tenofovir by peritoneal dialysis has not been studied.
Adverse reactions are defined by frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10).
Nutritional and metabolic disorders: very common - hypophosphatemia.
From the nervous system: very often - dizziness; often - headache.
On the part of the digestive system: very often - diarrhea, nausea, vomiting; often - abdominal pain, bloating, flatulence.
On the part of the liver: sometimes - increased levels of transaminases.
Skin and subcutaneous tissue disorders: very common - rash.
Systemic disorders and disorders related to the method of administration: very often - asthenia; often - fatigue.
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 5 years.
