Naivex 50mg Tablets treatment of HIV-1 infection in adults and children from 12 years old and weighing 40 kg or more in combination antiretroviral therapy (APT).
- Hypersensitivity to dolutegravir or any other component of the drug;
- Simultaneous reception with dofetilide;
- Children under 12 years old and weighing less than 40 kg.
- hepatic insufficiency of severe degree (class C on the Child-Pugh scale);
- With simultaneous use with medicinal products (prescription and over-the-counter), which can change the effect of the drug, or drugs that may change under the action of dolutegravir.
Therapy with Naivex 50mg Dolutegravir should be carried out by a doctor with experience in the treatment of HIV infection. The drug Dolutegravir can be taken regardless of food intake.
The recommended dose of Dolutegravir is 50 mg once a day. When used simultaneously with efavirenz, nevirapine, rifampicin, and tipranavir in combination with ritonavir, the recommended dose of Dolutegravir in this category of patients should be 50 mg 2 times a day.
Patients infected with HIV-1, with resistance to InI (documented or suspected clinically)
The recommended dose of the drug Naivex 50 mg Dolutegravir is 50 mg 2 times a day. The decision to use the drug Dolutegravir in such patients should be made taking into account the drug resistance to InI. In this category of patients, simultaneous use with efavirenz, nevirapine, rifampicin, and tipranavir in combination with ritonavir should be avoided.
Skipping the drug
If the patient misses Dolutegravir, he should take the missed dose as soon as possible, if at least 4 hours remain before the next dose. If there are less than 4 hours left until the next dose, the patient should not take the missed dose, and the drug should be resumed according to the schedule.
Children aged 12 to 18 years and weighing 40 kg and more
The recommended dose of Dolutegravir for patients who had not previously received InI treatment (age 12 to 18 years, body weight 40 kg and more) is 50 mg once a day.
There is insufficient data to recommend a dose of Dolutegravir to children aged 12 to 18 years with resistance to InI.
Children under 12 years of age and weighing less than 40 kg
Insufficient safety and efficacy data are available to recommend a dose of Dolutegravir to children younger than 12 years of age or weighing less than 40 kg.
Data on the drug overdose Dolutegravir are limited.
The limited experience of using higher single doses (up to 250 mg in healthy volunteers) revealed no special symptoms or signs other than those described in the “Side effect” section.
Further treatment should be carried out in accordance with clinical indications or recommendations of national toxicology centers, where applicable. There is no specific treatment for an overdose of Dolutegravir. In case of an overdose, supportive therapy and appropriate follow-up should be performed. Due to the high binding of dolutegravir to plasma proteins, it is unlikely that a significant amount of it can be excreted by dialysis.
Dolutegravir – (international transcription DTG) – a synthetic antiviral drug from the group of integrase inhibitors for oral administration. Dolutegravir was developed by ViiV Healthcare with the participation of GlaxoSmithKline, Pfizer and Shionogi & Co and approved by the FDA in August 2013 and the European Commission in January 2014. The mechanism of action of the drug is to suppress the catalytic activity of the enzyme HIV-integrase virus, which is necessary for replication of the virus in the host cell genome, leads to the formation of inactive viral particles and inhibition of further spread of infection in the human body. Only the HIV-1 virus is sensitive to dolutegravir.