Naivex-Tafero EM


QUICK OVERVIEW

Generic Name : Dolutegravir/ Emtricitabine/ Tenofovir Alafenamide
Category : HIV Drugs
Company Name : Hetero healthcare Ltd
Dosage Form: 30 TABLETS
Strength : 200mg;25mg and 50mg

  

Availability: In Stock

Medicine Overview of Naivex-Tafero EM Tablet


Uses of Naivex-Tafero EM Tablet


Naivex – tafero Em is indicated for the treatment for the patients having human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used in combination with other antiretroviral agents to treat  the HIV-1 infection in adults and pediatric patients  having at least 30- 35 kg weighing.

Side effects of Naivex-Tafero EM Tablet


Consult with your doctor if you feel any following side effects:

Major side effects of Naivex – Tafero EM tablets

Lactic acidosis,

severe hepatomegaly with steatosis

Renal effects:

Nephritis,

 Nephrogenic,

diabetes insipidus,

renal failure

GI events: Anorexia, abdominal distention, diarrhea, dyspepsia, flatulence

Less common side effects of Naivex – Tafero EM tablets

Bloody urine

Peeling skin

Black, tarry stools

Low frequency of urine

Decrease appetite

Muscle pain

Swollen glands

Swelling of the face, fingers, feet or lower legs

Troubled breathing

Unusual bruising

Yellow eyes and skin

Incidence not known

Clay colored stools

Decreased appetite

Stomach tenderness.

How to use Naivex-Tafero EM Tablet


Naivex – tafero Em recommended dose of one tablets of dolutegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg once in a day taken orally.

In some case  adults dose in Naivex may vary

Naivex recommended for New patients or experienced virologically suppressed patients  changing  to this drug combined with ripivirne given 50mg orally once a day

When coadministered with certain UGT1A or CYP450 inducers administred 50mg orally twice a day.

INSTI- experienced patients with certain INSTI- correlated resistance substitutions administer 50mg orally twice a day

In pediatric dose in Naivex

Patients weighing 30 to < 40mg administer 35mg orally once a day

Patients weighing atleast 40kg administer 50mg orally once a day.

Naivex – Tafero Em can be taken with or without food but probably taken with food to enhance exposure.

Overdose: Naivex– Tafero EM has no specific therapy for an overdose. If occurs then provide the patient with supportively with appropriate monitoring as necessary.

How to Naivex-Tafero EM Tablet works:


Naivex 50mg prevents the human immunodeficiency virus integrated by joining  to the integrase active site and stop the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration that is specific for the HIV proliferation cycle.

A synthetic nucleoside coordinate of cytidine is called emtricitabine, that  go via  phosphorylation occurring in- vitro cell to emtricitabine 5'-triphosphate, then take part  with deoxycytidine 5'-triphosphate and is incorporated into viral DNA which leads to  chain termination. Emtricitabine activity against HIV-1, HIV-2 viruses  and hepatitis B virus (HBV).

Tenofovir  Alafenamide (Tafero Em 25mg) is a inhibitor of Nucleotide reverse transcriptase that fight against viral infection . which act as an Phosphonamidate prodrug, then Tenofovir is hydrolized in vivo and then phosphorylated to the active metabolite to form Tenofovir diphosphate. Drug will prevents the  reproduction of HIV virus in human cells and then stops  the HIV virus from producing new viruses and a novel ester prodrug of the antiretroviral tenofovir, use to treat  HIV infection and chronic hepatitis B.Tafero 25mg cause fast chain termination and interferes with proviral DNA 27 transcription.

Absorption: rapidly absorped from GI Tract and peak plasma concentration is 2 to3 hours post dose.

Tenofovir Alafenamide (Tafero Em) Peak plasma concentration is approx 0.5hrs after the dose. Food effect: Tenofovir alafenamide  with a high fat meal increase AUC compared with administration in fasted state. Emtricitabine (tafero em) bioavailability is 93% peak plasma concentration is 1-2 hrs.

Distribution: Dolutegravir plasma protein binding is >99%.Tenofovir Alafenamide (Tafero Em)  has Plasma protein binding is 80% and Emtricitabine (Tafero Em)  human plasma bounding is <4%

Metabolism : primarily metabolized via glucuronidation through UGT1A1 with a minor CYP3A component. Only minimal metabolized by CYP3A and Emtricitabine (Tafero Em)  has limited metabolism

Elimination :Naivex reanal eliminated, 53% through feaces and 32% total oral dose  excreted in urine.The terminal half life is -14 hours. Excreted by kidneys, 32% of dose in feces and<1% excreted in  urine. Half life is 0.5hrs.while excretion in Emtricitabine (Tafero Em) is highly unchanged in urine and low limited in feaces and half life is 10hrs.


In Depth Information on Naivex-Tafero EM Tablet:


Expert Advice for Naivex-Tafero EM Tablets


Consult your doctor before these symptoms or conditions:

  • Allergic to dolutegavir, any other medications or any consitituent in Naivex – Tafero Em rtablets.
  • Treatment on dofetilide, probably doctor stop Naivex – Tafero Em
  • Using other prescription or non prescription , vitamins, herbal supplements using or decided to use.
  • When HIV-1 and HBV are coinfected in patients will leads to severe acute exacerbation of hepatitis B.
  • Lactic acidosis and severe hepatomegaly with steatosis used in combination  with other ARTs cause fatal cases.
  • New onset worsening renal impairment with Tenofovir will produce acute renal failure.
  • Taking antacids or laxatives which contain aluminium, magnesium, or calcium or buffered medications give the drugs 2 hours after or 6 hours after piror to take dolutegravir.
  • If you or had before kidney or liver disease
  • If you are pregnant or plan to pregnancy or breast feeding

Special Warnings of Naivex-Tafero EM Tablets



Alcohol


Naivex – Tafero Em Interaction with alcohol is unknown. Please consult the doctor.

Pregnancy


Naivex -Tafero EM  during pregnancy is probably safe to use. There are limited human studies and Animal studies have shown no adverse effect on the fetus. Please consult the doctor.The drug can be used during pregnancy If expected benefit justify the specific risk to the fetus.

Lactation


Naivex – Tafero EM is excreted into human milk is unknown. It is recommended breastfed mother with HIV infection avoid breastfeed to their infants at any circumstances to get ride of transmission of infection.

Driving


During treatment with Naivex- Tafero Em , dizziness is reported has side effects. Avoid driving until u feeling well to drive.



Kidney


No dosage adjustment required for patients with mild ,moderate,or severe renal impairment using Naivex - Tafero Em. Please consult with the doctor.

Liver


No dosage adjustment required for patients with mild ,moderate and no data available in severe hepatic impairment using Naivex - Tafero Em. Please consult with the doctor.



Missed Dosage


As soon as you remember take the missed dose. If time for next dose then skips the missed dose and follow the routine scheduled. Do not take more than one tablet per day. Please consult your doctor for changes in dose or new schedule for replace of missed dose.



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Naivex-Tafero EM

 
Brand Name : <--------------------> Naivex-Tafero EM
Category : <--------------------> HIV Drugs
Sub Category :<--------------------> Dolutegravir/ Emtricitabine/ Tenofovir Alafenamide
Company Name :<--------------------> Hetero healthcare Ltd
Ingeridents(Generic Name) :<--------------------> Dolutegravir/Emtricitabine/tenofovir Alafenamide
Dosage Form :<--------------------> 30 TABLETS
Package :<--------------------> 1X30
Strength :<--------------------> 200mg;25mg and 50mg

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