For Consumers

Approved antiretroviral drugs for pediatric treatment of HIV infection

 

Click on drug brand name for product label information.


Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Combivir

lamivudine and zidovudine

ViiV Healthcare

>12 yr and ≥ 30 kg:
Tablet:  1 tablet (300 mg zidovudine/ 150 mg lamivudine) twice daily

Not recommended for children <12 yrs. due to fixed dosage form that cannot be adjusted for this population
Generic formulation available 

Emtriva

emtricitabine (FTC)

Gilead Sciences

0-3 months:
Solution:  3 mg/kg once daily

3 months-17 yr.
Solution: 6 mg/kg once daily

>33 kg
Capsule:  200 mg once daily
Solution:  6 mg/kg once daily

Maximum dosage:
Solution:  240 mg/day

Epivir

lamivudine (3TC)

ViiV Healthcare

3 months-16 yr: 
Solution or tablet:  4 mg/kg twice daily

 

Maximum dosage:
150 mg twice daily
Generic formulation available

Epzicom

abacavir and lamivudine

ViiV Healthcare

Safety and effectiveness in pediatric patients not established

Not recommended for children < 12 yrs. due to fixed dosage form that cannot be adjusted for this population

Retrovir

zidovudine (ZDV), azidothymidine (AZT)

ViiV Healthcare

For treatment of HIV-1 infection:
Tablet/capsule/solution:
4 - < 9kg:
24 mg/kg/day divided two or three times daily

≥ 9 - < 30kg:
18 mg/kg/day divided two or three times daily

≥ 30kg:
600 mg/day divided two or three times daily

For prevention of maternal-fetal neonatal transmission

­<12 hours after birth-6 weeks:
Solution:  2 mg/kg every 6 hours until 6 weeks of age
IV:  1.5 mg/kg infused over 30 minutes every 6 hours until 6 weeks of age

Maximum dosage:  200 mg every 8 hours

Note different dosages for treatment vs. prevention of maternal-fetal transmission

IV form used if neonate unable to receive oral form

Generic formulation available

Trizivir

abacavir, zidovudine, and lamivudine

ViiV Healthcare

Safety and efficacy not established in pediatric patients, and should not be administered to adolescents weighing < 40 kg

 

Truvada

tenofovir disoproxil fumarate and emtricitabine

Gilead Sciences

>12 years and ≥35 kg:
1 tablet (300 mg tenofovir /200 emtricitabine) once daily

Not recommended for children <12 yrs. due to fixed dosage form that cannot be adjusted for this population

Videx EC

didanosine (ddI)

Bristol Myers Squibb

≥ 6 years and 20kg:
Capsule
20 - <25 kg:
200 mg once daily

25 - <60 kg:
250 mg once daily

>60 kg:
400 mg once daily

Maximum Dosage: 400 mg once daily
Videx powder for oral solution is available for children who cannot swallow tablets or weigh less than 20 kg (see below).

Videx

didanosine (ddI)

Bristol Myers Squibb

Powder for oral solution: 
2 weeks-8 months: 
100 mg/m2 twice daily

>8 months:  120 mg/m2 twice daily; dosing range 90-150 mg/m2

Maximum Dosage: 400 mg per day
Dosing recommendations for patients less than 2 weeks of age cannot be made because the pharmacokinetics in these children are too variable to determine appropriate dose.
There is no data on once-daily dosing in pediatric patients.

Patients with CNS disease may require higher doses.
Generic formulation available

Viread

tenofovir disoproxil fumarate (TDF)

Gilead Sciences

2-12 yrs:
Oral powder/tablet: 8 mg/kg once daily

>12 yrs and 35 kg:
Tablet: 300 mg once daily

Maximum dosage: 300 mg once daily
Please refer to the package insert for tablet dosing by weight band for children who weigh > 17 kg

Zerit

stavudine (d4T)

Bristol Myers Squibb

Birth-13 days: 
Tablet/oral solution: 
0.5 mg/kg every 12 hours

>14 days and <30 kg: 
Tablet/oral solution: 
1 mg/kg every 12 hours

>30 - < 60 kg: 30 mg
every 12 hours

>60 kg: 40 mg every 12 hours

Maximum Dosage: 40 mg every 12 hours
Generic formulation available

Ziagen

abacavir (ABC)

Glaxo Smith Kline

3 months-16 yr: 
Tablet/oral solution:  8 mg/kg
twice daily

Maximum dosage:  300 mg twice daily
Please refer to the package insert for tablet dosing by weight band for children who weigh > 14 kg

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Edurant

rilpivirine (RPV)

Janssen

Safety and efficacy not established in pediatric patients

 

Intelence

etravirine (ETV)

Janssen

≥ 3 years and > 16 kg:
Tablets
16 - < 20 kg: 100 mg twice daily
20 - < 25 kg: 125 mg twice daily
25 - < 30 kg: 150 mg twice daily
≥ 30 kg: 200 mg twice daily

Maximum dosage: 200 mg twice daily

 

Rescriptor

delavirdine (DLV)

ViiV Healthcare

Safety and effectiveness not established in HIV-1–infected individuals <16 years

 

Sustiva

efavirenz (EFV)

Bristol Myers-Squibb

>3 months and 3.5 kg
Tablet/capsule:
3.5  - < 5 kg: 100 mg once daily
5 - <7.5 kg: 150 mg once daily
7.5 - <15 kg:  200 mg once daily

15 - <20 kg:  250 mg once daily

20 - <25 kg:
  300 mg once daily

25 - <32.5 kg:  350 once daily

32.5 - <40 kg
:  400 mg once daily

>40 kg:  600 mg once daily

Maximum Dosage: 600 mg once daily
For children who cannot swallow capsules, the capsule contents can be administered with a small amount of food or infant formula using the capsule sprinkle method of administration. Please refer to the package insert for instructions. 
Tablets should NOT be crushed.
Dosing recommended at bedtime to limit CNS effects

Viramune

nevirapine (NVP)

Boehringer Ingelheim

≥ 15 days:
Oral suspension/tablet: 150 mg/m2 once daily for 14 days, then 150 mg/m2 twice daily

Maximum dosage:  400 mg per day
 

Viramune XR

Nevirapine (NVP)

Boehringer Ingelheim

6 - < 18 years:

Tablet:
BSA 0.58-0.83 kg/m2: 200 mg
once daily

BSA 0.84-1.16 kg/m2: 300 mg
once daily

BSA ≥1.17 kg/m2: 400 mg
once daily

 

Maximum dosage: 400 mg once daily
All children must initiate therapy with immediate-release Viramune for the first 14 days (see above)

Protease Inhibitors (PIs)

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Agenerase

amprenavir (APV)

GlaxoSmithKline

N/A

Product has been replaced by Lexiva (fosamprenavir), a prodrug of amprenavir.  Please refer to the Lexiva section for dosage information

Aptivus

tipranavir (TPV)

Boehringer Ingelheim

2-18 yrs:
Capsule/oral solution: 14 mg/kg
with 6 mg/kg ritonavir twice daily
(or 375 mg/m2  with ritonavir
150 mg/m2 twice daily)

 Maximum dosage: 500 mg with 200mg ritonavir twice daily

Crixivan

indinavir (IDV)

Merck

Safety and efficacy not established in pediatric patients

 

Invirase

saquinavir (SQV)

Hoffmann-La Roche

Safety and effectiveness in patients <16 years not established

 

Kaletra

lopinavir and ritonavir (LPV/r)

Abbott Laboratories

Patients receiving nevirapine or efavirenz with Kaletra should have their Kaletra dose increased. Dose calculation is based on the lopinavir component

14 days-6months:
16 mg/kg twice daily

6 months-12 yrs.:
Tablet/capsule/solution:
7 - <15 kg:  12 mg/kg twice daily (13 mg/kg with nevirapine)

15-40 kg:  10 mg/kg twice daily
(11 mg/kg with nevirapine)

>40 kg or >12 yr:  lopinavir 400 mg twice daily (533 mg with nevirapine)

Maximum dosage:
lopinavir 400 mg twice daily for patients who are not receiving nevirapine or efavirenz.

Kaletra should not be used in combination with NNRTIs in children less than 6 months of age.

 

Refer to package insert for BSA-based dosing information. 

Lexiva

fosamprenavir (FPV)

ViiV Healthcare

Protease Inhibitor-Naïve ≥ 4 Weeks OR Protease Inhibitor-Experienced ≥ 6 Months:
<11 kg:  
45 mg/kg with 7 mg/kg ritonavir twice daily
11 kg - <15 kg:
30 mg/kg with 3 mg/kg  ritonavir twice daily
15 kg - <20 kg:
23 mg/kg with 3 mg/kg ritonavir twice daily
≥ 20 kg
18 mg/kg with 3 mg/kg ritonavir twice daily
≥ 2 years and Protease-Inhibitor Naïve:
30 mg/kg twice daily without ritonavir

Maximum dose: 700 mg with 100 mg ritonavir twice daily

Data are insufficient to recommend: once-daily dosing of Lexiva alone or in combination with ritonavir

Norvir

ritonavir (RTV)

AbbVie

>1 month:  350-400 mg/m2 twice daily

Initiate dose at 250 mg/m2 twice daily and titrate upward every 2-3 days by 50 mg/m2 twice daily

Maximum dosage:  600 mg twice daily

Lower doses have been used to boost other protease inhibitors but the RTV doses used for boosting have not been specifically approved in children

Prezista

darunavir (DRV)

Janssen

≥ 3 yrs and 10 kg
Oral solution or tablet/capsule

Treatment naïve or experienced without DRV-associated substitutions:
10-< 15 kg:
35 mg/kg once daily with 7mg/kg ritonavir once daily 

15- < 30 kg:
600 mg with 100 mg RTV once daily

30- <40 kg:
675 mg with 100 mg RTV once daily

>40 kg:
800 mg with 100 mg RTV once daily

Treatment experienced with ≥1 DRV-associated substitution(s):
10-15 kg:
20 mg/kg twice daily with 3 mg/kg RTV twice daily

15- < 30 kg:
375 mg with 48 mg RTV twice daily

30- <40 kg:
450 mg with 60 mg RTV twice daily

>40 kg:
600 mg with 100 mg RTV twice daily

DRV should not be used in children < 3 years of age due to toxicity concerns.

Reyataz

atazanavir (ATV)

Bristol Myers Squibb

≥ 6 yrs and 15 kg:
Capsules
15- < 20 kg:
150 mg with 100 mg RTV once daily
20 - < 40 kg:
200 mg with 100 mg RTV once daily
≥ 40kg:
300 mg with 100 mg RTV once daily

Maximum dosage: 400 mg once daily
Administration with RTV is preferred. Dose for treatment-naïve children ≥ 13 years of age and ≥ 40 kg unable to tolerate RTV: 400 mg once daily (see package insert for details)

Viracept

nelfinavir (NFV)

Agouron Pharmaceuticals

2-13 yr: 
Tablets/powder :  45-55 mg/kg
twice daily or 25-35 mg/kg three times daily

Maximum dosage:
2500 mg/day

250 mg tablets are interchangeable with oral powder (625 mg tablets are not)

Reliable dosing recommendations could not be determined in patients < 2 years of age

Fusion Inhibitors

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Fuzeon

enfuvirtide, T-20 (ENF)

Hoffmann-La Roche

6-16 yr:
Subcutaneous injection: 2 mg/kg twice daily

Maximum dosage:
90 mg twice daily

Rotate injection sites

Entry Inhibitors

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Selzentry

maraviroc (MVC)

ViiV Healthcare

Safety and efficacy not established in pediatric patients

 

HIV integrase strand transfer inhibitors (INSTI)

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Isentress

raltegravir (RAL)

Merck & Co., Inc.

≥ 4 weeks and 3-11 kg:
Oral Suspension
3 - < 4 kg: 20 mg twice daily
4 - < 6 kg: 30 mg twice daily
6 - < 8 kg: 40 mg twice daily
8 - < 11 kg: 60 mg twice daily

≥ 11 - < 25 kg:
Oral Suspension/ Chewable Tablet  
6 mg/kg/dose twice daily.  Please see package insert for dosage by weight band

≥ 25 kg and unable to swallow tablet:
Chewable Tablet
25 - < 28 kg: 150 mg twice daily
28- < 40 kg: 200 mg twice daily
≥ 40 kg: 300 mg twice daily
6 years and ≥25 kg and able to swallow tablets: Film coated tablet  400 mg twice daily

Oral suspension, chewable tablets and film coated tablets are not bioequivalent
Maximum dose for chewable tablets: 300 mg twice daily
Maximum dose for film coated tablets: 400 mg twice daily

Tivicay

dolutegravir (DTG)

ViiV Healthcare

≥ 12 years and  40 kg:
Tablets
Treatment naïve OR treatment experienced but INSTI naïve: 50 mg once daily
Treatment experienced or naïve and co-administered with efavirenz, FPV/r, TPV/r, or rifampin: 50 mg twice daily
INSTI experienced with certain INSTI-associated resistance substitutions: 50 mg twice daily

 

Fixed Dose Combinations Providing Complete Regimen

Brand Name

Generic Name

Manufacturer Name

Pediatric Use Labeling

Special Information

Atripla

efavirenz, emtricitabine, tenofovir disoproxil fumarate

Gilead Sciences

≥ 12 years and 40 kg:
one tablet once daily

Not recommended for children <12 yrs. due to fixed dosage form that cannot be adjusted for this population

Complera

emtricitabine, rilpivirine, tenofovir disoproxil fumarate

Gilead Sciences

Safety and efficacy not established in pediatric patients

 

Stribild

elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate

Gilead Sciences

Safety and efficacy not established in pediatric patients

 

Body Surface Area can be calculated using the Mostellar Formula: Body Surface Area Calculation Formula
  

Additional resources related to pediatric drug development and use

Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Pediatric Exclusivity Labeling Changes related to the Best Pharmaceuticals for Children Act (BPCA)

Pediatric Labeling Changes Resulting from the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA)

Pediatric Drug Development

Drugs Used in the Treatment of HIV Infection

Generic Drugs Used in the Treatment of HIV Infection

 

Page Last Updated: 01/17/2014
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