U.S. Food and Drug Administration
Drugs Used in the Treatment of Pediatric HIV Infection

May 2007

Click on drug brand name for additional information.


Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Brand Name Generic Name(s) Manufacturer Name Pediatric Use Labeling Special Information
Combivir lamivudine and zidovudine GlaxoSmithKline >12 yr:
Tablet: 1 tablet (300 mg zidovudine/ 150 mg lamivudine) twice daily		 Use is contraindicated in children <12 yr. due to fixed dosage form that cannot be adjusted for this population
Emtriva FTC, emtricitabine Gilead Sciences 0-3 months:
Solution: 3 mg/kg/day

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

>16yr: Refer to adult dosing		 Maximum dosage:
150 mg twice daily
Epzicom abacavir/ lamivudine GlaxoSmithKline Safety and effectiveness in pediatric patients not established Use is contraindicated in children <12 yr. due to fixed dosage form that cannot be adjusted for this population
Hivid zalcitabine, ddC, dideoxycytidine Hoffmann-La Roche Safety and effectiveness in patients <13 years not established
Retrovir zidovudine, AZT, azidothymidine, ZDV GlaxoSmithKline 6 weeks-12 yr:
Tablet/capsule/solution: 160 mg/m2 every 8 hours

**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
Trizivir abacavir, zidovudine, and lamivudine GlaxoSmithKline Safety and efficacy not established in pediatric patients, and should not be administered to adolescents weighing <40 kg
Truvada tenofovir disoproxil/ emtricitabine Gilead Sciences, Inc. Safety and efficacy not established in pediatric patients <18 years
Videx EC enteric coated didanosine Bristol Myers-Squibb Safety and efficacy not established in pediatric patients
Videx didanosine, ddI, dideoxyinosine Bristol Myers-Squibb 2 weeks-8 months:
Powder for oral solution: 100 mg/m2 twice daily; 50 mg/m2 may be used for infants 2 weeks-4 months

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

Patients with CNS disease may require higher doses
Viread tenofovir disoproxil fumarate Gilead Safety and effectiveness in patients <18 years not established No pediatric studies have been documented to date
Zerit stavudine, d4T Bristol Myers-Squibb Birth-13 days:
Tablet/oral solution: 0.5 mg/kg/dose every 12 hours

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

>30 kg to < 60 kg: 30 mg every 12 hours

>60 kg: 40 mg every 12 hours
Ziagen abacavir GlaxoSmithKline 3 months-16 yr:
Tablet/oral solution: 8 mg/kg twice daily		 Maximum dosage: 300 mg twice daily


Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Brand Name Generic Name Manufacturer Name Pediatric Use Labeling Special Information
Rescriptor delavirdine, DLV Pfizer Safety and effectiveness not established in HIV-1–infected individuals <16 years
Sustiva efavirenz Bristol Myers-Squibb >3 yr.:
Tablet/capsule:

10-<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		 Dosing recommended at bedtime to limit CNS effects
Viramune nevirapine, BI-RG-587 Boehringer Ingelheim 2 months-<8 yr:
Tablet/oral suspension: 4 mg/kg once daily for 14 days, then 7 mg/kg twice daily

>8 yr: Tablet/oral suspension: 4 mg/kg once daily for 14 days, then 4 mg/kg twice daily		 Maximum dosage
2 months-<8 yr.: 400 mg/day (200 mg twice daily)

>8 yr.: 400 mg/day
(200 mg twice daily)


Protease Inhibitors (PIs)

Brand Name Generic Name(s) Manufacturer Name Pediatric Use Labeling Special Information
Agenerase amprenavir GlaxoSmithKline 4-16 yr. weighing <50 kg:
Capsule: 20 mg/kg twice daily or 15 mg/kg three times daily
Solution: 22.5 mg/kg twice daily or 17 mg/kg three times daily

>13 yrs. weighing >50 kg:
Capsule: 1200 mg twice daily
Solution: 1400 mg twice daily		 Maximum dosage:

Capsule: 2400 mg/day

Solution: 2800 mg/day

Capsules and oral solution are not interchangeable on a mg per mg basis
Aptivus tipranavir Boehringer Ingelheim Safety and effectiveness in pediatric patients not established.
Invirase saquinavir mesylate, SQV Hoffmann-La Roche Safety and effectiveness in patients <16 years not established
Kaletra lopinavir and ritonavir Abbott Laboratories Patients receiving nevirapine or efavirenz with Kaletra should have their dose of Kaletra increased.

6 months-12 yr:
Tablet/capsule/solution:
7-<15 kg: 12 mg/kg twice daily (13/3.25 mg/kg with nevirapine)

15-40 kg: 10 mg/kg twice daily (11/2.75 mg/kg with nevirapine)

>40 kg or >12 yr: lopinavir 400 mg/ ritonavir 100 mg twice daily (533/133 mg with nevirapine)

 Maximum dosage:

lopinavir 400 mg/ ritonavir 100 mg for patients who are not receiving nevirapine or efavirenz
Lexiva Fosamprenavir Calcium GlaxoSmithKline Safety and efficacy not established in pediatric patients
Norvir ritonavir, ABT-538 Abbott Laboratories >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 haven't been specifically approved in children
Prezista darunavir Tibotec, Inc. Safety and effectiveness in pediatric patients not established
Reyataz atazanavir sulfate Bristol-Myers Squibb Safety and efficacy not established in pediatric patients
Viracept nelfinavir mesylate, NFV Agouron Pharmaceuticals 2-13 yr:
Tablets/powder for: 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 Hoffmann-La Roche & Trimeris 6-16 yr:
Subcutaneous injection: 2 mg/kg twice daily		 Maximum dosage:
90 mg twice daily

Rotate injection sites

* "While some of these drugs may, in practice, be used in the treatment of children of various ages, the sponsors have not submitted adequate data to support a labeled pediatric indication at this time."

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

PREA Labeling Changes (Pediatric Research Equity Act)

Summaries of Medical and Clinical Pharmacology Reviews related to the Best Pharmaceuticals for Children Act (BPCA)

FDA Center for Drug Evaluation and Research Pediatrics

FDA Office of Pediatric Therapeutics

Drugs Used in the Treatment of HIV Infection

Generic Drugs Used in the Treatment of HIV Infection

This article was provided by U.S. Food and Drug Administration.


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