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Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome
current December 2007
Click on drug brand name for additional information.
| 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 |
| 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) |
| 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 | Therapy-Naïve 2 to 5 Years of
Age: Lexiva
Oral Suspension 30 mg/kg twice daily, not to exceed the adult dose of
LEXIVA 1,400 mg twice daily. Therapy-Naïve > 6 Years of Age: Either Lexiva Oral Suspension 30mg/kg twice daily not to exceed the adult dose of Lexiva 1,400 mg twice daily or Lexiva Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg twice daily not to exceed the adult dose of Lexiva 700 mg plus ritonavir 100 mg twice daily. Therapy-Experienced > 6 Years of Age: Lexiva Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the adult dose of LEXIVA 700 mg plus ritonavir 100 mg twice daily. Lexiva Oral Suspension 18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the adult dose of Lexiva 700 mg plus ritonavir 100 mg twice daily. When administered without ritonavir, the adult regimen of Lexiva Tablets 1,400 mg twice daily may be used for pediatric patients weighing at least 47 kg. When administered in combination with ritonavir, Lexiva Tablets may be used of pediatric patients weighing at least 39 kg; ritonavir capsules may be used for pediatric patients weighing at least 33 kg. |
The recommended dosage of Lexiva in patients > 2
years of age should be calculated based on body weight (kg) and should
not exceed the recommended adult dose. The data are insufficient to recommend: (1) once-daily dosing of Lexiva alone or in combination with ritonavir, and (2) any dosing of Lexiva in therapy-experienced patients 2 to 5 years of age. |
| 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 ablets are interchangeable with oral powder (625 mg tablets are not) Reliable dosing recommendations could not be determined in patients < 2 years of age |
| 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 |
| Brand Name | Generic Name | Manufacturer Name | Pediatric Use Labeling | Special Information |
|---|---|---|---|---|
| Selzentry | maraviroc | Pfizer | Safety and efficacy not established in pediatric patients |
| Brand Name | Generic Name | Manufacturer Name | Pediatric Use Labeling | Special Information |
|---|---|---|---|---|
| Isentress | raltegravir | Merck & Co., Inc. | Safety and efficacy not established in pediatric patients |
* "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."
†Body Surface area can be calculated using the following equation: 
Pediatric Exclusivity Labeling Changes related to the Best Pharmaceuticals for Children Act (BPCA)
PREA Labeling Changes (Pediatric Research Equity Act)
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