Drug (Click for Full Prescribing Information)

Recommended Age for Use^{[ref: DHHS Pediatric]}

Pediatric Formulation

NRTIs

• [Abacavir]

1 mo or older and HLA-B*5701 negative

• Oral solution 20 mg/mL
• Scored 300-mg tablet

• [drug: Abacavir/Lamivudine]

Pediatric patients with body weight ≥ 25 kg

• Fixed-dose combination

• [Emtricitabine]

All ages

• Oral solution 10 mg/mL

• [drug: Emtricitabine]/Tenofovir AF

Combined with NNRTI or INSTI in pediatric patients with body weight ≥ 25 kg

Combined with NNRTI, INSTI, or boosted PI in pediatric/adolescent patients with body weight ≥ 35 kg

• Fixed-dose combination

• [drug: Emtricitabine/Tenofovir] DF

Pediatric/adolescent patients with body weight ≥ 35 kg

• Fixed-dose combination

• Emtricitabine-Tenofovir DF Low Strength Preparations

• Emtricitabine 167 mg/Tenfovir DF 250 mg
• Emtricitabine 133 mg/Tenfovir DF 200 mg
• Emtricitabine 100 mg/Tenfovir DF 150 mg

Pediatric patients with body weight ≥ 28 kg

Pediatric patients with body weight ≥ 22 kg

Pediatric patients with body weight ≥ 17 kg

• Fixed-dose combinations

• [Lamivudine]

All ages

• Oral solution 10 mg/mL
• Oral solution 5 mg/mL
• Scored 150- and 300-mg tablets

[drug: Lamivudine/Tenofovir] DF

Pediatric/adolescent patients with body weight ≥ 35 kg

• Fixed-dose combination

[drug: Lamivudine/Zidovudine]

Pediatric/adolescent patients with body weight ≥ 30 kg

• Fixed-dose combination

• [drug: Tenofovir] AF

Pediatric/adolescent patients with body weight ≥ 25 kg

• Only available as part of fixed-dose combinations

• [Tenofovir] DF

2 yrs of age or older

• Oral powder
• 150-, 200-, 250-, and 300-mg tablets

• [Zidovudine]

4 wks or older

• Syrup 10 mg/mL
• 100-mg capsules
• 300-mg tablet

NNRTIs

• [Efavirenz]

3 yrs or older

• Capsules may be sprinkled on food

• Efavirenz 600 mg/Lamivudine/Tenofovir DF

Pediatric/adolescent patients with body weight ≥ 40 kg

• Fixed-dose combination
• Take on an empty stomach

• Efavirenz 400 mg/Lamivudine/Tenofovir DF

Pediatric/adolescent patients with body weight ≥ 35 kg

• Fixed-dose combination
• Take on an empty stomach

• [Etravirine]

ARV-experienced children 2 yrs of age or older and body weignt ≥10 kg

• 25-mg, 100-mg, 200-mg tablets

• [Nevirapine]

Any age (oral and immediate-release tablet)

• Oral suspension 10 mg/mL
• Immediate-release 200 mg tablets

6 yrs of age or older

• Extended-release 100-mg and 400- mg tablets

• [drug: Rilpivirine]

12 yrs of age or older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

• 25-mg tablet

• [drug: Emtricitabine/Rilpivirine/Tenofovir] DF

12 yrs of age or older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

• Fixed-dose combination
• Take with a meal

• [drug: Emtricitabine/Rilpivirine/Tenofovir] AF

12 yrs of age and older and body weight ≥ 35 kg with HIV-1 RNA ≤ 100,000 copies/mL

• Fixed-dose combination
• Take with a meal

PIs

• [Atazanavir]

3 mos of age or older and body weight ≥ 5 kg and < 25 kg

• Oral powder 50 mg/packet

6 yrs of age or older and ≥ 15 kg

• 150-, 200-, and 300-mg capsules

• [drug: Atazanavir/Cobicistat]

Pediatric/adolescent patients with body weight ≥ 35 kg

• Fixed-dose combination
• Take with food

• [drug: Cobicistat/Darunavir]

Pediatric/adolescent patients with body weight ≥ 40 kg

• Fixed-dose combination
• Take with food

• [drug: cobicistat darunavir emtricitabine tenof: Cobicistat/Darunavir/Emtricitabine/Tenofovir] AF

Pediatric/adolescent patients with body weight ≥ 40 kg

• Fixed-dose combination
• Take with food

• [Darunavir]

3 yrs of age or older and body weight ≥ 10 kg

• Oral suspension 100 mg/mL
• 75- and 150-mg tablets

• [Lopinavir/ritonavir]

Neonates at postmenstrual age of 42 wks and postnatal age ≥ 14 days

• Oral solution 80/20 mg/mL
• 100/25-mg tablet

• [Ritonavir]

Older than 1 mo

• Oral solution 80 mg/mL

INSTIs

• [drug: Abacavir/Dolutegravir/Lamivudine]

Pediatric patients with body weight ≥ 25 kg

• Fixed-dose combination

• [drug: Bictegravir/emtricitabine/tenofovir] AF

6 years of age or older and body weight ≥ 25 kg

• Fixed-dose combination

• [drug: Cobicistat/elvitegravir/emtricitabine/tenofovir] AF

Pediatric patients with body weight ≥ 25 kg

• Fixed-dose combination

• [drug: Cobicistat/elvitegravir/emtricitabine/tenofovir] DF

12 yrs of age or older and body weight ≥ 35 kg and SMR 4 or 5

• Fixed-dose combination

• [drug: Dolutegravir]

4 wks of age or older and body weight ≥ 3 kg

• 10-mg or 25-mg tablets

• [Raltegravir]

2 yrs or older

• Chewable tablets (100 mg scored and 25 mg)

4 wks or older and body weight 3 kg to
< 20 kg

• Powder for oral suspension 10 mg/mL

Full-term newborn to 4 wks of age and body weight ≥ 2 kg

• Powder for oral suspension 10 mg/mL

CCR5 Antagonist

• [drug: Maraviroc]

Body weight ≥ 6 kg and CCR5-tropic HIV

• Oral solution 20 mg/mL
• 25-, 75-, 150-, and 300-mg tablets