Emtricitabine + tenofovir alafenamide + elvitegravir + cobicistat
Generic name
Emtricitabine + tenofovir alafenamide + elvitegravir + cobicistat
Brand name
ATC Code
J05AR18
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| mean Cmax [ng/mL] (Coefficient of variation [%]) | |||||
| elvitegravir | cobicistat | emtricitabine | tenofovir alafenamide fumarate | tenofovir | |
| Children aged 8 to < 12 years, > 25 kg | 3055,2 (38,7) | 2079,4 (46,7) | 3397,4 (27,0) | 313,3 (61,2) |
26,1 (20,8) |
| Adolescents aged 12 to < 18 years, ≥ 35 kg | 2229,6 (19,2) | 1202,4 (35,0) | 2265,0 (22,5) | 121,7 (46,2) |
14,6 (20,0) |
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Treatment HIV infection |
|---|
|
Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
No adjustment required.GFR 30-50 ml/min/1.73 m2
No adjustment requiredGFR 10-30 ml/min/1.73 m2
Do not use. The dosing interval for emtricitabine must be adjusted. This is not possible with the combination preparation.GFR < 10 ml/min/1.73 m2
Do not use. The dosing interval for emtricitabine must be adjusted. This is not possible with the combination preparation.Patients on dialysis
Intermittent haemodialysis, continuous veno-venous haemodialysis and haemofiltration/haemodiafiltration, peritoneal dialysis: use of the combination preparation must be avoided because it is unsuitable for this. The dosing interval of emtricitabine must be adjusted.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
The safety profile in children and adolescents matches that of adults.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
DIRECT ACTING ANTIVIRALS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Nucleosides and nucleotides excl. reverse transcriptase inhibitors | ||
|---|---|---|
| J05AB01 | ||
| J05AB12 | ||
| J05AB06 | ||
| J05AB16 | ||
| J05AB04 | ||
| J05AB11 | ||
| J05AB14 | ||
| Phosphonic acid derivatives | ||
|---|---|---|
| J05AD01 | ||
| Protease inhibitors | ||
|---|---|---|
| J05AE08 | ||
| J05AE10 | ||
| J05AE07 | ||
| J05AE02 | ||
| J05AE04 | ||
| J05AE03 | ||
| J05AE01 | ||
| Nucleoside and nucleotide reverse transcriptase inhibitors | ||
|---|---|---|
| J05AF06 | ||
| J05AF02 | ||
| J05AF09 | ||
| J05AF10 | ||
| J05AF05 | ||
| J05AF04 | ||
| J05AF07 | ||
| J05AF13 | ||
| J05AF13 | ||
| J05AF01 | ||
| Non-nucleoside reverse transcriptase inhibitors | ||
|---|---|---|
| J05AG06 | ||
| J05AG03 | ||
| J05AG04 | ||
| J05AG01 | ||
| J05AG05 | ||
| Neuraminidase inhibitors | ||
|---|---|---|
| J05AH02 | ||
| J05AH01 | ||
| Antivirals for treatment of HIV infections, combinations | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX28 | ||
| J05AX12 | ||
| J05AX07 | ||
| J05AX09 | ||
| J05AX08 | ||
| J05AX24 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR20 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Integrase inhibitors | ||
|---|---|---|
| J05AJ04 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP54 | ||
| J05AP57 | ||
| J05AP51 | ||
| J05AP08 | ||
| J05AP55 | ||
Reference
- Gilead Sciences Ireland UC, SmPC Genvoya (EU/1/15/1061) Rev 27, 28-11-2022, www.ema.europa.eu
Changes
Therapeutic Drug Monitoring
Overdose
