- 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) |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Treatment HIV infection |
|---|
|
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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.
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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.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| 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 | ||
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Reference
- Gilead Sciences Ireland UC, SmPC Genvoya (EU/1/15/1061) Rev 27, 28-11-2022, www.ema.europa.eu
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Changes
Changes
