Bictegravir+emtricitabine+tenofoviralafenamide
Generic name
Bictegravir+emtricitabine+tenofoviralafenamide
Brand name
ATC Code
J05AR20
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
A pharmacokinetic study in children 6 - < 12 years old and ≥ 25 kg (50 children) and ≥ 2 years old and ≥ 14 - < 25 kg (22 children) showed higher Cmax (bictegravir) and AUC and/or Cmax (emtricitabine and tenofoviralafenamide) than in adults [SmPC].
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
With impaired renal function, the AUC of emtricitabine increases. This increases the risk of side effects.
With creatinine clearance less than 30 ml/min: the dosing interval of emtricitabine should be adjusted. Therefore, avoid using the fixed combination, because fixed combinations of emtricitabine with tenofoviralafenamide (TAF), bictegravir are not suitable for this dose adjustment.
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 is similar to that of adults.
In children who for 48 weeks received other products
received tenofoviralafenamide, reductions in bone mineral density of the spine and total-body-less-head ( TBLH, total-body-less-head) ≥ 4% have been reported.
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 in children
Reductions in bone mineral density (BMD ≥ 4%) of the spine and total-body-less-head (TBLH) have been reported in patients aged 3 to < 12 years who received products containing tenofoviralafenamide) for 48 weeks. The
long-term effects of changes in BMD on growing bone, including the risk of fracture, are uncertain. A multidisciplinary approach is recommended to decide on appropriate monitoring during treatment.
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 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Other antivirals | ||
|---|---|---|
| J05AX28 | ||
| J05AX12 | ||
| J05AX07 | ||
| J05AX09 | ||
| J05AX08 | ||
| J05AX24 | ||
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS | ||
|---|---|---|
| J05AR02 | ||
| J05AR13 | ||
| J05AR25 | ||
| J05AR18 | ||
| J05AR19 | ||
| J05AR03 | ||
| J05AR09 | ||
| J05AR10 | ||
| Integrase inhibitors | ||
|---|---|---|
| J05AJ04 | ||
| Antivirals for treatment of HCV infections | ||
|---|---|---|
| J05AP54 | ||
| J05AP57 | ||
| J05AP51 | ||
| J05AP08 | ||
| J05AP55 | ||
Reference
- Gilead Sciences Ireland UC, SmPC Biktarvy (EU EU/1/18/1289/001) Rev 15, 23-01-2023, www.ema.europa.eu
Changes
Therapeutic Drug Monitoring
Overdose
