Pharmacokinetics in children
No information is present at this moment.
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 |
- Oral
- Capsule, hard
-
≥ 6 years
and
15
up to
35 kg
-
200
mg/day
in 1
dose Combined with ritonavir (100 mg/day in a single dose).
- Directions for administration:
Take with food.
-
≥ 6 years
and
≥ 35 kg
-
300
mg/day
in 1
dose combined with ritonavir (100 mg/day in a single dose).
- Directions for administration:
take with food.
- Powder for oral use
-
≥ 3 months
and
5
up to
15 kg
-
200
mg/day
in 1
dose Combined with ritonavir (80 mg/day in a single dose).
- Directions for administration:
Take with food. l (e.g. apple sauce or yoghurt) or drink (e.g. milk, infant formula or water). For infants who are not yet ingesting solid food or cannot drink from a cup, mix with a little infant formula and administer with a syringe.
-
≥ 3 months
and
15
up to
35 kg
-
250
mg/day
in 1
dose Combined with ritonavir (80 mg/day in a single dose).
- Directions for administration:
Take with food.
-
≥ 3 months
and
≥ 35 kg
-
300
mg/day
in 1
dose Combined with ritonavir (100 mg/day in a single dose).
- Directions for administration:
Take with food.
|
Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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
Prolonged PQ and QT interval (more common in children)
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
- Use in children younger than 3 months due to the risk of kernicterus
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
Children are susceptible to cardiac conduction disorders. Asymptomatic prolongation of the PQ interval has been reported more frequently in children than in adults, and asymptomatic first- and second-degree AV block has also been reported.
Ineffective: in pre-treated children, no efficacy is to be expected with ≥4 'protease inhibitor'(PI) mutations. This may be the case even with less than 4 'protease inhibitor'(PI) mutations.
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 |
|
|
|
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
|
|
|
|
J05AR18
|
|
|
|
J05AR19
|
|
|
|
J05AR03
|
|
|
|
J05AR09
|
|
|
|
J05AR10
|
| Other antivirals |
|
|
|
J05AX28
|
|
|
|
J05AX12
|
|
|
|
J05AX07
|
|
|
|
J05AX09
|
|
|
|
J05AX08
|
|
|
|
J05AX24
|
| ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS |
|
|
|
J05AR02
|
|
|
|
J05AR20
|
|
|
|
J05AR13
|
|
|
|
J05AR25
|
|
|
|
J05AR18
|
|
|
|
J05AR19
|
|
|
|
J05AR03
|
|
|
|
J05AR09
|
|
|
|
J05AR10
|
| Integrase inhibitors |
|
|
|
J05AJ04
|
| Antivirals for treatment of HCV infections |
|
|
|
J05AP54
|
|
|
|
J05AP57
|
|
|
|
J05AP51
|
|
|
|
J05AP08
|
|
|
|
J05AP55
|
References
-
Bristol-Meyers Squibb Pharma EEIG, SmPC Reyataz poeder voor oraal gebruik (EU/1/03/267/007) Rev 52. 18-02-2022, www.ema.europa.eu
-
Bristol-Meyers Squibb Pharma EEIG, SmPC Reyataz capsule (EU/1/03/267/004) Rev 52.18-02-2022, www.ema.europa.eu
-
Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life. , HIV Med, doi:10.1111/hiv.12217
-
Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children., Guideline for the use of Antiretroviral agents in pediatric HIV infection, www.aidsinfo.nig.gov/contentfiles/lvguidelines/pediatricguidelines.pdf, Geraadpleegd 12 sept 2016, O1-O140
-
Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life., HIV Med, doi:10.1111/hiv.12217
Therapeutic Drug Monitoring
Overdose