Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART)-experienced paediatric patients from the age of 3 years and at least 15 kg body weight.
PREZISTA oral suspension, 75mg, 150mg, 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):
PREZISTA 400 mg tablets may be used to provide suitable dose regimens (see section 4.2):
For the treatment of HIV-1 infection in ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with PREZISTA in such ART-experienced adults, genotypic testing should guide the use of PREZISTA (see sections 4.2, 4.3, 4.4 and 5.1).In deciding to initiate treatment with PREZISTA co-administered with low dose ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
Therapy should be initiated by a health care provider experienced in the management of HIV infection. After therapy with PREZISTA has been initiated, patients should be advised not to alter the dosage, dose form or discontinue therapy without discussing with their health care provider.
PREZISTA must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with PREZISTA.
The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
The weight-based dose of PREZISTA and ritonavir in paediatric patients is provided in the table below. The recommended dose of PREZISTA with low dose ritonavir should not exceed the recommended adult dose (600/100 mg twice daily).
| Recommended dose for treatment-experienced paediatric patients (3 to 17 years of age) for PREZISTA tablets and ritonavir | |
|---|---|
| Body weight (kg) | Dose (twice daily) |
| ≥ 15 kg–< 30 kg | 375 mg (3.8ml) PREZISTA/50 mg (0.6ml) ritonavira |
| ≥ 30 kg–< 40 kg | 450 mg (4.6ml) PREZISTA/60 mg (0.8ml) ritonavira |
| ≥ 40 kg | 600 mg (6 ml)PREZISTA/100 mg (1.2ml) ritonavir |
a with ritonavir oral solution: 80 mg/ml
PREZISTA oral suspension can be used in patients unable to swallow PREZISTA tablets. PREZISTA is also available as 75 mg, 150 mg, 300 mg, 400 mg and 600 mg film-coated tablets.
The use of only 75 mg and 150 mg tablets or the 100 mg/ml oral suspension to achieve the recommended dose of PREZISTA could be appropriate when there is a possibility of hypersensitivity to specific colouring agents.
The following guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours (twice daily regimen) or approximately 24 hours (once daily regimen).
If using the twice daily regimen: in case a dose of PREZISTA and/or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible. If this was noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
If using the once daily regimen: in case a dose of PREZISTA and/or ritonavir was missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible. If this was noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Limited information is available in this population and therefore PREZISTA should be used with caution in this age group (see sections 4.4 and 5.2).
Darunavir is metabolised by the hepatic system. No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, PREZISTA should be used with caution in these patients. No pharmacokinetic data are available in patients with severe hepatic impairment. Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile. Therefore, PREZISTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
ART-experienced paediatric patients less than 3 years of age or less than 15 kg body weight, and ART-naïve paediatric patients
The safety and efficacy of PREZISTA with low dose ritonavir in ART-naïve children have not been established. PREZISTA/rtv should not be used in paediatric patients below 3 years of age or less than 15 kg body weight (see sections 4.4 and 5.3).
Patients should be instructed to take PREZISTA with low dose ritonavir within 30 minutes after completion of a meal. The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
PREZISTA suspension is administered orally. Shake the bottle vigorously prior to each dose. The supplied oral dosing pipette should not be used for any other medicinal products.
Human experience of acute overdose with PREZISTA co-administered with low dose ritonavir is limited. Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of the tablet formulation of darunavir in combination with ritonavir have been administered to healthy volunteers without untoward symptomatic effects.
There is no specific antidote for overdose with PREZISTA. Treatment of overdose with PREZISTA consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. If indicated, elimination of unabsorbed active substance is to be achieved by emesis or gastric lavage. In general gastric lavage should not be performed more than 1 hour after ingestion of an overdose.Administration of activated charcoal may also be used to aid in removal of unabsorbed active substance. Since darunavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
Oral suspension: 2 years.
Tablets: 3 years.
Oral suspension: Do not store above 30°C.
Do not refrigerate or freeze. Avoid exposure to excessive heat.
Store in the original container.
Tablets: This medicinal product does not require any special storage conditions.
Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene closure with LDPE liner packaged with a 6 ml oral dosing pipette with 0.2 ml gradations. The bottle neck is filled with a low density polyethylene (LDPE) insert that accomodates the dosing pipette.
PREZISTA oral suspension is available in packs of one bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 480 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 240 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
Opaque, white, high density polyethylene (HDPE) plastic, 160 ml bottle containing 60 tablets, fitted with polypropylene (PP) child resistant closure.
One bottle.
No special requirements for disposal.
Oral suspension: Shake the bottle vigorously prior to each dose. The supplied oral dosing pipette should not be used for any other medicinal products
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