Loading…
Symtuza is a brand name for Darunavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of Symtuza (see sections 4.2, 4.4, and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Therapy should be initiated by a physician experienced in the management of HIV-1 infection. Posology The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
Antiretroviral Therapy (ART)-naïve patients The recommended dose regimen is one film-coated tablet of Symtuza once daily taken with food. 1). * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V. Advice on missed doses If a dose of Symtuza is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of Symtuza with food as soon as possible.
If a missed dose is noticed later than 12 hours of the time it is usually taken, it should not be taken and the patient should resume the usual dosing schedule. In case a patient vomits within 1 hour of taking the medicinal product, another dose of Symtuza should be taken with food as soon as possible.
If a patient vomits more than 1 hour after taking the medicinal product, the patient does not need to take another dose of Symtuza until the next regularly scheduled time. 2). Hepatic impairment No dose adjustment of Symtuza is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, Symtuza should be used with caution in these patients, as the darunavir and cobicistat components of Symtuza are metabolised by the hepatic system.
2). Renal impairment No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min. 2). 2). Paediatric population The safety and efficacy of Symtuza in children aged 3-11 years, or weighing < 40 kg, have not yet been established.
No data are available. 3). 2). 6). 2). The tablet should not be crushed.
Summary of the safety profile The overall safety profile of Symtuza is based on data from a randomised, double-blinded, comparative Phase 2 trial, GS-US-299-0102 (N = 103 on darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), data from 2 Phase 3 trials TMC114FD2HTX3001 (AMBER, N = 362 on D/C/F/TAF) and TMC114IFD3013 (EMERALD, N = 763 on D/C/F/TAF), and on all available clinical trial and post-marketing data of its components.
As Symtuza contains darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, the adverse reactions associated with each of the individual compounds may be expected. 8%). 1%). Tabulated list of adverse reactions Adverse reactions are listed by system organ class (SOC) and frequency category in Table 2.
Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and not known (frequency cannot be estimated from the available data) 19 Table 2 MedDRA system organ class Frequency category Adverse reaction Blood and lymphatic system disorders common anaemia Immune system disorders common (drug) hypersensitivity uncommon immune reconstitution inflammatory syndrome Metabolism and nutrition disorders common diabetes mellitus, anorexia, hypercholesterolaemia, low density lipoprotein increased, hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia uncommon hyperglycaemia Psychiatric disorders common abnormal dreams Nervous system disorders very common headache common dizziness Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, flatulence uncommon pancreatitis acute, pancreatic enzymes increased Hepatobiliary disorders common hepatic enzyme increased uncommon acute hepatitisa, cytolytic hepatitisa Skin and subcutaneous tissue disorders very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis) common pruritus, urticaria uncommon angioedema rare drug reaction with eosinophilia and systemic symptomsa, Stevens-Johnson syndromea not known toxic epidermal necrolysisa, acute generalised exanthematous pustulosisa Musculoskeletal and connective tissue disorders common arthralgia, myalgia uncommon osteonecrosis Renal and urinary disorders rare crystal nephropathya§ Reproductive system and breast disorders uncommon gynaecomastiaa General disorders and administration site conditions common asthenia, fatigue 20 Investigations common increased blood creatinine a Additional adverse reactions only seen with darunavir/ritonavir in other trials or post-marketing experience § Adverse reaction identified in the post-marketing setting.
1) or with HIV-1 RNA ≥ 100 000 copies/mL or CD4+ cell count < 100 cells x 106/L. 2). Cobicistat levels decrease and may not provide sufficient boosting. The substantial reduction in darunavir exposure may result in virological failure and an increased risk of mother to child transmission of HIV infection.
6). Patients co-infected with HIV and hepatitis B or C virus Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. The safety and efficacy of Symtuza in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Tenofovir alafenamide is active against hepatitis B virus (HBV). In case of concomitant antiviral therapy for hepatitis C, please refer also to the relevant Summary of Product Characteristics for these medicinal products. Discontinuation of Symtuza therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Patients co-infected with HIV and HBV who discontinue Symtuza should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of hepatitis B therapy may be warranted.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation. g. fumarate, phosphate, or succinate), lamivudine, or adefovir dipivoxil used for the treatment of HBV infection.
Mitochondrial dysfunction Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues.
The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia). These events are often transitory. Some late-onset neurological 5 disorders have been reported (hypertonia, convulsion, abnormal behaviour).
1. Patients with severe (Child-Pugh Class C) hepatic impairment. 5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St. g. 5) - ticagrelor
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Darunavir in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Per the guideline on Summary of Product Characteristics (Revision 2, September 2009), the frequency of this adverse reaction in the post-marketing setting was determined using the "Rule of 3". Description of selected adverse reactions Rash Rash is a common adverse reaction in patients treated with darunavir.
4). 5% (7/465) of patients discontinued treatment due to rash, of whom one for rash and hypersensitivity. 1% (39/763) of patients receiving Symtuza experienced rash (most of which were grade 1), none discontinued treatment due to rash.
4). In the Phase 3 trial of Symtuza in treatment-naïve patients, increases from baseline were observed in the fasting lipid parameters total cholesterol, direct low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol, and triglycerides at Week 48 and 96 (see Table 3).
The median increases from baseline were greater in the D/C/F/TAF group compared with the DRV/ cobicistat (COBI)+F/ tenofovir disoproxil fumarate (TDF) group at Week 48. 001 for all 4 lipid parameters when comparing D/C/F/TAF versus D/C + F/TDF at Week 48 * No comparator data available beyond Week 48 Musculoskeletal abnormalities Increased creatine phosphokinase (CPK), myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Osteonecrosis Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 4). Immune reconstitution inflammatory syndrome In HIV infected patients with severe immune deficiency at the time of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; […]
Whether the neurological disorders are transient or permanent is currently unknown. Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. 2). g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir. Patients with pre-existing liver dysfunction, including chronic hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products. Appropriate laboratory testing should be conducted prior to initiating therapy with Symtuza and patients should be monitored during treatment.
Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of Symtuza treatment.
3). Nephrotoxicity Post-marketing cases of renal impairment, including acute renal failure and proximal renal tubulopathy have been reported with tenofovir alafenamide-containing products. 3). It is recommended that renal function is assessed in all patients prior to, or when, initiating therapy with Symtuza and that it is also monitored during therapy in all patients as clinically appropriate.
In patients who develop clinically significant decreases in renal function or evidence of proximal renal tubulopathy, discontinuation of Symtuza should be considered. Renal impairment Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
This effect on serum creatinine, leading to a decrease in the estimated creatinine clearance, should be taken into consideration when Symtuza is administered to patients, in whom the estimated creatinine […]