Loading…
Biktarvy is a brand name for Bictegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Biktarvy is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 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 infection. Posology Paediatric patients at least 2 years of age and weighing at least 14 kg to less than 25 kg One 30 mg/120 mg/15 mg tablet to be taken once daily.
Adults and paediatric patients weighing at least 25 kg One 50 mg/200 mg/25 mg tablet to be taken once daily. 3 Missed doses If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule.
If a patient misses a dose of Biktarvy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken.
If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose. 2). Hepatic impairment No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
2). Renal impairment No dose adjustment of Biktarvy is required in patients weighing ≥ 35 kg with estimated creatinine clearance (CrCl) ≥ 30 mL/min. No dose adjustment of Biktarvy is required in adult patients with end stage renal disease (estimated creatinine clearance < 15 mL/minute) who are receiving chronic haemodialysis.
2). On days of haemodialysis, Biktarvy should be administered after completion of haemodialysis treatment. 2). No data are available to make dose recommendations in patients weighing < 35 kg with renal impairment or in paediatric patients less than 18 years with end stage renal disease.
Paediatric population The safety and efficacy of Biktarvy in children less than 2 years of age or weighing less than 14 kg have not yet been established. No data are available. Method of administration Oral use. 2). Due to the bitter taste, it is recommended that the film-coated tablets should not be chewed or crushed.
For patients who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken immediately.
Summary of the safety profile In clinical studies of treatment-naïve patients receiving Biktarvy, the most frequently reported adverse reactions in the double-blind phase (Week 144) were headache (5%), diarrhoea (5%) and nausea (4%).
14 Tabulated list of adverse reactions The assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies with Biktarvy and from post-marketing experience. The adverse reactions in Table 2 are listed by system organ class and frequency.
Frequencies are defined as follows: common (≥ 1/100 to < 1/10) uncommon (≥ 1/1 000 to < 1/100) and rare (≥ 1/10 000 to < 1/1 000).
Table 2:
Tabulated list of adverse reactions1 Frequency Adverse reaction Blood and lymphatic system disorders Uncommon: anaemia2 Psychiatric disorders Common: depression, abnormal dreams Uncommon: suicidal ideation, suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness), anxiety, sleep disorders Nervous system disorders Common: headache, dizziness Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain, dyspepsia, flatulence Hepatobiliary disorders Uncommon: hyperbilirubinaemia Skin and subcutaneous tissue disorders Uncommon: angioedema3,4, rash, pruritus, urticaria4 Rare: Stevens-Johnson syndrome5 Musculoskeletal and connective tissue disorders Uncommon: arthralgia General disorders and administration site conditions Common: Fatigue Investigations Common: weight increased 1 With the exception of angioedema, anaemia, urticaria and Stevens-Johnson syndrome (see footnotes 2-5), all adverse reactions were identified from Biktarvy clinical studies.
The frequencies were derived from the double-blind phase (Week 144) of Phase 3 Biktarvy clinical studies in treatment-naïve patients (GS-US-380-1489 and GS-US-380-1490). 2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
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. There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV).
Biktarvy contains tenofovir alafenamide, which is active against hepatitis B virus (HBV). Discontinuation of Biktarvy 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 Biktarvy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Liver disease The safety and efficacy of Biktarvy in patients with significant underlying liver disorders have not been established. Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. Weight and metabolic parameters An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Such changes may in part be linked to disease control and lifestyle. For lipids and weight, there is in some cases evidence for a treatment effect. For monitoring of blood lipids and glucose, reference is made to established HIV treatment guidelines.
Lipid disorders should be managed as clinically appropriate. Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
1. Co-administration with rifampicin and St. 5). 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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.
3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products. 4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
5 This adverse reaction was identified through post-marketing surveillance for Biktarvy. The frequency has been calculated using 3/X, where X represent the cumulative number of subjects exposed to Biktarvy in clinical trials (N=3963).
4). Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise. 4). 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). 15 Changes in serum creatinine Bictegravir has been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine, however these changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Increases in serum creatinine occurred by Week 4 of treatment and remained stable through Week 144. 6] μmol/L) from baseline to Week 144 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
There were no discontinuations due to renal adverse reactions through Week 144 in patients administered Biktarvy in clinical studies. Changes in bilirubin In Studies GS-US-380-1489 and GS-US-380-1490, total bilirubin increases were observed in 17% of treatment-naïve patients administered Biktarvy through Week 144.
5 x Upper Limit of Normal [ULN]), and were not associated with hepatic adverse reactions or other liver related laboratory abnormalities. Five patients administered Biktarvy (1%) had grade 3 bilirubin increases that were not considered related to study drug.
There were no discontinuations due to hepatic adverse reactions through Week 144 in Biktarvy clinical studies. Paediatric population The safety of Biktarvy was evaluated in 50 HIV-1 infected adolescents aged 12 to < 18 years and weighing ≥ 35 kg through Week 96 (48-week main phase and 48-week extension), in 50 children aged 6 to < 12 years and weighing ≥ 25 kg through Week 96 (48-week main phase and 48-week extension), and in 22 children ≥ 2 years of age and weighing ≥ 14 to < 25 kg through Week 24 in an open-label clinical study (GS-US-380-1474).
In this study, no new adverse reactions have been observed in paediatric subjects aged 2 years and older living with HIV-1 as compared to adult subjects living with HIV-1. Bone mineral density data were not collected in this study. 4).
Other special populations Patients co-infected with hepatitis B In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed […]
There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine. The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
These events have often been transitory. Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour). Whether such neurological disorders are transient or permanent is currently unknown. These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown aetiology, particularly neurologic findings.
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. Immune Reactivation Syndrome In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis 5 jirovecii pneumonia.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Opportunistic infections Patients should be advised that Biktarvy or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. 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 Biktarvy 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 Biktarvy should be considered.
2). In a study of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 96 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
Efficacy was also maintained in […]