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Odefsey is a brand name for Emtricitabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or…
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. 2). If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule.
If a patient misses a dose of Odefsey by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 4 hours of taking Odefsey another tablet should be taken with food.
If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose. 2). 3 Renal impairment No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
2). 2). On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment. Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
No data are available to make dose recommendations in children less than 18 years with end stage renal disease. Hepatic impairment No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment.
Odefsey should be used with caution in patients with moderate hepatic impairment. 2). Paediatric population The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
No data are available. Method of administration Oral use. 2). It is recommended that the film-coated tablet is not chewed, crushed or split due to the bitter taste.
Summary of the safety profile The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat were nausea (11%), diarrhoea (7%), and headache (6%).
The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking rilpivirine hydrochloride in combination with emtricitabine + tenofovir disoproxil fumarate were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%).
Tabulated summary of adverse reactions Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which patients received emtricitabine + tenofovir alafenamide given with elvitegravir + cobicistat as a fixed-dose combination tablet, pooled data from patients who received rilpivirine 25 mg once daily in combination with other antiretroviral medicinal products in the controlled studies TMC278-C209 and TMC278-C215, patients who received Odefsey in Studies GS-US-366-1216 and GS-US-366-1160, and post-marketing experience.
The adverse reactions in Table 2 are listed by system organ class and highest frequency observed. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100). 18 Table 2: Tabulated list of adverse reactions Frequency Adverse reaction Blood and lymphatic system disorders Common: decreased white blood cell count1, decreased haemoglobin1, decreased platelet count1 Uncommon: anaemia2 Immune system disorders Uncommon: immune reactivation syndrome1 Metabolism and nutrition disorders Very common: increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1 Common: decreased appetite1, increased triglycerides (fasted)1 Psychiatric disorders Very common: insomnia1 Common: depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1 Nervous system disorders Very common: headache1, 3, dizziness1, 3 Common: somnolence1 Gastrointestinal disorders Very common: nausea1, 3, increased pancreatic amylase1 Common: abdominal pain1, 3, vomiting1, 3, increased lipase1, abdominal discomfort1, dry mouth1, flatulence3, diarrhoea3 Uncommon: dyspepsia3 Hepatobiliary disorders Very common: increased transaminases (AST and/or ALT)1 Common: increased bilirubin1 Skin and subcutaneous tissue disorders Common: rash1, 3 Uncommon: severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon: arthralgia3 General disorders and administration site conditions Common: fatigue1, 3 1 Adverse reactions identified from rilpivirine clinical studies.
Virologic failure and development of resistance There are insufficient data to justify the use in patients with prior NNRTI failure. 1). 4% with efavirenz). 1% in the emtricitabine/tenofovir disoproxil fumarate + efavirenz arm. The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class. 1). 1). Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
9). Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Odefsey should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
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 Odefsey 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). Discontinuation of Odefsey 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 Odefsey 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 Odefsey 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.
1. 5), including: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin • rifabutin, rifampicin, rifapentine • omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole • dexamethasone (oral and parenteral doses), except as a single dose treatment • St.
John’s wort (Hypericum perforatum)
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2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
3 Adverse reactions identified from clinical studies of emtricitabine + tenofovir alafenamide-containing products. 4 Adverse reaction identified through post-marketing surveillance of emtricitabine/rilpivirine/tenofovir disoproxil fumarate.
5 Adverse reaction identified through post-marketing surveillance for emtricitabine-containing products. 6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products. Laboratory abnormalities Changes in serum creatinine for rilpivirine-containing regimens The pooled data from the Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients also demonstrate that serum creatinine increased and estimated glomerular filtration rate (eGFR) decreased over 96 weeks of treatment with rilpivirine.
Most of this increase in creatinine and decrease in eGFR occurred within the first four weeks of treatment. 73 m2) for eGFR were observed. In patients who entered the studies with mild or moderate renal impairment, the serum creatinine increase observed was similar to that seen in patients with normal renal function.
These increases do not reflect a change in actual glomerular filtration rate (GFR). Changes in lipid laboratory tests In studies in treatment-naïve patients receiving emtricitabine + tenofovir alafenamide (FTC + TAF) or emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), both given with elvitegravir + cobicistat as a fixed-dose combination tablet, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density 19 lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides). 006 for the difference between treatment groups). Switching from a TDF-based regimen to Odefsey may lead to slight increases in lipid parameters.
In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
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If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered. 5 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, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. 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.
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 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 […]