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Rukobia is a brand name for Fostemsavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen (see sections 4.4 and 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
Rukobia should be prescribed by physicians experienced in the management of HIV infection. Posology The recommended dose is 600 mg of fostemsavir twice daily. Missed doses If the patient misses a dose of fostemsavir, the patient should take the missed dose as soon as the patient remembers, unless it is almost time for the next dose.
In this case, the missed dose should be skipped and the next dose should be taken according to the regular schedule. The patient should not take a double dose to make up for the forgotten dose. 2). 2). 2). Paediatric population 3 The safety and efficacy of fostemsavir in children and adolescents aged less than 18 years have not yet been established.
2, but no recommendation on a posology can be made. Method of administration Oral use. 2). The prolonged-release tablet should be swallowed whole with water, and not chewed, crushed or split.
4). The most commonly seen adverse reactions were diarrhoea (24%), headache (17%), nausea (15%), rash (12%), abdominal pain (12%), and vomiting (11%). Tabulated list of adverse reactions The adverse reactions identified in clinical trials are listed in Table 2 by body system, organ class and frequency.
Frequencies are defined as 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), very rare (<1/10,000). 4) Gastrointestinal disorders Very common Diarrhoea, nausea, abdominal pain3, vomiting Common Dyspepsia, flatulence Hepatobiliary disorders Common Transaminases increased4 Skin and subcutaneous tissue disorders Very common Rash5 Common Pruritus6 Musculoskeletal and connective tissue disorders Common Myalgia General disorders and administration site conditions Common Fatigue Investigations Common Blood creatinine increased, blood creatine phosphokinase increased 1 Calculated based on safety data from 570 subjects (n=370 from phase III [BRIGHTE] study at 144 weeks, and n=200 from phase IIb study with mean duration 174 weeks).
2Includes central nervous system immune reconstitution inflammatory response and immune reconstitution inflammatory syndrome. 3Includes abdominal discomfort, abdominal pain and abdominal pain upper. 4Includes increases in ALT, AST, hepatic enzymes and transaminases.
5Includes rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic and rash vesicular. 6Includes pruritus and pruritus generalised. Description of selected adverse reactions Changes in laboratory chemistries Increases in creatine phosphokinase (CPK) were observed following treatment with fostemsavir, which were mainly mild or moderate.
These changes were rarely associated with musculoskeletal complaints and are not considered clinically relevant. Clinically relevant increases in serum creatinine have primarily occurred in patients with identifiable risk factors for reduced renal function, including pre-existing medical history of renal disease and/or concomitant medicinal products known to cause increases in creatinine.
Immune reconstitution inflammatory syndrome In HIV-infected patients with severe immune deficiency at the time of initiation of anti-retroviral therapy (ART), an inflammatory reaction to asymptomatic or residual opportunistic infections 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 ART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci (formerly P.
carinii) pneumonia. Any inflammatory symptoms must be evaluated without delay and treatment initiated when necessary. Autoimmune disorders (such as Graves’ disease, autoimmune hepatitis, polymyositis and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment and sometimes can be an atypical presentation.
1). g. amiodarone, disopyramide, ibutilide, procainamide, quinidine, or sotalol) or in patients with relevant pre-existing cardiac disease. Elderly patients may be more susceptible to drug-induced QT interval prolongation. Patients with hepatitis B or C virus co-infection Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Opportunistic infections Patients should be advised that fostemsavir or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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A causal association between fostemsavir and elevation in serum creatinine has not been established. 12 Asymptomatic elevations in creatinine, creatine phosphokinase and liver enzymes were mainly grade 1 or 2 and did not require interruption of treatment.
Increases in direct (conjugated) bilirubin have been observed following treatment with fostemsavir. g. sepsis, cholangiocarcinoma or other complications of viral hepatitis co-infection). In the remaining reports, elevations in direct bilirubin (without clinical jaundice) were typically transient, occurred without increases in liver transaminases and resolved on continued fostemsavir.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. 4 Osteonecrosis Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement. Restricted range of antiviral activity In vitro data indicate that the antiviral activity of temsavir is restricted to HIV-1 Group M strains.
1). Within HIV-1 group M, there is considerably reduced antiviral activity against CRF01_AE virus. 1). It is recommended that Rukobia is not used to treat infections due to HIV-1 Group M subtype CRF01_AE strains. 5). 5). When fostemsavir was co-administered with oral contraceptives, temsavir increased concentrations of ethinyl oestradiol.
5). Furthermore, caution is advised particularly in patients with additional risk factors for thromboembolic events. When fostemsavir is co-administered with tenofovir alafenamide (TAF), temsavir is expected to increase plasma concentrations of TAF via inhibition of OATP1B1/3 and/or BCRP.
5).