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APRETUDE is a brand name for Cabotegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Apretude is indicated in combination with safer sex practices for short term pre- exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see section 4.2 and section 4.4). Apretude tablets may be used as: • oral lead-in to assess…
Verbatim from this product's MHRA label. Tap a section to expand.
Apretude should be prescribed by a healthcare professional experienced in the management of HIV PrEP. 3). A combined antigen/antibody test as well as an HIV-RNA-based test should both be negative. Prescribers are advised to perform both tests, even if the result of the HIV- RNA-based test will become available after oral administration.
If a combined testing strategy including both tests is not available, testing should follow local guidelines. Prior to starting Apretude, individuals should be carefully selected to agree to the required dosing schedule and counselled about the importance of adherence to scheduled dosing visits to help reduce the risk of acquiring HIV-1 infection.
The healthcare provider and individual may decide to use cabotegravir tablets as an oral lead-in prior to the initiation of Apretude injection to assess tolerability (see Table 1) or may proceed directly to Apretude injections (see Apretude injection SmPC).
4). One Apretude 30 mg tablet should be taken, once daily with or without food. Table 1 Recommended dosing schedule Oral lead-in Medicinal product During month 1 Apretude 30 mg once daily Oral dosing for missed injections of cabotegravir.
If a delay of more than 7 days from a scheduled injection visit cannot be avoided, Apretude 30 mg tablets may be used once daily to replace one scheduled injection visit. The first dose of oral cabotegravir (or an alternative oral PrEP therapy) should be taken two months (+/- 7 days) after the last injection of cabotegravir.
For oral PrEP durations greater than two months, an alternative PrEP regimen to oral cabotegravir is recommended. Injection dosing should be resumed on the day oral cabotegravir dosing completes or within 3 days, thereafter (see Apretude injection SmPC).
Missed doses If the individual misses a dose of Apretude tablets, the individual should take the missed dose as soon as possible, providing the next dose is not due within 12 hours. If the next dose is due within 12 hours, the individual should not take the missed dose and simply resume the usual dosing schedule.
Vomiting If an individual vomits within 4 hours of taking Apretude tablets, another Apretude tablet should be taken. If an individual vomits more than 4 hours after taking Apretude tablets, the individual does not need to take another tablet until the next regularly scheduled dose.
Summary of the safety profile The most frequently reported adverse reactions in HPTN 083 were: headache (17%) and diarrhoea (14%). The most frequently reported adverse reactions in HPTN 084 were: headache (23%) and transaminase increased (19%).
Tabulated list of adverse reactions Adverse reactions for cabotegravir were identified from the Phase III clinical studies; HPTN 083 and HPTN 084; and post-marketing data. In HPTN 083, the median time on blinded study product was 65 weeks and 2 days (1 day to 156 weeks and 1 day), with a total exposure on cabotegravir of 3231 person years.
In HPTN 084, the median time on blinded study product was 64 weeks and 1 day (1 day to 153 weeks and 1 day), with a total exposure on cabotegravir of 2009 person years. The adverse reactions identified for cabotegravir in adults and adolescents are listed in Table 3 by 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). Table 3 Tabulated list of adverse reactions MedDRA System organ class (SOC) Frequency category Adverse reactions Immune system disorders Uncommon Hypersensitivity*4 Common Abnormal dreams Insomnia Depression Anxiety Psychiatric disorders Uncommon Suicide attempt4; Suicidal ideation4 (particularly in individuals with a pre-existing psychiatric illness) Very common Headache Common Dizziness Nervous system disorders Uncommon Somnolence Very common DiarrhoeaGastrointestinal disorders Common Nausea Abdominal pain1 Flatulence Vomiting Hepatobiliary Disorders Uncommon Hepatotoxicity Common Rash2 Uncommon Urticaria*4 Angioedema*4 Skin and subcutaneous tissue disorders Very rare Stevens-Johnson syndrome*4, toxic epidermal necrolysis*4 Musculoskeletal and Common Myalgia connective tissue disorders Very common Pyrexia3 General disorders and administrative site conditions Common Fatigue Malaise Very common Transaminase increasedInvestigations Uncommon Weight increased Blood bilirubin increased 1Abdominal pain includes the following grouped MedDRA preferred terms: upper abdominal pain and abdominal pain.
1). 2) are achieved and maintained within hours after initiation of oral lead-in. The exact time from initiation of Apretude for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. g. knowledge of HIV1 status, regular testing for other sexually transmitted infections, condom use).
3). Individuals should be re-confirmed to be HIV-negative at frequent intervals. A combined antigen/antibody test as well as an HIV-RNA-based test should both be negative. Prescribers are advised to perform both tests, even if the result of the HIV-RNA-based test will become available after oral administration.
If a combined testing strategy including both tests is not available, testing should follow local guidelines while taking Apretude. If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, HIV-1 status should be reconfirmed.
Potential risk of resistance There is a potential risk of developing resistance to cabotegravir if an individual acquires HIV-1 either before, or while taking or following discontinuation of cabotegravir. To minimise this risk, it is essential to confirm HIV-1 negative status at frequent intervals.
A combined antigen/antibody test as well as an HIV-RNA-based test should both be negative. Prescribers are advised to perform both tests, even if the result of the HIV-RNA-based test will become available after oral administration. If a combined testing strategy including both tests is not available, testing should follow local guidelines.
Individuals who are diagnosed with HIV-1 should immediately begin anti-retroviral therapy (ART). Apretude alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in some individuals with undetected HIV-1 infection who were only taking Apretude.
Alternative forms of PrEP should be considered following discontinuation of cabotegravir for those individuals at continuing risk of HIV acquisition and initiated within 2 months of the final cabotegravir injection. Importance of adherence Individuals should be counselled periodically to strictly adhere to the recommended oral lead-in dosing schedule in order to reduce the risk of HIV-1 acquisition and the potential development of resistance.
1. 4). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Special populations Elderly No dose adjustment is required in elderly individuals. 2). Hepatic impairment No dose adjustment is required in individuals with mild or moderate hepatic impairment (Child-Pugh score A or B). 2]). If administered in an individual with severe hepatic impairment, cabotegravir should be used with caution.
2]). Cabotegravir has not been studied in individuals with end-stage renal disease on renal replacement therapy. As cabotegravir is greater than 99% protein bound, dialysis is not expected to alter exposures of cabotegravir. If administered in an individual on renal replacement therapy, cabotegravir should be used with caution.
Paediatric population The safety and efficacy of cabotegravir in children and adolescents weighing less than 35 kg have not been established. No data are available. Method of administration Oral use.
2Rash includes the following grouped MedDRA preferred terms: rash, rash erythematous, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic. 3Pyrexia includes the following grouped MedDRA preferred terms: pyrexia and feeling hot.
4This adverse reaction was identified through post-marketing reporting. The frequency category is based on individuals exposed to cabotegravir in clinical studies. 4 ‘Hypersensitivity reactions’. 0 n=598) in weight from baseline, respectively.
0 n=218) in weight from baseline, respectively. Changes in laboratory chemistries In both HPTN 083 and HPTN 084, a similar proportion of participants in the cabotegravir and TDF/FTC groups were observed to have elevated hepatic transaminases (ALT/AST) levels and maximum post baseline increases were mostly Grades 1 and 2.
In HPTN 083, the number of participants in the cabotegravir vs TDF/FTC groups who experienced maximum post baseline Grade 3 or 4 ALT levels were 40 (2%) vs 44 (2%) and Grade 3 or 4 AST levels were; 68 (3%) vs 79 (3%), respectively.
In HPTN 084, the number of participants in the cabotegravir vs TDF/FTC groups who experienced maximum post baseline Grade 3 or 4 ALT levels were 12 (< 1%) vs 18 (1%) and Grade 3 and 4 AST levels were; 15 (< 1%) vs 14 (< 1%), respectively.
A few participants in both the cabotegravir and TDF/FTC groups had adverse reactions of AST or ALT increased which resulted in discontinuation of study product. In HPTN 083, the number of participants in the cabotegravir vs TDF/FTC groups who discontinued due to ALT increased were: 29 (1%) vs 31 (1%) and due to AST increased were 7 (< 1%) vs 8 (< 1%), respectively.
In HPTN 084, the number of participants in the cabotegravir vs TDF/FTC groups who discontinued due to ALT increased were 12 (< 1%) vs 15 (< 1%) and there were no discontinuations due to AST increased. Adolescents Based on data from two open-label multicenter clinical trials (HPTN 083-01 and HPTN 084- 01) in 64 HIV-uninfected, at-risk adolescents (weighing ≥ 35 kg at enrolment) receiving cabotegravir, no new safety issues were identified in adolescents compared with the safety profile established in adults receiving cabotegravir for HIV-1 PrEP in HPTN 083 and HPTN 084.
1). 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 Yellow Card Scheme Website: […]
Hypersensitivity reactions Hypersensitivity reactions have been reported in association with integrase inhibitors including cabotegravir. These reactions were characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury.
Apretude and other suspected medicinal products should be discontinued immediately, should signs or symptoms of hypersensitivity develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema).
8). 8). Administration of cabotegravir oral lead-in was used in clinical studies to help identify individuals who may be at risk of hepatotoxicity. Clinical and laboratory monitoring are recommended and Apretude tablets should be discontinued if hepatotoxicity is confirmed, and individuals managed as clinically indicated.
8). Although clinical studies did not show an increased incidence of psychiatric illness in adolescents compared to adult subjects, given the vulnerability of the adolescent population, adolescents should be counselled before prescribing, and periodically while receiving Apretude, and managed as clinically indicated.
5). 5). Excipients Individuals with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.