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Vocabria is a brand name for Cabotegravir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg), who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral…
Verbatim from this product's EMA label. Tap a section to expand.
3 Vocabria should be prescribed by physicians experienced in the management of HIV infection. Each injection should be administered by a healthcare professional. Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing.
Prior to starting Vocabria injection, healthcare professionals should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
4). The healthcare provider and patient may decide to use cabotegravir tablets as an oral lead-in prior to the initiation of cabotegravir injection to assess tolerability to cabotegravir (see Table 1) or may proceed directly to cabotegravir injections (see Table 2 for monthly and Table 3 for every 2 month dosing recommendations).
4). One cabotegravir 30 mg tablet should be taken with one rilpivirine 25 mg tablet, once daily. When administered with rilpivirine, cabotegravir tablets should be taken with a meal (see cabotegravir tablet prescribing information). Table 1 Oral Lead-in Dosing Schedule ORAL LEAD-IN Medicinal product For one month (at least 28 days), followed by the Initiation Injectiona Cabotegravir 30 mg once daily Rilpivirine 25 mg once daily a see Table 2 for monthly injection dosing schedule and Table 3 for every 2 month dosing schedule.
Monthly dosing Initiation injection (600 mg corresponding to 3 mL dose) On the final day of current antiretroviral therapy or oral lead-in therapy, the recommended initial dose of Vocabria injection is a single 600 mg intramuscular injection.
Vocabria injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit. Continuation injection (400 mg corresponding to 2 mL dose) After the initiation injection, the continuation injection dose of Vocabria is a single 400 mg monthly intramuscular injection.
Vocabria injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit. Patients may be given injections up to 7 days before or after the date of the monthly 400 mg injection schedule.
Summary of the safety profile The most frequently reported adverse reactions (ARs) were injection site reactions, headache, and pyrexia5. 4). Tabulated list of adverse reactions The ARs identified for cabotegravir or rilpivirine are listed in Table 7 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). Table 7 Tabulated summary of adverse reactions1 MedDRA System Organ Class (SOC) Frequency Category ARs for Vocabria + rilpivirine regimen Immune system disorders Uncommon Hypersensitivity* Psychiatric disorders Common Depression Anxiety Abnormal dreams Insomnia Uncommon Suicide attempt; Suicidal ideation (particularly in patients with a pre-existing history of psychiatric illness) Nervous system disorders Very common Headache Common Dizziness Uncommon Somnolence 12 Vasovagal reactions (in response to injections) Gastrointestinal disorders Common Nausea Vomiting Abdominal pain2 Flatulence Diarrhoea Hepatobiliary Disorders Uncommon Hepatotoxicity Skin and subcutaneous tissue disorders Common Rash3 Uncommon Urticaria* Angioedema* Very rare Stevens-Johnson syndrome*, toxic epidermal necrolysis* Musculoskeletal and connective tissue disorders Common Myalgia General disorders and administrative site conditions Very common Injection site reactions (pain4 and discomfort, nodule, induration) Pyrexia5 Common Injection site reactions (swelling, erythema, pruritus, bruising, warmth, haematoma) Fatigue Asthenia Malaise Uncommon Injection site reactions (cellulitis, abscess, anaesthesia, haemorrhage, discolouration) Investigations Common Weight increased Uncommon Transaminase increased Blood bilirubin increased 1The frequency of the identified ARs are based on all reported occurrences of the events and are not limited to those considered at least possibly related by the investigator.
2Abdominal pain includes the following grouped MedDRA preferred term: abdominal pain, upper abdominal pain. 3Rash includes the following grouped MedDRA preferred terms: rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic.
Risk of resistance following treatment discontinuation To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months.
If virologic failure is suspected, an alternative regimen should be adopted as soon as possible. 9). Baseline factors associated with virological failure Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI 30 kg/m2.
Available data suggest that virologic failure occurs more often when these patients are treated according to the every 2 month dosing regimen as compared to the monthly dosing regimen. 1). Severe cutaneous adverse reactions (SCARs) The severe cutaneous adverse reactions, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported very rarely in association with cabotegravir treatment.
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, cabotegravir should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS or TEN with the use of cabotegravir, treatment with cabotegravir must not be restarted in this patient at any time. Hypersensitivity reactions 8 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. Vocabria 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).
1. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Table 2 Recommended monthly intramuscular dosing schedule INITIATION INJECTION CONTINUATION INJECTION Medicinal product Initiate injection on the last day of either current ART therapy or oral lead-in (if used) One month after initiation injection and monthly onwards Vocabria 600 mg 400 mg Rilpivirine 900 mg 600 mg Every 2 Month Dosing Initiation Injections – one month apart (600 mg) On the final day of current antiretroviral therapy or oral lead-in therapy, the recommended initial Vocabria injection is a single 600 mg intramuscular injection.
One month later, a second Vocabria 600 mg intramuscular injection should be administered. Patients may be given the second 600 mg initiation injection up to 7 days before or after the scheduled dosing date. Vocabria injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit.
Continuation Injections – 2 months apart (600 mg) After the initiation injections, the recommended Vocabria continuation injection dose is a single 600 mg intramuscular injection administered every 2 months. Vocabria injection and rilpivirine injection should be administered at separate gluteal injection sites at the same visit.
Patients may be given injections up to 7 days before or after the date of the every 2 month, 600 mg injection schedule. Table 3 Recommended every 2 month intramuscular dosing schedule INITIATION INJECTIONS CONTINUATION INJECTIONS Medicinal product Initiate injection on the last day of either current ART therapy or oral lead-in (if used).
One month later, a second initiation injection should be administered. Two months after last initiation injection and every 2 months onwards Vocabria 600 mg 600 mg Rilpivirine 900 mg 900 mg Dosing recommendations when switching from monthly to every 2 month injections Patients switching from a monthly continuation injection schedule to an every 2 month continuation injection schedule should receive a single 600 mg intramuscular injection of cabotegravir one month after the last 400 mg continuation injection dose and then 600 mg every 2 months thereafter.
Dosing recommendations when switching from every 2 month to monthly injections 5 Patients switching from an every 2 month continuation injection schedule to a monthly continuation dosing schedule should receive a single 400 mg intramuscular injection of cabotegravir 2 months after the last 600 mg continuation injection dose and then 400 mg monthly thereafter.
Missed doses Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate. See Tables 4 and 5 for dosing recommendations after a missed injection. Missed monthly injection If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy (one 30 mg cabotegravir tablet and one 25 mg rilpivirine tablet once daily) may be used to replace up to 2 consecutive monthly injection visits.
Limited data is […]
4May rarely result in temporary gait disturbance. 5Pyrexia includes the following grouped MedDRA preferred terms: feeling hot, body temperature increased. The majority of pyrexia events were reported within one week of injections. 4. The overall safety profile at Week 96 and Week 124 in the FLAIR study was consistent with that observed at Week 48, with no new safety findings identified.
1). Description of selected adverse reactions Local injection site reactions (ISRs) Up to 1% of subjects discontinued treatment with Vocabria plus rilpivirine because of ISRs. When dosing monthly, up to 84% of subjects reported injection site reactions; out of 30393 injections, 6815 ISRs were reported.
When dosing every 2 months, 76% of patients reported injection site reactions; out of 8470 injections, 2507 ISRs were reported. The severity of reactions was generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects).
3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of overall ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time. 5 kg in weight subjects continuing on their current antiretroviral therapy (CAR) gained a median of 1 kg (pooled analysis).
3 kg in the CAR arms. 0 kg. Changes in laboratory chemistries Small, non-progressive increases in total bilirubin (without clinical jaundice) were observed with treatment with Vocabria plus rilpivirine. These changes are not considered clinically relevant as they likely reflect competition between cabotegravir and unconjugated bilirubin for a common clearance pathway (UGT1A1).
Elevated transaminases (ALT/AST) were observed in subjects receiving Vocabria plus rilpivirine during clinical studies. These elevations were primarily attributed to acute viral hepatitis. 4). Elevated lipases were observed during clinical trials with Vocabria plus rilpivirine; Grade 3 and 4 lipase increases occurred at a higher incidence with Vocabria plus rilpivirine compared with CAR.
These elevations were generally asymptomatic and did not lead to Vocabria plus rilpivirine discontinuation. One case of fatal pancreatitis with Grade 4 lipase and confounding factors (including history of pancreatitis) has been reported in study ATLAS-2M, for which causality to the injection regimen could not be ruled out.
Paediatric population Based on data from the week 16 (Cohort 1C, n=30) and week 24 analysis (Cohort 2, n=144) of the MOCHA study (IMPAACT 2017), no new safety concerns were identified in adolescents (aged at least 12 years and weighing 35 kg or more) when compared with the safety profile established in adults.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product […]
Clinical status, including liver aminotransferases should be monitored and appropriate therapy initiated. 1). 8). Administration of cabotegravir oral lead-in was used in clinical studies to help identify patients who may be at risk of hepatotoxicity.
Monitoring of liver chemistries is recommended and treatment with Vocabria should be discontinued if hepatotoxicity is suspected (see Long acting properties of Vocabria injection). HBV/HCV co-infection Patients with hepatitis B co-infection were excluded from studies with Vocabria.
It is not recommended to initiate Vocabria in patients with hepatitis B co-infection. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus. Limited data is available in patients with hepatitis C co-infection.
Monitoring of liver function is recommended in patients with hepatitis C co-infection. 5). 5). Immune reactivation syndrome In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (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 are 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 reconstitution, 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 Vocabria 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 these associated HIV diseases.
Excipients This medicinal product contains polysorbate 20 (see section 2), which may cause allergic reactions. 9