Vocabria 30 mg Tablet

Film-coated tablets: VOCABRIA tablets are indicated in combination with rilpivirine tablets for short-term (see section 4.2) treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine for:

• oral lead-in to assess tolerability of cabotegravir prior to administration of long-acting (LA) VOCABRIA injection.
• oral therapy for adults who will miss planned dosing with VOCABRIA injection.

Suspension for Injection: Cabotegravir injection is indicated in combination with rilpivirine injection for treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine.

Posology: Therapy should be initiated by a medical practitioner experienced in the management of HIV infection. VOCABRIA is indicated for the treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should be consulted for recommended dosing.

Prior to starting VOCABRIA, 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.

Film-coated tablets: VOCABRIA may be taken with or without food. When taken at the same time as rilpivirine, VOCABRIA should be taken with a meal.

Suspension for Injection: Refer to the u2018Instructions for Useu2019 for detailed step by step injection procedure (see section 6.6). VOCABRIA injection should be administered by a healthcare professional. When administering the VOCABRIA injection, healthcare professionals should take into consideration the BMI of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. VOCABRIA and rilpivirine injections should be administered at separate gluteal injection sites during the same visit.

Adults: The healthcare provider and patient may proceed directly to LA injectable therapy (see Tables 2 and 3, for monthly and every 2-month dosing recommendations, respectively). Alternatively, VOCABRIA oral tablets may be used as an oral lead-in prior to the initiation of VOCABRIA injection to assess tolerability to cabotegravir (see Table 1).

Oral lead-in (film-coated tablets): When used for oral lead-in, VOCABRIA oral tablets are recommended for approximately one month (at least 28 days) in virologically suppressed patients prior to the initiation of cabotegravir injection to assess tolerability to cabotegravir. VOCABRIA tablets should be taken together with rilpivirine tablets.

Table 1 Oral Lead-in Dosing Schedule in Adults

ORAL LEAD - IN Medicine For 1 month (at least 28 days), followed by the Initiation Injection a VOCABRIA 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 (suspension for injection): Initiation injection: On the final day of prior antiretroviral therapy or oral lead-in, the recommended initial VOCABRIA injection dose in adults is a single 3 mL (600 mg) intramuscular injection. Continuous injections: After the initiation injection, the recommended VOCABRIA continuation injection dose in adults is a single 2 mL (400 mg) intramuscular injection, administered monthly. Patients may be given injections up to 7 days before or after the date of the monthly 2 mL dosing schedule.

Table 2 Recommended Oral Lead-in and Monthly Intramuscular Dosing Schedule in Adults

INITIATION INJECTION CONTINUATION INJECTIONS Medicine Direct to Injection (month 1) OR Following oral lead-in (month 2) One month after initiation injection and monthly onwards VOCABRIA 3 mL (600 mg) 2 mL (400 mg) Rilpivirine 3 mL (900 mg) 2 mL (600 mg)

Every 2-month dosing (suspension for injection): Initiation injections: On the final day of prior antiretroviral therapy or oral lead-in, the recommended initial VOCABRIA injection dose in adults is a single 3 mL (600 mg) intramuscular injection. One month later, a second 3 mL (600 mg) intramuscular injection should be administered. Patients may be given the second 3 mL (600 mg) initiation injection up to 7 days before or after the scheduled dosing date. Continuation injections: After the second initiation injection, the recommended VOCABRIA continuation injection dose in adults is a single 3 mL (600 mg) intramuscular injection administered every 2-months. Patients may be given injections up to 7 days before or after the date of the u2018every 2-month,u2019 3 mL dosing schedule.

Table 3 Recommended Every 2-Month Intramuscular Dosing Schedule in Adults

INITIATION INJECTIONS CONTINUATION INJECTIONS Medicine Direct to injection: months 1 and 2 OR Following oral lead-in (month 2) Month 5 onwards VOCABRIA 3 mL (600 mg) 3 mL (600 mg) Rilpivirine 3 mL (900 mg) 3 mL (900 mg)

Change in Dosing Frequency: 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 dosing schedule should receive a single 3 mL (600 mg) intramuscular injection of cabotegravir one month after the last 2 mL (400 mg) continuation injection dose and then 3 mL (600 mg) every 2 months thereafter. Dosing Recommendations when Switching from Every 2-Month to Monthly Injections: 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 VOCABRIA 2 months after the last 600 mg continuation injection dose and then 400 mg monthly thereafter.

Missed dose: Film-coated tablet: If the patient misses a dose of oral VOCABRIA, the patient should take the missed dose as soon as possible. Suspension for injection: Adherence to the injection dosing schedule is strongly recommended. Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate (see Tables 4 and 5).

Missed monthly Injection: If a delay of more than 7 days from a scheduled injection visit cannot be avoided, VOCABRIA tablets (30 mg) may be used in combination with rilpivirine tablets (25 mg) once daily to replace up to 2 consecutive monthly injection visits. For oral therapy durations greater than 2 months, an alternative oral regimen is recommended. The first dose of oral therapy should be taken one month (u00b1 7 days) after the last injection dose of VOCABRIA or rilpivirine. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 4.

Table 4 Injection Dosing Recommendations After Missed Injections or Oral Therapy for patients on monthly injection dosing

Time since last injection Recommendation u2264 2 months: Continue with the monthly 2 mL injections dosing schedule as soon as possible

Missed 2-month injection: If a delay of more than 7 days from a scheduled injection visit cannot be avoided, VOCABRIA tablets (30 mg) may be used in combination with rilpivirine tablets (25 mg) once daily to replace one 2-monthly injection visit. For oral therapy durations greater than 2 months, an alternative oral regimen is recommended. The first dose of oral therapy should be taken two months (u00b1 7 days) after the last injection dose of VOCABRIA or rilpivirine. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 5.

Table 5 Injection Dosing Recommendations After Missed Injections or Oral Therapy for patients on every 2-month injection dosing

> 2 months: Re-initiate the patient on the 3 mL dose, and then continue to follow the monthly 2 mL injection dosing schedule.

Missed Injection Visit Time since last injection Recommendation (all injections are 3 mL) Injection 2 u2264 2 months Resume with 3 mL (600 mg) injection as soon as possible and continue with 2-month injection dosing schedule. > 2 months Re-initiate the patient on the 3 mL (600 mg) dose, followed by a second 3 mL initiation injection one month later. Then follow the every 2-month injection dosing schedule.

Injection 3 or later u2264 3 months Resume with 3 mL (600 mg) injection as soon as possible and continue with 2-month injection dosing schedule. > 3 months Re-initiate the patient on the 3 mL (600 mg) dose, followed by a second 3 mL initiation injection one month later. Then follow the every 2-month injection dosing schedule.

VOCABRIA is contraindicated in patients:

• with known hypersensitivity to cabotegravir or to any of the excipients in the tablets or the injection formulation
• receiving rifampicin, rifapentine, phenytoin, phenobarbitone, carbamazepine and oxcarbazepine.

VOCABRIA is only indicated for treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should also be consulted.

Hypersensitivity reactions: Hypersensitivity reactions have been reported in association with other integrase inhibitors. These reactions were characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury. Administration of VOCABRIA oral lead-in was used in clinical studies to help identify patients who may be at risk of a hypersensitivity reaction. While no such reactions have been observed to date in association with VOCABRIA, medical practitioners should remain vigilant and should discontinue VOCABRIA and other suspected agents 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). Clinical status, including liver aminotransferases should be monitored and appropriate therapy initiated. (See section 4.2, section 4.3 and Long-acting properties of VOCABRIA injection below and section 5.1 clinical efficacy and safety).

Hepatotoxicity: Hepatotoxicity has been reported in a limited number of patients receiving VOCABRIA with or without known pre-existing hepatic disease (see section 4.8). Monitoring of liver chemistries is recommended and treatment with cabotegravir should be discontinued if hepatotoxicity is suspected (see Long-acting properties of VOCABRIA injection).

Long-acting properties of cabotegravir injection: Residual concentrations of cabotegravir injection may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer), therefore, medical practitioners should take the prolonged release characteristics of VOCABRIA into consideration when the medicinal product is discontinued (see section 4.5, section 4.6 and section 4.9).

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 cabotegravir 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.

Interactions with medicinal products: Caution should be given to prescribing VOCABRIA with medicines that may reduce its exposure (see section 4.5).

Lipodystrophy and metabolic abnormalities: Combination antiretroviral therapy has been associated with the redistribution/accumulation of body fat, including central obesity, dorso-cervical fat, enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and elevated serum lipid and glucose levels in HIV patients. Clinical examination should include evaluation for physical signs of fat redistribution. Patients with evidence of lipodystrophy should have a thorough cardiovascular risk assessment.

Immune Reconstitution Inflammatory Syndrome: Immune reconstitution inflammatory syndrome (IRIS) is an immunopathological response resulting from the rapid restoration of pathogen-specific immune responses to pre-existing antigens combined with immune dysregulation, which occurs shortly after starting combination Anti-Retroviral Therapy (cART). Typically, such reaction presents by paradoxical deterioration of opportunistic infections being treated or with unmasking of an asymptomatic opportunistic disease, often with an atypical inflammatory presentation. IRIS usually develops within the first three months of initiation of ART and occurs more commonly in patients with low CD4 counts. Common examples of IRIS reactions to opportunistic diseases are tuberculosis, cytomegalovirus retinitis, and cryptococcal meningitis. Appropriate treatment of the opportunistic disease should be instituted or continued and ART continued. Inflammatory manifestations generally subside after a few weeks. Severe cases may respond to glucocorticoids, but there is only limited evidence for this in patients with tuberculosis IRIS. Autoimmune disorders (such as Graves' disease) have also been reported as IRIS reactions; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

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 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.

Opportunistic infections: Patients receiving VOCABRIA should be advised that they may continue to develop opportunistic infections and other complications of HIV infection, and therefore they should remain under close observation by healthcare professionals experienced in the treatment of patients with associated HIV disease. Regular monitoring of viral load and CD4 counts needs to be done.

Transmission of infection: While effective viral suppression with antiviral suppression, including VOCABRIA, has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.

Concomitant treatment with rilpivirine: VOCABRIA is indicated for the treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should be consulted.

VOCABRIA tablets contain lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take VOCABRIA tablets.

VOCABRIA tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially u2018sodium-free.u2019

VOCABRIA Suspension for injections contain mannitol: mannitol may have a mild laxative effect.

VOCABRIA is indicated for the treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should be consulted for associated interactions.

Effect of cabotegravir on the pharmacokinetics of other medicines: In vivo, cabotegravir did not have an effect on midazolam, a CYP3A4 probe. Cabotegravir is not a clinically relevant inhibitor of the following enzymes and transporters: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, UGT1A1, UGT1A3, UGT1A4, UGT1A6, UGT1A9, UGT2B4, UGT2B7, UGT2B15, and UGT2B17, P-gp, breast cancer resistance protein (BCRP), Bile salt export pump (BSEP), organic cation transporter (OCT)1, OCT2, OATP1B1, OATP1B3, multidrug and toxin extrusion transporter (MATE) 1, MATE 2-K, multidrug resistance protein (MRP) 2 or MRP4. Cabotegravir inhibited the organic anion transporters (OAT) 1 (IC50 = 0,81 u03bcM) and OAT3 (IC50 = 0,41 u03bcM) in vitro, however, based on physiologically based pharmacokinetic (PBPK) modelling no interaction with OAT substrates is expected at clinically relevant concentrations. In vitro, cabotegravir did not induce CYP1A2, CYP2B6, or CYP3A4. Based on these data and the results of interaction studies, cabotegravir is not expected to affect the pharmacokinetics of medicines that are substrates of these enzymes or transporters. Based on the in vitro and clinical interaction profile, cabotegravir is not expected to alter concentrations of other antiretroviral medicines including protease inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, entry inhibitors, and ibalizumab.

Effect of other medicines on the pharmacokinetics of cabotegravir: Cabotegravir is primarily metabolised by UGT1A1 with some contribution from UGT1A9. Medicines which are strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir plasma concentrations leading to lack of efficacy (see section 4.3). Simulations using PBPK show that no clinically significant interaction is expected following co-administration of VOCABRIA with medicines that inhibit UGT enzymes. In vitro, cabotegravir was not a substrate of OATP1B1, OATP1B3, OATP2B1 or OCT1. Cabotegravir is a substrate of P-gp and BCRP, however, because of its high permeability, no alteration in absorption is expected when co-administered with either P-gp or BCRP inhibitors. No interaction studies have been performed with VOCABRIA injection. The interaction data provided in Table 6 is obtained from studies with oral VOCABRIA.

Table 6 Interactions

Concomitant Medicine Class: Medicine Name Effect on Concentration of Cabotegravir or Concomitant Medicine Clinical Comment HIV-1 Antiviral Medicines Non-nucleoside Reverse Transcriptase Inhibitor: Etravirine Cabotegravir u2194 AUC u2191 1 % C max u2191 4 % Cu03c4 u2194 0 % Etravirine did not significantly change cabotegravir plasma concentration. No dosage adjustment is required. Non-nucleoside Reverse Transcriptase Inhibitor: Rilpivirine Cabotegravir u2194 AUC u2191 12 % C max u2191 5 % Cu03c4 u2191 14 % Rilpivirine u2194 AUC u2193 1 % C max u2193 4 % Cu03c4 u2193 8 % Rilpivirine did not significantly change cabotegravir plasma concentration or vice versa. No dose adjustment of VOCABRIA is necessary when co-administered with rilpivirine. Other Medicines Rifampicin Cabotegravir u2193 AUC u2193 59 % C max u2193 6 % Rifampicin significantly decreased cabotegravir plasma concentration, which is likely to result in loss of therapeutic effect. Co-administration of VOCABRIA with rifampicin is contraindicated. Dosing recommendations for co-administration of VOCABRIA (oral and injection) with rifampicin have not been established. Rifapentine Cabotegravir u2193 Rifapentine may significantly decrease cabotegravir plasma concentrations, concomitant use is contraindicated. Rifabutin Cabotegravir u2193 AUC u2193 21 % C max u2193 17 % Cu03c4 u2193 8 % VOCABRIA tablets: Rifabutin did not significantly change cabotegravir plasma concentration. No dose adjustment is required. Prior to initiation of oral VOCABRIA therapy, the prescribing information for VOCABRIA injection should be consulted regarding concomitant use with rifabutin. VOCABRIA injection: Rifabutin may decrease cabotegravir plasma concentrations, concomitant use should be avoided. Anticonvulsants: Carbamazepine Oxcarbazepine Phenytoin Phenobarbitone Cabotegravir u2193 Metabolic inducers may significantly decrease cabotegravir plasma concentrations. Concomitant use is contraindicated.

Concomitant Medicine Class: Medicine Name Effect on Concentration of Cabotegravir or Concomitant Medicine Clinical Comment Antacids (e.g., magnesium, calcium or aluminium) Cabotegravir u2193 VOCABRIA tablets: Co-administration of antacid supplements has the potential to decrease oral cabotegravir absorption and has not been studied. Antacid products containing polyvalent cations are recommended to be administered at least 2 hours before or 4 hours after oral VOCABRIA. VOCABRIA injection: Interaction is not relevant following parenteral administration. Oral contraceptives (Ethinyl estradiol (EE) and levonorgestrel EE u2194 AUC u2191 2 % C max u2193 8 % Cu03c4 u2194 0 % LNG u2194 Cabotegravir did not significantly change EE and levonorgestrel plasma concentrations to a clinically relevant extent. No dose adjustment of oral contraceptives is necessary when co-administered with VOCABRIA.

Pregnancy: Safety in pregnancy has not been established. There are no studies of cabotegravir in pregnant women. The effect on human pregnancy is unknown. Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but caused a delay in delivery that was associated with reduced survival and viability of rat offspring at exposures higher than for therapeutic doses (see section 5.3). The relevance to human pregnancy is unknown. Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection, therefore, consideration should be given to the potential for foetal exposure during pregnancy (see section 4.4).

Lactation: Safety in lactation has not been established. Health experts recommend that where possible HIV infected women do not breast feed their infants in order to avoid transmission of HIV. In settings where formula feeding is not feasible, local official lactation and treatment guidelines should be followed when considering breast feeding during antiretroviral therapy. It is expected that cabotegravir will be secreted into human milk based on animal data, although this has not been confirmed in humans. Cabotegravir may be present in human milk for up to 12 months or longer after the last cabotegravir injection.

Fertility: Animal studies indicate no effects of cabotegravir on male or female fertility (see section 5.3).

VOCABRIA may cause dizziness. Patients experiencing dizziness should avoid driving and operation of machinery.

Clinical trial data: VOCABRIA + rilpivirine were administered as a combination regimen (monthly and every 2-month dosing) and associated adverse events (AEs) are listed in Table 6. AEs listed include those attributable to both the oral and injectable formulations of VOCABRIA and rilpivirine. When frequencies differed between phase III studies, the highest frequency category is quoted in Table 7. The most frequently reported AEs from monthly dosing studies were injection site reactions (up to 84 %), headache (up to 12 %) and pyrexia 3 (10 %). The most frequently reported AERs from the 2-month dosing were injection site reactions (76 %), headache (7 %) and pyrexia 3 (7 %).

The AEs identified in these studies are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (u2265 1/10), common (u2265 1/100 and < 1/10), uncommon (u2265 1/1000 and < 1/100), rare (u2265 1/10 000 and < 1/1000) and very rare (< 1/10 000), including isolated reports.

Table 7: Adverse Events

MedDRA System Organ Class (SOC) Frequency Category AEs for cabotegravir + rilpivirine regimen Psychiatric disorders Common Depression, anxiety, abnormal dreams, insomnia Nervous system disorders Very common Headache Common Dizziness Uncommon Somnolence, vasovagal reactions (in response to injections) Gastrointestinal disorders Common Nausea, vomiting, abdominal pain 1, flatulence, diarrhoea Hepatobiliary Disorders Uncommon Hepatotoxicity Skin and subcutaneous tissue disorders Common Rash 2 Musculoskeletal and connective tissue disorders Common Myalgia General disorders and administrative site conditions Very common Injection site reactions 4 (pain and discomfort, site nodule, induration), pyrexia 3 Common Injection site reactions 4 (swelling, erythema, pruritus, bruising, warmth, haematoma), fatigue, asthenia, malaise Uncommon Injection site reactions 4 (cellulitis, abscess, anaesthesia, haemorrhage, discolouration) Investigations Common Weight increased Uncommon Transaminase increased 1 Abdominal pain includes the following grouped MedDRA preferred terms: abdominal pain, upper abdominal pain. 2 Rash includes the following grouped MedDRA preferred terms: Rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic. 3 Pyrexia includes the following grouped MedDRA preferred terms: pyrexia, body temperature increased, feeling hot. Some events of pyrexia had a close temporal association with injection. 4 Injection site reactions listed in the table have been reported in 2 subjects or more.

Local Injection Site Reactions (ISRs): In each of the three Phase III studies, approximately u2264 1 % of subjects discontinued treatment with cabotegravir + rilpivirine because of ISRs. When dosing monthly, out of 30 393 injections, 6 815 ISRs were reported. When dosing every 2 months, out of 8 470 injections, 2 507 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, and no subjects experienced Grade 4 ISRs. The median duration of overall ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time. Weight increased: At the Week 48 time point, subjects in FLAIR and ATLAS, who received VOCABRIA + rilpivirine gained a median of 1,5 kg in weight (pooled analysis). In the individual studies FLAIR and ATLAS, the median weight gains in the VOCABRIA + rilpivirine arms were 1,3 kg and 1,8 kg respectively. At the 48-week timepoint, in ATLAS-2M the median weight gain in both the monthly and 2-monthly CAB+RPV dosing arms was 1,0 kg. Changes in laboratory chemistries: Small, non-progressive increases in total bilirubin (without clinical jaundice) were observed with treatment with cabotegravir + rilpivirine. These changes are not considered clinically relevant as they likely reflect competition between CAB and unconjugated bilirubin for a common clearance pathway (UGT1A1). Elevated transaminases (ALT/AST) were observed in subjects receiving VOCABRIA + rilpivirine during the clinical trials. These elevations were primarily attributed to acute viral hepatitis. A few subjects had transaminase elevations attributed to suspected drug-related hepatotoxicity. Elevated lipases were observed during clinical trials with VOCABRIA + rilpivirine; Grade 3 and 4 lipase increases occurred with cabotegravir + rilpivirine. These elevations were generally asymptomatic and did not lead to discontinuation. Asymptomatic creatine phosphokinase (CPK) elevations, mainly in association with exercise, have also been reported with VOCABRIA + rilpivirine treatment. For other AEs associated with rilpivirine, the relevant prescribing information should be consulted.

Post-marketing data: No data available.

Reporting of adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u20186.04 Adverse Drug Reactions Reporting Formu2019, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

There is no specific treatment for overdose with VOCABRIA. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available. Cabotegravir is known to be highly protein bound in plasma; therefore, dialysis is unlikely to be helpful in removal of drug from the body. Management of overdose with VOCABRIA injection should take into consideration the prolonged exposure to medicine following an injection (see section 4.4).