VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML

GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOMSTERIGENICS BELGIUM (FLEURUS) (STERILIZATION) (BELGIUM)🇸🇬 Health Sciences Authority

Approval Date: Jul 5, 2022
Approval ID: 2efaa885cccecf31
Company: GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS) - UNITED KINGDOMSTERIGENICS BELGIUM (FLEURUS) (STERILIZATION) (BELGIUM)
Type: Therapeutic

Approval Details

Approval Id: 2efaa885cccecf31
Drug Name: VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML
Product Name: VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML
Approval Number: SIN16542P
Approval Date: 2022-07-05
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SUSPENSION
Dosage: Dosage and Administration Pharmaceutical Form Film-coated tablet and suspension for injection Posology Therapy should be initiated by a physician 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. Method of Administration Film-coated Tablet 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 Instructions for Use for detailed step by step injection procedure (see Instructions for Use & Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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. Cabotegravir and rilpivirine injections should be administered at separate gluteal injection sites during the same visit. Adults and adolescents (at least 12 years of age and weighing at least 35 kg) The health care 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 VOCABRIA injection to assess tolerability to cabotegravir. VOCABRIA tablets should be taken together with rilpivirine tablets. <img src="/TGIF/Vocabria-Table1_141125.png" alt="Vocabria Dosage Table 1" /> Monthly Dosing (Suspension for Injection) Initiation Injection (600 mg corresponding to 3 mL dose) On the final day of prior antiretroviral therapy or oral lead-in, the recommended initial VOCABRIA injection dose is a single 3 mL (600 mg) intramuscular injection. Continuation Injection (400 mg corresponding to 2 mL dose) After the initiation injection, the recommended VOCABRIA continuation injection dose 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. <img src="/TGIF/Vocabria-Table2_141125.png" alt="Vocabria Dosage Table 2" /> Every 2 Month Dosing (Suspension for Injection) Initiation Injections – 1 month apart (600 mg corresponding to 3 mL dose) On the final day of prior antiretroviral therapy or oral lead-in, the recommended initial VOCABRIA injection dose 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 – 2 months apart (600 mg corresponding to 3 mL dose) After the second initiation injection, the recommended VOCABRIA continuation injection dose 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 every 2 month, 3 mL dosing schedule. <img src="/TGIF/Vocabria-Table3_141125.png" alt="Vocabria Dosage Table 3" /> 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 VOCABRIA 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) in combination with rilpivirine tablets (25 mg) once daily may be used for up to 2 consecutive months. Alternatively, any other fully suppressive oral antiretroviral regimen may be used until injections are resumed. Current HIV treatment guidelines should be considered when selecting the regimen. The first dose of oral therapy should be taken one month (+/–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. <img src="/TGIF/Vocabria-Table4_200124.png" alt="Vocabria Dosage Table 4" /> Missed 2 month injection If a delay of more than 7 days from a scheduled injection visit cannot be avoided, VOCABRIA tablets (30 mg) in combination with rilpivirine tablets (25 mg) once daily may be used for up to 2 consecutive months. Alternatively, any other fully suppressive oral antiretroviral regimen may be used until injections are resumed. Current HIV treatment guidelines should be considered when selecting the regimen. The first dose of oral therapy should be taken two months (+/–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. <img src="/TGIF/Vocabria-Table5_200124.png" alt="Vocabria Dosage Table 5" /> Children and Adolescents The safety and efficacy of VOCABRIA in children aged less than 12 years or adolescents weighing less than 35 kg have not been established. Elderly No dose adjustment is required in elderly patients. There are limited data available on the use of VOCABRIA in patients aged 65 years and over (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No dosage adjustment is required in patients with mild (creatinine clearance ≥60 to <90 mL/min), moderate (creatinine clearance ≥30 to <60 mL/min) or severe renal impairment (creatinine clearance ≥15 to <30 mL/min and not on dialysis) (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Cabotegravir has not been studied in patients with end-stage renal disease on renal replacement therapy. Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). VOCABRIA has not been studied in patients with severe hepatic impairment (Child-Pugh score C) (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAMUSCULAR
Indication Info: Indications Film-coated Tablets: VOCABRIA tablets are indicated in combination with rilpivirine tablets for short term (see Dosage and Administration) treatment of human immunodeficiency virus (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 regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class: <ul> <li>oral lead-in to assess tolerability of cabotegravir prior to administration of long acting (LA) VOCABRIA injection.</li> <li>oral therapy for adults and adolescents who will miss planned dosing with VOCABRIA injection.</li> </ul> Suspension for Injection: VOCABRIA injection is indicated in combination with rilpivirine injection for treatment of 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 regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: Contraindications VOCABRIA is contraindicated in patients: <ul> <li>with known hypersensitivity to cabotegravir or to any of the excipients in the tablets or the injection formulation.</li> <li>receiving rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine and oxcarbazepine.</li> </ul> VOCABRIA is only indicated for treatment of HIV in combination with rilpivirine, therefore, the prescribing information for rilpivirine should also be consulted.
Atc Code: J05AJ04
Atc Item Name: cabotegravir
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

Cabotegravir

200mg/ml

CABOTEGRAVIR

200 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jul 5, 2022

Approval ID

2efaa885cccecf31

Type

Therapeutic

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