REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MG/ML

Cilag AG (SWITZERLAND)🇸🇬 Health Sciences Authority

Approval Date: Aug 11, 2022
Approval ID: 4f2398cf26a1e494
Company: Cilag AG (SWITZERLAND)
Type: Therapeutic

Approval Details

Approval Id: 4f2398cf26a1e494
Drug Name: REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MG/ML
Product Name: REKAMBYS PROLONGED-RELEASE SUSPENSION FOR INJECTION 300MG/ML
Approval Number: SIN16568P
Approval Date: 2022-08-11
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence Holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SUSPENSION, EXTENDED RELEASE
Dosage: Dosage and Administration REKAMBYS® should always be co-administered with cabotegravir injection. Therefore, the cabotegravir injection prescribing information should be consulted. Prior to starting REKAMBYS®, the healthcare professional should carefully select 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 associated with missed doses. Method of administration For gluteal intramuscular (IM) injection use only. Do not inject intravenously. REKAMBYS® should be administered by a healthcare professional. When administering REKAMBYS®, the healthcare professional should take into consideration the body mass index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. REKAMBYS® and cabotegravir injections should be administered at separate gluteal injection sites during the same visit. Posology Adults and adolescents (at least 12 years of age and weighing at least 35 kg) REKAMBYS® may be initiated with an oral lead-in or without (direct to injection). The healthcare professional and patient may decide to proceed directly to REKAMBYS® therapy (see Tables 2 and 3, for monthly and every 2 months dosing recommendations, respectively). Alternatively, rilpivirine tablets may be used as an oral lead-in prior to the initiation of REKAMBYS® injections to assess tolerability to rilpivirine (see Table 1). Oral lead-in When oral tablets are used for oral lead-in to assess tolerability to rilpivirine and cabotegravir prior to the initiation of REKAMBYS®, EDURANT is recommended for approximately 1 month (at least 28 days) in virologically suppressed patients. One EDURANT 25 mg tablet should be taken once daily with a meal and should be administered with one cabotegravir 30 mg tablet once daily. The EDURANT prescribing information should be consulted. <img src="/TGIF/Rekambys-Table1_241225.png" alt="Rekambys Dosage Table 1" /> Every 1 month dosing Initiation injection (900 mg corresponding to 3 mL dose) On the final day of current antiretroviral therapy or oral lead-in, the recommended initiation dose of REKAMBYS® is a single 3 mL (900 mg) intramuscular injection. Continuation injections (600 mg corresponding to 2 mL dose) After the initiation injection, the recommended continuation injection dose of REKAMBYS® is a single 2 mL (600 mg) monthly intramuscular injection. Patients may be given injections up to 7 days before or after the date of the monthly 2 mL injection schedule. <img src="/TGIF/Rekambys-Table2_241225.png" alt="Rekambys Dosage Table 2" /> Every 2 months dosing Initiation injections (1 month apart: 900 mg corresponding to 3 mL dose) On the final day of current antiretroviral therapy or oral lead-in, the recommended initial REKAMBYS® injection dose is a single 3 mL (900 mg) intramuscular injection. One month later, a second 3 mL (900 mg) intramuscular injection should be administered. Patients may be given the second 3 mL (900 mg) injection up to 7 days before or after the scheduled dosing date. Continuation injections (2 months apart: 900 mg corresponding to 3 mL dose) After the second initiation injection, the recommended REKAMBYS® continuation injection dose is a single 3 mL (900 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 months 3 mL injection schedule. <img src="/TGIF/Rekambys-Table3_241225.png" alt="Rekambys Dosage Table 3" /> Change in dosing frequency Dosing recommendation when switching from monthly to every 2 months injections Patients switching from a monthly continuation injection schedule to an every 2 months continuation injection schedule should receive a single 3 mL (900 mg) intramuscular injection of REKAMBYS® one month after the last 2 mL (600 mg) continuation injection dose and then 3 mL (900 mg) every 2 months thereafter. Dosing recommendation when switching from every 2 months to monthly injections Patients switching from an every 2 months continuation injection schedule to a monthly continuation injection schedule should receive a single 2 mL (600 mg) intramuscular injection of REKAMBYS® two months after the last 3 mL (900 mg) REKAMBYS® continuation injection dose and then 2 mL (600 mg) monthly thereafter. Missed dose(s) Adherence to the injection schedule is strongly recommended. Patients who miss an injection visit should be clinically reassessed to ensure resumption of therapy is appropriate. See Tables 4 and 5 for dosing recommendations after a missed injection. Missed every 1 month injection dose If a delay of more than 7 days from a scheduled injection visit cannot be avoided, oral therapy (EDURANT [25 mg] and cabotegravir tablets [30 mg] once daily) may be used for up to 2 consecutive months. Alternatively, any other fully suppressive oral antiretroviral regimen may be used (which may include rilpivirine) until injections are resumed (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Current HIV treatment guidelines should be considered when selecting the regimen. The first dose of oral therapy should be taken 1 month (±7 days) after the last injection dose of REKAMBYS® and cabotegravir. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 4. <img src="/TGIF/Rekambys-Table4_241225.png" alt="Rekambys Dosage Table 4" /> Missed every 2 months injection dose If a delay of more than 7 days from a scheduled injection visit cannot be avoided, oral therapy (EDURANT [25 mg] and cabotegravir tablets [30 mg] once daily) may be used for up to 2 consecutive months. Alternatively, any other fully suppressive oral antiretroviral regimen may be used (which may include rilpivirine) until injections are resumed (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Current HIV treatment guidelines should be considered when selecting the regimen. The first dose of oral therapy should be taken 2 months (±7 days) after the last injection doses of REKAMBYS® and cabotegravir. Injection dosing should be resumed on the day oral dosing completes, as recommended in Table 5. <img src="/TGIF/Rekambys-Table5.png" alt="Rekambys Dosage Table 5" /> Transition from REKAMBYS® to another HIV treatment A fully suppressive antiretroviral regimen should be initiated no later than one month after the final injection of REKAMBYS® when dosed monthly and no later than 2 months after the final injection of REKAMBYS® when dosed every 2 months. If virologic failure is suspected, an alternative regimen should be initiated as soon as possible. Special populations Children less than 12 years of age and adolescents weighing less than 35 kg The safety and efficacy of REKAMBYS® in children less than 12 years of age or adolescents weighing less than 35 kg have not been established. Treatment with REKAMBYS® is not recommended in children less than 12 years of age or adolescents weighing less than 35 kg. Elderly (65 years of age and older) There is limited information regarding the use of REKAMBYS® in patients >65 years of age. No dose adjustment of REKAMBYS® is required in elderly patients (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No dose adjustment of REKAMBYS® is required in patients with mild and moderate renal impairment. In patients with severe renal impairment or end stage renal disease, the combination of REKAMBYS® with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk. Subjects with estimated creatinine clearance < 50mL/min/1.73m2 were not included in the Phase 3 studies. No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No dose adjustment of REKAMBYS® is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B) but caution is advised in patients with moderate hepatic impairment. REKAMBYS® has not been studied in patients with severe hepatic impairment (Child-Pugh score C) therefore REKAMBYS® is not recommended in these patients (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAMUSCULAR
Indication Info: Indications REKAMBYS® is indicated, in combination with cabotegravir 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 regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Pharmacological Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications: Contraindications Hypersensitivity to rilpivirine or to any of the excipients. REKAMBYS® should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction), which may result in loss of therapeutic effect of REKAMBYS® (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information): <ul> <li>the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin</li> <li>the antimycobacterials rifabutin, rifampicin, rifapentine</li> <li>the glucocorticoid systemic dexamethasone, except as a single dose treatment</li> <li>St John’s wort (Hypericum perforatum)</li> </ul> When using oral rilpivirine, proton pump inhibitors are also contraindicated. The prescribing information for cabotegravir should also be consulted.
Atc Code: J05AG05
Atc Item Name: rilpivirine
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

Rilpivirine

300mg/mL

RILPIVIRINE

300 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Aug 11, 2022

Approval ID

4f2398cf26a1e494

Type

Therapeutic

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