In combination w/ cabotegravir inj for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen w/o present or past evidence of viral resistance to, & no prior virological failure w/, agents of the NNRTI & integrase inhibitor class.
Oral lead-in: 25 mg rilpivirine + 30 mg cabotegravir tab once daily during mth 1 (at least 28 days) to assess tolerability to rilpivirine & cabotegravir. Every-1-mth IM dosing Initiation inj: 900 mg rilpivirine + 600 mg cabotegravir at mth 2, on the final day of oral lead-in therapy. Continuation inj: 600 mg rilpivirine + 400 mg cabotegravir mthly at mth 3 onwards. Patients may be given inj up to 7 days before or after the date of mthly inj schedule. Every-2-mth IM dosing Initiation inj: 900 mg rilpivirine + 600 mg cabotegravir mthly at mth 2 (on the final day of oral lead-in therapy) & mth 3. Continuation inj: 900 mg rilpivirine + 600 mg cabotegravir every 2 mth beginning at mth 5 onwards. Patients may be given inj up to 7 days before or after the date of the every-2-mth inj schedule. Switching from every-1-mth to every-2-mth IM dosing Single 900 mg inj 1 mth after the last 600 mg continuation inj & then 900 mg every 2 mth thereafter. Switching from every-2-mth to every-1-mth IM dosing Single 600 mg inj 2 mth after the last 900 mg continuation inj & then 600 mg mthly thereafter.
Avoid inadvertent inj into a blood vessel. Always co-administer w/ cabotegravir inj at separate gluteal inj sites. Adopt an alternative, fully suppressive antiretroviral regimen no later than 1 mth after the last every-1-mth inj or 2 mth after the last every-2-mth inj to minimise the risk of developing viral resistance following treatment discontinuation. May remain in systemic circulation for prolonged periods (up to 4 yr in some patients) after treatment discontinuation. Take into account the baseline factors associated w/ increased risk of virological failure (archived rilpivirine resistance mutations, HIV-1 subtype A6/A1 or BMI ≥30 kg/m2) before starting the regimen. Not recommended to initiate in patients w/ hepatitis B co-infection. Monitoring of liver function is recommended in patients w/ hepatitis C co-infection. Risk of immune reactivation syndrome; opportunistic infections; residual risk of HIV transmission. Observe patients briefly (approx 10 min) after the inj. Caution w/ co-administration of a medicinal product w/ known risk of torsade de pointes. Do not administer w/ other antiretroviral medicinal products, except cabotegravir inj. Contains <1 mmol Na (23 mg) per inj (essentially Na-free). May impair ability to drive or operate machinery. Patients w/ severe renal impairment or end-stage renal disease; moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment. Pregnancy. Do not breast-feed. Childn & adolescents <18 yr.
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