Rekambys Dosage/Direction for Use

Therapy should be prescribed by a physician experienced in the management of HIV infection. Each injection should be administered by a healthcare professional.
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.
Following discontinuation of REKAMBYS in combination with cabotegravir injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of REKAMBYS or two months after the last every 2 months injection of REKAMBYS (see Precautions).
The prescribing information for cabotegravir injection should be consulted for recommended dosing.
Posology: Oral lead-in: Prior to the initiation of REKAMBYS, rilpivirine oral tablets, together with cabotegravir oral tablets, should be taken for approximately 1 month (at least 28 days) to assess tolerability to rilpivirine and cabotegravir (see Precautions). One rilpivirine 25-mg tablet should be taken with a meal with one cabotegravir 30-mg tablet once daily.
Every 1 month dosing: Initiation injection (900 mg corresponding to 3 mL): On the final day of oral lead-in, the recommended initiation injection dose of rilpivirine in adults is a single 900 mg intramuscular injection.
Continuation injection (600 mg corresponding to 2 mL): After the initiation injection, the recommended continuation injection dose of rilpivirine in adults is a single 600 mg monthly intramuscular injection. Patients may be given injections up to 7 days before or after the date of the monthly injection schedule. (See Table 7.)

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Every 2 months dosing: Initiation Injections - 1 month apart (900 mg corresponding to 3 mL): On the final day of oral lead-in, the recommended initial rilpivirine injection dose in adults is a single 900 mg intramuscular injection (month 2).
One month later (month 3), a second 900 mg intramuscular injection should be administered. Patients may be given the second 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): After the initiation injections, the recommended rilpivirine continuation injection dose in adults is a single 900 mg intramuscular injection administered every 2 months beginning at month 5. Patients may be given injections up to 7 days before or after the date of the every 2 months injection schedule. (See Table 8.)

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Dosing Recommendations 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 900 mg intramuscular injection of REKAMBYS one month after the last 600 mg REKAMBYS continuation injection dose and then 900 mg every 2 months thereafter.
Dosing Recommendations 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 600 mg intramuscular injection of REKAMBYS two months after the last 900 mg REKAMBYS continuation injection dose and then 600 mg monthly thereafter.
Missed doses: Patients who miss an injection visit should be clinically reassessed to ensure resumption of therapy is appropriate. See Tables 9 and 10 for dosing recommendations after a missed injection.
Missed every 1 month injection (Oral Dosing to Replace Up to 2 Consecutive Monthly Injections): If a patient plans to miss a scheduled injection by more than 7 days, daily oral therapy (one rilpivirine tablet [25 mg] and one cabotegravir tablet [30 mg]) may be used to replace up to 2 consecutive monthly injection visits. The first dose of oral therapy should be taken 1 month (±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 9.
In case more than two months need to be covered for, ie, missing more than two monthly injections, an alternative oral regimen should be initiated one month (±7 days) after the final injection of REKAMBYS. (See Table 9.)

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Missed every 2 months injection (Oral Dosing to Replace 1 Every 2 Months Injection): If a patient plans to miss a scheduled injection visit by more than 7 days, daily oral therapy (one rilpivirine tablet [25 mg] and one cabotegravir tablet [30 mg]) may be used to replace one 'every 2 months' injection visit. The first dose of oral therapy should be taken approximately two 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 10.
In case more than two months need to be covered for, ie, missing more than one 'every 2 months' injection, an alternative oral regimen should be initiated two months (±7 days) after the final injection of REKAMBYS. (See Table 10.)

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Special populations: Elderly: There is limited information regarding the use of REKAMBYS in patients >65 years of age. No dose adjustment of REKAMBYS is required in older patients (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild or 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 <50 mL/min/1.73 m² 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 Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment 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. No data are available in patients with severe hepatic impairment (Child-Pugh score C); therefore REKAMBYS is not recommended in these patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of REKAMBYS in children and adolescents aged <18 years have not been established. No data are available.
Method of administration: For intramuscular use.
Care should be taken to avoid inadvertent injection of REKAMBYS into a blood vessel.
REKAMBYS should be administered by a healthcare professional. For instructions on administration, see Cautions for Usage.
REKAMBYS should always be co-administered with a cabotegravir injection. REKAMBYS and cabotegravir injections should be administered at separate gluteal injection sites during the same visit. The order of injections is not important.
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.
The vial should be held firmly and shaken vigorously for a full 10 seconds. The vial should be inverted and the resuspension should be checked. It should look uniform. If the suspension is not uniform, the vial should be shaken again. It is normal to see small air bubbles.
Injections must be administered to the ventrogluteal (recommended) or the dorsogluteal sites.