Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 sections 4.2, 4.4 and 5.1).
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 section 4.4).
The prescribing information for cabotegravir injection should be consulted for recommended dosing.
REKAMBYS may be initiated with oral lead-in or without (direct to injection).
The healthcare professional and patient may decide to use rilpivirine tablets as an oral lead-in prior to the initiation of REKAMBYS injections to assess tolerability (see Table 1), or proceed directly to REKAMBYS therapy (see Tables 2 and 3, for monthly and every 2 months dosing recommendations, respectively).
When used for 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. One rilpivirine 25-mg tablet should be taken with a meal with one cabotegravir 30-mg tablet once daily (see Table 1).
Table 1. Oral Lead-in Dosing Schedule in Adults:
| Oral Lead-In | |
| Drug | For one month (at least 28 days), followed by the Initiation Injectiona |
| Rilpivirine | 25 mg once daily with a meal |
| Cabotegravir | 30 mg once daily |
a see Table 2 for monthly injection dosing schedule and Table 3 for every 2 months injection dosing schedule.
On the final day of current antiretroviral therapy or oral lead-in, the recommended initiation injection dose of rilpivirine in adults is a single 900 mg intramuscular injection.
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.
Table 2. Recommended monthly intramuscular injection dosing schedule in adult patients:
| Medicinal Product | Initiation injection | Continuation injections |
| Initiate injection on the last day of either current ART therapy or oral lead-in (if used) | One month after initiation injection and monthly onwards | |
| Rilpivirine | 900 mg | 600 mg |
| Cabotegravir | 600 mg | 400 mg |
On the final day of current antiretroviral therapy or oral lead-in, the recommended initial rilpivirine injection dose in adults is a single 900 mg intramuscular injection.
One month later, 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.
After the initiation injections, the recommended rilpivirine continuation injection dose in adults is a single 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 injection schedule.
Table 3. Recommended every 2 months intramuscular injection dosing schedule in adult patients:
| Initiation injections | Continuation injections | |
| Medicinal Product | Initiate injection on the last day of either current ART therapy or oral lead-in (if used). One month later, a second initiation injection should be administered. | Two months after last initiation injection and every 2 months onwards |
| Rilpivirine | 900 mg | 900 mg |
| Cabotegravir | 600 mg | 600 mg |
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.
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.
Patients who miss an injection visit should be clinically reassessed to ensure resumption of therapy is appropriate. See Table 4 and 5 for dosing recommendations after a missed injection.
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. Limited data is available on oral bridging with other fully suppressive antiretroviral therapy (ART) (mainly INI-based), see section 5.1.
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 4.
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.
Table 4. REKAMBYS dosing recommendations after missed injections or oral therapy for patients on monthly injection dosing:
| Time since last injection | Recommendation |
| ≤2 months: | Continue with the monthly 600 mg injection schedule as soon as possible. |
| >2 months: | Re-initiate the patient on the 900 mg dose, and then continue to follow the monthly 600 mg injection schedule. |
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. Limited data is available on oral bridging with other fully suppressive ART (mainly INI-based), see section 5.1.
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 5.
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.
Table 5. REKAMBYS dosing recommendations after missed injections or oral therapy for patients on every 2 months injection dosing:
| Missed Injection Visit | Time since last injection | Recommendation (all injections are 3 mL) |
| Injection 2 | ≤2 months | Continue with the 900 mg injection as soon as possible and continue with every 2 months injection schedule. |
| >2 months | Re-initiate the patient on the 900 mg dose, followed by a second 900 mg initiation injection one month later. Then follow the every 2 months injection schedule. | |
| Injection 3 or later | ≤3 months | Continue with the 900 mg injection as soon as possible and continue with every 2 months injection schedule. |
| >3 months | Re-initiate the patient on the 900 mg dose, followed by a second 900 mg initiation injection one month later. Then follow the every 2 months injection schedule. |
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 sections 5.1 and 5.2).
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 section 5.2).
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 section 5.2).
The safety and efficacy of REKAMBYS in children and adolescents aged <18 years have not been established. No data are available.
For intramuscular use.
Care should be taken to avoid inadvertent injection of REKAMBYS into a blood vessel. The suspension should be injected slowly (see section 4.4).
Prior to administration, the REKAMBYS vial should be brought to room temperature.
REKAMBYS should be administered by a healthcare professional. For instructions on administration, see “Instructions for Use” in the package leaflet.
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 pack contains 1 injection needle (see section 6.5).
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.
There is currently limited experience with REKAMBYS overdose. If overdose occurs, the patient should be treated supportively and as clinically indicated, with monitoring of vital signs and ECG (QT interval), as necessary. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
3 years.
Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C.
Once the suspension has been drawn into the syringe, the injection should be administered as soon as possible, but may remain in the syringe for up to 2 hours. If 2 hours are exceeded, the medicine, syringe, and needle must be discarded.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Prior to administration, the vial should be brought to room temperature (not to exceed 25°C). The vial may remain in the carton at room temperature for up to 6 hours. If not used after 6 hours, it must be discarded (refer to section 6.3).
Type I glass vial.
600 mg pack: Each pack contains one clear 4-mL glass vial, with a butyl elastomer stopper and an aluminium overseal with a plastic flip-off button, 1 syringe (0.2 mL graduation), 1 vial adaptor and 1 needle for injection (23 gauge, 1½ inch).
900 mg pack: Each pack contains one clear 4-mL glass vial, with a butyl elastomer stopper and an aluminium overseal with a plastic flip-off button, 1 syringe (0.2 mL graduation), 1 vial adaptor and 1 needle for injection (23 gauge, 1½ inch).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Full instructions for use and handling of REKAMBYS are provided in the package leaflet (see Instructions for Use).
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