Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term 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) for:
Vocabria should be prescribed by physicians experienced in the management of HIV infection.
Vocabria tablets are indicated for the short-term treatment of HIV in combination with rilpivirine tablets, therefore, the prescribing information for rilpivirine tablets should be consulted for recommended dosing.
Prior to starting Vocabria, healthcare professionals should carefully select patients who agree to the required monthly 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 (see section 4.4).
The healthcare provider and patient may decide to use Vocabria tablets as an oral lead-in prior to the initiation of cabotegravir injection to assess tolerability to cabotegravir (see Table 1) or may proceed directly to cabotegravir injections (see cabotegravir injection SmPC).
Prior to the initiation of cabotegravir injection, Vocabria tablets together with rilpivirine tablets should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir and rilpivirine (see section 4.4). One Vocabria 30 mg tablet should be taken with one rilpivirine 25 mg tablet, once daily.
Table 1. Recommended Dosing Schedule in Adult Patients:
| ORAL LEAD IN | |
| Medicinal Product | During month 1 |
| Vocabria | 30 mg once daily |
| Rilpivirine | 25 mg once daily |
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy (one Vocabria 30 mg tablet and one rilpivirine 25 mg tablet once daily) may be used to replace up to 2 consecutive monthly injection visits or one, every 2 month injection visit. For oral therapy durations greater than two months, an alternative oral regimen is recommended.
The first dose of oral therapy should be taken one month ( +/ - 7 days) after the last injection doses of cabotegravir and rilpivirine for patients being given monthly injections. For patients being given every 2-month injections, the first dose of oral therapy should be taken 2 months ( +/ - 7 days) after the last injection doses of cabotegravir and rilpivirine. Injection dosing should be resumed on the day oral dosing completes.
If the patient misses a dose of Vocabria tablets, the patient should take the missed dose as soon as possible, providing the next dose is not due within 12 hours. If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking Vocabria tablets, another Vocabria tablet should be taken. If a patient vomits more than 4 hours after taking Vocabria tablets, the patient does not need to take another dose of Vocabria until the next regular scheduled dose.
No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over (see section 5.2).
No dosage adjustment is required in patients with mild to severe renal impairment (CrCL <30 mL/min and not on dialysis [see section 5.2]). Cabotegravir has not been studied in patients with end-stage renal disease on renal replacement therapy. As cabotegravir is greater than 99% protein bound, dialysis is not expected to alter exposures of cabotegravir. If administered in a patient on renal replacement therapy, cabotegravir should be used with caution.
No dosage adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). Cabotegravir has not been studied in patients with severe hepatic impairment (ChildPugh score C [see section 5.2]). If administered in a patient with severe hepatic impairment, cabotegravir should be used with caution.
The safety and efficacy of Vocabria in children and adolescents aged under 18 years have not been established. No data is available.
Oral use.
Vocabria tablets may be taken with or without food. When taken at the same time as rilpivirine tablets, Vocabria tablets should be taken with a meal.
There is no specific treatment for Vocabria overdose. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Cabotegravir is known to be highly protein bound in plasma; therefore, dialysis is unlikely to be helpful in removal of medicinal product from the body.
3 years.
This medicinal product does not require any special storage conditions.
White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner. Each bottle contains 30 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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