- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of cabotegravir.
HIV infection in adults- in combination with other antiretrovirals
Short-term treatment, in combination with rilpivirine tablets, of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 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 for:
Oral lead in to assess tolerability of cabotegravir and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection.
Oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.
Cabotegravir 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.
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.
Oral lead in
Cabotegravir tablets with rilpivirine tablets should be taken for approximately one month (at least 28 days) prior to initiation of cabotegravir injection to assess tolerability.
One cabotegravir tablet should be taken with one rilpivirine 25mg tablet, once daily.
Oral dosing for missed injections of cabotegravir
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy 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 been 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.
Injection dosing should be resumed on the day oral dosing completes.
Additional Dosage Information
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 cabotegravir tablets, another cabotegravir tablet should be taken.
Children under 18 years
Precautions and Warnings
Obese patients with a BMI equal or greater than 30kg/m2
Patients over 65 years
End stage renal disease
Glucose-galactose malabsorption syndrome
HIV infection with A6 or A1 subtype
Severe hepatic impairment
Treatment does not prevent risk of transmission of HIV
Advise ability to drive/operate machinery may be affected by side effects
HIV therapy: Must be used in combination with other antiretrovirals
Treatment should be initiated by doctor experienced in HIV management
Autoimmune disorders can occur many months after initiation of treatment
Monitor hepatic enzymes
Discontinue immediately following signs of acute hepatotoxicity
Inflammatory symptoms should be evaluated and treated appropriately
May develop immune reactivation syndrome
Risk of developing opportunistic infections
Discontinue if hypersensitivity reactions occur
Take another dose if vomiting occurs within 4 hours
Cabotegravir has not been studied in patients with end-stage renal disease on renal replacement therapy. Since cabotegravir is greater than 99% protein bound, dialysis is not expected to modify exposures of cabotegravir. If administration is required to a patient on renal replacement therapy, cabotegravir should be used with caution.
Prior to starting treatment, it should be taken into account that multivariable analyses indicated that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI equal or greater than 30kg/metres squared.
Limited data is available in patients with hepatitis C co-infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.
Typically, immune reactivation syndrome reactions have been observed within the first few weeks or months of initiation of the antiretroviral treatment. For example, cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been observed, however, the reported time to onset is more variable and these reactions can occur many months after initiation of treatment.
Pregnancy and Lactation
Cabotegravir is contraindicated during pregnancy.
The manufacturer advises that cabotegravir tablets are not recommended during pregnancy unless the expected benefit justifies the potential risk to the foetus. There is a limited amount of data from the use of cabotegravir in pregnancy, the effect on human pregnancy is unknown. Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but, exposures higher than the therapeutic dose showed reproductive toxicity in animals.
Cabotegravir is contraindicated during breastfeeding.
The manufacturer recommends that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV. It is expected that cabotegravir will be excreted into human breast milk based on animal data, although this has not been confirmed in humans.
Increase in serum transaminases
Serum bilirubin increased
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2021
Summary of Product Characteristics: Vocabria 30mg film-coated tablets. ViiV Healthcare UK Limited. Revised June 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.