Cabotegravir parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of cabotegravir.
Drugs List
Therapeutic Indications
Uses
HIV infection in adults- in combination with other antiretrovirals
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.
Dosage
Cabotegravir injections are indicated for the treatment of HIV-1 in combination with rilpivirine injections, therefore, the prescribing information for rilpivirine injection 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.
Adults
Oral lead in
Prior to starting cabotegravir injection, oral cabotegravir in combination with oral rilpivirine should be taken for approximately one month (at least 28 days) to assess tolerability to cabotegravir and rilpivirine.
Monthly dosing
Initiation injection (600mg corresponding to 3ml dose)
On the final day of oral lead in therapy, the recommended initial dose of cabotegravir injection in adults is a single 600mg intramuscular injection.
Continuation injection (400mg corresponding to 2ml dose)
Single 400mg monthly intramuscular injection.
Patients may be given injections up to 7 days before or after the date of the monthly 400mg injection schedule.
Every two month dosing
Initiation injections (one month apart - 600mg)
On the final day of oral lead in therapy, the recommended initial dose of cabotegravir injection in adults is a single 600mg intramuscular injection (month 2).
One month later (month 3), a second cabotegravir 600mg intramuscular injection should be administered. Patients may be given the second 600mg initiation injection up to 7 days before or after the scheduled dosing date.
Continuation injections (two months apart - 600mg)
Single 600mg intramuscular injection (month 5) administered every two months.
Patients may be given injections up to 7 days before or after the date of the every two month, 600mg injection schedule.
Additional Dosage Information
Switching from monthly to every two month injections
Patients should receive a single 600mg intramuscular injection of cabotegravir one month after the last 400mg continuation injection dose and then 600mg every two months thereafter.
Switching from every two month to monthly injections
Patients should receive a single 400mg intramuscular injection of cabotegravir two months after the last 600mg continuation injection dose and then 400mg monthly thereafter.
Missed doses
Missed monthly injections
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy may be used to replace 2 consecutive monthly injection visits. 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. Injection dosing should be resumed on the day oral dosing completes.
Missed two month injections
If a patient plans to miss a scheduled injection visit by more than 7 days, oral therapy may be used to replace one, two-monthly injection visits. For oral therapy durations greater than two months, an alternative oral regimen is recommended. The first dose of oral therapy should be taken two months (+/- 7 days) after the last injection doses of cabotegravir and rilpivirine. Injection dosing should be resumed on the day oral dosing completes.
Discontinuation
After discontinuation of cabotegravir and rilpivirine injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of cabotegravir when dosed monthly and no later than two months after the final injection of cabotegravir when dosed every two months.
Administration
For intramuscular use only.
Injections should be administered to the ventrogluteal (recommended) or the dorsogluteal sites.
Cabotegravir injection should always be co-administered with rilpivirine injection. The order of injections is not important. Cabotegravir and rilpivirine should be administered at separate gluteal injection sites at the same visit. Care should be taken to avoid inadvertent injection into a blood vessel. Body Mass Index (BMI) of a patient should be taken into consideration to ensure that the needle length is sufficient to reach the gluteus muscle.
Contraindications
Children under 18 years
Breastfeeding
Hepatitis B
Pregnancy
Precautions and Warnings
Obese patients with a BMI equal or greater than 30kg/m2
Patients over 65 years
End stage renal disease
Hepatitis C
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
Contains polysorbate
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
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
Pregnancy
Cabotegravir is contraindicated during pregnancy.
The manufacturer advises that cabotegravir is 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 has been detected in systemic circulation for up to 12 months or longer after an injection.
Lactation
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. Cabotegravir may be present in human milk for up to 12 months or longer after the last injection.
Side Effects
Abdominal pain
Abscess (intramuscular injection site)
Anxiety
Asthenia
Autoimmune disorders
Autoimmune hepatitis
Bruising at injection site
Cellulitis (injection site)
Depression
Diarrhoea
Discolouration (injection site)
Dizziness
Dream abnormalities
Erythema at injection site
Fatigue
Flatulence
Graves' disease
Haematoma (injection site)
Haemorrhage (injection site)
Headache
Hepatotoxicity
Hypersensitivity reactions
Increase in serum transaminases
Induration (injection site)
Insomnia
Local pain (intramuscular injection site)
Localised areas of anaesthesia
Malaise
Myalgia
Nausea
Nodules (injection site)
Opportunistic infections
Pruritus
Pyrexia
Rash
Serum bilirubin increased
Somnolence
Swelling (injection site)
Vomiting
Weight gain
Overdosage
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 ).
Further Information
Last Full Review Date: November 2021
Reference Sources
Summary of Product Characteristics: Vocabria 600mg prolonged-release suspension for injection. ViiV Healthcare UK Limited. Revised June 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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