Drugs List

Therapeutic Indications

Uses

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.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
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
Glucose-galactose malabsorption syndrome
Hepatitis C
HIV infection with A6 or A1 subtype
Lactose intolerance
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 lactose
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

Pregnancy

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.

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.

Side Effects

Abdominal pain
Anxiety
Asthenia
Autoimmune disorders
Autoimmune hepatitis
Depression
Diarrhoea
Dizziness
Dream abnormalities
Fatigue
Flatulence
Graves' disease
Headache
Hepatotoxicity
Hypersensitivity reactions
Increase in serum transaminases
Insomnia
Malaise
Myalgia
Nausea
Opportunistic infections
Pyrexia
Rash
Serum bilirubin increased
Somnolence
Vomiting
Weight gain

Presentation

Oral formulation of cabotegravir.

Drugs List

Therapeutic Indications

Uses

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.

Dosage

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.

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia
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
Glucose-galactose malabsorption syndrome
Hepatitis C
HIV infection with A6 or A1 subtype
Lactose intolerance
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 lactose
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

Pregnancy

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.

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.

Side Effects

Abdominal pain
Anxiety
Asthenia
Autoimmune disorders
Autoimmune hepatitis
Depression
Diarrhoea
Dizziness
Dream abnormalities
Fatigue
Flatulence
Graves' disease
Headache
Hepatotoxicity
Hypersensitivity reactions
Increase in serum transaminases
Insomnia
Malaise
Myalgia
Nausea
Opportunistic infections
Pyrexia
Rash
Serum bilirubin increased
Somnolence
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 30mg film-coated tablets. ViiV Healthcare UK Limited. Revised June 2021.