Cobicistat oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of cobicistat.
Drugs List
Therapeutic Indications
Uses
Antiretroviral combination therapy-HIV infected adults and children over 12
Cobicistat is indicated as a pharmacokinetic enhancer of atazanavir or darunavir as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older.
Dosage
Cobicistat is used in combination with atazanavir 300mg once daily or darunavir 800mg once daily, therefore the atazanavir or darunavir Summary of Product Characteristics should be consulted.
Adults
150mg once daily.
Children
Children aged 12-18 years old weighing 35kg and over:
150mg once daily.
Patients with Renal Impairment
No dose adjustment required.
Cobicistat should not be initiated in patients with creatinine clearance less than 70ml/minute if any co-administered agent requires dose adjustment based on creatinine clearance. Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Dialysis patients
Cobicistat has not been studied in patients receiving dialysis, and, therefore no recommendation can be made.
Additional Dosage Information
Missed dose
If the patient misses a dose of cobicistat within 12 hours of the time it is usually taken, they should take cobicistat with food as soon as possible and resume normal dosing schedule in combination with atazanavir or darunavir. If a patient misses a dose of cobicistat by more than 12 hours, they should not take the missed dose and simply resume the usual dosing schedule.
Contraindications
Children under 12 years
Children weighing less than 35kg
Breastfeeding
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Renal dialysis
Switch to more suitable alternative before planned pregnancy
Treatment does not prevent risk of transmission of HIV
HIV therapy: Must be used in combination with other antiretrovirals
Treatment should be initiated by doctor experienced in HIV management
Contains sunset yellow (E110) - may cause allergic reaction
Advise patient to take with or after food
Advise patient to seek advice at first indications of pregnancy
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Female: Barrier or non-hormonal contraception advised during treatment
Pregnancy and Lactation
Pregnancy
Cobicistat is contraindicated during pregnancy.
The manufacturer does not recommend cobicistat treatment to be initiated during pregnancy and women who become pregnant during therapy with this product should be switched to an alternative regimen.
Treatment with cobicistat in combination with elvitegravir or darunavir during second and third trimester of pregnancy has shown to substantially lower elvitegravir or darunavir exposure respectively, which may result in virological failure and increase the risk of transmission of HIV from the mother to infant.
Animal studies do not indicate direct or indirect harmful effects of cobicistat with respect to reproductive toxicity.
Lactation
Cobicistat is contraindicated in breastfeeding.
It is unknown whether cobicistat/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of cobicistat/metabolites in milk.
A risk to the newborns/infants cannot be excluded. Therefore, cobicistat should not be used during breastfeeding.
In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breastfeed their infants under any circumstances.
Side Effects
Abdominal distension
Abdominal pain
Asthenia
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dysgeusia
Dyspepsia
Fatigue
Flatulence
Haematuria
Headache
Hyperbilirubinaemia
Hyperglycaemia
Increased appetite
Insomnia
Jaundice
Myalgia
Nausea
Nephrolithiasis
Proteinuria
Pruritus
Pyrexia
Rash
Scleral icterus
Sleep disturbances
Somnolence
Vomiting
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: June 2019
Reference Sources
Summary of Product Characteristics: Tybost 150mg film-coated tablet. Gilead Science Ltd. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 October 2021
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.