(darunavir · DailyMed)
DARUNAVIR+COBICISTAT 800/150MG TABLET
DARUNAVIR+COBICISTAT
What it does
Cobicistat is a medication that helps boost the effectiveness of certain other drugs used to treat viral infections, particularly HIV.
Commonly used for: human immunodeficiency virus (HIV), viral infections
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.
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Sourcing - Kenya onlyRegistration & product details
Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:41 · updated 2026-09-29 04:33:05
Drug Interactions
231Severe (29)
Acalabrutinib - increases exposure
Cobicistat is predicted to increase the exposure to acalabrutinib. Avoid.
Antifungals,azoles - affects exposure
Cobicistat is predicted to affect the exposure to antifungals, azoles (voriconazole). Avoid.
Antihistamines,non-Sedating - increases exposure
Cobicistat is predicted to increase the exposure to antihistamines, non-sedating (mizolastine). Avoid.
Antipsychotics, Second Generation - increases exposure
Cobicistat is predicted to increase the exposure to antipsychotics, second generation (lurasidone, quetiapine). Avoid.
Benzodiazepines - increases exposure
Cobicistat moderately increases the exposure to benzodiazepines (alprazolam). Avoid.
Moderate (49)
Alfentanil - increases exposure
Cobicistat is predicted to increase the exposure to opioids (alfentanil, buprenorphine, fentanyl, oxycodone). Monitor and adjust dose.
Alfuzosin - increases exposure
Cobicistat is predicted to moderately increase the exposure to alpha blockers (alfuzosin, tamsulosin). Use with caution or avoid.
Alphablockers - increases exposure
Cobicistat is predicted to moderately increase the exposure to alpha blockers (alfuzosin, tamsulosin). Use with caution or avoid.
Amlodipine - increases exposure
Cobicistat is predicted to increase the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.
Antiarrhythmics - increases exposure
Cobicistat is predicted to increase the exposure to antiarrhythmics (propafenone). Monitor and adjust dose.
Unknown (153)
Abemaciclib - increases exposure
Cobicistat is predicted to increase the exposure to abemaciclib. Avoid or adjust abemaciclib dose, p. 1056.
Alitretinoin - increases exposure
Cobicistat is predicted to increase the exposure to retinoids (alitretinoin). Adjust alitretinoin dose, p. 1382.
Almotriptan - increases exposure
Cobicistat increases the exposure to triptans (almotriptan).
Alprazolam - increases exposure
Cobicistatmoderatelyincreasestheexposuretoalprazolam. Avoid.oStudy
Amiodarone - increases concentration
Cobicistat potentially increases the concentration of antiarrhythmics (amiodarone, disopyramide, flecainide, lidocaine).
Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact
About cobicistat
Cobicistat is a medication that helps boost the effectiveness of certain other drugs used to treat viral infections, particularly HIV.
What it treats
- human immunodeficiency virus (HIV)
- viral infections
How it works
Cobicistat works by increasing the levels of other medications in the body, making them more effective in fighting infections.
Who it's for
Cobicistat is for people who are being treated for HIV and need additional support from other medications.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
About darunavir
Darunavir is an antiviral medicine used to treat HIV infection.
What it treats
- HIV infection
- human immunodeficiency virus (HIV)
How it works
It helps to control the virus, allowing the immune system to work better.
Who it's for
This medicine is for people living with HIV.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Cobicistat
BNF-referencedCobicistat is a pharmacokinetic enhancer that is used to boost the effectiveness of certain antiretroviral medications, specifically atazanavir and darunavir. It is not an antiviral drug itself and does not possess any direct activity against HIV. By inhibiting the cytochrome P450 3A (CYP3A) isoforms, cobicistat increases the systemic concentration of co-administered CYP3A substrates, allowing for effective viral suppression at lower doses of these drugs.
Indications
- HIV infection resistant to other protease inhibitors
- Pharmacokinetic enhancement of atazanavir
- Pharmacokinetic enhancement of darunavir
Dosage
Children: Refer to BNF for Children for appropriate paediatric dosing.
Adults: 150 mg once daily by mouth.
Mechanism of action
Cobicistat acts as a mechanism-based inhibitor of cytochrome P450 3A (CYP3A) isoforms. This inhibition reduces the metabolism of CYP3A substrates, such as atazanavir and darunavir, leading to increased systemic exposure and enhanced antiviral effects at lower dosages. It is important to note that cobicistat does not exhibit any intrinsic anti-HIV activity.
Pharmacodynamics
The pharmacodynamic profile of cobicistat is primarily characterized by its ability to enhance the plasma concentrations of certain antiretroviral drugs through CYP3A inhibition. This results in improved efficacy of these drugs while minimizing potential side effects associated with higher doses. Cobicistat's lack of direct antiviral action means it is always used in conjunction with other antiretroviral agents.
Pharmacokinetics
Cobicistat is well absorbed after oral administration, with peak plasma concentrations typically occurring within 1 to 4 hours. It has a high protein binding rate, primarily to albumin and alpha-1 acid glycoprotein. The drug undergoes hepatic metabolism predominantly via CYP3A. The elimination half-life of cobicistat is approximately 3 to 4 hours, and it is excreted mainly in the feces. Monitoring of liver function is recommended due to the potential for hepatotoxicity.
Adverse effects
- Abdominal pain
- Anaemia
- Appetite decreased
- Asthenia
- Depression
- Diarrhoea
- Flatulence
- Headache
- Insomnia
- Nausea
- Rash
Interactions
- cobicistat + acalabrutinib: Severe (increases exposure)
- cobicistat + dronedarone: Severe (increases exposure)
- cobicistat + second-generation antipsychotics: Severe (increases exposure)
- cobicistat + lurasidone: Severe (increases exposure)
- cobicistat + quetiapine: Severe (increases exposure)
- cobicistat + cariprazine: Severe (increases exposure)
- cobicistat + lercanidipine: Severe (increases exposure)
- cobicistat + the active metabolite of clopidogrel: Severe (decreases concentration)
- cobicistat + antiarrhythmics: Severe (increases exposure)
- cobicistat + antifungals, azoles: Severe (affects exposure)
Precautions
- Caution in patients with abnormal liver function tests or signs of liver injury.
- Caution in patients with renal impairment, particularly with eGFR less than 80 mL/minute/1.73 m2.
- Manufacturer advises monitoring liver function before treatment and periodically during treatment.
Pregnancy
Manufacturer advises use only if the potential benefit outweighs the risk, due to toxicity observed in animal studies.
Breast-feeding
Cobicistat is not recommended during breastfeeding due to the potential for adverse effects in nursing infants.
Storage
Store below 30°C. Protect from moisture and light.
Formulations
- Tablets: 150 mg
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Clinical monograph: Darunavir
BNF-referencedDarunavir is a potent HIV protease inhibitor used in the treatment of HIV infection. It is utilized as part of highly active antiretroviral therapy (HAART) and is effective in suppressing viral replication, leading to improved immune function and reduced morbidity and mortality associated with HIV infection. Darunavir is typically administered in combination with other antiretroviral agents to enhance therapeutic efficacy.
Indications
- HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy
- HIV infection in combination with other antiretroviral drugs in treatment-naive patients
Dosage
Children: For children weighing 14-20 kg: 0.5 tablet twice daily; for children weighing 30 kg and above: 1 tablet twice daily. Refer to BNF for Children for detailed dosing guidelines.
Adults: 800 mg once daily or 600 mg twice daily, depending on previous treatment history and viral load.
Mechanism of action
Darunavir functions by binding to the HIV-1 protease enzyme, which is critical for viral protein processing and maturation necessary for HIV replication. By inhibiting the protease, darunavir prevents the cleavage of Gag-Pol proteins in infected cells, thus halting the formation of mature and infectious virions. Its ability to interact with multiple sites on the protease enzyme contributes to its effectiveness, particularly against resistant strains of HIV.
Pharmacodynamics
As a protease inhibitor, darunavir effectively lowers HIV viral load and enhances CD4 cell counts when used in combination with ritonavir and other antiretroviral medications. This mechanism leads to a significant decrease in morbidity and mortality rates in patients with HIV infection, improving overall health outcomes.
Pharmacokinetics
Darunavir is well-absorbed following oral administration. It has a high protein binding rate, primarily to albumin and alpha-1 acid glycoprotein. The drug undergoes hepatic metabolism, primarily via the cytochrome P450 system, particularly CYP3A4, and has a half-life that allows for once or twice daily dosing. The pharmacokinetics may vary based on the presence of food and other medications.
Adverse effects
- rash
- nausea
- diarrhea
- headache
- fatigue
- hepatotoxicity
- gastrointestinal disorders
- depression
- memory loss
- gynaecomastia
- nephrolithiasis
- severe cutaneous adverse reactions (SCARs)
Interactions
- darunavir + cobicistat: increased risk of adverse reactions
- darunavir + ritonavir: synergistic effect on HIV suppression
- darunavir + raltegravir: unknown interaction, increased risk of rash
Precautions
- monitor liver function tests
- watch for signs of severe skin reactions
- caution in patients with a history of drug allergies
- monitor for signs of nephrolithiasis
- consider potential drug interactions with other antiretrovirals
Pregnancy
Darunavir is generally considered safe to use during pregnancy; however, it should be used under the guidance of a healthcare provider as part of a comprehensive antiretroviral therapy plan.
Breast-feeding
Darunavir is excreted in breast milk; the decision to breastfeed while on darunavir should involve a risk-benefit assessment with a healthcare provider.
Storage
Store at room temperature, protect from moisture and light. Keep out of reach of children.
Formulations
- Darunavir oral suspension 100 mg/ml
- Darunavir 400 mg tablets
- Darunavir 600 mg tablets
- Darunavir 800 mg tablets
- Darunavir 75 mg tablets
- Darunavir 150 mg tablets
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Molecular reference: Cobicistat
PubChem CID 25151504Molecular formula: C40H53N7O5S2
Mechanism of action
Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A (CYP3A) isoforms. Inhibition of CYP3A-mediated metabolism by cobicistat increases the systemic exposure of CYP3A substrates atazanavir and darunavir and therefore enables increased anti-viral activity at a lower dosage. Cobicistat does not have any anti-HIV activity on its own.
Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.
Molecular reference: Darunavir
PubChem CID 213039Molecular formula: C27H37N3O7S
Mechanism of action
The HIV-1 protease enzyme is necessary for viral precursor protein processing and viral maturation in preparation for infection, and is therefore a target for antiretroviral therapy for HIV. Protease inhibitors are used as a part of highly active antiretroviral therapy (HAART) in patients diagnosed with HIV infection. It has been shown to effectively suppress the virus, leading to significantly decreased morbidity and mortality rates. Darunavir, a HIV protease inhibitor, prevents HIV replication through binding to the enzyme, stopping the dimerization and the catalytic activity of HIV-1 protease. In particular, it inhibits the cleavage of HIV encoded Gag-Pol proteins in cells that have been infected with the virus, halting the formation of mature virus particles, which spread the infection. The close contact that darunavir makes with the primary chains of the active site amino acids (Asp-29 and Asp-30) on the protease likely contributes to its potency and efficacy against resistant variants of HIV-1. Darunavir is known to bind to different sites on the enzyme: the active site cavity and the surface of one of the flexible flaps in the protease dimer. Darunavir can adapt to changes in the shape of a protease enzyme due to its molecular flexibility. Darunavir as a protease inhibitor inhibits the cleavage of HIV encoded gag-pol polyproteins in virus infected cells, thereby preventing the formation of mature and infectious new virions. It was selected for its potency against wild type HIV-1 and HIV strains resistant to currently approved protease inhibitors. Darunavir is an inhibitor of the HIV-1 protease. It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.
Pharmacodynamics
Darunavir is an inhibitor of the human immunodeficiency virus (HIV) protease, which prevents HIV viral replication. When administered with ritonavir in combination antiretroviral therapy, darunavir significantly decreases viral load and increases CD4 cell counts, decreasing the morbidity and mortality of HIV infection.
Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.
This drug in other countries
The same active ingredient registered across other registries we cover - including different brands.
- DARUNAVIR AND RITONAVIR TABLETS · Unisel
- DARUNAVIR TABLETS 400MG · Dawa
- DARUNAVIR TABLETS 400MG · Unisel
- DARUNAVIR TABLETS 400MG · Laurus Labs Limited
- DARUNAVIR TABLETS 600MG · Dawa
- DARUNAVIR TABLETS 600MG · Unisel
- DARUNAVIR · Cipla
- DARUNAVIR TABLETS 600 MG · Laurus Labs Limited
- DURART 600 · Mylan Laboratories
- Darunavir · Hetero Laboratories
- Darunavir · Laurus Labs Limited
- Darunavir · Laurus Labs Limited
- DARUNAVIR CIPLA 150 CIPLA
- DARUNAVIR CIPLA 400 CIPLA
- DARUNAVIR CIPLA 600 CIPLA
- DARUNAVIR CIPLA 75 CIPLA
- DRINAV 400/50
- DRINAV 800/100
- DARUNAVIR AND RITONAVIR TABLETS · Hetero Labs
- DARUNAVIR AND RITONAVIR TABLETS · Hetero Labs
- DARUNAVIR TABLETS 600 MG · Hetero Labs
- DARUNAVIR)-600 · Cipla
- DARUNAVIR-400 · Cipla
- DURART 600 · Mylan Laboratories
- DURART 600 · Mylan Laboratories
- DURART 800 · Mylan Laboratories
- Darunavir 400mg Tablets · Laurus Labs Ltd
- Darunavir 400mg+ Ritonavir 50mg Tablets · Hetero Labs
- Darunavir 600 tablets · Hetero Labs
- Darunavir 600mg Tablets · Laurus Labs Ltd
- DARUNAVIR · Cipla
- DARUNAVIR · Laurus Labs
- DARUNAVIR · Laurus Labs
- DARUNAVIR · Laurus Labs
- DARUNAVIR AND RITONAVIR TABLETS 800MG/100MG · Hetero Labs
- DARUNAVIR; RITONAVIR · Mylan Laboratories