Formulary
Darunavir: Indications, Dosing, Side Effects and Interactions
Darunavir clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 5 min read
Darunavir: Indications, Dosing, Side Effects and Interactions
Darunavir clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy-with low-dose ritonavir**
- **Adult** (By Mouth): 600 mg twice daily, alternatively 800 mg once daily, once daily dose only to be used if no resistance to darunavir, if plasma HIV-RNA concentration less than 100 000 copies/mL, and if CD4 cell count greater than 100 cells10 6 / litre.
**HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy-with cobicistat**
- **Adult** (By Mouth): 800 mg once daily, dose appropriate if no resistance to darunavir, if plasma HIV-RNA concentration less than 100 000 copies/mL, and if CD4 cell count greater than 100 cells 10 6 /litre.
**HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy-with low-dose ritonavir**
- **Adult** (By Mouth): 800 mg once daily.
**HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy-with cobicistat**
- **Adult** (By Mouth): 800 mg once daily.
**HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy-with low-dose ritonavir for darunavir**
- **Child 3-17 years (body-weight 15-29 kg)** (By mouth): 375 mg twice daily.
- **Child 3-17 years (body-weight 30-39 kg)** (By mouth): 450 mg twice daily.
- **Child 3-17 years (body-weight 40 kg and above)** (By mouth): 600 mg twice daily.
- **Child 12-17 years** (By mouth): 800 mg once daily, once daily dose only to be used if no resistance to darunavir, if plasma HIV-RNA concentration less than 100 000 copies/mL, and if CD4 cell count greater than 100 cells106/ litre.
**HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy-with cobicistat for darunavir**
- **Child 12-17 years (body-weight 40 kg and above)** (By mouth): 800 mg once daily, dose appropriate if no resistance to darunavir, if plasma HIV-RNA concentration less than 100 000 copies/mL, and if CD4 cell count greater than 100 cells 106/litre.
**HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy-with low-dose ritonavir for darunavir**
- **Child 12-17 years (body-weight 40 kg and above)** (By mouth): 800 mg once daily.
**HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy-with cobicistat for darunavir**
- **Child 12-17 years (body-weight 40 kg and above)** (By mouth): 800 mg once daily.
Cautions
For all protease inhibitors Haemophilia (increased risk of bleeding)
Contraindications
For all protease inhibitors Acute porphyrias
Side effects
For all protease inhibitors Common or very common Angioedema; anxiety; appetite abnormal; arthralgia; asthenia; diabetes mellitus; diarrhoea; dizziness; dyslipidaemia; fever; gastrointestinal discomfort; gastrointestinal disorders; headache; hepatic disorders; hypersensitivity; hypertension; myalgia; nausea; oral ulceration; pancreatitis; peripheral neuropathy; seizure; skin reactions; sleep disorders; syncope; taste altered; urinary frequency increased; vomiting Uncommon Alopecia; dry mouth; immune reconstitution inflammatory syndrome; myocardial infarction; osteonecrosis; weight increased Rare or very rare Stevens-Johnson syndrome Side-effects For darunavir Uncommon Anaemia; angina pectoris; arrhythmias; burping; chest pain; concentration impaired; confusion; constipation; cough; depression; drowsiness; dry eye; dyspnoea; eye erythema; feeling hot; flushing; gout; gynaecomastia; haemorrhage; herpes simplex; hyperglycaemia; hypothyroidism; leucopenia; malaise; memory loss; mood altered; muscle spasms; muscle weakness; nail discolouration; nephrolithiasis; neutropenia; oral disorders; osteoporosis; pain; peripheral oedema; polydipsia; QT interval prolongation; renal impairment; sensation abnormal; sexual dysfunction; sweat changes; throat irritation; thrombocytopenia; urinary disorders; urine abnormalities; vertigo Rare or very rare Arthritis; chills; feeling abnormal; joint stiffness; musculoskeletal stiffness; palpitations; rhinorrhoea; severe cutaneous adverse reactions (SCARs); visual impairment Side-effects, further information Mild to moderate rash occurs commonly, usually within the first 4 weeks of therapy and resolves without stopping treatment. Severe skin rash (including Stevens-Johnson syndrome and toxic epidermal necrolysis) occurs less frequently and may be accompanied by fever, malaise, arthralgia, myalgia, oral lesions, conjunctivitis, hepatitis, or eosinophilia; treatment should be stopped if this develops.
Interactions
**Severe interactions:**
- CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone) Fluticasone: in a clinical study where...
**Other interactions (177):**
- The interaction profile of darunavir may differ depending on whether ritonavir or cobicistat is used as pharmacoenhancer.
- The recommendations given for concomitant use of darunavir and other medicinal products may therefore differ depending on whether darunavir is boosted with ritonavir or cobicistat (see sections 4.3...
- Medicinal products that affect darunavir exposure (ritonavir as pharmacoenhancer) Darunavir and ritonavir are metabolised by CYP3A.
- Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of these compounds and consequently...
- Co-administration of darunavir and ritonavir with other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir, which may result in increased plasma...
- Co-administration with strong CYP3A4 inhibitors is not recommended and caution is warranted, these interactions are described in the interaction table below (e.g.
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk; if required, use the twice daily dose regimen. For use with cobicistat, see darunavir with cobicistat or darunavir with cobicistat, emtricitabine and tenofovir alafenamide .
Hepatic impairment
For all protease inhibitors In general, manufacturers advise use with caution in patients with chronic hepatitis B or C (increased risk of hepatic side-effects). Hepatic impairment For darunavir Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).
Medicinal forms
Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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