Individual generic drug information

darunavir

Reference monograph

Part of registered formulation

DARUNAVIR

Reference record: Darunavir
Source: BNF 80 (2020–2021)
Printed source pages: 716
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Darunavir only.

Indications And Dose

HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy—with low-dose ritonavir ▶BY MOUTH Infection ▶Adult: 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 cells6106/ litre HIV infection in combination with other antiretroviral drugs in patients previously treated with antiretroviral therapy—with cobicistat ▶BY MOUTH ▶Adult: 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 6106/litre HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy—with low-dose ritonavir ▶BY MOUTH ▶Adult: 800 mg once daily HIV infection in combination with other antiretroviral drugs in patients not previously treated with antiretroviral therapy—with cobicistat ▶BY MOUTH ▶Adult: 800 mg once daily

Source page 716

Allergy And Cross Sensitivity

Use with caution in patients with sulfonamide sensitivity.

Source page 716

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include strawberry.

Source page 716

Safety

Extracted information for Darunavir only.

Interactions

→Appendix 1: HIV-protease inhibitors

Source page 716

Side Effects

▶Uncommon Angina pectoris. arrhythmias. burping. chest pain. concentration impaired. confusion. constipation. cough. depression. dry eye. eye erythema. feeling hot. ﬂushing. gout. gynaecomastia. haemorrhage. herpes simplex. hyperglycaemia. hypothyroidism. leucopenia. memory loss. mood altered. muscle weakness. myocardial infarction. nail discolouration. nephrolithiasis. 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). syncope. 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.

Source page 716

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 below or darunavir with cobicistat, emtricitabine and tenofovir alafenamide p. 695.

Source page 716

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).

Source page 716

Monitoring Requirements

Monitor liver function before and during treatment.

Source page 716

Dose and formulations

Extracted information for Darunavir only.

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Oral suspension CAUTIONARY AND ADVISORY LABELS 21 ▶Prezista (Janssen-Cilag Ltd) Darunavir (as Darunavir ethanolate) 100 mg per 1 ml Prezista 100mg/ml oral suspension sugar-free | 200 ml P £248.17 Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Darunavir (Non-proprietary) Darunavir (as Darunavir ethanolate) 400 mg Darunavir 400mg tablets | 60 tablet P £297.80 Darunavir (as Darunavir ethanolate) 600 mg Darunavir 600mg tablets | 60 tablet P £402.02 (Hospital only) | 60 tablet P £379.67–£446.70 Darunavir (as Darunavir ethanolate) 800 mg Darunavir 800mg tablets | 30 tablet P £268.02 DT = £268.02 (Hospital only) | 30 tablet P £253.13–£297.80 DT = £268.02 ▶Prezista (Janssen-Cilag Ltd) Darunavir (as Darunavir ethanolate) 75 mg Prezista 75mg tablets | 480 tablet P £446.70 Darunavir (as Darunavir ethanolate) 150 mg Prezista 150mg tablets | 240 tablet P £446.70 Darunavir (as Darunavir ethanolate) 400 mg Prezista 400mg tablets | 60 tablet P £297.80 Darunavir (as Darunavir ethanolate) 600 mg Prezista 600mg tablets | 60 tablet P £446.70 Darunavir (as Darunavir ethanolate) 800 mg Prezista 800mg tablets | 30 tablet P £297.80 DT = £268.02

Source page 716

Clinical care

Extracted information for Darunavir only.

Patient And Carer Advice

Missed doses If a dose is more than 6 hours late on the twice daily regimen (or more than 12 hours late on the once daily regimen), the missed dose should not be taken and the next dose should be taken at the normal time.

Source page 716

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

600 mg twice daily, alternatively 800 mg once

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily, dose appropriate if no

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

darunavir

Reference monograph

Part of registered formulation

DARUNAVIR

Reference record: Darunavir
Source: BNF 80 (2020–2021)
Printed source pages: 716
Age groups indexed: 1

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Darunavir only.

Indications And Dose

Source page 716

Allergy And Cross Sensitivity

Use with caution in patients with sulfonamide sensitivity.

Source page 716

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include strawberry.

Source page 716

Safety

Extracted information for Darunavir only.

Interactions

→Appendix 1: HIV-protease inhibitors

Source page 716

Side Effects

Source page 716

Pregnancy

Source page 716

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available).

Source page 716

Monitoring Requirements

Monitor liver function before and during treatment.

Source page 716

Dose and formulations

Extracted information for Darunavir only.

Medicinal Forms

Source page 716

Clinical care

Extracted information for Darunavir only.

Patient And Carer Advice

Source page 716

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

First line only; read the complete Indications and dose section above.

600 mg twice daily, alternatively 800 mg once

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily, dose appropriate if no

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Adults

First line only; read the complete Indications and dose section above.

800 mg once daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 716

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.