Formulary
Etravirine: Indications, Dosing, Side Effects and Interactions
Etravirine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Etravirine: Indications, Dosing, Side Effects and Interactions
Etravirine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**HIV infection in combination with other antiretroviral drugs (including a boosted protease inhibitor) in patients previously treated with antiretrovirals (initiated by a specialist)**
- **Adult** (By Mouth): 200 mg twice daily, to be taken after food.
**HIV infection in combination with other antiretroviral drugs (including a boosted protease inhibitor) in patients previously treated with antiretrovirals (initiated by a specialist) for etravirine**
- **Child 2-17 years (body-weight 10-19 kg)** (By mouth): 100 mg twice daily, to be taken after food.
- **Child 2-17 years (body-weight 20-24 kg)** (By mouth): 125 mg twice daily, to be taken after food.
- **Child 2-17 years (body-weight 25-29 kg)** (By mouth): 150 mg twice daily, to be taken after food.
- **Child 2-17 years (body-weight 30 kg and above)** (By mouth): 200 mg twice daily, to be taken after food.
Cautions
Elderly
Contraindications
Acute porphyrias
Side effects
Common or very common Anaemia; anxiety; appetite decreased; asthenia; constipation; diabetes mellitus; diarrhoea; drowsiness; dry mouth; dyslipidaemia; dyspnoea exertional; gastrointestinal discomfort; gastrointestinal disorders; headache; hyperglycaemia; hypersensitivity; hypertension; memory loss; myocardial infarction; nausea; peripheral neuropathy; renal failure; sensation abnormal; skin reactions; sleep disorders; stomatitis; sweat changes; thrombocytopenia; vision blurred; vomiting Uncommon Angina pectoris; angioedema; atrial fibrillation; bronchospasm; concentration impaired; confusion; gynaecomastia; haematemesis; hepatic disorders; immune reconstitution inflammatory syndrome; pancreatitis; seizure; syncope; tremor; vertigo Rare or very rare Haemorrhagic stroke; severe cutaneous adverse reactions (SCARs); Stevens-Johnson syndrome (especially in children and adolescents) Frequency not known Osteonecrosis Side-effects, further information Hypersensitivity reactions Rash, usually in the second week, is the most common side-effect and appears more frequently in females. Life-threatening hypersensitivity reactions reported usually during week 3-6 of treatment and characterised by rash, eosinophilia, and systemic symptoms (including fever, general malaise, myalgia, arthralgia, blistering, oral lesions, conjunctivitis, and hepatitis). Discontinue permanently if hypersensitivity reaction or severe rash develop. If rash mild or moderate (without signs of hypersensitivity reaction), may continue without interruption-usually resolves within 2 weeks.
Interactions
**Severe interactions:**
- Table 2: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas Effects on drug levels Least Squares Mean Ratio (90% CI; 1.00 = No effect)...
- Tenofovir disoproxil 245 mg once daily b tenofovir AUC 1.15 (1.09-1.21) C min 1.19 (1.13-1.26) C max 1.15 (1.04-1.27) etravirine AUC 0.81 (0.75-0.88) C min 0.82 (0.73-0.91) C max 0.81...
- Concomitant use of etravirine with efavirenz or nevirapine may cause a significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of etravirine.
- HIV Protease Inhibitors (PIs) - Unboosted (i.e.
- Integrase Strand Transfer Inhibitors Dolutegravir 50 mg once daily Dolutegravir + darunavir/ritonavir 50 mg once daily + 600/100 mg twice daily Dolutegravir + Lopinavir/ritonavir 50 mg once daily +...
- ANTIMALARIALS Artemether/ Lumefantrine 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours artemether AUC 0.62 (0.48-0.80) C min 0.82 (0.67-1.01) C max 0.72 (0.55-0.94) dihydroartemisinin AUC...
**Other interactions (80):**
- Medicinal products that affect etravirine exposure Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation of the metabolites by uridine diphosphate glucuronosyl...
- Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
- Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
- Medicinal products that are affected by the use of etravirine Etravirine is a weak inducer of CYP3A4.
- Co-administration of etravirine with medicinal products primarily metabolised by CYP3A4 may result in decreased plasma concentrations of such medicinal products, which could decrease or shorten...
- Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Hepatic impairment
Manufacturer advises caution in moderate impairment and in patients with hepatitis B or C (increased risk of hepatic side effects); avoid in severe impairment (no information available).
Medicinal forms
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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