Formulary
Dolutegravir: Indications, Dosing, Side Effects and Interactions
Dolutegravir is an inhibitor of HIV integrase.
MedNext Academy | 5 min read
Dolutegravir: Indications, Dosing, Side Effects and Interactions
Dolutegravir is an inhibitor of HIV integrase.
Drug action
Dolutegravir is an inhibitor of HIV integrase.
Indications and dose
**HIV infection without resistance to other inhibitors of HIV integrase [in combination with other antiretroviral drugs] (specialist use only)**
- **Adult** (By Mouth Using Tablets): 50 mg once daily.
- **Adult** (By Mouth Using Dispersible Tablets): 30 mg once daily.
**HIV infection in patients with resistance to other inhibitors of HIV integrase [in combination with other antiretroviral drugs] (specialist use only)**
- **Adult** (By Mouth Using Tablets): 50 mg twice daily, dose to be taken with food.
- **Adult** (By Mouth Using Dispersible Tablets): 30 mg twice daily, dose to be taken with food.
**HIV infection [in combination with other antiretroviral drugs (with concomitant carbamazepine, efavirenz, etravirine (without boosted protease inhibitors, but see also Interactions), fosphenytoin, phenobarbital, phenytoin, primidone, nevirapine, oxcarbazepine, St John's wort, or rifampicin)] (specialist use only)**
- **Adult** (By Mouth Using Tablets): 50 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Adult** (By Mouth Using Dispersible Tablets): 30 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
**HIV infection without resistance to other inhibitors of HIV integrase [in combination with other antiretroviral drugs] (specialist use only) for dolutegravir**
- **Child 6-11 years (body-weight 14-19 kg)** (By mouth using tablets): 40 mg once daily, alternatively 20 mg twice daily.
- **Child 6-17 years (body-weight 20 kg and above)** (By mouth using tablets): 50 mg once daily, alternatively 25 mg twice daily.
- **Child 1-5 months (body-weight 3-5 kg)** (By mouth using dispersible tablets): 5 mg once daily.
- **Child 1-5 months (body-weight 6-9 kg)** (By mouth using dispersible tablets): 10 mg once daily, alternatively 5 mg twice daily.
- **Child 6 months-17 years (body-weight 6-9 kg)** (By mouth using dispersible tablets): 15 mg once daily, alternatively 10 mg twice daily.
- **Child 6 months-17 years (body-weight 10-13 kg)** (By mouth using dispersible tablets): 20 mg once daily, alternatively 10 mg twice daily.
- **Child 6 months-17 years (body-weight 14-19 kg)** (By mouth using dispersible tablets): 25 mg once daily, alternatively 15 mg twice daily.
- **Child 6 months-17 years (body-weight 20 kg and above)** (By mouth using dispersible tablets): 30 mg once daily, alternatively 15 mg twice daily.
**HIV infection [in combination with other antiretroviral drugs (with concomitant carbamazepine, efavirenz, etravirine (without boosted protease inhibitors, but see also Interactions), fosphenytoin, phenobarbital, phenytoin, primidone, nevirapine, oxcarbazepine, St John's wort, or rifampicin)] (specialist use only) for dolutegravir**
- **Child 6-11 years (body-weight 14-19 kg)** (By mouth using tablets): 40 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 6-17 years (body-weight 20 kg and above)** (By mouth using tablets): 50 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 1-5 months (body-weight 3-5 kg)** (By mouth using dispersible tablets): 5 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 1-5 months (body-weight 6-9 kg)** (By mouth using dispersible tablets): 10 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 6 months-17 years (body-weight 6-9 kg)** (By mouth using dispersible tablets): 15 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 6 months-17 years (body-weight 10-13 kg)** (By mouth using dispersible tablets): 20 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 6 months-17 years (body-weight 14-19 kg)** (By mouth using dispersible tablets): 25 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
- **Child 6 months-17 years (body-weight 20 kg and above)** (By mouth using dispersible tablets): 30 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected.
Side effects
Common or very common Anxiety; depression; diarrhoea; dizziness; fatigue; flatulence; gastrointestinal discomfort; headache; nausea; skin reactions; sleep disorders; vomiting Uncommon Arthralgia; hepatic disorders; hypersensitivity; immune reconstitution inflammatory syndrome; myalgia; suicidal behaviours Side-effects, further information Hypersensitivity Hypersensitivity reactions (including severe rash, or rash accompanied by fever, malaise, arthralgia, myalgia, blistering, oral lesions, conjunctivitis, angioedema, eosinophilia, or raised liver enzymes) reported uncommonly. Discontinue immediately if any sign or symptoms of hypersensitivity reactions develop. Osteonecrosis Osteonecrosis has been reported in patients with advanced HIV disease or following long-term exposure to combination antiretroviral therapy.
Interactions
**Severe interactions:**
- Possible toxicity with phenytoin on stopping primidone); stiripentol, tiagabine, valproic acid, zonisamide.
- Dolutegravir ND No significant change in dolutegravir kinetics at steady state.
- 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 +...
- Additional drug-drug interaction studies were performed with the following medical products and showed no clinically significant interactions with Glecaprevir/Pibrentasvir: abacavir, amlodipine,...
**Other interactions (9):**
- Integrase strand transfer inhibitors dolutegravir Interaction not studied.
- Expected: maribavir dolutegravir No dose adjustment is required.
- Cobicistat 1.7 (1.5, 1.9) Sofosbuvir Velpatasvir 1.4 (1.2, 1.5) Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily) Dolutegravir No dose...
- INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas Interaction Geometric mean change (%) Recommendations concerning co-administration HIV...
- Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Dolutegravir (50 mg q.d.) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.) Sofosbuvir: AUC: Cmax: GS-3310072 AUC: Cmax: Cmin: ...
- Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) + Dolutegravir (50 mg q.d.) + Emtricitabine/Tenofovir disoproxil fumarate (200 mg/300 mg q.d.) Sofosbuvir: AUC: C max : GS-331007 2 AUC: C max : C...
Pregnancy
Specialist sources indicate dolutegravir may be considered from 6 weeks' gestation if expected benefit outweighs risk-see Important Safety Information . Higher dose folic acid is recommended due to increased risk of neural tube defects-see Prevention of neural tube defects (in those in the high-risk group who wish to become pregnant or who are at risk of becoming pregnant ) in folic acid . A
Hepatic impairment
Manufacturer advises caution in severe impairment-no information available.
Medicinal forms
Tablet,Tablet
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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