DOLUTEGRAVIR = DTG oral

Last updated: October 2021

Prescription under medical supervision


Therapeutic action

– Antiretroviral, inhibitor of HIV integrase

Indications

– HIV infection and post-exposure prophylaxis (PEP), in combination with other antiretrovirals

Forms and strengths

– 10 mg dispersible tablet 
– 50 mg tablet

Dosage

– The dose is given once daily.
Child 4 weeks and over and adult:

WeightDoseTablets 

3 to < 6 kg 

5 mg  

½ disp tab 10 mg  

6 to < 10 kg 

15 mg  

1 ½ disp tab 10 mg 

10 to < 14 kg 

20 mg  

2 disp tab 10 mg   

14 to < 20 kg 

25 mg 

2 ½ disp tab 10 mg   

≥ 20 kg 

30 mg or 50 mg 

3 disp tab 10 mg or 1 tab 50 mg         

Duration

– Depending on the efficacy and tolerance of dolutegravir.

Contra-indications, adverse effects, precautions

– Do not administer simultaneously with antacids (aluminium or magnesium hydroxide, etc.), ferrous salts, calcium and zinc salts (effect of dolutegravir decreased). These drugs must be taken at least 6 hours before or 2 hours after dolutegravir.
– Administer with caution to patients with severe hepatic impairment or coinfection with hepatitis B or hepatitis C virus.
– May cause: 
• insomnia, depression, anxiety, dizziness, headache, skin rash, gastrointestinal disturbances (nausea, vomiting, diarrhoea, etc.); 
• rarely: hepatotoxicity, hypersensitivity reactions. 
– In patients taking:
• metformin: reduce the daily dose of metformin to 1 g (effect of metformin increased) and check regularly blood glucose level and renal function.
• enzyme-inducing drug (rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine): double the daily dose of dolutegravir (effect of dolutegravir decreased), e.g. 30 mg 2 times daily rather than 30 mg once daily, and maintain the double dose up to 2 weeks after treatment completion.
– In women of childbearing age, use offer hormonal or non-hormonal contraception.
– Pregnancy: small increased risk of neural tube defects but the benefits outweigh the risks. The administration of folic acid during the first trimester may reduce this risk.

Remarks

– Three 10 mg dispersible tablets is equivalent to one 50 mg tablet.
– In children 20 kg and over, preferably use 
50 mg tablet unless they cannot swallow tablets.
– Do not chew, cut or crush dispersible tablets. They can be swallowed or dispersed in water.
– Also comes in fixed-dose combination (tenofovir 300 mg/lamivudine 300 mg/dolutegravir 50 mg). Preferably use this formulation when available in adolescents 30 kg and over and adults. In patients taking enzyme-inducing drugs, give the fixed-dose combination in the morning and dolutegravir 50 mg in the evening. 
– Storage: below 25 °C -