DOLUTEGRAVIR = DTG oral

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    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:

     

    Weight Dose Tablets 

    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, 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