Drug Action
Dolutegravir is an inhibitor of HIV integrase.
Source page 700
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Individual generic drug information
Extracted information for Dolutegravir only.
Dolutegravir is an inhibitor of HIV integrase.
Source page 700
HIV infection without resistance to other inhibitors of HIV integrase, in combination with other antiretroviral drugs ▶BY MOUTH ▶Adult: 50 mg once daily HIV infection in patients where resistance to other inhibitors of HIV integrase suspected, in combination with other antiretroviral drugs ▶BY MOUTH ▶Adult: 50 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, rifampicin, or tipranavir) ▶BY MOUTH ▶Adult: 50 mg twice daily, avoid concomitant use with these drugs if resistance to other inhibitors of HIV integrase suspected
Source pages 700, 701
Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (May 2014) that dolutegravir (Tivicay ®) is accepted for use within NHS Scotland when used in combination with other anti- retroviral medicines for the treatment of HIV infected adults. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. All Wales Medicines Strategy Group (AWMSG) decisions The All Wales Medicines Strategy Group has advised (October 2017) that dolutegravir (Tivicay ®) is recommended as an option for use within NHS Wales in combination with other anti-retroviral medicinal products Infection for the treatment of HIV infected adults. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.
Source page 701
Extracted information for Dolutegravir only.
MHRA/CHM ADVICE: DOLUTEGRAVIR (TIVICAY ®, TRIUMEQ ®, JULUCA ®): SIGNAL OF INCREASED RISK OF NEURAL TUBE DEFECTS; DO NOT PRESCRIBE TO WOMEN SEEKING TO BECOME PREGNANT; EXCLUDE PREGNANCY BEFORE INITIATION AND ADVISE USE OF EFFECTIVE CONTRACEPTION (JUNE 2018) New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking dolutegravir. The MHRA advises: . dolutegravir should not be prescribed to women who are trying to become pregnant; . pregnancy should be excluded in women of childbearing potential with pregnancy testing before starting dolutegravir; . women of childbearing potential should be advised to use effective contraception throughout treatment with dolutegravir; . if pregnancy is confirmed in the first trimester while a woman is taking dolutegravir, switch to an alternative treatment unless there is no suitable alternative; . women taking dolutegravir for HIV should be advised not to stop taking their medicine without first consulting their doctor.
Source page 701
→Appendix 1: dolutegravir
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▶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 tendencies 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.
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Manufacturer advises avoid, see Important Safety Information.
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Manufacturer advises caution in severe impairment—no information available.
Source page 701
Extracted information for Dolutegravir only.
There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Tivicay (ViiV Healthcare UK Ltd) Dolutegravir (as Dolutegravir sodium) 10 mg Tivicay 10mg tablets | 30 tablet P £99.75 DT = £99.75 Dolutegravir (as Dolutegravir sodium) 25 mg Tivicay 25mg tablets | 30 tablet P £249.38 DT = £249.38 Dolutegravir (as Dolutegravir sodium) 50 mg Tivicay 50mg tablets | 30 tablet P £498.75 DT = £498.75 Combinations available: Abacavir with dolutegravir and lamivudine, p. 684. Lamivudine with dolutegravir, p. 690
Source page 701
Extracted information for Dolutegravir only.
Patients or carers should be given advice on how to administer dolutegravir tablets. Missed doses If a dose is more than 20 hours late on the once daily regimen (or more than 8 hours late on the twice daily regimen), the missed dose should not be taken and the next dose should be taken at the normal time.
Source page 701
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50 mg once daily
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Candidate age grouping · source page 700
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50 mg twice daily, dose to be taken with food
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 700
First line only; read the complete Indications and dose section above.
50 mg twice daily, avoid concomitant use with
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 701