UK Prescribing Information

Ziagen® abacavir 300mg tablets and 20mg/ml oral solution 

Trizivir® abacavir 300mg/lamivudine 150mg/zidovudine 300mg tablets

Kivexa® abacavir 600mg/lamivudine 300mg tablets 
Prescribing Information

See Summary of Product Characteristics (SmPC) before prescribing.

Indications: HIV in adults, adolescents and children weighing at least 25 kg as part of combination therapy. Screen for HLA-B*5701 prior to use. Dose: one tablet daily with or without food. Elderly: No pharmacokinetic data in 65+ yrs. Renal impairment: Creatinine clearance <50ml/min: not recommended. Hepatic impairment: not recommended in moderate or severe hepatic impairment. Monitor closely in mild hepatic impairment. Contraindications: Hypersensitivity to any ingredient. Special warnings/precautions: Risk of hypersensitivity reactions (HSR). Do not initiate in patients who are HLA-B*5701 positive on screening or had previous suspected abacavir HSR. Stop Kivexa without delay if HSR suspected. Never re-introduce any abacavir-containing product after suspected HSR. Risks of virological failure, immune reactivation syndrome, osteonecrosis, increased weight, lipids, glucose. Monitor LFTs in Hepatitis B/C co-infection. Inconclusive data on relationship between abacavir 

and MI; minimise modifiable CV risk factors (e.g. smoking, hypertension, hyperlipidaemia). Use with cladribine, emtricitabine or high doses of co-trimoxazole not recommended. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC section 4.5). If unavoidable, consider more frequent viral load monitoring. Abacavir increased riociguat concentrations. Consider dose adjustment of riociguat. Pregnancy/lactation: Not recommended. Do not breast-feed. Side effects: See SmPC for full details. Hypersensitivity, GI disturbance, headache, anorexia, insomnia, rash, fever, lethargy, fatigue, malaise, arthralgia, muscle disorders, nasal symptoms, cough, alopecia, blood dyscrasias, rhabdomyolysis, lactic acidosis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Basic NHS costs: £352.25 for 30 tablets. MA number: EU/1/04/298/002. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H,

3811 LP Amersfoort, Netherlands.

Further information available from: customercontactuk@gsk.com

Freephone 0800 221 441.

POM 

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.  

Date of approval: January 2021 

PI-0393v3

Adverse events should be reported. For the UK, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK on 0800 221441.

Triumeq (dolutegravir/abacavir/lamivudine) Prescribing Information

Please refer to Prescribing Information as follows:

  • England, Scotland & Wales (GB)
  • Northern Ireland (NI)

Prescribing Information – England, Scotland & Wales (GB)

Triumeq dolutegravir 50mg/abacavir 600mg/lamivudine 300mg tablets

See Summary of Product Characteristics (SmPC) before prescribing.

Indication: HIV in over 12 years and > 40kg. Screen for HLA-B*5701 prior to use. Do not use if HLA-B*5701 positive. Dose: one tablet once daily with or without food. Elderly: Limited data in 65+ yrs. Creatinine clearance <50ml/min or moderate/severe hepatic impairment: Not recommended. Monitor closely in mild hepatic impairment. Contraindications: Hypersensitivity to any ingredient. Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special warnings/precautions: Both abacavir and dolutegravir are associated with risk of hypersensitivity reactions (HSR). Do not initiate in HLA-B*5701+ or previous suspected abacavir HSR. Stop Triumeq without delay if HSR suspected. Never reintroduce any dolutegravir- or abacavir-containing product after suspected HSR. Risks of immune reactivation syndrome, osteonecrosis, increased weight, lipids, glucose. Monitor LFTs in Hepatitis B/C co-infection. Inconclusive data on relationship between abacavir and MI; minimise all modifiable CV risk factors (e.g. smoking, hypertension, hyperlipidaemia). Not recommended if dolutegravir required b.d. (with etravirine [without boosted PI], efavirenz, nevirapine, rifampicin, boosted tipranavir, carbamazepine, oxcarbazepine, phenytoin, phenobarbital and St John’s Wort). Use with cladribine not recommended. Use with Mg/Al-containing antacids, calcium, multivitamins or iron requires dosage separation. Caution with metformin: monitor renal function and consider metformin dose adjustment. Abacavir increased riociguat concentrations. Consider dose adjustment of riociguat. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC section 4.5). If unavoidable, consider more frequent viral load monitoring. Pregnancy/lactation: Women of childbearing potential should be 

counselled about the potential risk of neural tube defects with dolutegravir (a component of Triumeq), including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment with Triumeq should be discussed with the patient. If a pregnancy is confirmed in the first trimester while on Triumeq, the benefits and risks of continuing Triumeq versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account. Most neural tube defects occur within the first 4 weeks of embryonic development after conception (approximately 6 weeks after the last menstrual period). Triumeq may be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus. Do not breast-feed. Side effects: See SmPC for details. Headache, insomnia, sleep/dream disorders, GI disturbance, fatigue, hypersensitivity, anorexia, depression, anxiety, dizziness, somnolence, lethargy, malaise, cough, nasal symptoms, rash, pruritus, alopecia, arthralgia, myalgia, asthenia, fever, elevations of ALT, AST and CPK, blood dyscrasias, suicidal ideation or suicide attempt, rhabdomyolysis, acute hepatic failure, increased bilirubin, lactic acidosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Basic NHS costs: 30 tablets: £798.16. MA number: EU/1/14/940/001. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands. Further information is available from customercontactuk@gsk.com Freephone 0800 221 441.

POM 

Trade marks are owned by or licensed to the ViiV Healthcare group of companies. 

Date of approval: January 2021                                                                                                PI-2529v5

Adverse events should be reported. For the UK, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.  

Prescribing Information - Northern Ireland

Triumeq dolutegravir 50mg/abacavir 600mg/lamivudine 300mg tablets

See Summary of Product Characteristics (SmPC) before prescribing.

Indication: HIV in over 12 years and > 40kg. Screen for HLA-B*5701 prior to use. Do not use if HLA-B*5701 positive. Dose: one tablet once daily with or without food. Use an additional 50mg tablet of dolutegravir approximately 12 hours after the dose of Triumeq when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s Wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir. Elderly: Limited data in 65+ yrs. Creatinine clearance <50ml/min or moderate/severe hepatic impairment: Not recommended. Monitor closely in mild hepatic impairment. Contraindications: Hypersensitivity to any ingredient. Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special warnings/precautions: Both abacavir and dolutegravir are associated with risk of hypersensitivity reactions (HSR). Do not initiate in HLA-B*5701+ or previous suspected abacavir HSR. Stop Triumeq without delay if HSR suspected. Never reintroduce any dolutegravir- or abacavir-containing product after suspected HSR. Risks of immune reactivation syndrome, osteonecrosis, increased weight, lipids, glucose. Monitor LFTs in Hepatitis B/C co-infection. Inconclusive data on relationship between abacavir and MI; minimise all modifiable CV risk factors (e.g. smoking, hypertension, hyperlipidaemia). Use with cladribine not recommended. Use with Mg/Al-containing antacids requires dosage separation. Use with supplements or multivitamins containing calcium, iron or magnesium also requires dosage separation if not taken at the same time with food. Caution with metformin: monitor renal function and consider metformin dose adjustment. Abacavir increased riociguat concentrations. Consider dose adjustment of riociguat. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC section 4.5). If unavoidable, consider more

frequent viral load monitoring. Pregnancy/lactation: Women of childbearing potential should be counselled about the potential risk of neural tube defects with dolutegravir (a component of Triumeq), including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment with Triumeq should be discussed with the patient. If a pregnancy is confirmed in the first trimester while on Triumeq, the benefits and risks of continuing Triumeq versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account. Most neural tube defects occur within the first 4 weeks of embryonic development after conception (approximately 6 weeks after the last menstrual period). Triumeq may be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus. Do not breast-feed. Side effects: See SmPC for details. Headache, insomnia, sleep/dream disorders, GI disturbance, fatigue, hypersensitivity, anorexia, depression, anxiety, dizziness, somnolence, lethargy, malaise, cough, nasal symptoms, rash, pruritus, alopecia, arthralgia, myalgia, asthenia, fever, elevations of ALT, AST and CPK, blood dyscrasias, suicidal ideation or suicide attempt, rhabdomyolysis, acute hepatic failure, increased bilirubin, lactic acidosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Basic NHS costs: 30 tablets: £798.16. MA number: EU/1/14/940/001. MA holder: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands. Further information is available from customercontactuk@gsk.com Freephone 0800 221 441.

POM 

Trade marks are owned by or licensed to the ViiV Healthcare group of companies.

Date of approval: July 2021                                                                                                PI-8445

Adverse events should be reported. For the UK, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.  

Date of approval of combined PI: July 2021                                                                      PI-8446

UK Prescribing Information