UK Prescribing Information

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

See Summary of Product Characteristics* before prescribing

Indication: HIV in adults, adolescents and children as part of combination therapy. Screen for HLA-B*5701 prior to use. Dose: Taken with or without food. Adults, adolescents and children weighing at least 25 kg: 600mg once daily or 300mg twice daily. Children weighing less than 25 kg : dose by weight : ≥20 kg to <25 kg: 450mg daily (either as one and a half tablets once daily, or half a tablet in the morning and one tablet in the evening). 14 to 20 kg: 300mg daily (either as one tablet once daily or half a tablet twice daily). Children < 3 months: limited data available. Oral solution: adults, adolescents and children weighing at least 25 kg: 600mg (30ml) once daily or 300mg (15ml) twice daily. Children weighing less than 25 kg : Children ≥1 year of age: 8 mg/kg twice daily or 16mg/kg once daily, up to a maximum of daily dose of 600 mg (30 ml). Children aged 3 months to 1 year: 8 mg/kg twice daily. Limited data on once daily dosing. Elderly: No pharmacokinetic data in 65+ yrs. Renal impairment: Avoid in end-stage renal disease. Hepatic impairment: Not recommended inmoderate or severe hepatic impairment. Monitor closely in mild hepatic impairment. Contraindications: Hypersensitivity to any ingredient.

Warnings/precautions: Risk of hypersensitivity reactions (HSR). Do not initiate in HLA-B*5701+ or previous suspected abacavir HSR. Stop Ziagen 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 ; oral solution - fructose intolerance, parahydroxybenzoate allergy. Monitor LFTs in patients with pre-existing liver dysfunction (including Hepatitis B/C co-infection).Inconclusive data on relationship between abacavir and MI; minimise modifiable CV risk factors (e.g. smoking, hypertension, hyperlipidaemia). Pregnancy/lactation: Not recommended. Avoid breast-feeding. Side effects: See SPC* for full details. Hypersensitivity, GI disturbance, anorexia, headache, fever, lethargy, fatigue, rash, lactic acidosis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. Basic NHS costs: £177.60 for 60 tablets EU/1/99/112/001; £47.36 for 240ml oral solution EU/1/99/112/002. MA holder: ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS. Further information is available from Customer Contact Centre, GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT.

POM

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard*. Adverse events should also be reported to GlaxoSmithKline on
0800 221 441.

Adverse events should be reported. For Ireland, adverse events should be reported directly to the
HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace,
Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be reported to
GlaxoSmithKline on 1800 244 255.

Ziagen is a registered trademark of the ViiV Healthcare Group of Companies

Date of approval: August 2016

UK/ABC/0002/11(5)

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

See Summary of Product Characteristics* before prescribing

Indications: HIV infection in adults (18yrs +) in special circumstances (e.g. TB co-infection). Usecomponents separately for first 6 -8 weeks. Screen for HLA-B*5701 prior to use. Dose: one tablet twice daily with or without food. Elderly: No pharmacokinetic data in 65+ yrs. Renal impairment: CrCl ≤ 50ml/min: use separate components. Hepatic impairment: Not recommended in moderate or severe hepatic impairment. Monitor closely in mild hepatic impairment. Contraindications: Hypersensitivity to any ingredient; abnormally low neutrophils or Hb level; end-stage renal disease. Warnings/precautions: Risk of hypersensitivity reactions (HSR). Do not initiate in HLA-B*5701+ or previous suspected abacavir HSR. Stop Trizivir without delay if HSR suspected. Never re-introduce any abacavir-containing product after suspected HSR. Risks of lactic acidosis, haematological adverse reactions, immune reactivation syndrome, osteonecrosis, lipoatrophy, increased weight, lipids, glucose. Monitor LFTs in patients with pre-existing liver dysfunction (including 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 stavudine, ribavirin, cladribine, emtricitabine or high doses of co-trimoxazole not recommended. Separate doses of Trizivir and clarithromycin by at least two hours. Concomitant treatment with potentially nephrotoxic or myelosuppressive medicinal products, antifungals, uricosurics or valproic acid may increase risk of zidovudine toxicity. Pregnancy/lactation: Not recommended. Avoid breast-feeding. Side effects: See SPC* for full details. Hypersensitivity, GI disturbance, headache, blood dyscrasias, insomnia, dizziness, cough, nasal symptoms, fever, malaise, fatigue, arthralgia, muscle disorders, rash, alopecia, anorexia, lethargy, raised liver enzymes and bilirubin, cardiomyopathy, rhabdomyolysis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. Basic NHS costs: £432.69 for 60 tablets EU/1/00/156/004. MA holder: ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS. Further information is available from Customer Contact Centre, GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT.

POM

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard*. Adverse events should also be reported to GlaxoSmithKline on
0800 221 441.

Adverse events should be reported. For Ireland, adverse events should be reported directly to the
HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace,
Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be reported to
GlaxoSmithKline on 1800 244 255.

Trizivir is a registered trademark of the ViiV Healthcare Group of Companies.

Date of approval: April 2016

UK/ALZ/0001/13(4)

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

See Summary of Product Characteristics* 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. 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 cotrimoxazole 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. Pregnancy/lactation: Not recommended. Avoid breast-feeding. 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: 30 tablets: £352.25 EU/1/04/298/002. MA holder: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands. Further information is available from Customer Contact Centre, GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT.

POM S1A

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

Date of approval: November 2018 

UK/ABC3TC/0008/13(13)

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

Adverse events should be reported. For Ireland, adverse events should be reported directly to the
HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace,
Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be reported to
GlaxoSmithKline on 1800 244 255.

Triumeq®  dolutegravir 50mg/abacavir 600mg/lamivudine 300mg tablets
Prescribing Information

See Summary of Product Characteristics* 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. 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/Alcontaining antacids, calcium, multivitamins or iron requires dosage separation. Caution with metformin: monitor renal function and consider metformin dose adjustment. 

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: Before initiating Triumeq, women of childbearing potential (WOCBP) should undergo pregnancy testing. WOCBP who are taking Triumeq should use effective contraception. Triumeq should not be used during the first trimester due to the potential risk of neural tube defects, unless there is no alternative. Triumeq should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus. Avoid breastfeeding. Side effects: See SPC 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, lactic acidosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Basic NHS costs: 30 tablets: £798.16 EU/1/14/940/001. MA holder: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands. Further information is available from Customer Contact Centre, GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT.

POM S1A

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

Date of approval: July 2019                                                                                                PI-2529

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

Adverse events should be reported. For Ireland, adverse events should be reported directly to the
HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace,
Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be reported to
GlaxoSmithKline on 1800 244 255.

* ViiV Healthcare does not recommend, endorse or accept liability for sites controlled by third parties.

UK Prescribing Information