Tivicay

Tivicay

dolutegravir

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Dolutegravir
Indications/Uses
In combination w/ other anti-retroviral medicinal products for the treatment of HIV infected adults & adolescents >12 yr.
Dosage/Direction for Use
Patients infected w/ HIV-1 w/o documented/clinically suspected resistance to the integrase class 50 mg once daily. Administer bd in this population when co-administered w/ other medicines (eg, efavirenz, nevirapine, tipranavir/ritonavir or rifampicin). Patients infected w/ HIV-1 w/ resistance to the integrase class (documented/clinically suspected) 50 mg bd. Adolescent 12-17 yr & weighing at least 40 kg infected w/ HIV-1 w/o resistance to the integrase class 50 mg once daily.
Administration
May be taken with or without food. Patients infected w/ HIV w/ resistance to the integrase class: Should be taken with food.
Contraindications
Hypersensitivity. Co-administration w/ dofetilide.
Special Precautions
Presence of integrase class resistance. Discontinue immediately if signs or symptoms of hypersensitivity reactions develop. Immune reactivation syndrome. Monitor liver biochemistries in patients w/ hepatitis B &/or C co-infection. May still develop opportunistic infections & other complications of HIV infection. Drug interactions, osteonecrosis. May affect ability to drive or operate machinery. Women of childbearing potential should use effective contraception throughout treatment. Pregnancy & lactation. Childn <12 yr or weighing <40 kg.
Adverse Reactions
Headache; nausea, diarrhoea. Insomnia, abnormal dreams, depression, anxiety; dizziness; vomiting, flatulence, upper abdominal pain, abdominal pain, abdominal discomfort; rash, pruritus; fatigue; ALT &/or AST elevations, creatine phosphokinase (CPK) elevations.
Drug Interactions
Decreased plasma conc w/ etravirine, efavirenz, nevirapine, tipranavir/ritonavir, fosamprenavir/ritonavir, darunavir/ritonavir, darunavir/ritonavir + etravirine, oxcarbazepine, phenytoin, phenobarb, carbamazepine, St. John's wort, Mg- & Al-containing antacid, Ca, Fe, multivitamin supplements, rifampicin. Increased plasma conc w/ atazanavir, atazanavir/ritonavir, telaprevir. Increased plasma conc of dofetilide, metformin.
MIMS Class
Antivirals
ATC Classification
J05AJ03 - dolutegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Tivicay FC tab 50 mg
Packing/Price
30's
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