- Approval Id
- 1f70321c20370cd6
- Drug Name
- TRIUMEQ FILM COATED TABLET 50mg/600mg/300mg
- Product Name
- TRIUMEQ FILM COATED TABLET 50mg/600mg/300mg
- Approval Number
- SIN15100P
- Approval Date
- 2016-10-14
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Film-coated tablets</p>
<p><em>TRIUMEQ</em> therapy should be initiated by a physician experienced in the management of HIV infection.</p>
<p><em>TRIUMEQ</em> should not be administered to adults or adolescents who weigh less than 40 kg.</p>
<p><em>TRIUMEQ</em> can be taken with or without food.</p>
<p><em>TRIUMEQ</em> is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 30 mL/min or with mild hepatic impairment. Separate preparations of <em>TIVICAY</em>, <em>ZIAGEN</em> or <em>EPIVIR</em> should be administered in cases where discontinuation or dose adjustment is indicated. In these cases, the physician should refer to the individual product information for these medicinal products. A separate preparation of <em>TIVICAY</em> is available where a dose adjustment is required due to drug-drug interactions (<em>see Interactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Since the recommended dose of dolutegravir is 50 mg twice daily for patients with resistance to integrase inhibitors, the use of <em>TRIUMEQ</em> is not recommended for patients with integrase inhibitor resistance.</p>
<p><strong>Populations</strong></p>
<ul>
<li><p><strong>Adults and adolescents</strong></p>
<p>The recommended dose of <em>TRIUMEQ</em> in adults and adolescents weighing at least 40 kg is one tablet once daily.</p></li>
<li><p><strong>Children</strong></p>
<p><em>TRIUMEQ</em> is not currently recommended for treatment of children less than 12 years of age or weighing less than 40 kg.</p></li>
<li><p><strong>Elderly</strong></p>
<p>There are limited data available on the use of <em>TIVICAY</em>, <em>ZIAGEN</em> and <em>EPIVIR</em> in patients aged 65 years and over. However, there is no evidence that elderly patients require a different dose than younger adult patients (<em>see Pharmacokinetics – Special Patient Populations</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, concomitant medicinal products or disease.</p></li>
<li><p><strong>Renal impairment</strong></p>
<p>Whilst no dosage adjustment of dolutegravir or abacavir is necessary in patients with renal impairment, a dose reduction of <em>EPIVIR</em> is required due to decreased clearance. Therefore, <em>TRIUMEQ</em> is not recommended for use in patients with a creatinine clearance less than 30 mL/min (<em>see Pharmacokinetics – Special Patient Populations</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li>
<li><p><strong>Hepatic impairment</strong></p>
<p>A dose reduction of <em>ZIAGEN</em> may be required for patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with <em>TRIUMEQ</em>, the separate preparations of <em>TIVICAY</em>, <em>ZIAGEN</em> and <em>EPIVIR</em> should be used when this is judged necessary. Abacavir is contraindicated in patients with moderate and severe hepatic impairment. <em>TRIUMEQ</em> is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh grade B or C) (<em>see Pharmacokinetics – Special Patient Populations</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>TRIUMEQ</em> is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents from 12 years of age and weighing at least 40 kg, who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in <em>TRIUMEQ</em>.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em>TRIUMEQ</em> is contraindicated in patients with known hypersensitivity to dolutegravir, abacavir or lamivudine, or to any of the excipients.</p>
<p><em>TRIUMEQ</em> must not be administered concurrently with medicinal products with narrow therapeutic windows, that are substrates of organic cation transporter 2 (OCT2), including but not limited to dofetilide, pilsicainide or fampridine (also known as dalfampridine; <em>see Interactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>TRIUMEQ</em> is contraindicated in patients with moderate and severe hepatic impairment.</p>
- Atc Code
- J05AR13
- Atc Item Name
- lamivudine, abacavir and dolutegravir
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
