- Approval Id
- 99b4bf0a3abfc367
- Drug Name
- DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG
- Product Name
- DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG
- Approval Number
- SIN15909P
- Approval Date
- 2020-03-13
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2. DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 General</strong><br>
DELSTRIGO is a fixed-dose combination product containing 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate (tenofovir DF).</p>
<p><strong>2.2 Adult Patients</strong><br>
The recommended dosage regimen of DELSTRIGO in adults is one tablet taken orally once daily with or without food.</p>
<p><u>Missed Dose</u><br>
If the patient misses a dose of DELSTRIGO, the patient should take DELSTRIGO as soon as possible unless it is almost time for the next dose. The patient should not take 2 doses at one time and instead take the next dose at the regularly scheduled time.</p>
<p><strong>2.3 Pediatric Patients</strong><br>
Safety and efficacy of DELSTRIGO have not been established in patients younger than 18 years of age <em>[see Clinical Pharmacology (10.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.4 Elderly Patients</strong><br>
There are limited data available on the use of doravirine, lamivudine and tenofovir DF in patients aged 65 years and over. There is no evidence that elderly patients require a different dose than younger adult patients <em>[see Use in Specific Populations (6.4) and Clinical Pharmacology (10.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. Special care is advised in this age group due to age associated changes such as decreases in renal function.</p>
<p><strong>2.5 Renal Impairment</strong><br>
Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and tenofovir DF cannot be altered, patients with estimated creatinine clearance less than 50 mL/min should not receive DELSTRIGO <em>[see Warnings and Precautions (4.2), Use in Specific Populations (6.5) and Clinical Pharmacology (10.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.6 Hepatic Impairment</strong><br>
No dose adjustment of DELSTRIGO is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. DELSTRIGO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) <em>[see Use in Specific Populations (6.6) and Clinical Pharmacology (10.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.7 Co-administration with Rifabutin</strong><br>
If DELSTRIGO is co-administered with rifabutin, one tablet of doravirine (PIFELTRO) should be taken approximately 12 hours after the dose of DELSTRIGO <em>[see Drug Interactions and Other Forms of Interactions (5.2) and Clinical Pharmacology (10.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1. INDICATIONS AND USAGE</strong></p>
<p>DELSTRIGO is indicated for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to NNRTIs, lamivudine, or tenofovir.</p>
- Contraindications
- <p><strong>3. CONTRAINDICATIONS</strong></p>
<p>DELSTRIGO should not be co-administered with drugs that are strong cytochrome P450 CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO <em>[see Clinical Pharmacology (10.5)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. These drugs include, but are not limited to, the following:</p>
<ul>
<li>the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin</li>
<li>the androgen receptor inhibitor enzalutamide</li>
<li>the antimycobacterials rifampin, rifapentine</li>
<li>the cytotoxic agent mitotane</li>
<li>St. John’s wort <em>(Hypericum perforatum)</em></li>
<li>lumacaftor</li>
</ul>
<p>DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to any component of this combination.</p>
- Atc Code
- J05AR24
- Atc Item Name
- lamivudine, tenofovir disoproxil and doravirine
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
