Dolutegravir
دولوتگراویر
🦠 Antiinfectives For Systemic UseIntegrase inhibitor (INSTI)
Market / country: 🇺🇸 USA
Tivicay (US)
🧮 Dose calculator
HIV-1 infection (treatment) · Regimen source: FDA Tivicay · 2.2
- • Always in combination with other antiretrovirals. FDA Tivicay · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Previous hypersensitivity to dolutegravir; concomitant dofetilide. FDA Tivicay · 4
Warnings
- • Hypersensitivity and hepatotoxicity; immune reconstitution syndrome. FDA Tivicay · 5
Important interactions
- • Dofetilide: contraindicated. FDA Tivicay · 4
- • Antacids, calcium or iron supplements: take dolutegravir 2 h before or 6 h after (or together with food for calcium/iron). FDA Tivicay · 7
Formulations
- 10 mg tablet — tablet 🇺🇸 USA FDA Tivicay · 3
- 25 mg tablet — tablet 🇺🇸 USA FDA Tivicay · 3
- 50 mg tablet — tablet 🇺🇸 USA FDA Tivicay · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tivicay · 8.1
“Risk Summary Data from two, ongoing birth outcome surveillance studies in Botswana and Eswatini which together include over 14,000 individuals evaluated during pregnancy show similar prevalence of neural tube defects among infants born to individuals taking dolutegravir at the time of conception compared to those born …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tivicay · 8.2
“Risk Summary Dolutegravir is present in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Tivicay · 8.4
“Children and Adolescent Participants with HIV 1 The safety, pharmacokinetics, and effectiveness of TIVICAY and TIVICAY PD were evaluated in 75 treatment-naïve or treatment-experienced, INSTI-naïve pediatric and adolescent participants with HIV‑1 aged 4 weeks to less than 18 years weighing at least 3 kg in an …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tivicay · 8.5
“In general, caution should be exercised in the administration of TIVICAY in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology ( 12.3 )] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA213983
- DailyMed (FDA label)FDA Tivicay
- MedlinePlus (NIH)Dolutegravir
- WHO ATC/DDDJ05AJ03
- Darooyab (Iran)Dolutegravir
🇮🇷 Registered in Iran Darooyab · G-5462/Dolutegravir
Dosage forms with Iranian generic codes, per Darooyab.
- 51948 · DOLUTEGRAVIR TABLET ORAL 50 mg · قرص دولوتگراویر ۵۰ میلیگرم
- 52421 · DOLUTEGRAVIR TABLET ORAL 25 mg · قرص دولوتگراویر ۲۵ میلیگرم
- 52420 · DOLUTEGRAVIR TABLET ORAL 10 mg · قرص دولوتگراویر ۱۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tivicay · 3FDA Tivicay · 2.2FDA Tivicay · 2.3, Table 4FDA Tivicay · 2.3FDA Tivicay · 2.1FDA Tivicay · 4FDA Tivicay · 5FDA Tivicay · 7FDA Tivicay · 8.1FDA Tivicay · 8.2FDA Tivicay · 8.4FDA Tivicay · 8.5FDA Tivicay · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5462/Dolutegravir
- Clinical review⚠ Unverified