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Cabotegravir/rilpivirine long-acting injection

کابنوا (کابوتگراویر + ریلپیویرین تزریقی)

⚠ Unverified

🦠 Antiinfectives For Systemic UseLong-acting injectable HIV regimen

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA212888 ATC J05AJ04 ATC J05AG05

Market / country: 🇺🇸 USA

Cabenuva (US)

🧮 Dose calculator

Disease / regimen

HIV-1 infection (treatment) · Regimen source: FDA Cabenuva · 2.4 FDA Cabenuva · 2.5 FDA Cabenuva · 2.3

⛔ Initiation: cabotegravir 600 mg + rilpivirine 900 mg. Monthly: then 400/600 mg every month. Every 2 months: 600/900 mg at months 1 and 2, then every 2 months. Two separate gluteal injections. Optional oral lead-in. FDA Cabenuva · 2.4 FDA Cabenuva · 2.5 FDA Cabenuva · 2.3

🛡️ Safety & information

Contraindications

⛔ Prior hypersensitivity to cabotegravir or rilpivirine; UGT1A1/CYP3A inducers (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, dexamethasone, St John’s wort). FDA Cabenuva · 4

Warnings

• Post-injection reactions (rilpivirine-like toxicity); hypersensitivity; hepatotoxicity; depression; long-acting exposure up to 12 months after stopping. FDA Cabenuva · 5

Formulations

Kit: cabotegravir 600 mg/3 mL + rilpivirine 900 mg/3 mL (or 400/600 mg) — injection 🇺🇸 USA FDA Cabenuva · 3

👥 Special populations

🤰 PregnancyUse with caution
Label: insufficient human data; discuss benefit-risk with people who could become or are pregnant (drug persists up to 12 months). FDA Cabenuva · 8.1
“There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA with individuals of childbearing potential or during pregnancy.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Cabenuva · 8.2
“Risk Summary Based on limited data after oral administration, rilpivirine is present in human breast milk.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Cabenuva · 8.4
“The safety and effectiveness of CABENUVA have been established in adolescents aged 12 to younger than 18 years and weighing at least 35 kg, which is supported by the following: • Trials in adults [see Clinical Studies ( 14.1 )] • MOCHA (NCT03497676) trial in adolescents, in which virologically suppressed adolescents …”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Cabenuva · 8.5
“In general, caution should be exercised in administration of CABENUVA in elderly patients, reflecting 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)NDA212888
DailyMed (FDA label)FDA Cabenuva
MedlinePlus (NIH)Cabotegravir Cabotegravir and Rilpivirine Injection
WHO ATC/DDDJ05AJ04 J05AG05
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Cabenuva · 3 FDA Cabenuva · 2.4 FDA Cabenuva · 2.5 FDA Cabenuva · 2.3 FDA Cabenuva · 4 FDA Cabenuva · 5 FDA Cabenuva · SPL approval / marketing category FDA Cabenuva · 8.1 FDA Cabenuva · 8.2 FDA Cabenuva · 8.4 FDA Cabenuva · 8.5
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)✅ Present
Darooyab · search
Clinical review⚠ Unverified

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