Albuvirtide Injection (Aikening) – HIV | HongKong DengYue Medicine

Albuvirtide Application Scope

Albuvirtide (ABT) is indicated for the treatment of HIV‑1 infection in treatment‑experienced adults and adolescents, used in combination with other antiretroviral agents for patients with virologic failure or multidrug-resistant HIV‑1.

Albuvirtide Characteristics

• Ingredients:Active: Albuvirtide (ABT), a 3‑maleimimidopropionic acid (MPA)-modified peptide fusion inhibitor (~160 mg/vial) .

• Properties:​Long‑acting HIV‑1 fusion inhibitor targeting gp41; irreversibly conjugates to human serum albumin for extended half‑life (≈10–12 days).

• Packaging Specification:​Single‑use vial containing 160 mg Albuvirtide per vial, supplied for intravenous infusion .

• Storage:​Active pharmaceutical ingredient stored at –20 °C; finished injection product stored at 2–8 °C under refrigeration.

• Expiry Date:As per label; typically specified as calendar months from manufacture (e.g. 24 months shelf life; exact expiry on carton) — consult product packaging.

• Executive Standard: ​China NMPA approval standards for HIV fusion inhibitors under conditional approval status since 2018 .

• Approval Number:Granted marketing approval by China’s National Medical Products Administration (NMPA) in 2018, under brand name Albuvirtide / Aikening.

• Date of Revision:Most recent label update aligned with post‑marketing safety data; e.g. regulatory update in 2021 regarding use in liver‑impaired patients and minimal CYP450 interactions.

• Manufacturer:Frontier Biotechnologies (also known as Frontier Pharmaceuticals) in China; marketed under brand Aikening.

Guidelines for the Use of Albuvirtide Injection

• Dosage and Administration:

  • Loading dose: 320 mg intravenously once daily for 3 consecutive days, followed by weekly 320 mg maintenance IV infusion together with optimized background antiretroviral regimen.

  • Missed Dose:If a weekly maintenance dose is missed, administer as soon as feasible; do not double dose — resume regular weekly schedule.​

• Adverse Reactions:

  • Generally well tolerated; low incidence of hepatotoxicity (~2.2%) in patients with liver impairment or HBV co-infection; injection-site reactions are mild to moderate.

• Contraindications:Known hypersensitivity to it or any excipients; not recommended in severe hepatic failure unless under close monitoring.

• Precautions:

  • Monitor liver function in patients with hepatic impairment; minimal drug–drug interactions due to non‑CYP450 metabolic pathway; favorable safety in patients with HBV co-infection, high HIV‑RNA, or concurrent mycobacterial infections.​

Albuvirtide Interactions

• It is not metabolized by the CYP450 system, minimizing classic drug–drug interactions; however, careful review with other long‑acting injectables or QT‑prolonging agents is advised.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.