Monday, April 21, 2025

Abevac vial

 Abevac is a purified bee‑venom immunotherapeutic produced by Egypt’s Holding Company for Biological Products & Vaccines (Vacsera), formulated as lyophilized 1 mg vials for intradermal injection in rheumatoid arthritis and studied for antimicrobial and immunomodulatory applications. Each 1 ml vial contains 1 mg of purified Apis mellifera venom, 9 mg sodium chloride, and water for injection, and is registered with the Egyptian Ministry of Health . Its principal bioactive peptide, melittin, disrupts microbial membranes via pore formation, yielding potent antibacterial activity against Gram‑positive pathogens (e.g., S. aureus, MRSA) and shows immunomodulatory effects by inhibiting key inflammatory signaling pathways .


Product Overview


Manufacturer & Presentation


Abevac is manufactured and quality‑controlled by Vacsera (the only vaccine and sera producer in Egypt), with Vacsera’s pipeline explicitly listing “Abevac (Bee Venom)” as a therapeutic product . It is presented as a lyophilized powder in a 1 mg vial to be reconstituted with sterile water for injection immediately prior to use .


Composition


Purified Bee Venom (Apis mellifera): 1 mg per 1 ml, containing melittin, phospholipase A₂, apamin, and other peptides.


Sodium Chloride: 9 mg to maintain isotonicity.


Water for Injection: q.s. to 1 ml .



Indications & Mechanisms


Rheumatoid Arthritis Immunotherapy


Abevac is indicated as an adjunctive treatment for rheumatoid arthritis, leveraging controlled intradermal exposure to induce immunotolerance and down‑regulate pro‑inflammatory mediators (e.g., NF‑κB, JAK/STAT) .


Antibacterial Activity


In vitro studies demonstrate that Abevac exhibits significant bactericidal effects against Gram‑positive bacteria—S. aureus, MRSA, B. cereus, and S. pyogenes—with minimum inhibitory concentrations as low as 15.5 µg/ml, outperforming penicillin in disc diffusion assays (inhibition zones up to 21.4 mm) .


Dosage & Administration


Immunotherapy Schedule


Clinical protocols (e.g., for chronic HCV patients treated intradermally) have employed escalating doses starting at 300 µg/ml twice weekly for up to 12 months, following a rush‑immunotherapy schedule during the first week . While rheumatoid arthritis regimens vary, intradermal injections are typically administered under medical supervision at outpatient immunotherapy centers.


Administration Route


Abevac must be administered via intradermal injection only, by a trained healthcare professional, with resuscitation equipment on hand due to anaphylaxis risk .


Clinical & Preclinical Studies


Antibacterial Efficacy: Demonstrated superior potency to penicillin against Gram‑positive pathogens in disc diffusion and MIC assays .


Immunological Effects: In a human study on chronic HCV patients, intradermal bee‑venom injections led to significant increases in IgG levels and decreased IgE, ALT, and AST over 12 months, with 37 % of participants achieving undetectable HCV RNA .


Anti‑Arthritic Activity: Animal models using complete Freund’s adjuvant–induced arthritis showed that systemic bee‑venom (60 mg/kg) reduced joint swelling, ESR, TNF‑α, and IL‑1β, comparable to methotrexate, and attenuated NF‑κB activation in synovium .


Traditional Use: Historical records trace bee‑venom therapy to ancient Egypt and Greece, and modern reviews confirm its anti‑inflammatory properties via IRAK2/TAK1/NF‑κB and RANKL/RANK pathway modulation .



Safety, Side Effects & Precautions


Common Reactions & Risks


Local reactions (redness, swelling, itching) occur in most patients; systemic effects can include nausea, dizziness, hypotension, and very rarely anaphylaxis .


Contraindications & Monitoring


Absolute: Known allergy to bee venom or components.


Relative: Pregnancy (use reduced maintenance doses), immunosuppression, cardiovascular instability .

All patients require observation for at least 30 minutes post‑injection.



Storage & Handling


Store lyophilized Abevac vials in a cool, dry place away from light; reconstitute with water for injection immediately before use .



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References


Vacsera Holding Co. for Biological Products & Vaccines: Abevac presentation details 


Yousef SM, et al. Abevac antibacterial study against Gram‑positive bacteria (2016) 


Elfiky AA, et al. Immunological effects of Abevac in chronic HCV patients (2013) 


Therapeutic potential reviews and mechanistic st

udies on bee venom in arthritis 


WebMD: Bee‑venom safety and side effects 



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