Inoserp PAN-AFRICA







It is a sterile, highly purified lyophilized preparation of equine F(ab´)2 immunoglobulin fragments neutralizing with high specificity the venoms.

Region


Is a polyvalent equine antivenom specifically indicated for the treatment of sub-Saharan African snake bites.




Species


  • Viperidae:

  • Bitis arietans, Bitis gabonica, Bitis nasicornis, Bitis rhinoceros, Echis leucogaster, Echis ocellatus, Echis pyramidum.

  • Elipidae:

  • Dendroaspis angusticeps, Dendroaspis jamesoni, Dendroaspis polylepis, Dendroaspis viridis, Naja haje, Naja katiensis, Naja melanoleuca, Naja nigricollis, Naja nubiae, Naja pallida, Naja senegalensis.


FREQUENT MEDICAL QUESTIONS & ANSWERS

  • What is the compositión of InoserpTM PAN-AFRICA?

    InoserpTM PAN-AFRICA is made of antibodies specifically targeting the most dangerous species of sub-Saharan Africa. InoserpTM PAN-AFRICA is a polyvalent antivenom because it covers several species.


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    InoserpTM PAN-AFRICA is composed of equine derived antibodies or immunoglobulin fragments F(ab’)2, which have been raised against the venoms of medically important species of the sub-Saharan region.

  • InoserpTM PAN-AFRICA protects against the envenomation of the most dangerous snake species of sub-Saharan Africa. Overall, 18 medical important snake species both viperids and elapids are covered as follows:

    Viperidae: Bitis arietans, Bitis gabonica, Bitis nasicornis, Bitis rhinoceros, Echis leucogaster, Echis ocellatus, Echis pyramidum.

    Elapidae: Dendroaspis angusticeps, Dendroaspis jamesoni, Dendroaspis polylepis, Dendroaspis viridis, Naja haje, Naja katiensis, Naja melanoleuca, Naja nigricollis, Naja nubiae, Naja pallida, Naja senegalensis.


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    A recent cross-neutralization study has shown that the antivenom actually covers 6 additional species through cross-neutralization: Atractaspis irregularis, Cerastes cerastes, Dispolidus typus, Naja anchieta, Naja annulifera, Naja mossambica. Overall, with 24 species, InoserpTM PAN-AFRICA provides the largest coverage of medically important species in sub-Saharan Africa(1).

  • Inosan Biopharma antivenoms have been designed to offer the best protection against the most medical important snake species and also the best safety to patients thanks to a high quality manufacturing process.


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    • Inosan Biopharma antivenoms are polyvalent and cover most species that are medically important for the relevant region. Venoms used for the immunization process come from species representative of the regions the antivenoms are intended for.
    • Inosan antivenoms are made of highly specific F(ab’)2(2), meaning that there is a high proportion of effective F(ab’)2 capable to specifically bind to the toxic components of the venoms and neutralize them. Thanks to its high specificity, Inosan antivenoms can include more species in one vial with less proteins.
    • Inosan Biopharma antivenoms are highly purified level with F(ab’)2 level reaching 95%(2). They have a low protein level (<10%, no more than 100 mg of protein per mL in the resuspended product) and are preservatives free.
  • InoserpTM< PAN-AFRICA benefits from the largest clinical evaluation done in sub-Saharan Africa compared to any other antivenom. All studies performed have shown that InoserpTM PAN-AFRICA rapidly reduces bleeding and neurotoxic disorders(3).


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    The rate of amputation and death has been shown to be very low following the use of InoserpTM PAN-AFRICA. In a recent independent review of the available clinical data, InoserpTM PAN-AFRICA appears in the short-list of polyvalent antivenoms available in sub-Saharan Africa with the most favorable benefit/risk ratio(4).

  • The large use and clinical studies performed so far have shown that InoserpTM PAN-AFRICA was very well tolerated. When occurring, adverse events are usually of mild intensity and resolve spontaneously or with treatment.


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    According to the clinical studies performed, adverse events have been reported in less than 10% of patients(5). They may include sweating, nausea, rashes, modest decrease in blood pressure, anaphylactoid reaction (allergic type) associated with facial erythema and cough. The risk of an anaphylactic shock cannot be excluded but remains very rare. Similar reactions to serum sickness may appear after around 6 days of the onset of the treatment. The clinical signs are fever, pruritus, erythema or urticaria, adenopathy, and arthralgia. However, this type of reactions is observed in less than 1% of the patients.

  • InoserpTM PAN-AFRICA should be administered as soon as possible after the first signs of envenomation in order to maximize its efficacy. The recommended dosage is 2 vials (through IV route). Further administration (2 vials) might be repeated as necessary.


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    InoserpTM PAN-AFRICA should be administered intravenously through slow direct injection of infusion. It is recommended to evaluate the patient every 2 hours after the initial administration and to renew administration (2 vials) as long as symptoms persist or are getting worse. A larger number of vials might be administered depending on the severity or the type of envenomation such as neurotoxic bites.

  • People who are allergic to equine origin proteins or to excipients contained in the product should not be administered the antivenom.


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    Due to the fatal risk associated with envenomation, Inosan Biopharma antivenoms may be dispensed in the specific population of allergic patients to equine origin proteins, provided that treatment for anaphylactic shock can be implemented immediately<.

  • Dosage should be the same for adults and children, irrespective of weight, because the same quantity of venom is injected.


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    Envenomation in children generally leads to more severe symptoms and a higher rate of lethality and sequelae. This is due to their small body weight and volume that lead to a lower dilution of venom. Available clinical data show that the safety and efficacy in the pediatric population is not different from the adults(4).

  • Inosan Biopharma antivenoms are lyophilized and can be stored at room temperature up to 30°C with excursions up to 40°C for reduced periods.


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    Inosan Biopharma antivenoms are lyophilized, this makes the management of the antivenom very convenient and inexpensive compared to liquid presentations, particularly in tropical regions.

  • The manufacturing process of Inosan Biopharma antivenoms complies with the highest GMP standards especially with regards to batch reproducibility and product stability.


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    Inosan Biopharma maintains GMP certification at all times from COFEPRIS, the Mexican agency, recognized by the WHO, for the qualification of manufacturers of vaccines and biological products. In addition, Inosan follows the guidelines for the manufacturing of antivenom products established by the WHO.



For more information, please contact: medinfo@inosanbiopharma.com

References...


(1) Martinez et Al. Preclinical evaluation of the polyspecific antivenom InoserpTM PAN-AFRICA against the venoms of elapids and viperids of sub-Saharan Africa region: neutralization of toxic activities. World congress of IST 2019.

(2) Mathé et Al. A new generation of F(ab’)2 antivenoms made of highly purified and specific immunoglobulin fragments. Venoms Toxins 2020.

(3) Chippaux et Al. Snakebites in Cameroon: Evaluation of snake antivenom in Africa (ESAA) and real life conditions. Venom Week 2022.

(4) Potet et Al. Reviewing evidence of the clinical effectiveness of commercially available antivenoms in sub-Saharan Africa identifies the need for a multi-centre, multi-antivenom clinical trial. PLOS NTD 2019.

(5) Chippaux et Al. Evaluation of a new polyvalent antivenom against snakebite envenomation (Inoserp® Panafricain) in two different epidemiological settings: Northern Benin and Maritime Guinea]. Médecine et Santé Tropicales 2015.