Fusafungine
Also known as: Bioparox, Fusafungina, Fusafungine, Locabiosol, Locabiotal, Rhinofluimucil
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Summary
Fusafungine is a mixture of cyclic octapeptide antibiotics derived from Fusarium species, formerly formulated as a nasal spray for the symptomatic treatment of acute rhinitis. It was withdrawn from the market due to reports of severe allergic reactions, including anaphylaxis.
Mechanism of Action
Inhibits bacterial protein synthesis and exhibits anti‑inflammatory effects by reducing neutrophil chemotaxis and cytokine release in nasal mucosa
Routes of Administration
Goals & Uses
- Relief of nasal congestion and rhinorrheaSymptom ReliefModerate
- Treatment of acute pharyngitisENT/infectious DiseaseLow
- Local anti-inflammatory effect in upper airwaysAnti InflammatoryLow
- Treatment of acute rhinitis/sinusitisENT/infectious DiseaseLow
- Treatment of laryngitisENT/infectious DiseaseLow
Contraindications
- Known hypersensitivity to fusafungine or any component of the formulationAllergyHigh
- Children under 30 months of agePediatricHigh
- Severe asthma or chronic obstructive pulmonary diseaseRespiratoryModerate
- History of hypersensitivity to fusafungine or enniatinsAllergy/immunologyHigh
- Pregnancy (especially first trimester)ReproductiveModerate
- Asthma or severe bronchospasmRespiratoryHigh
Adverse Effects
- Nasal irritation / burning sensationLocalCommon
- AnaphylaxisImmunologicRareSevere life-threatening allergic reaction
- SneezingLocal ReactionCommon
- Epistaxis (nosebleed)Local/NasalUncommon
- BronchospasmRespiratoryRare
- Dysgeusia (altered taste)SensoryUncommon
- Anaphylaxis / severe hypersensitivityImmunologicRare
- Local nasal/throat irritationLocal ReactionCommon
- Urticaria / skin rashDermatologicUncommon
Drug Interactions
- Other inhaled corticosteroidsLow
Population Constraints
- Elderly patients with reactive airwaysGeriatricRelative
- Patients with atopic history or asthmaAllergy/respiratoryRelative
- Pediatric patients under 30 monthsPediatricAbsolute
- Pregnant or breastfeeding womenReproductiveRelative
- Children under 12 yearsAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionWithdrawnApproved: acute rhinitisWithdrawn in 2016 due to severe allergic reactions
- United StatesUnapprovedNever submitted for FDA approval
- United KingdomWithdrawnApproved: Upper respiratory tract infectionsFollowed EMA withdrawal decision; no longer marketed.
Withdrawn in the EU (2016) and many other jurisdictions because of risk of serious hypersensitivity reactions; never approved in the United States.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Fusafungine?
Fusafungine is a mixture of cyclic octapeptide antibiotics derived from Fusarium species, formerly formulated as a nasal spray for the symptomatic treatment of acute rhinitis. It was withdrawn from the market due to reports of severe allergic reactions, including anaphylaxis.
What is Fusafungine used for?
Fusafungine is educationally associated with: Relief of nasal congestion and rhinorrhea, Treatment of acute pharyngitis, Local anti-inflammatory effect in upper airways, Treatment of acute rhinitis/sinusitis, Treatment of laryngitis. Educational only — not medical advice.
How is Fusafungine administered?
Recorded routes of administration: Intranasal, Nasal, Oropharyngeal Inhalation.
What are the potential side effects of Fusafungine?
Reported adverse effects include: Nasal irritation / burning sensation, Anaphylaxis, Sneezing, Epistaxis (nosebleed), Bronchospasm, Dysgeusia (altered taste), Anaphylaxis / severe hypersensitivity, Local nasal/throat irritation, Urticaria / skin rash. This list is not exhaustive — consult a qualified clinician.
Who should avoid Fusafungine?
Recorded contraindications: Known hypersensitivity to fusafungine or any component of the formulation, Children under 30 months of age, Severe asthma or chronic obstructive pulmonary disease, History of hypersensitivity to fusafungine or enniatins, Pregnancy (especially first trimester), Asthma or severe bronchospasm. Consult a qualified clinician before use.