Vosevi
Vosevi
Generic Name
Vosevi
Mechanism
- Budesonide nanoparticle formulation:
- The aerosolized drug penetrates the nasal mucosa and is retained on the mucosal surface for up to 24 h.
- *Intracellular*: Budesonide binds to glucocorticoid receptors, translocates to the nucleus, and modulates transcription of anti‑inflammatory genes while inhibiting pro‑inflammatory cytokines (IL‑4, IL‑5, IL‑13).
- Reduced systemic exposure:
- Nanoparticles limit systemic absorption, lowering the risk of adrenal suppression seen with systemic steroids.
Pharmacokinetics
| Parameter | Vosevi (budesonide) |
| Absorption | Nasal mucosal uptake; first‑pass hepatic metabolism predominantly via CYP3A4. |
| Bioavailability | ~1 % systemic. |
| Half‑life | 3‑5 h (systemic), ~12 h (nasal depot). |
| Elimination | Urinary conjugates; excreted <2 % unchanged. |
| Drug interactions | Strong CYP3A4 inhibitors (e.g., ketoconazole) may increase systemic budesonide exposure; conversely, CYP3A4 inducers (e.g., rifampin) may reduce efficacy. |
Indications
- Chronic rhinosinusitis without nasal polyposis (CRSsNP):
- Adults and adolescents 12 y+.
- Improves endoscopic, symptom, and quality‑of‑life metrics over 12 weeks.
- Allergic rhinitis (seasonal or perennial):
- Adjunct to antihistamines/alumina for moderate‑to‑severe symptoms.
> *Note*: Not approved for acute sinusitis or for use as a reliever in asthma.
Contraindications
| Category | Key Points |
| Contraindications |
• Known hypersensitivity to budesonide or any excipient. • Current or recent history of invasive fungal sinus infection. |
| Warnings / Precautions |
• Immunocompromised patients: monitor for opportunistic infections. • Adrenal suppression: rare; consider tapering if using high‑dose oral steroids concurrently. • Pregnancy: Category B; use only if benefits outweigh risks. • Pediatric use: Limited data below 12 y; reserve for severe cases. |
Dosing
- Adults & Adolescents ≥12 y
- Standard dose: 4 sprays (200 µg) once daily for 12 weeks.
- Maintenance: After 12 weeks, 2 sprays (100 µg) daily may be sufficient for symptom control.
- Application technique
- Tilt head back 15°.
- Place one spray in each nostril, aiming at the anterior third of the nasal cavity.
- Breathe in gently to allow aerosol deposition.
> *Tip*: Use a new syringe for each patient to avoid cross‑contamination.
Adverse Effects
Common (≤10 %)
• Local irritation: burning, tingling, dryness.
• Headache.
• Nasal obstruction or crusting.
Serious (≤1 %)
• Fungal sinusitis (especially in immunosuppressed).
• Systemic immunosuppression: adrenal suppression, weight gain, hyperglycemia (rare).
• Rare ocular effects: increased intra‑ocular pressure.
Monitoring
- Baseline & periodic:
- Nasal endoscopy (if severe CRS).
- Adverse effect check‑in: focus on fungal symptoms or systemic signs.
- If concomitant systemic steroids: consider morning serum cortisol.
- Adrenal axis: Not routinely required unless long‑term systemic steroids are used concurrently.
Clinical Pearls
- Nanoparticle delivery is the secret – the prolonged mucosal residence time explains the superior efficacy of Vosevi compared to older intranasal steroids of similar potency.
- Patient counseling: Emphasize that *a full 12‑week course is critical* for measurable benefit; stepping down earlier often leads to recurrence.
- Combination therapy: In severe CRS, Vosevi can be used alongside oral antibiotics or a short course of oral steroids for a rapid response, then tapered off the oral agent.
- Use in pregnancy: Because of low systemic bioavailability, Vosevi remains a reasonable option when topical alternatives are ineffective.
- Adherence tips: Encourage daily dosing at the same time; consider using a scheduled reminder or a small diary.
- Storage: Keep in the refrigerator when not used; return to room temperature 24 h before use to avoid temperature‑induced potency loss.
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