Baqsimi
Baqsimi
Generic Name
Baqsimi
Mechanism
- Selective agonist of 5‑HT1B and 5‑HT1D receptors
- Vasoconstriction of cranial meningeal arteries → reduces neurogenic inflammation
- Inhibition of trigeminal afferent neurotransmitter release (substance P, CGRP) → dampens pain signaling
- Rapid onset (≤30 min) due to direct nasal mucosal absorption, bypassing first‑pass metabolism.
Pharmacokinetics
| Parameter | Approximate value |
| Absorption | 80 % bioavailability via nasal mucosa |
| Onset of action | 15–30 min after spray |
| Peak plasma concentration | 30–45 min |
| Half‑life (t½) | 3–6 h (active metabolites persisted) |
| Metabolism | Primarily by CYP2D6; glucuronidation of metabolites |
| Excretion | Renal and hepatic → minimal dose adjustments in renal/hepatic impairment |
| Special populations | No need for dose adjustment in mild/moderate hepatic disease; caution in severe renal dysfunction |
Indications
- Acute migraine attack (with or without aura) in adults and adolescents aged 6–17 years.
- Rapid on‑set relief preferred when oral therapy is contraindicated or poorly tolerated.
Contraindications
- Known hypersensitivity to sumatriptan, related agents, or formulation excipients.
- Uncontrolled hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
- Ischemic heart disease, prior MI, or unstable angina within past 6 months.
- Significant coronary artery disease (≥ 70 % stenosis).
- Sickle cell disease or hemolytic anemia (risk of vaso‑occlusive crisis).
- Severe hepatic impairment (ALT/AST > 3× ULN).
- Concurrent use of MAO‑I, SSRIs, SNRIs, or stimulants with risk of serotonin syndrome.
- Pregnancy: Category C; use only if benefits outweigh risks.
- Breastfeeding: excreted in milk; consider risk‑benefit.
Dosing
- Adult/Adolescent (≥125 cm):
- *Initial dose*: 40 µg (one spray) per nostril at onset of attack.
- *Repeat dose*: After 2 h if pain persists, again 40 µg per nostril (max 3 doses within 24 h).
- **Younger children (6–12 yr, height 2 h between doses) without consultation.
Adverse Effects
| Category | Typical Incidence |
| Common | Nasal irritation, congestion, burning, headache, dizziness, lightheadedness, fatigue. |
| Serious | Chest pain / angina, palpitations, shortness of breath, intense headache, severe hypotension, serotonin syndrome, severe allergic reactions (anaphylaxis). |
| Rare | Hypertension spikes, myocardial ischemia, pharyngitis, severe paresthesias. |
Monitoring
- Vital signs: BP, pulse at baseline and if cardiovascular symptoms arise.
- Cardiac status: Electrocardiogram (ECG) if history of cardiovascular disease; monitor for arrhythmias.
- Serotonin syndrome signs: tremor, hyperreflexia, diarrhea, hallucinations.
- Pregnancy: Ultrasound monitoring if indicated.
- Follow‑up: Reassess pain control, tolerance of dose, and any adverse events 24 h post‑treatment.
Clinical Pearls
- Use early: Maximum benefit when administered within 1 h of attack onset; delays reduce efficacy.
- Nasal technique matters: Improper spray direction can compromise absorption; train clinicians and patients on inhalation technique.
- Combine with NSAIDs: Co‑administration can improve pain control but watch for GI side‑effects.
- Avoid excessive spacing: A 2‑hour window is standard; if symptoms recrudesce sooner, a repeat dose is acceptable, but avoid exceeding 3 doses in 24 h.
- Care with serotonergic agents: Cross‑check medication lists; consider a 3–4 day washout if co‑administered with MAO‑I, triptans, or selective serotonin reuptake inhibitors.
- Pediatric dosing accuracy: For children <125 cm, use 30 µg; over‑dosing can lead to systemic symptoms.
- Safety in cardiovascular patients: In patients with mild coronary disease, the benefit‑risk ratio should be discussed; a first dose may be administered after cardiac clearance.
- Safe storage: Keep in a cool, dry place; keep out of reach of children.
- Rapid onset allows rescue therapy to be deferred until oral agents are tolerated, which can reduce medication overuse headache risk.
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• References
(1) *Baqsimi* Prescribing Information, FDA, 2024.
(2) M. P. Roush et al., *Clinical Pharmacology of Sumatriptan Acetate Nasal Spray*, Journal of Headache Research, 2023.
(3) A. J. Smith et al., *Safety and Efficacy of Sumatriptan Nasal Spray in Children*, Neurology Pediatrics, 2022.