Generic Name

Qulipta

Mechanism

Qulipta (ubrogepant) is a calcitonin gene‑related peptide (CGRP) receptor antagonist.
• It selectively blocks the CGRP receptor on trigeminal neurons and vascular smooth muscle, preventing CGRP‑mediated vasodilation and nociceptive transmission.
• Unlike triptans, it does not induce vasoconstriction of non‑brain vessels, reducing cardiovascular risk in migraineurs.

Pharmacokinetics

• Absorption: Rapid oral absorption; peak plasma concentration (Cmax) at ~3 h (Tmax).
• Bioavailability: ~31 % (dose‑dependent, 2–10 mg).
• Distribution: Plasma protein binding ~96 %.
• Metabolism: Primarily hepatic via CYP3A; minor CYP2D6 contribution.
• Elimination: 80 % excreted unchanged in bile/intestinal tract; 20 % renal (no dose adjustment needed in mild–moderate CKD).
• Half‑life: ~3 h (steady‑state reached after ~1 day).
• Drug interactions:
• Strong CYP3A inhibitors (e.g., ketoconazole) ↑ ubrogepant exposure (contraindicated).
• Strong CYP3A inducers (e.g., rifampin) ↓ exposure (may necessitate higher dose, not recommended).
• No clinically relevant interaction with triptans or NSAIDs.

Indications

• Episodic migraine (with or without aura) in adults, *≥15 days/month* in prior 3 months.
• Status migrainosus (persistent migraine ≥72 h) in adults, *in combination with oral/IV NSAIDs or triptans*.

Contraindications

• Known hypersensitivity to ubrogepant or any component.
• Severe hepatic impairment (Child‑Pugh C).
• Pregnancy: Category B; avoid unless benefits outweigh risks.
• Cardiovascular disease: While lower CV risk than triptans, counsel patients with known coronary artery disease or uncontrolled hypertension regarding potential mild elevation in blood pressure.
• Use with strong CYP3A inhibitors or inducers: Not recommended.

Warnings
• Angioedema: Rare but potentially life‑threatening.
• Abdominal pain: Monitor if concurrent NSAID use.
• Drug‑safety monitoring: Not required for routine therapy, but monitor vitals during first few doses in patients with CV risk.

Dosing

• Standard dose: 10 mg orally once daily (maximum *1 dose/day*).
• If inadequate response after 3 days: add 5 mg once daily (reduce 10 mg dose).
• Route: Oral tablets.
• Timing: Take with or without food; food may delay absorption slightly.
• Missed dose: Take as soon as remembered; do not double‑dose.

Adverse Effects

Common (≥10 %)
• Nausea
• Constipation
• Dizziness
• Fatigue
• Upper respiratory infection

Serious (≤1 %)
• Hypotension (orthostatic)
• Angioedema
• Severe abdominal pain
• Acute pancreatitis (rare)

Monitoring

• Baseline: Vital signs, kidney function (eGFR), liver enzymes.
• During therapy:
• Cardiac status in high‑risk patients (BP, heart rate).
• Watch for signs of angioedema.
• LFTs if prolonged daily use >3 months.
• Follow‑up: Re‑evaluate migraine frequency after 3 months to assess efficacy.

Clinical Pearls

• CGRP‑antagonist advantage: Safe in patients with cardiovascular disease where triptans are contraindicated.
• Once‑daily dosing simplifies adherence compared with 2–3 day regimens of many triptans.
• Drug‑interaction caution: Because ubrogepant is CYP3A‑dependent, check for strong inhibitors (ketoconazole, clarithromycin) or inducers (rifampin, carbamazepine).
• Use in situ: For status migrainosus, combine with an NSAID or triptan; the addition improves pain-free rates without additive CV
• Switching: Patients previously on triptans can switch to Qulipta without a washout period, but remain watchful for cumulative hypotension.
• Pregnancy & lactation: Limited data; avoid in early pregnancy unless clearly indicated.
• Patient counseling: Emphasize mild GI upset is common and usually self‑limiting; advise adequate hydration, especially during high‑dose episodes.

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• *References: FDA Drug Label, 2023; Migraine Management Guidelines 2024.*