dihydroergotamine intranasal (Rx)

Brand and Other Names:Migranal
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal solution

  • 0.5mcg/actuation (4mg/ampule with intranasal sprayer)
  • Also contains caffeine (10 mg/ampule; 1.25mg/actuation)
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Migraine Headache

Indicated for acute treatment of migraine with or without aura

1 spray (0.5 mg) in each nostril, repeat after 15-30 minutes for a total of 4 sprays (2 mg); not to exceed 6 sprays (3mg)/24 hr or 8 sprays (4 mg)/week

Dosing Considerations

Not intended for prophylaxis of migraine

Not for chronic, daily use

Not for management of hemiplegic or basilar migraine

Administration

Prior to administration, the pump must be primed (ie, squeeze 4 times) before use

Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial) after 8 hr

Store below 25°C (77°F)

Do not refrigerate or freeze

Safety and efficacy not established

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Interactions

Interaction Checker

and dihydroergotamine intranasal

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Rhinitis (26%)

            1-10%

            Nausea (10%)

            Altered taste (8%)

            Application site reactions (6%)

            Vomiting (4%)

            Somnolence (3%)

            Paraesthesia (2%)

            Pharyngitis (3%)

            Diarrhea (2%)

            Sinusitis (1%)

            Hot flashes (1%)

            Fatigue (1%)

            Asthenia (1%)

            Dry mouth (1%)

            Stiffness (1%)

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            Warnings

            Black Box Warnings

            Serious and/or life-threatening peripheral ischemia has been reported with coadministration of this drug with potent CYP 3A4 inhibitors (including protease inhibitors and macrolide antibiotics)

            Because CYP3A4 inhibition elevates the serum ergotamine levels, the risk of vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased

            Concurrent use of these potent CYP3A4 inhibitors are contraindicated

            Contraindications

            Hypersensitivity

            Peripheral vascular disease, severe hepatic/renal impairment, ischemic heart disease, uncontrolled hypertension, sepsis, pregnancy, breastfeeding women

            Recent vascular surgery

            Hemiplegic or basilar migraine

            Coadministration with potent CYP3A4 inhibitors

            Peripheral or central vasoconstrictors

            Cautions

            Coadministration with less potent CYP3A4 inhibitors

            Fibrotic complications reported (pleural and retroperitoneal fibrosis with prolonged parenteral use)

            May cause coronary vasospasm

            Avoid in patients with unrecognized CAD (ie, patient with risk factors)

            May cause vasospastic reactions including myocardial, peripheral vascular, and colonic ischemia

            May elevate blood pressure

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: Contraindicated; excreted in human milk and is known to inhibit prolactin

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Binds with high affinity to 5-HT-1Dα and 5-HT-1Dβ; also bind to serotonin 5-HT-1A, -2A, and -2C receptors, noradrenaline α2A, α2B, and alpha receptors, and dopamine D2L and D3 receptors

            Therapeutic activity attributed to agonist effect at 5-HT-1D receptors, which includes vasoconstriction of intracranial blood vessels, or activation of 5-HT1D may inhibit proinflammatory neuropeptide release

            Absorption

            Bioavailability: 32%

            Distribution

            Protein bound: 93%

            Vd: 800 L

            Metabolism

            Metabolites: 8'-β-hydroxydihydroergotamine (active); metabolites represent 20-30% of plasma AUC

            Elimination

            Half-life: 10 hr

            Renal clearance: 0.1 L/min

            Total body clearance: 1.5 mL/min

            Excretion: Major excretory route is in the bile and feces; urine 2%

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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