zavegepant intranasal (Rx)

Brand and Other Names:Zavzpret

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal solution

  • 10mg/spray

Migraine

Indicated for acute treatment of migraine with or without aura

10 mg single spray in 1 nostril PRN

Not to exceed 10 mg/24 hr period

Safety of treating >8 migraines/30 days has not been established

Dosage Modifications

Renal impairment

  • CrCl ≥30 mL/min: No dosage adjustment necessary
  • CrCl <30 mL/min: Avoid use; not studied

Hepatic impairment

  • Mild or moderate (Child-Pugh A or B): No dosage adjustment necessary
  • Severe (Child-Pugh C): Avoid use

Dosing Considerations

Limitation of use

  • Not indicated for migraine prevention

Safety and efficacy not established

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Interactions

Interaction Checker

and zavegepant intranasal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (29)

              • clarithromycin

                clarithromycin will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • cyclosporine

                cyclosporine will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 and NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP13B and NTCP substrate).

              • daclatasvir

                daclatasvir will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • encorafenib

                encorafenib will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • erythromycin base

                erythromycin base will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • ezetimibe

                ezetimibe will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • fostemsavir

                fostemsavir will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • indomethacin

                indomethacin will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • irbesartan

                irbesartan will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • levocarnitine

                levocarnitine will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • naphazoline

                naphazoline will decrease the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of intranasal decongestants with zavegepant intranasal. If unavoidable, administer intranasal decongestants at least 1 hr after zavegepant.

              • oxymetazoline intranasal

                oxymetazoline intranasal will decrease the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of intranasal decongestants with zavegepant intranasal. If unavoidable, administer intranasal decongestants at least 1 hr after zavegepant.

              • phenylephrine nasal

                phenylephrine nasal will decrease the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of intranasal decongestants with zavegepant intranasal. If unavoidable, administer intranasal decongestants at least 1 hr after zavegepant.

              • pioglitazone

                pioglitazone will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • propylhexedrine

                propylhexedrine will decrease the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of intranasal decongestants with zavegepant intranasal. If unavoidable, administer intranasal decongestants at least 1 hr after zavegepant.

              • rifampin

                rifampin will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • rifamycin

                rifamycin will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • rosiglitazone

                rosiglitazone will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • simvastatin

                simvastatin will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • sulfasalazine

                sulfasalazine will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              • trofinetide

                trofinetide will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Trofinetide (an OATP131 and OATP13B inhibitor) may increase plasma levels of OATP131 or OATP13B substrates. Avoid coadministration with sensitive substrates.

              • velpatasvir

                velpatasvir will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • voxilaprevir

                voxilaprevir will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. OATP1B3 inhibitors may result in a significant increase in systemic exposure of zavegepant (an OATP1B3 substrate).

              • xylometazoline

                xylometazoline will decrease the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of intranasal decongestants with zavegepant intranasal. If unavoidable, administer intranasal decongestants at least 1 hr after zavegepant.

              • zafirlukast

                zafirlukast will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  Taste disorder (18%)

                  1-10%

                  Nausea (4%)

                  Nasal discomfort (3%)

                  Vomiting (2%)

                  <1%

                  Hypersensitivity, including facial swelling and urticaria

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                  Warnings

                  Contraindications

                  History of hypersensitivity to zavegepant or other ingredients

                  Cautions

                  Hypersensitivity reactions reported, including facial swelling and urticaria; initiate appropriate therapy if hypersensitivity occurs

                  Ask patient to discuss prescription, OTC medications, or herbal supplements that they take or plan to take

                  Drug interaction overview

                  • Substrate of OATP1B3 and NTCP
                  • OATP1B3 or NTCP inhibitors
                    • Avoid coadministration
                    • Inhibitors of organic anion transporting polypeptide 1B3 (OATP1B3) or sodium taurocholate cotransporting polypeptide (NTCP) transporters may significantly increase zavegepant exposure
                  • OATP1B3 or NTCP inducers
                    • Avoid coadministration
                    • Inducers of OATP1B3 or NTCP transporters may decrease zavegepant exposure
                  • Intranasal decongestants
                    • Dosage modification
                    • Avoid coadministration; if unavoidable, administer intranasal decongestants at least 1 hr after zavegepant
                    • Coadministration may decrease systemic exposure and efficacy of zavegepant
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                  Pregnancy & Lactation

                  Pregnancy

                  Data are not available on developmental risk associated with the use in pregnant females

                  Animal studies

                  • No adverse developmental effects have been observed following SC administration to pregnant animals at doses associated with plasma exposures higher than those used clinically

                  Clinical considerations

                  • Data suggest that women with migraine may be at increased risk for preeclampsia and gestational hypertension during pregnancy

                  Lactation

                  Data are unavailable regarding the presence of zavegepant or its metabolites in human milk, effects on breastfed infants, or effects on milk production

                  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

                  Calcitonin gene-related peptide (CGRP) receptor antagonist; binds to CGRP receptor, which is thought to be causally involved in migraine pathophysiology

                  Absorption

                  Peak plasma concentration: ~30 minutes

                  Absolute bioavailability: ~5%

                  Distribution

                  Protein bound: ~90%

                  Vd: 1774 L

                  Metabolism

                  Metabolized primarily by CYP3A4 and to a lesser extent by CYP2D6

                  Unchanged zavegepant was most prevalent (~90%) circulating component in human plasma

                  No major metabolites (ie, >10%) were detected in plasma

                  Elimination

                  Half-life: 6.55 hr

                  Clearance: 266 L/hr

                  Excretion

                  • Primarily excreted via biliary/fecal route
                  • Feces ~80%; urine 11% (recovered as unchanged drug after single 5-mg IV dose)
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                  Administration

                  Intranasal Administration

                  Do not test spray, prime, or press plunger before use

                  Each individual unit only sprays 1 time and cannot be reused

                  For intranasal use only

                  Storage

                  Store at controlled room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

                  Do not freeze

                  Do not test spray, prime, or press plunger before use

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  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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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.