atogepant (Rx)

Brand and Other Names:Qulipta
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg
  • 30mg
  • 60mg

Migraine

Indicated for preventive treatment of episodic migraine

10 mg, 30 mg, or 60 mg PO qDay with or without food

Dosage Modifications

Dosage modifications for drug interactions

  • Coadministration with strong CYP3A4 inhibitors: 10 mg PO qDay
  • Coadministered with moderate or weak CYP3A4 inhibitors: No dosage adjustment necessary
  • Coadministration with strong and moderate CYP3A4 inducers: 30 or 60 mg PO qDay
  • Coadministration with organic anion transporting polypeptide (OATP) inhibitors: 10 or 30 mg PO qDay

Renal impairment

  • Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl 15-29 mL/min) and end-stage renal disease (ESRD) (CrCl <15 mL/min): Not studied; use lowest dose (10 mg qDay)
  • ESRD undergoing intermittent dialysis: Take dose after dialysis

Hepatic impairment

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

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and atogepant

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (45)

                • acetaminophen

                  acetaminophen will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • acetaminophen IV

                  acetaminophen IV will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • acetazolamide

                  acetazolamide will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • alprazolam

                  alprazolam will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • amiodarone

                  amiodarone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • aprepitant

                  aprepitant will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • atazanavir

                  atazanavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • bicalutamide

                  bicalutamide will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • ceritinib

                  ceritinib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • chloramphenicol

                  chloramphenicol will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • clarithromycin

                  clarithromycin will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • clotrimazole

                  clotrimazole will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • clozapine

                  clozapine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • cobicistat

                  cobicistat will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • conivaptan

                  conivaptan will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • crizotinib

                  crizotinib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • cyclosporine

                  cyclosporine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • darunavir

                  darunavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • desipramine

                  desipramine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • diltiazem

                  diltiazem will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • dronedarone

                  dronedarone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                  elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • entacapone

                  entacapone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • erythromycin base

                  erythromycin base will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • erythromycin ethylsuccinate

                  erythromycin ethylsuccinate will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • erythromycin lactobionate

                  erythromycin lactobionate will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • erythromycin stearate

                  erythromycin stearate will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • fedratinib

                  fedratinib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • grapefruit

                  grapefruit will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • idelalisib

                  idelalisib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • indinavir

                  indinavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • isoniazid

                  isoniazid will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • itraconazole

                  itraconazole will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • ketoconazole

                  ketoconazole will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • lonafarnib

                  lonafarnib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • mifepristone

                  mifepristone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • nefazodone

                  nefazodone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • nelfinavir

                  nelfinavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • posaconazole

                  posaconazole will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • quinupristin/dalfopristin

                  quinupristin/dalfopristin will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                • ritonavir

                  ritonavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • rucaparib

                  rucaparib will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • saquinavir

                  saquinavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • tipranavir

                  tipranavir will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                • voriconazole

                  voriconazole will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Recommended atogepant dosage is 10 mg PO qDay when coadministered with strong CYP3A4 inhibitors.

                Minor (0)

                  Previous
                  Next:

                  Adverse Effects

                  1-10%

                  Nausea (5-9%)

                  Constipation (6%)

                  Fatigue/somnolence (4-6%)

                  Decreased weight (3.2-4.9%)

                  Decreased appetite (1-2%)

                  Elevated AST/ALT (1%)

                  <1%

                  Constipation (0.5%)

                  Nausea (0.5%)

                  Fatigue/somnolence (0.5%)

                  Previous
                  Next:

                  Warnings

                  Contraindications

                  None

                  Cautions

                  Drug interaction overview

                  • Substrate of CYP3A4, OATP1B1, OATP1B3, and OAT1
                  • CYP3A4 inhibitors
                    • Coadministered with strong CYP3A4 inhibitors: Recommended atogepant dosage is 10 mg qDay
                    • Coadministered with moderate or weak CYP3A4 inhibitors: No dosage adjustment necessary
                    • CYP3A4 inhibitors may increase exposure of atogepant
                  • CYP3A4 inducers
                    • Coadministration with strong or moderate CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort, efavirenz, etravirine): Recommended atogepant dosage is 30 or 60 mg qDay
                    • Coadministration with weak CYP3A4 inducers: No dosage adjustment necessary
                    • CYP3A4 inducers may decrease exposure of atogepant
                  • OATP inhibitors
                    • Coadministration with OATP inhibitors (eg, cyclosporine): Recommended atogepant dosage is 10 or 30 mg qDay
                    • OATP inhibitor may increase in exposure of atogepant
                  Previous
                  Next:

                  Pregnancy & Lactation

                  Pregnancy

                  There are no adequate data on developmental risk associated with use in pregnant females

                  Published data suggest migraine may increase the risk of preeclampsia and gestational hypertension during pregnancy

                  Animal data

                  • Oral administration during organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically

                  Lactation

                  There are no data on presence of atogepant in human milk, effects on breastfed infants, or effects on milk production

                  In lactating rats, oral dosing resulted in levels of atogepant in milk ~2-fold higher than that in maternal plasma

                  Consider the developmental and health benefits of breastfeeding along with mother’s clinical need and any potential adverse effects on breastfed infant or from underlying maternal condition

                  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.

                  Previous
                  Next:

                  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 time: ~1-2 hr

                  Accumulation: None

                  Effect of food

                  • Administration with high-fat meal: AUC and Cmax reduced by ~18% and 22%, respectively, with no effect on median peak plasma time

                  Distribution

                  Protein bound: ~4.7% (unbound)

                  Vd: 292 L

                  Metabolism

                  Primarily metabolized by CYP3A4

                  Parent compound (atogepant) and a glucuronide conjugate metabolite (M23) were the most prevalent circulating components in human plasma

                  Elimination

                  Half-life: ~11 Hr

                  Clearance: 19 L/hr

                  Excretion (unchanged atogepant): 42% (feces); 5% (urine)

                  Previous
                  Next:

                  Administration

                  Oral Administration

                  Take with or without food

                  Storage

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

                  Previous
                  Next:

                  Images

                  No images available for this drug.
                  Previous
                  Next:

                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
                  Previous
                  Next:

                  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.
                  • Manage and view all your plans together – even plans in different states.
                  • 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.
                  Additional Offers
                  Email to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

                  Email Forms to Patient

                  From:

                  To:

                  The recipient will receive more details and instructions to access this offer.

                  By clicking send, you acknowledge that you have permission to email the recipient with this information.

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