Dihydroergotamine
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of BREKIYA with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ].
WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS See full prescribing information for complete boxed warning. Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of BREKIYA with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ].
Dosing in kidney impairment
4 CONTRAINDICATIONS BREKIYA is contraindicated in patients: with concomitant use of strong CYP3A4 inhibitors [see Warnings and Precautions and Drug Interactions ] with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina [see Warnings and Precautions ] with uncontrolled hypertension [see Warnings and Precautions ] with peripheral arterial disease with sepsis following vascular surgery with severe hepatic impairment with severe renal impairment with known hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in BREKIYA [see Warnings and Precautions ] with recent use (i.e., within 24 hours) of other 5-HT 1 agonists, ergotamine-containing or ergot-type medications [see Drug Interactions ] with concomitant use of peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure [see Warnings and Precautions ] Concomitant use of strong CYP3A4 inhibitors Ischemic heart disease or coronary artery vasospasm Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment Concomitant use of other 5-HT 1 agonists or ergotamine-containing or ergot-type medications within 24 hours Hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in BREKIYA Concomitant use with peripheral and central vasoconstrictors 5 WARNINGS AND PRECAUTIONS Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities: In patients with risk factors predictive of coronary artery disease, consider first dose administration under medical supervision with an electrocardiogram.
Preparation and administration
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Important Administration Instructions See the “Instructions for Use” for detailed steps for administering the subcutaneous injection using the autoinjector. Preparation BREKIYA is a prefilled, single-dose disposable autoinjector intended to be given subcutaneously into the skin of the middle thigh. Rotate injection sites.
Choose an injection site at least 2 inches away from the last injection site. Do not inject into moles, scars, birthmarks, or areas where the skin is tender, bruised, red, or hard. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Carefully examine the liquid medication for discoloration, cloudiness, floating flakes or particles. Administer only if clear and colorless. Administration Remove the red needle cap by pulling it straight off. Position the autoinjector straight onto the cleaned injection site with the white safety guard resting on the skin.
Push the autoinjector down and press and release the gray activation button to start the injection. A “click” will sound when the injection starts. The autoinjector takes approximately 10 seconds to deliver the dose; when the viewing window is fully blocked (completely blue), the full dose has been administered.
Drug interactions
Check dihydroergotamine against a medication listLabel text (7 paragraphs)
Beta Blockers/Nicotine: May potentiate/provoke vasoconstriction. ( 7.3 , 7.5 ) Selective Serotonin Reuptake Inhibitors: Weakness, hyperreflexia, and incoordination may occur with coadministration. ( 7.6 )
7.1 CYP3A4 Inhibitors There have been rare reports of serious adverse events in connection with the coadministration of intravenous administration of dihydroergotamine and strong CYP3A4 inhibitors resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities [see Warnings and Precautions (5.1) ]. The use of strong CYP3A4 inhibitors with BREKIYA is contraindicated [see Contraindications (4) ]. Administer moderate CYP3A4 inhibitors with caution.
7.2 Triptans Triptans (serotonin [5-HT 1B/1D receptor agonists) have been reported to cause coronary artery vasospasm, and its effect could be additive with BREKIYA. Therefore, triptans and BREKIYA should not be taken within 24 hours of each other [see Contraindications (4) ].
7.3 Beta Blockers There have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
7.4 Vasoconstrictors BREKIYA is contraindicated for use with peripheral and central vasoconstrictors because the combination may cause synergistic elevation of blood pressure [see Warnings and Precautions (5.5) ].
7.5 Nicotine Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy [see Warnings and Precautions (5.4) ] .
7.6 Selective Serotonin Reuptake Inhibitors Weakness, hyperreflexia, and incoordination have been reported rarely when 5-HT 1 agonists have been co-administered with selective serotonin reuptake inhibitors (SSRI’s) (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline).
Contraindications
4 CONTRAINDICATIONS BREKIYA is contraindicated in patients: with concomitant use of strong CYP3A4 inhibitors [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina [see Warnings and Precautions (5.4) ] with uncontrolled hypertension [see Warnings and Precautions (5.5) ] with peripheral arterial disease with sepsis following vascular surgery with severe hepatic impairment with severe renal impairment with known hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in BREKIYA [see Warnings and Precautions (5.9) ] with recent use (i.e., within 24 hours) of other 5-HT 1 agonists, ergotamine-containing or ergot-type medications [see Drug Interactions (7.2) ] with concomitant use of peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure [see Warnings and Precautions (5.5) ] Concomitant use of strong CYP3A4 inhibitors ( 4 ) Ischemic heart disease or coronary artery vasospasm ( 4 ) Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment ( 4 ) Concomitant use of other 5-HT 1 agonists or ergotamine-containing or ergot-type medications within 24 hours ( 4 ) Hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in BREKIYA (4) Concomitant use with peripheral and central vasoconstrictors ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from published literature indicate an increased risk of preterm delivery with dihydroergotamine, the active moiety in BREKIYA, use during pregnancy. Avoid use of BREKIYA during pregnancy [see Warnings and Precautions (5.7) ] . Data collected over decades have shown no increased risk of major birth defects or miscarriage with the use of dihydroergotamine mesylate during pregnancy .
In animal reproduction studies, adverse effects on development were observed following administration of dihydroergotamine mesylate during pregnancy (decreased fetal body weight and/or skeletal ossification) in rats and rabbits or during pregnancy and lactation in rats (decreased body weight and impaired reproductive function in the offspring) at doses that were not associated with maternal toxicity (see Data). The estimated rate of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Intranasal administration of dihydroergotamine mesylate to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weight and/or skeletal ossification at doses of 0.16 mg/day or greater.
A no-effect level for adverse effects on embryofetal toxicity was not identified in rats. Intranasal administration of dihydroergotamine mesylate to pregnant rabbits throughout organogenesis resulted in decreased skeletal ossification at 3.6 mg/day. The no-effect dose for adverse effects on embryofetal toxicity in rabbits was 1.2 mg/day. Intranasal administration of dihydroergotamine mesylate to female rats throughout pregnancy and lactation resulted in decreased body weight and impaired reproductive function (decreased mating indices) in the offspring at doses of 0.16 mg/day or greater. A no-effect dose for adverse developmental effects in rats was not established.
Effects on offspring development occurred at doses below those that produced evidence of maternal toxicity in these studies. Dihydroergotamine-induced intrauterine growth retardation…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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