Dihydroergotamine is an ergotamine derivative sold in the U.S. under 6 brand and generic names, for cluster headache, postpartum hemorrhage and orthostatic hypotension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Brekiya (Autoinjector) (application NDA215400). Other dihydroergotamine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous injection only. ( 2.1 ) Recommended dosage is 1 mg administered subcutaneously as a single 1 mL autoinjector. ( 2.1 ) Do not exceed 3 mg (3 doses) in a 24-hour period. ( 2.1 ) Do not exceed 6 mg (6 doses) in a week. ( 2.1 ) Prior to initiation, a cardiovascular evaluation is recommended. ( 2.2 ) 2.1 Recommended Dosage BREKIYA autoinjector is for subcutaneous injection only. The recommended dose of BREKIYA is 1 mg administered subcutaneously via a single 1 mL autoinjector. The dose may be repeated, as needed, at 1-hour intervals to a total maximum of 3 mg (3 doses) in a 24-hour period. Do not exceed 6 mg (6 doses) total in a week. 2.2 Assessment Prior to First Dose Prior to initiation of BREKIYA, a cardiovascular evaluation is recommended [see Warnings and Precautions (5.3) ] . For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of BREKIYA take place in the setting of an equipped healthcare facility. 2.3 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…
The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors [see Boxed Warning and Warnings and Precautions (5.1) ] Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities [see Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions and Fatalities [see Warnings and Precautions (5.3) ] Other Vasospasm Related Adverse Reactions [see Warnings and Precautions (5.4) ] Increase in Blood Pressure [see Warnings and Precautions (5.5) ] Medication Overuse Headache [see Warnings and Precautions (5.6) ] Preterm Labor [see Warnings and Precautions (5.7) ] Fibrotic Complications [see Warnings and Precautions (5.8) ] Hypersensitivity [see Warnings and Precautions (5.9) ] The following adverse reactions associated with the use of dihydroergotamine were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure. Serious cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | Generic | $35 | View → | |
| 2 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 )…
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…
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| 3 | Not yet rated | Prescription | Injectable | Generic | $35 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $35 | View → |
| 5 | Not yet rated | Prescription | Spray/Inhaler | Generic | $35 | View → |
| 6 | Not yet rated | Prescription | Spray/Inhaler | Generic | $35 | View → |