brekiya (autoinjector)
Pharmaranks rates Brekiya (Autoinjector) 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Brekiya (Autoinjector) (Dihydroergotamine Mesylate) is an ergotamine derivative used to treat Cluster Headache, Postpartum Hemorrhage, Orthostatic Hypotension, Migraine Disorders.
Dihydroergotamine Mesylate · by Amneal
Available as a generic: Dihydroergotamine Mesylate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Dihydroergotamine Mesylate
- Drug class
- Ergotamine Derivative
- Form
- Injectable
- Strength
- Dihydroergotamine Mesylate 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Amneal
- Half-life
- about 9 to 13 hours, depending on the form (how long it stays in your system)
- What the pharmacy pays
- ~$34.84 per ml — not your price
- FDA application
- NDA215400
- FDA boxed warning
- Yes — see the boxed warning
What is Brekiya (Autoinjector)?
From the FDA label:BREKIYA (dihydroergotamine mesylate) injection is an ergotamine derivative. Dihydroergotamine mesylate is a white or almost white, crystalline powder. It is slightly soluble in water and chloroform and sparingly soluble in methanol. The chemical name for dihydroergotamine mesylate is ergotaman-3´,6´,18-trione,9,10-dihydro-12´-hydroxy-2´-methyl-5´-(phenylmethyl) monomethanesulfonate (salt). Its molecular weight is 679.8g/mol and its molecular formula is C 33 H 37 N 5 O 5 ∙CH 4 O 3 S. The chemical structure is BREKIYA is a clear, colorless, sterile solution supplied in 1 mL single-dose autoinjector for subcutaneous administration. Each mL contains 1 mg dihydroergotamine mesylate, USP (equivalent to 0.86 mg of dihydroergotamine). BREKIYA also contains ethanol, USP 6.1% by volume; glycerin, USP 15% by weight; water for injection, USP; may contain methanesulfonic acid and/or sodium hydroxide, NF for pH adjustment. pH range is 3.4 to 4.9. 1
How to use
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…
Side effects
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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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) ].
Warnings
Important safety information
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. ( 5.2 ) Cerebrovascular Adverse Reactions and Fatalities: Cerebrovascular hemorrhage, subarachnoid hemorrhage, and stroke have been reported; discontinue BREKIYA if suspected. ( 5.3 ) Other Vasospasm Related Adverse Reactions: BREKIYA may cause vasospasm or elevation in blood pressure. Discontinue if signs or symptoms of vasoconstriction develop. ( 5.4 , 5.5 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.6 ) Preterm Labor: Advise pregnant women of the risk. ( 5.7 , 8.1 ) Fibrotic Complications: Pleural and retroperitoneal fibrosis have been reported following prolonged daily use of dihydroergotamine mesylate. Do not exceed the BREKIYA dosing guidelines or use for chronic daily administration. ( 5.8 ) 5.1 Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine and strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or and ischemia of the extremities is increased. Hence, concomitant use of BREKIYA with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) and Drug Interactions (7.1) ]. 5.2 Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities The potential for cardiac adverse reactions exists with BREKIYA treatment. Serious adverse cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine mesylate. These events have included acute myocardial infarction, life-threatening disturbances of cardiac rhythm (e.g., ventricular tachycardia and ventricular fibrillation), coronary artery vasospasm, and transient myocardial ischemia. Prior to initiation of BREKIYA, a cardiovascular evaluation is recommended to determine if the patient is free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. If, during the cardiovascular evaluation, the patient’s medical history (including risk factors), or electrocardiographic investigation findings are consistent with coronary artery vasospasm or myocardial ischemia, BREKIYA should not be administered [see Contraindications (4) ]. For patients with risk factors predictive of coronary artery disease (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) 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, unless the patient has previously received dihydroergotamine. During the interval immediately following the first use of BREKIYA, an electrocardiogram is recommended in those patients with risk factors because ischemia can occur in the absence of clinical symptoms. 5.3 Cerebrovascular Adverse Reactions and Fatalities The potential for adverse cerebrovascular events exists with BREKIYA treatment. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with dihydroergotamine mesylate; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the dihydroergotamine mesylate having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). Discontinue BREKIYA if a cerebrovascular event is suspected. 5.4 Other Vasospasm Related Adverse Reactions BREKIYA, like other ergot alkaloids, may cause vasospastic reactions other than coronary artery vasospasm. Myocardial, peripheral vascular, and colonic ischemia have been reported with dihydroergotamine mesylate. Dihydroergotamine associated vasospastic phenomena may also cause muscle pains, numbness, coldness, pallor, and cyanosis of the digits. In patients with compromised circulation, persistent vasospasm may result in gangrene or death. BREKIYA should be discontinued immediately if signs or symptoms of vasoconstriction develop. Patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following the use of any 5-HT agonist, including BREKIYA, should be evaluated by a healthcare provider. 5.5 Increase in Blood Pressure Significant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with dihydroergotamine mesylate. BREKIYA is contraindicated in patients with uncontrolled hypertension [see Contraindications (4) ]. An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT 1 agonist in a study evaluating subjects undergoing cardiac catheterization. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Preterm Labor Based on the mechanism of action of dihydroergotamine and findings from the published literature, BREKIYA may cause preterm labor. Avoid use of BREKIYA during pregnancy [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.2) ]. 5.8 Fibrotic Complications The potential for fibrotic complications exists with BREKIYA treatment. There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of dihydroergotamine mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs has been associated with cardiac valvular fibrosis. Rare cases have also been reported in association with the use of dihydroergotamine mesylate; however, in those cases, patients also received drugs known to be associated with cardiac valvular fibrosis. Administration of BREKIYA should not exceed the dosing guidelines and should not be used for chronic daily administration [see Dosage and Administration (2.1) ]. 5.9 Hypersensitivity The rigid needle shield of the BREKIYA autoinjector contains a needle cover (located inside the cap) that contains dry natural rubber, which is made from latex. BREKIYA is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids or latex.
Who should not take Brekiya (Autoinjector)
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 )
Overdose — what happens if you take too much
Symptoms Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. In general, the symptoms of an acute BREKIYA overdose may be similar to those of an ergotamine overdose, although there may be less pronounced nausea and vomiting with BREKIYA. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain. In laboratory animals, dihydroergotamine was lethal when given at intravenous doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits. Treatment Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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).
How long does Dihydroergotamine Mesylate stay in your body?
The elimination half-life of dihydroergotamine mesylate is about 9 to 13 hours, depending on the form — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The injection label states a terminal half-life of about 9 hours after intramuscular or intravenous dosing, with a multi-exponential decline. Nasal forms read slightly longer because absorption is slower: the nasal spray label gives about 10 hours (biphasic decline) and the Atzumi nasal powder label gives an apparent half-life of about 13 hours. The major metabolite, 8'-beta-hydroxydihydroergotamine, binds adrenergic and 5-HT receptors as strongly as the parent drug and is equally potent at constricting veins, so its effects can outlast what the parent's half-life suggests — but the label explicitly says its pharmacokinetics have not been quantified, so no metabolite half-life exists in the labeling. No studies have been done on how kidney or liver impairment, age, sex, or race change these numbers; the drug is contraindicated outright in severe hepatic or renal impairment. Clearance is 1.5 L/min and mainly hepatic (excreted in bile and feces; only 6-7% of unchanged drug appears in urine), so liver disease and CYP3A4 inhibitors such as ritonavir, clarithromycin, and erythromycin are the real-world drivers of accumulation. There is no extended-release dihydroergotamine.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Dihydroergotamine Mesylate Injection, USP — FDA label, Clinical Pharmacology (DailyMed).
Drug class
May treat (source: NIH RxClass)
See how Brekiya (Autoinjector) ranks — best-rated ergotamine derivative for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Brekiya (Autoinjector) treat?
- Brekiya (Autoinjector) (Dihydroergotamine Mesylate) may be used to treat cluster headache, postpartum hemorrhage, orthostatic hypotension, migraine disorders, xerostomia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Brekiya (Autoinjector) rated?
- pharmaranks gives Brekiya (Autoinjector) a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Brekiya (Autoinjector) cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $34.84 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Brekiya (Autoinjector)?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brekiya (Autoinjector). To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brekiya (Autoinjector)?
- Brekiya (Autoinjector) is marketed by Amneal. You can see Amneal's full profile, rating, and other products on pharmaranks.
- Is Brekiya (Autoinjector) a brand-name or generic drug?
- Brekiya (Autoinjector) is a brand-name product with the active ingredient Dihydroergotamine Mesylate. Lower-cost generic equivalents containing Dihydroergotamine Mesylate are available — ask your pharmacist.
- Is Brekiya (Autoinjector) available over the counter?
- No. Brekiya (Autoinjector) is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brekiya (Autoinjector) come in?
- Brekiya (Autoinjector) is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Brekiya (Autoinjector)?
- Brekiya (Autoinjector) is classified as ergotamine derivative, per the FDA's Established Pharmacologic Class.
- Is Brekiya (Autoinjector) FDA-registered?
- Brekiya (Autoinjector) is on record with the U.S. FDA under application number NDA215400. You can verify this on its official FDA label.
- Has Brekiya (Autoinjector) been recalled by the FDA?
- Brekiya (Autoinjector) has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Brekiya (Autoinjector) safe?
- There's no single safe-or-not verdict. pharmaranks gives Brekiya (Autoinjector) a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Brekiya (Autoinjector)?
- Brekiya (Autoinjector)'s side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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brekiya (autoinjector)
70/100