Products Affected - Description

• • Dihydroergotamine Mesylate injection, Provepharm, 1 mg/mL, 1 mL ampule, 10 count, NDC 81284-0411-10

Reason for the Shortage

• • Bausch Health has discontinued DHE 45.
  • Hikma has dihydroergotamine mesylate injection available.
  • Perrigo has discontinued dihydroergotamine mesylate injection.
  • Provepharm did not provide a reason for the shortage.

Available Products

• • Dihydroergotamine Mesylate injection, Hikma, 1 mg/mL, 1 mL ampule, 10 count, NDC 00143-9273-10

• • Provepharm has dihydroergotamine mesylate 1 mg/mL 1 mL ampules on back order and the company estimates a release date of mid-April 2025.

• • This drug is used in adult patients for the acute treatment of cluster headache and/or migraine headaches with and without aura. It is not intended for chronic use.
  • Off-label indications include: medication overuse headaches, intractable migraine, orthostatic hypotension, and pelvic congestion with pain

• • Do not take dihydroergotamine within 24 hours of a triptan or another ergotamine preparation due to increased risk of coronary artery vasospasm.

• • Alternative agents for the management of Cluster Headaches
  • Dihydroergotamine is commercially available in both a nasal and aerosol solution. The indications for the injectable and nasal formulations are the same and may be interchanged. However, the dosing is different.
  • 1. The 0.5 mg per spray: 1 spray into each nostril; repeat after 15 minutes (4 sprays per dose) Maximum 4 sprays per 24 hours
  • 2. The 0.725 mg per spray: 1 spray into each nostril (2 sprays per dose); may repeat as needed after > 1 hour for a total of 4 sprays. Maximum 4 sprays per 24 hours; 6 sprays per 7 days.
  • Alternative agents that are effective for aborting and reducing headaches and that are recommended for use by The American Headache Society include:
  • 1. Sumatriptan - both subcutaneous (6 mg) and nasal spray (20 mg) are effective in improving headache response
  • 2. Zolmitriptan - both nasal spray (5-10 mg) and oral (5-10 mg) are effective in improving headache response
  • 3. Octreotide - subcutaneous (100 mcg) is effective in improving headache response
  • 4. Oxygen - 100% oxygen 6-12 L/min is effective in improving headache response
  • Alternative agents for the management of Migraine Headaches
  • For mild-to-moderate attacks treatment options recommended for use by The American Headache Society include: nonsteroidal anti-inflammatory drugs, nonopioid analgesic, acetaminophen, caffeinated analgesic combinations (eg, aspirin + acetaminophen + caffeine)
  • For severe attacks or mild-to-moderate attacks that respond poorly to the nonspecific therapy treatment options recommended for use by The American Headache Society include:
  • 1. Selective serotonin (5-HT1B, 1D) receptor agonist (eg, sumatriptan)
  • 2. Small molecule CGRP receptor antagonists (eg, ubrogepant, rimegepant)
  • 3. Selective serotonin (5-HT1F) receptor agonist (eg, lasmiditan)

• 1. Dihydroergotamine (D.H.E. 45) [prescribing information]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; October 2022.
  2. Dihydroergotamine. Lexidrug Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed; Accessed Aug 12, 2024.
  3. Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of Cluster Headache: The American Headache Society Evidence-Based Guidelines. Headache. 2016;56(7):1093-1106. doi:10.1111/head.12866
  4. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021-1039. doi:10.1111/head.14153