Dihydroergotamine
Drug class: Antineoplastic Agents
Usage of Dihydroergotamine
Vascular Headaches
Acute treatment of migraine attacks (with or without aura) or cluster headaches.
One of several preferred initial therapies in moderate to severe migraines or mild to moderate migraines that respond poorly to NSAIAs.
IV treatment of intractable migraines† [off-label] (e.g., status migrainosus† [off-label]); usually used in combination with IV antiemetic.
Not recommended for management of hemiplegic or basilar migraine or for prophylaxis or chronic daily management of migraine.
Other Uses
Used in combination with low-dose heparin therapy for prevention of postoperative DVT and pulmonary embolism; generally has been replaced by other more effective therapies (e.g., low molecular weight heparin alone, warfarin).
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How to use Dihydroergotamine
General
Vascular HeadachesAdministration
Administer by IM, IV, or sub-Q injection or by nasal inhalation using a spray pump.
Administer by nasal inhalation or by IM, sub-Q, or direct IV injection for the acute treatment of migraine; if self-administration by parenteral route is desired, sub-Q injection generally is preferred because of ease of administration.
Administer by IM, sub-Q, or direct IV injection for the acute treatment of cluster headaches; sub-Q injection generally is preferred for self-administration because of ease of administration.
Administer by direct IV injection or continuous IV infusion† [off-label] for the acute treatment of intractable migraines in an inpatient setting.
Dihydroergotamine preparations are not recommended for prolonged daily use.
Intranasal Administration
Nasal solution intended for topical intranasal use only, and must not be injected.
Prior to initial use, assemble and fully prime the spray pump (i.e., spray 4 times). Consult the manufacturer’s patient instructions for information on assembly, priming, and use of the nasal spray pump.
Spray once in each nostril; wait 15 minutes and spray once again in each nostril. Do not tilt head back or inhale through nose while administering the drug.
Discard nasal spray applicator (with any remaining drug in opened ampul) 8 hours after assembly.
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
To minimize adverse local effects, some clinicians suggest flushing the IV line or port with 10–20 mL of sodium chloride 0.45 or 0.9% prior to administering the drug. Do not mix with buffers (e.g., sodium bicarbonate, sodium acetate) to minimize local adverse effects (see Compatibility under Stability).
DilutionFor continuous IV infusion† [off-label], add 3 mg of dihydroergotamine mesylate in 1 L of sodium chloride 0.9%, resulting in a final concentration of 3 mcg/mL.
Rate of AdministrationMay administer undiluted by direct IV injection over 1–2 minutes.
Has been administered by continuous IV infusion† [off-label] as a 3-mcg/mL solution at a rate of 126 mcg (42 mL) per hour.
Sub-Q Administration
Administer sub-Q into the middle of thigh after aspiration (to guard against accidental intravascular injection).
To minimize adverse local effects, some clinicians suggest diluting usual sub-Q dose (1 mg) with 1 mL of sodium chloride 0.9%. Do not mix with buffers (e.g., sodium bicarbonate, sodium acetate) to minimize local adverse effects (see Compatibility under Stability).
Dosage
Available as dihydroergotamine mesylate; dosage expressed in terms of the salt.
Adults
Vascular Headaches Migraine Intranasal0.5 mg (1 spray) in each nostril (1 mg total) initially; repeat 15 minutes later for a total dose of 2 mg. Higher dosages provide no additional benefit.
IV1 mg by direct IV injection initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 2 mg has been given in a 24-hour period.
Alternatively, 3 mg has been administered by continuous IV infusion† over 24 hours for the treatment of intractable migraines.
IM1 mg initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 3 mg has been given in a 24-hour period.
Sub-Q1 mg initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 3 mg has been given in a 24-hour period.
Cluster Headaches IV1 mg initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 2 mg has been given in a 24-hour period.
IM1 mg initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 3 mg has been given in a 24-hour period.
Sub-Q1 mg initially, followed by 1 mg at 1-hour intervals until the attack has abated or a total of 3 mg has been given in a 24-hour period.
Prescribing Limits
Adults
Vascular Headaches IntranasalSafety of >3 mg in any 24-hour period and >4 mg in any 7-day period has not been established.
IVMaximum 2 mg in any 24-hour period.
Maximum total weekly dosage: 6 mg.
IMMaximum 3 mg in any 24-hour period.
Maximum total weekly dosage: 6 mg.
Sub-QMaximum 3 mg in any 24-hour period.
Maximum total weekly dosage: 6 mg.
Warnings
Contraindications
Warnings/Precautions
Warnings
Use only in patients in whom a clear diagnosis of migraine has been established.
Fetal/Neonatal Morbidity and MortalityMay cause fetal harm; developmental toxicity observed in animals. Possesses oxytocic properties.
If used during pregnancy, or if pregnancy occurs during therapy, apprise the patient of the potential hazard to the fetus.
FibrosisRetroperitoneal and pleuropulmonary fibrosis reported following long-term daily use. Possible fibrotic thickening of cardiac valves with continuous, long-term administration.
Do not administer on a chronic daily basis.
Cardiac EffectsPossible myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbance, and death. (See Contraindications.)
Use not recommended in patients in whom unrecognized CAD is likely (e.g., postmenopausal women, men >40 years of age, patients with risk factors such as hypertension, hypercholesterolemia, obesity, diabetes mellitus, smoking, or family history of CAD) unless there is satisfactory evidence from a prior cardiovascular evaluation that the patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.
Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.
Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.
Patients with symptoms suggestive of angina after receiving dihydroergotamine should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.
Cerebrovascular EventsPossible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.
Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack) may be increased in patients with migraine.
Other Cardiovascular or Vasospastic EffectsPeripheral vascular ischemia and colonic ischemia reported. Further evaluation recommended if signs or symptoms suggestive of decreased arterial flow (e.g., manifestations of ischemic bowel syndrome or Raynaud’s phenomenon) occur following administration.
Substantial increases in BP reported rarely in patients with or without history of hypertension. (See Contraindications.)
Increases in mean pulmonary artery pressure observed following administration of another 5-HT1 receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.
ErgotismPotential for ergotism, manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia; if left untreated, can progress to gangrene. Do not exceed recommended dosages.
If signs and symptoms of impaired circulation occur, immediately discontinue therapy.
Local Effects of Intranasal AdministrationNasal or throat irritation reported frequently following intranasal administration (see Common Adverse Effects under Cautions). Effects of long-term, repeated administration on nasal and respiratory mucosa have not been systematically evaluated to date; however, nasal and throat examinations performed in a limited number of patients revealed no evidence of mucosal injury following repeated administration over periods up to 36 months.
Specific Populations
PregnancyCategory X. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications, under Cautions.)
LactationNot known whether dihydroergotamine is distributed into milk; however, ergotamine is distributed into milk and may cause vomiting, diarrhea, weak pulse, and unstable BP in nursing infants. Dihydroergotamine is contraindicated in nursing women.
Inhibits prolactin.
Pediatric UseSafety and efficacy not established in children.
Geriatric UseInsufficient experience with intranasal dihydroergotamine in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.
Hepatic ImpairmentContraindicated in patients with severe hepatic impairment.
Renal ImpairmentContraindicated in patients with severe renal impairment.
Common Adverse Effects
With parenteral dihydroergotamine, vasospasm, paresthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating.
With intranasal dihydroergotamine, mild-to-moderate nasal or throat irritation (e.g., congestion, burning sensation, dryness, paresthesia, discharge, epistaxis, pain, soreness), taste disturbances, rhinitis, application site reactions, dizziness, nausea, vomiting.
What other drugs will affect Dihydroergotamine
Extensively metabolized, principally by CYP3A4. Inhibits CYP3A.
Drugs Affecting Hepatic Microsomal Enzymes
Potent CYP3A4 inhibitors: Potential pharmacokinetic interaction (increased serum dihydroergotamine concentrations); potentially fatal cerebral ischemia and/or ischemia of the extremities possible. Concomitant use with potent CYP3A4 inhibitors contraindicated.
Less-potent CYP3A4 inhibitors: Similar effects not reported to date; however, consider possibility of serious toxicity during concomitant use.
Specific Drugs and Foods
Drug or Food
Interaction
Comment
Antidepressants, SSRIs (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline)
Weakness, hyperreflexia, and/or incoordination reported rarely with other 5-HT1 receptor agonists
Potential decrease in dihydroergotamine metabolism
Use with caution
Antifungals, azole (e.g., fluconazole, itraconazole, ketoconazole)
Potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole): Inhibition of dihydroergotamine metabolism and increased risk of potentially fatal cerebral ischemia and/or ischemia of the extremities
Less potent CYP3A4 inhibitors (e.g., fluconazole): Potential decrease in dihydroergotamine metabolism
Concomitant use of potent CYP3A4 inhibitors contraindicated
Use less potent CYP3A4 inhibitors with caution
Clotrimazole
Potential decrease in dihydroergotamine metabolism
Use with caution
Ergot alkaloids (e.g., ergotamine, methysergide)
Potential for excessive vasoconstriction
Use within 24 hours contraindicated
Grapefruit juice
Potential decrease in dihydroergotamine metabolism
Use with caution
HIV protease inhibitors (e.g., ritonavir, nelfinavir, indinavir, saquinavir)
Potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, indinavir): Inhibition of dihydroergotamine metabolism and increased risk of potentially fatal cerebral ischemia and/or ischemia of the extremities
Less potent CYP3A4 inhibitors (e.g., saquinavir): Potential decrease in dihydroergotamine metabolism
Concomitant use of potent CYP3a4 inhibitors contraindicated
Use less potent CYP3A4 inhibitors with caution
Macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin)
Inhibition of dihydroergotamine metabolism; increased risk of potentially fatal cerebral ischemia and/or ischemia of the extremities
Concomitant use contraindicated
Nefazodone
Potential decrease in dihydroergotamine metabolism
Use with caution
Nicotine
Possible vasoconstriction and increased ischemic response
Use with caution
Propranolol
Potentiation of dihydroergotamine's vasoconstrictive action
Use with caution
Serotonin (5-HT1) receptor agonists (e.g., sumatriptan)
Additive vasoconstrictor effects
Use within 24 hours contraindicated
Vasoconstrictors, peripheral or central
Additive increases in BP
Concomitant use contraindicated
Zileuton
Potential decrease in dihydroergotamine metabolism
Use with caution
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