Usual Adult Dose for Migraine

Parenteral:
Initial dose: 1 mg IM/IV/subcutaneously

• Additional 1 mg dose may be given at hourly intervals as needed not to exceed daily maximums

Maximum doses:

• IV: 2 mg/24 hours; 6 mg/7-day period
• IM/subcutaneously: 3 mg/ 24 hours; 6 mg/ 7-day period

Nasal Spray:
Initial dose: 0.5 mg (1 spray) intranasally into both nostrils; repeat in 15 minutes
Total dose: 2 mg (2 sprays in each nostril 15 minutes apart)

• Acute doses greater than 2 mg have not been shown to provide additional benefits

Maximum doses: 3 mg/24 hours; 4 mg/7-day period

Comments:

• This drug should only be used where a clear diagnosis of migraine headache has been established.
• This drug is not intended for chronic daily administration.

Use: For the acute treatment of migraine headaches with or without aura.

Usual Adult Dose for Cluster Headache

Initial dose: 1 mg IM/IV/subcutaneously

• Additional 1 mg dose may be given at hourly intervals as needed not to exceed daily maximums

Maximum doses:

• IV: 2 mg/24 hours; 6 mg/7-day period
• IM/subcutaneously: 2 mg/ 24 hours; 6 mg/ 7-day period

Comments:

• This drug is not intended for chronic daily administration.

Use: For the acute treatment of cluster headache episodes.

Renal Dose Adjustments

Severe renal impairment: Use is contraindicated

Liver Dose Adjustments

Severe hepatic impairment: Use is contraindicated

Dose Adjustments

Elderly: Use with caution; no information on use in patients over 65 years as they were excluded from clinical trials

Precautions

US BOXED WARNING: CONCOMITANT ADMINISTRATION WITH POTENT CYP450 3A4 INHIBITORS:

• Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of this drug with potent CYP450 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP450 3A4 inhibition elevates the serum levels of this drug, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased.

CONTRAINDICATIONS:

• Hypersensitivity to ergot alkaloids
• Concomitant use of potent CYP450 3A4 inhibitors (e.g. protease inhibitors, macrolide antibiotics, ketoconazole, itraconazole)
• Ischemic heart disease (angina pectoris, history of myocardial infarction, or silent ischemia)
• Coronary artery vasospasm including Prinzmetal's variant angina
• Uncontrolled hypertension
• Use within 24 hours of 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide
• Hemiplegic or basilar migraine
• Peripheral arterial disease
• Sepsis
• Following vascular surgery
• Severe hepatic impairment
• Severe renal impairment
• Pregnancy
• Nursing mothers
• Concomitant use with peripheral and central vasoconstrictors

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Nasal Spray:

• For intranasal use only; once assembled, one vial and one nasal sprayer unit contain one complete dose (4 sprays)
• To assemble, lift tab to bend blue cover back, completely remove blue cover, metal seal, and stopper; insert spray pump into vial and turn clockwise until tight
• Prime pump with 4 sprays prior to first use
• Spray once into each nostril, wait 15 minutes and repeat
• Do not tilt head back or sniff through your nose while spraying or immediately after

Ampules:

• May be administered IM/IV or subcutaneously
• For patients who self administer, they should receive instructions for subcutaneous use; subcutaneous dose should be administered into middle of thigh, well above the knee

Storage requirements:

• Ampules and Nasal spray (unopened): Protect from light; store below 77F (25C); do not refrigerate or freeze
• Ampule: Dispose of ampule 1 hour after opening
• Nasal spray: Dispose of nasal spray vial 8 hours after opening

General:

• This drug should only be used when a clear diagnosis of migraine headache has been established; not indicated for the treatment of hemiplegic or basilar migraine.
• Patients at risk of coronary artery disease (CAD) should have a satisfactory cardiovascular (CV) evaluation prior to initiating therapy; due to the possibility of CV testing not detecting underlying CAD, it is strongly recommended that the first dose be administered in a medically equipped facility with an ECG performed after dosing.

Monitoring:

• Consider ECG monitoring after first dose in patients with risk factors for coronary artery disease (CAD)
• Patients with CAD risk factors, and those who acquire risk factors predictive of CAD, should undergo periodic cardiovascular evaluation

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should report any numbness or tingling in toes or fingers, muscle pain in the arms and legs, weakness in legs, chest pain, changes in heart rate, swelling, or itching to their healthcare provider promptly; patients should be aware of the risk of serious cardiovascular side effects and the importance of seeking medical advice promptly if they occur.
• Patients should be advised to talk with their doctor or pharmacist before taking any new medications or supplements.
• Patients should be instructed not to take more than the prescribed amount of medication without talking to their healthcare provider.
• This drug may cause dizziness; patients should avoid driving or operating machinery until adverse effects are determined.
• Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.

Frequently asked questions

• What are the new drugs for the treatment of migraines?