Dosage & Administration
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Trudhesa Prescribing Information
TRUDHESA is contraindicated in patients:
- with concomitant use of strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, or indinavir), macrolide antibiotics (e.g., erythromycin or clarithromycin), and antifungals (ketoconazole or itraconazole)[see Warnings and Precautions (5.1)and Drug Interactions (7.1)]
- with ischemic heart disease (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 ergot alkaloids
- with recent use (i.e., within 24 hours) of other 5-HT1agonists (e.g., sumatriptan) or 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
- Patients with ischemic heart disease or coronary artery vasospasm
- Patients with uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
- Patients with hypersensitivity to ergot alkaloids
- Concomitant use of other 5-HT1agonists (e.g., sumatriptan) or ergotamine-containing or ergot-type medications within 24 hours
- Concomitant use of peripheral and central vasoconstrictors
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors, including protease inhibitors, macrolide antibiotics, and antifungals. 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 TRUDHESA with strong CYP3A4 inhibitors is contraindicated
There have been rare reports of serious adverse events in connection with the coadministration of intravenous administration of dihydroergotamine and strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, indinavir), macrolide antibiotics (e.g., erythromycin, clarithromycin), and antifungals (e.g., ketoconazole, itraconazole), resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities
TRUDHESA is indicated for the acute treatment of migraine with or without aura in adults.
- The recommended dose of TRUDHESA is 1.45 mg (administered as one metered spray of 0.725 mg into each nostril). ()
2.1 Dosing InformationThe recommended dose of TRUDHESA is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril).
The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses of TRUDHESA within a 24-hour period or 3 doses within a 7-day period.
- The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses within a 24-hour period or 3 doses within 7 days. ()
2.1 Dosing InformationThe recommended dose of TRUDHESA is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril).
The dose may be repeated, if needed, a minimum of 1 hour after the first dose. Do not use more than 2 doses of TRUDHESA within a 24-hour period or 3 doses within a 7-day period.
- Prior to initiation, a cardiovascular evaluation is recommended. ()
2.2 Assessment Prior to First DosePrior to initiation of TRUDHESA, a cardiovascular evaluation is recommended
[see Warnings and Precautions (5.2)]. 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 TRUDHESA take place in the setting of an equipped healthcare facility. - TRUDHESA is for nasal administration only. ()
2.3 Important Administration InstructionsTRUDHESA is for nasal administration only and must not be injected.
TRUDHESA must be assembled prior to use (see Instructions for Use). Use or discard TRUDHESA within 8 hours once the vial has been opened or the product has been assembled.
Prime the assembled TRUDHESA before initial use by releasing 4 sprays. Use TRUDHESA immediately after priming. Discard TRUDHESA immediately after use. Open and prepare a new TRUDHESA if an additional dose is needed.
- Assemble and prime (i.e., pumped 4 times) before use. ()
2.3 Important Administration InstructionsTRUDHESA is for nasal administration only and must not be injected.
TRUDHESA must be assembled prior to use (see Instructions for Use). Use or discard TRUDHESA within 8 hours once the vial has been opened or the product has been assembled.
Prime the assembled TRUDHESA before initial use by releasing 4 sprays. Use TRUDHESA immediately after priming. Discard TRUDHESA immediately after use. Open and prepare a new TRUDHESA if an additional dose is needed.
- Use TRUDHESA immediately after priming and then discard. ()
2.3 Important Administration InstructionsTRUDHESA is for nasal administration only and must not be injected.
TRUDHESA must be assembled prior to use (see Instructions for Use). Use or discard TRUDHESA within 8 hours once the vial has been opened or the product has been assembled.
Prime the assembled TRUDHESA before initial use by releasing 4 sprays. Use TRUDHESA immediately after priming. Discard TRUDHESA immediately after use. Open and prepare a new TRUDHESA if an additional dose is needed.
TRUDHESA (dihydroergotamine mesylate) nasal spray is a single-dose, drug-device combination product containing a vial of dihydroergotamine mesylate with a clear and colorless to faintly yellow solution and an intranasal delivery device. Each spray delivers 0.725 mg of dihydroergotamine mesylate.
- Pregnancy: Based on animal data, may cause fetal harm ()
8.1 PregnancyRisk SummaryAvailable data from published literature indicate an increased risk of preterm delivery with TRUDHESA use during pregnancy. Avoid use of TRUDHESA during pregnancy
[see Warnings and Precautions (5.7)]. Data collected over decades have shown no increased risk of major birth defects or miscarriage with use of dihydroergotamine mesylate during pregnancy.In animal studies, adverse effects on embryofetal development were observed following administration of dihydroergotamine mesylate during pregnancy (decreased fetal body weight and/or skeletal ossification) in rats and rabbits or during pregnancy and lactation in rats (decreased body weight and impaired reproductive function in the offspring) in rats at doses less than those used clinically and which were not associated with maternal toxicity
(see Data).The estimated rate of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
DataAnimal DataIntranasal administration of dihydroergotamine mesylate to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weight and/or skeletal ossification at doses of 0.16 mg/day (associated with plasma exposures [AUC] less than that in humans at the maximum recommended human dose [MRHD] of 2.9 mg) or greater. A no-effect level for embryofetal toxicity was not identified in rats. Intranasal administration of dihydroergotamine mesylate to pregnant rabbits throughout organogenesis resulted in decreased skeletal ossification at 3.6 mg/day. At the no-effect dose (1.2 mg/day) for adverse effects on embryofetal development in rabbits, plasma exposures (AUC) were less than that in humans at the MRHD.
Intranasal administration of dihydroergotamine mesylate to female rats throughout pregnancy and lactation resulted in decreased body weight and impaired reproductive function (decreased mating indices) were observed in the offspring at doses of 0.16 mg/day or greater. A no-effect dose for adverse developmental effects in rats was not established.
Effects on development occurred at doses below those that produced evidence of significant maternal toxicity in these studies.
Dihydroergotamine-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone.
- Lactation: Advise not to use during breastfeeding. ()
8.2 LactationRisk SummaryThere are no data on the presence of dihydroergotamine in human milk; however, ergotamine, a related drug, is present in human milk. There are reports of diarrhea, vomiting, weak pulse, and unstable blood pressure in breastfed infants exposed to ergotamine. TRUDHESA may reduce milk supply because it may decrease prolactin levels. Because of the potential for reduced milk supply and serious adverse events in the breastfed infant, including diarrhea, vomiting, weak pulse, and unstable blood pressure, advise patients not to breastfeed during treatment with TRUDHESA and for 3 days after the last dose. Breast milk supply during this time should be pumped and discarded.
TRUDHESA is contraindicated in patients:
- with concomitant use of strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, or indinavir), macrolide antibiotics (e.g., erythromycin or clarithromycin), and antifungals (ketoconazole or itraconazole)[seeand
5.1 Peripheral Ischemia Following Coadministration with Strong CYP3A4 InhibitorsSerious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors, including protease inhibitors, macrolide antibiotics, and antifungals. 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 TRUDHESA with strong CYP3A4 inhibitors is contraindicated
[see Contraindications (4)and Drug Interactions (7.1)].]7.1 CYP3A4 InhibitorsThere have been rare reports of serious adverse events in connection with the coadministration of intravenous administration of dihydroergotamine and strong CYP3A4 inhibitors, such as protease inhibitors (e.g., ritonavir, nelfinavir, indinavir), macrolide antibiotics (e.g., erythromycin, clarithromycin), and antifungals (e.g., ketoconazole, itraconazole), 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 dihydroergotamine is contraindicated[see Contraindications (4)]. Administer moderate CYP3A4 inhibitors (e.g., saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, clotrimazole) with caution. - with ischemic heart disease (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]
5.4 Other Vasospasm Related Adverse ReactionsTRUDHESA, 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 mesylate 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. TRUDHESA 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 TRUDHESA, should be evaluated by a healthcare provider.
- with uncontrolled hypertension [see]
5.5 Increase in Blood PressureSignificant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with dihydroergotamine mesylate. TRUDHESA 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-HT1agonist in a study evaluating subjects undergoing cardiac catheterization.
- with peripheral arterial disease
- with sepsis
- following vascular surgery
- with severe hepatic impairment
- with severe renal impairment
- with known hypersensitivity to ergot alkaloids
- with recent use (i.e., within 24 hours) of other 5-HT1 agonists (e.g., sumatriptan) or ergotamine-containing or ergot-type medications [see]
7.2 TriptansTriptans (serotonin [5-HT] 1B/1D receptor agonists) have been reported to cause coronary artery vasospasm, and its effect could be additive with TRUDHESA. Therefore, triptans and TRUDHESA should not be taken within 24 hours of each other
[see Contraindications (4)]. - with concomitant use of peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure [see]
5.5 Increase in Blood PressureSignificant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with dihydroergotamine mesylate. TRUDHESA 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-HT1agonist in a study evaluating subjects undergoing cardiac catheterization.