TM Owner Bausch Health
Migranal 4mg/mL Nasal Spray
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Indications & Clinical Uses
- Migranal (dihydroergotamine mesylate) 4 mg/mL nasal spray is an ergot alkaloid used for the acute treatment of migraine headache attacks, with or without aura, in adults.
- It is used by the patient at the first sign of a migraine to reduce headache pain and associated symptoms; it is not approved for migraine prevention, for hemiplegic or basilar migraine, or for cluster headache.
- Migranal is not intended for daily or chronic use, and treatment is limited to no more than 3 mg in any 24-hour period and 4 mg in any 7-day period.
- It is a self-administered outpatient treatment once a healthcare provider has confirmed the diagnosis of migraine and ruled out cardiovascular disease.
- Migranal is marketed in the United States by Bausch Health; the same molecule is also available as an injectable formulation for hospital or clinic use, which is a different product with a different route of administration.
Side Effects
- Migranal carries a boxed warning for serious and sometimes life-threatening peripheral ischemia (reduced blood flow to fingers, toes or other tissue) when taken together with potent CYP3A4 inhibitors such as certain protease inhibitors and macrolide antibiotics, for example ritonavir, clarithromycin or erythromycin; this combination is contraindicated.
- The most common side effects, reported in more than 1 in 10 people, are rhinitis (nasal irritation or runny nose) and nausea.
- Other common effects, affecting up to around 1 in 10 people, include altered taste, application-site burning, vomiting, dizziness, drowsiness and sore throat.
- Seek urgent medical attention for numbness, tingling, coldness, pain, or blue or pale discoloration of the fingers or toes, chest pain, or sudden severe headache, as these can signal serious vasospasm or cardiac ischemia.
- Gently clear excess spray from the nostril after use.
Precautions & Warnings
- Migranal must not be used within 24 hours of a triptan, such as sumatriptan, or another ergot-type medicine, because combining ergot-class drugs increases the risk of prolonged vasoconstriction.
- It is contraindicated in ischaemic heart disease, coronary artery spasm, uncontrolled high blood pressure, peripheral arterial disease, sepsis, and within 24 hours of certain vascular surgery, as well as in severe liver or kidney impairment.
- It must not be used during pregnancy, as ergot alkaloids can cause uterine contractions and harm the fetus, and it should not be used while breastfeeding.
- Migranal is for intranasal use only and must never be injected.
- Because it can raise blood pressure, it should be used with caution in anyone with borderline hypertension, with periodic blood pressure checks.
- It is not recommended for hemiplegic or basilar migraine, since it may worsen ischaemic symptoms in these migraine subtypes.
Avoid Interactions
- Migranal must not be combined with potent CYP3A4 inhibitors, including certain HIV protease inhibitors such as ritonavir, macrolide antibiotics such as erythromycin or clarithromycin, and azole antifungals such as ketoconazole or itraconazole, because these raise dihydroergotamine blood levels and the risk of severe peripheral ischemia.
- Do not use Migranal within 24 hours of a triptan or another ergot-containing medicine, and avoid other vasoconstrictors or heavy nicotine use, which can add to blood-vessel-narrowing effects.
- Beta-blockers may increase peripheral vasoconstriction when combined with dihydroergotamine.
- Tell your healthcare provider about all prescription and over-the-counter medicines, herbal products and supplements you take, especially anything affecting liver enzymes, before using Migranal, and do not exceed the maximum dose or use other migraine medicines on the same day without medical advice.
References
Frequently Asked Questions
Migranal (dihydroergotamine mesylate) nasal spray treats a migraine attack once it has started, in adults. It is not for preventing migraines or for hemiplegic or basilar migraine. Use it at the first sign of head pain for the best effect.
Spray once (0.5 mg) into each nostril, then repeat the same two sprays 15 minutes later, for a total dose of 2 mg. Do not use more than 3 mg in 24 hours or 4 mg in any 7-day period.
The most common effects are nasal irritation and nausea, each affecting more than 1 in 10 people. Migranal has a boxed warning for serious peripheral ischemia (reduced blood flow) if combined with strong CYP3A4-inhibiting drugs. Get urgent help for cold, numb or blue fingers or toes.
Do not use Migranal within 24 hours of a triptan or another ergot medicine, and avoid combining it with protease inhibitors, macrolide antibiotics like clarithromycin, or azole antifungals, which sharply raise the risk of severe vasospasm. Avoid it in pregnancy and if you smoke heavily.
Store Migranal below 25°C (77°F) and never refrigerate or freeze it. Once a vial is opened, discard any unused spray after 8 hours. Keep the sprayer and ampules in the original carton, away from children.
No. Migranal is contraindicated in pregnancy because ergot alkaloids like dihydroergotamine can cause uterine contractions and harm the fetus. It should also be avoided while breastfeeding. Tell your healthcare provider immediately if you are or could be pregnant before using it.
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