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FDA Labeling Changes
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ALSUMA (sumatriptan injection) 6 mg/0.5 mL is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
ALSUMA should only be used where a clear diagnosis of migraine or cluster headache has been established. Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine or cluster headache or who experience a headache that is atypical for them.
For a given attack, if a patient does not respond to the first dose of ALSUMA, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
ALSUMA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. [see Contraindications (4.7)]
There is currently no drug history available for this drug.
Sumatriptan is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT1) agonist. Sumatriptan delivered as the succinate salt is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
The empirical formula is C14H21N3O2S • C4H6O4, representing a molecular weight of 413.5.
ALSUMA is a clear, colorless to pale yellow, sterile, non-pyrogenic solution for subcutaneous injection. Each 0.5 mL of ALSUMA 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3.