Alsuma (Sumatriptan) - Indications and Dosage

INDICATIONS AND USAGE

ALSUMA™ (sumatriptan injection) is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache.

Limitations of Use:

• Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with ALSUMA, reconsider the diagnosis of migraine before ALSUMA is administrated to treat any subsequent attacks.
• ALSUMA is not indicated for the prevention of migraine attacks.

DOSAGE AND ADMINISTRATION

Dosing Information

The maximum single recommended dose of ALSUMA is 6 mg injected subcutaneously.

The maximum recommended dose that may be given in 24 hours is two doses of ALSUMA separated by at least 1 hour. Controlled clinical trials have failed to show a clear benefit with the administration of a second 6 mg dose in patients who have failed to respond to a first dose. A second 6 mg dose should only be considered if some response to a first injection was observed.

Administration Using ALSUMA

ALSUMA is only for subcutaneous use. Intramuscular or intravascular delivery must be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.

ALSUMA is for single use only. Visually inspect the medication for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted. Discard unused portions. [see Patient Counseling Information]

DOSAGE FORMS AND STRENGTHS

ALSUMA contains 6 mg of sumatriptan (as 8.4 mg sumatriptan succinate), which is delivered as a subcutaneous injection in a single dose.

ALSUMA is supplied as a single-use auto-injector pre-filled with sumatriptan succinate drug solution and fully-assembled for use.

HOW SUPPLIED/STORAGE AND HANDLING

ALSUMA contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution in a single-dose pre-filled auto-injector.

Injection Strength	Package Contents	NDC#
6 mg	Two 6 mg single dose ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injectors	0069-0138-02
	ALSUMA Physician Insert
	Patient Instructions for Use

Store at 25°C, excursions permitted 15° to 30°C (59° to 86° F). Protect from light. Do not refrigerate.