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Alsuma

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Alsuma

Alsuma

INDICATIONS

Acute Treatment of Migraine Attacks and Cluster Headache

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.

Important Limitations

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]

DOSAGE AND ADMINISTRATION

ALSUMA is only for subcutaneous use.

The maximum single recommended adult 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 that clear benefit is associated with the administration of a second 6 mg dose in patients who have failed to respond to a first dose.

Since the injection is intended to be given subcutaneously, 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. Discard unused portions. [see PATIENT INFORMATION]

HOW SUPPLIED

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.

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.

Package Contents

Two 6 mg single dose ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injectors
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.

Manufactured by : Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer Inc. company. Distributed by: Pfizer Labs, Division of Pfizer Inc., NY, NY 10017

Last reviewed on RxList: 4/26/2013
This monograph has been modified to include the generic and brand name in many instances.

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