"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
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
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 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.
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
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. Revised: Apr 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/23/2014
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