"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
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 Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks.
- Sumavel DosePro is not indicated for the prevention of migraine attacks.
DOSAGE AND ADMINISTRATION
The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. For the treatment of migraine, if side effects are dose limiting, a lower dose (4 mg) may be used [see Clinical Studies]. For the treatment of cluster headache, the efficacy of a lower dose has not been established.
The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses of Sumavel DosePro separated by at least 1 hour. Sumavel DosePro may be given at least 1 hour following a dose of another sumatriptan product. A second dose should only be considered if some response to a first dose was observed.
Administration Using Sumavel® DosePro®
Sumavel DosePro is available for use as 4 mg or 6 mg needle-free delivery systems. It is intended to be given subcutaneously only. Sumavel DosePro is designed for patient self-administration to sites on the abdomen or the thigh with an adequate subcutaneous thickness to accommodate penetration of sumatriptan injection into the subcutaneous space. Administration should not be made within 2 inches of the naval. Sumavel DosePro is not to be administered to other areas of the body, including the arm.
Instruct patients on the proper use of Sumavel DosePro and direct them to use proper injection sites. Patients should be instructed not to use Sumavel DosePro if the tip of the device is tilted or broken off upon removal from packaging [see PATIENT INFORMATION].
Sumavel DosePro is for single use only. Discard after use.
Dosage Forms And Strengths
Sumavel DosePro is a prefilled, single-dose, needle-free subcutaneous delivery system delivering 0.5 mL of sterile solution containing 4 mg or 6 mg sumatriptan (as the succinate salt).
Storage And Handling
Each Sumavel DosePro needle-free delivery system contains sumatriptan (base) in 0.5 mL, in a sterile, nonpyrogenic solution and is supplied as follows:
Sumavel DosePro, 4 mg in a package of six prefilled,
single-dose units (NDC 43376-104-06).
Sumavel DosePro, 6 mg in a package of six prefilled, single-dose units (NDC 43376-106-06).
Store at 20 °C to 25°C (68°F to 77°F), with excursions permitted between 15 °C to 30°C (59 °F to 86°F). Do not freeze. Protect from light.
Manufactured by Patheon UK, Limited, Swindon, United Kingdom. Manufactured for: Zogenix, Inc., San Diego, CA 92130. Revised: November 2013
Last reviewed on RxList: 1/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Sumavel DosePro Information
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