2.1 Dosing Information

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 (14.1)]. 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.

2.2 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. Instruct patients to not use Sumavel DosePro if the tip of the device is tilted or broken off upon removal from packaging [see Patient counseling Information (17) and Instructions for Use].

Sumavel DosePro is for single use only. Discard after use.