Acute Treatment of Migraine Attacks and Cluster Headache

Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

Important Limitations

Sumavel DosePro 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 Sumavel DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.

Sumavel DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. [see CONTRAINDICATIONS]

Sumavel DosePro is for subcutaneous use only and is designed for patient self-administration to the abdomen or thigh. Sumavel DosePro is not to be administered to other areas of the body, including the arm. Sumavel DosePro is not to be administered intramuscularly or intravenously.

Administer one Sumavel DosePro to the abdomen or thigh to deliver subcutaneously 6 mg of sumatriptan (as the succinate salt) per 0.5 mL dose. One Sumavel DosePro is the maximum single recommended adult dose. The maximum recommended dose that may be given in 24 hours is two doses of Sumavel DosePro (or one dose of Sumavel Dosepro and one dose of another sumatriptan product), separated by at least 1 hour. Controlled clinical trials with sumatriptan injection 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.

Patients should be instructed to use administration 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 navel. 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 6 mg sumatriptan (as the succinate salt).

Storage And Handling

Each Sumavel DosePro needle-free delivery system delivers 6 mg sumatriptan (base) in 0.5 mL, in a sterile, nonpyrogenic solution. Sumavel DosePro is supplied in a package of six prefilled, single-dose units (NDC 43376-106-06).

Store at 20–25°C (68–77°F), with excursions permitted between 15–3°C (59– 86°F). Do not freeze.

Manufactured by Patheon UK, Limited Swindon, United Kingdom. Manufactured for: Zogenix, Inc. San Diego, CA 92130. Revised: 05/2011

Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.