ALSUMA® (sumatriptan injection) 6 mg/0.5 mL, a prescription medication indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes, will be facing a prolonged out-of-stock situation beginning in September 2013.
Pfizer recognizes the importance of ALSUMA to our customers and patients, and is working to address the situation. However, we do not anticipate having ALSUMA available on the market before September 2015.
It is important to note that Pfizer cannot make any recommendations regarding an alternative and/or substitute therapy for ALSUMA.
Pfizer apologizes for the inconvenience this may cause. Please direct medically related questions about ALSUMA to Pfizer Medical Information at 1-800-438-1985.
We appreciate your patience and understanding as we strive for a resolution.
Please see full Prescribing Information
IMPORTANT SAFETY INFORMATION
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- Do not administer ALSUMA intravenously or intramuscularly
- Do not use ALSUMA in patients with ischemic heart disease or in patients who have symptoms of or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal variant angina), or other significant underlying cardiovascular disease, cerebrovascular syndromes (including strokes of any type as well as transient ischemic attacks), or peripheral vascular disease including ischemic bowel disease
- Do not use ALSUMA in the management of hemiplegic or basilar migraine
- Do not use ALSUMA in patients with uncontrolled hypertension because ALSUMA may increase blood pressure. ALSUMA should be administered with caution to patients with controlled hypertension, as transient increases in blood pressure with significant clinical events have been observed
- Do not use ALSUMA within 24 hours of any ergotamine-containing or ergot-type medication and/or another 5-HT1 agonist (e.g., triptans)
- Do not use ALSUMA in patients with known hypersensitivity (anaphylaxis/anaphylactoid) to sumatriptan or any of its components. Hypersensitivity reactions have occurred on rare occasions in patients receiving sumatriptan, and such reactions can be life threatening or fatal.
Serious adverse cardiac events including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, vasospasm, and death have been reported within a few hours following the administration of sumatriptan. Some of these events have occurred in patients with no prior history of cardiac disease and with documented absence of coronary artery disease (CAD).
It is strongly recommended that ALSUMA not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. It is recommended that patients who are intermittent long-term users of 5-HT1 agonists, including ALSUMA, and who have or acquire risk factors predictive of CAD, undergo periodic cardiovascular evaluation as they continue to use ALSUMA.
Patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, or transient ischemic attacks). Some fatalities have been reported in patients who have displayed a possible primary cerebral hemorrhage, subarachnoid hemorrhage, stroke, and/or other cerebrovascular events.
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including ALSUMA, particularly during combined use with selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors and particularly during treatment initiation and dose increases.
The co-administration of ALSUMA and a monoamine oxidase A inhibitor is not generally recommended and may lead to increased sumatriptan plasma levels.
There have been rare reports of seizure following administration of sumatriptan. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
In controlled studies in migraine patients with sumatriptan injection, the most common adverse reactions (≥2% and more frequent than placebo) were injection site reactions (59% sumatriptan, 24% placebo); tingling (14%, 3%); dizziness/vertigo (12%, 4%); warm/hot sensation (11%, 4%); flushing (7%, 2%); pressure sensation (7%, 2%); feeling of heaviness (7%, 1%); burning sensation (7%, <1%); numbness (5%, 2%); feeling of tightness (5%, <1%); chest discomfort (5%, 1%); musculoskeletal weakness (5%, <1%); neck pain/stiffness (5%, <1%); drowsiness/sedation (3%, 2%); tightness in chest (3%, <1%); feeling strange (2%, <1%); tight feeling in head (2%, <1%); discomfort in nasal cavity/sinuses (2%, <1%); myalgia (2%, <1%); headache (2%, <1%), and jaw discomfort (2%, 0%).
In controlled clinical trials assessing sumatriptan injection as treatment in patients with cluster headaches, the most common adverse events compared with placebo were paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4%, 0%), and bronchospasm (1%, 0%).
In an open-label study evaluating the usability of ALSUMA, the most common adverse reactions (≥5%) were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).
ALSUMA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The use of ALSUMA in elderly patients is not recommended.
Keep ALSUMA and all medicines out of the reach of children.
ALSUMA (sumatriptan injection) 6 mg/0.5 mL Auto-Injector for subcutaneous use is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes in adults.
ALSUMA should only be used when a clear diagnosis of migraine or cluster headache has been established. ALSUMA is not intended for the prophylactic therapy of migraine.