Editorial note: Sumavel® DosePro® was discontinued by Endo Pharmaceuticals in February 2018. More information available here.
Sumavel® DosePro® is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine, with or without aura, in adults who have a clear migraine diagnosis. It is also indicated for the treatment of cluster headaches. It is administered by subcutaneous delivery (under the skin). Sumavel comes in a 4mg or 6mg prefilled, ready-to-use, single-dose disposable autoinjector called the DosePro.
Sumavel works quickly and is intended to reduce acute migraine symptoms. It is not intended as a prophylactic therapy to prevent the onset of migraine.
Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing on more than 10 days per month. Symptoms of overuse may need to be treated and detoxification from migraine medications may be required.
What are the ingredients in Sumavel?
The active ingredient in Sumavel is sumatriptan.
How does Sumavel work?
Sumavel is believed to work by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) around the brain. The effect is to reduce inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms.
What are the possible side effects of Sumavel?
Many clinical trials evaluated the safety and efficacy of Sumavel. The most common side effects experienced by those taking Sumavel include:
- Injection site reactions
- Tingling or numbness in the fingers or toes
- Flushing (warm red skin or face)
- Discomfort or stiffness in the neck
- Feeling weak, drowsy, or tired
This is not an exhaustive list of all potential side effects of Sumavel. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Sumavel, contact your doctor or healthcare provider immediately.
Things to note about Sumavel
Sumavel is a clear, colorless to pale yellow, sterile solution. It comes in a prefilled autoinjector. The DosePro has a gray plastic handle and snap-off tip, a lavender lever for the 4 mg dose and green lever for the 6 mg dose. It has a glass medication chamber that is prefilled with sumatriptan solution. The handle has a compressed nitrogen gas source so the DosePro delivers medication by pushing it through a small hole in a glass medication chamber. The resulting stream of medication is propelled through the skin, and is delivered subcutaneously without a needle. Before starting Sumavel talk with your doctor if you:
- Have a history of hypersensitivity to sumatriptan
- Have a history of coronary artery disease (CAD), angina or heart attacks
- Have a history of Wolff-Parkinson-White syndrome or arrhythmias, or conduction pathway disorders
- Have a history of stroke or transient ischemic attack (TIA)
- Have a history of hemiplegic or basilar migraine which may be at increased stroke risk
- Have peripheral vascular disease (circulation in the extremities)
- Have ischemic bowel disease
- Have a history of uncontrolled hypertension
- Have taken a ergot-containing medication or other triptans within the 24 hours prior to migraine
- Have taken a MAO-A inhibitor within 2 weeks prior to migraine
- Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
- Have severe hepatic (liver) impairment
- Are pregnant or planning to get pregnant, as there is limited information on the use of Sumavel in pregnancy. It should be used only if the potential benefit of Sumavel therapy exceeds risk to the fetus.
Individuals with the above conditions should be monitored closely while taking Sumavel.
If there is no response to the first migraine attack treated with Sumavel a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.
A cardiovascular evaluation should be performed on patients who have never taken a triptan medication but who have multiple cardiovascular risk factors (e.g. increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Sumavel. For those with a cardiac history, the first dose should be administered in a medically supervised setting, and electrocardiogram (ECG) should be performed immediately afterward.
Sumavel is delivered subcutaneously using the DosePro delivery system that contains a recommended dosage of 6 mg or 4 mg if dose-limiting side effects are present. There is maximum dose of 12 mg in any 24-hour period. Each dose must be separated by at least 1 hour. The DosePro is a prefilled, ready-to-use, single dose, needle-free disposable system. It should only be injected into the abdomen or the thigh in areas with adequate subcutaneous thickness to accommodate penetration of the drug into the subcutaneous space. The DosePro should not be placed within 2 inches of the navel or other areas of the body.
A small droplet of blood may be visible after the injection. Gently press a cotton ball or gauze over the area and cover it with a small adhesive bandage, if needed. Do not rub the area.
Each Sumavel carton, regardless of dosage strength, contains 6 DosePro prefilled single-dose units. They should be stored at room temperature and protected from light.
A healthcare professional should train patients or caregivers in the proper technique for administering Sumavel. Patients should understand that they may hear a loud burst of air and feel a sensation when the dose is delivered via the DosePro. If the tip of the device is tilted or broken off upon removal from packaging they should not be used. The DosePro should not be used in an area where the skin is bruised, irritated or red, infected, or scarred. Safe disposal practices should be used for the DosePro.
For additional details, read the full prescribing information of Sumavel.