Axert® (almotriptan malate)

Axert® (almotriptan malate) is a selective 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. Axert does have an indication for children 12-17 for migraine headache pain. It is taken by mouth for the relief of migraine severity, from moderate or severe pain to mild or no pain.

Axert generally works within 30 minutes to 2 hours. It is intended to reduce acute migraine symptoms, as it will only treat a migraine that has already begun. It should not to be used as prophylactic therapy to prevent the onset of migraine.

Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing on 10 or more days per month for 3 months or longer. Symptoms of overuse may need to be treated and detoxification from migraine medications may be required.

What are the ingredients in Axert?

The active ingredient in Axert is almotriptan malate.

How does Axert work?

Axert works by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) in the brainstem. It also reduces the inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms. Axert works best if it is taken as soon as migraine symptoms appear.

What are the possible side effects of Axert?

Many clinical trials evaluated the safety and efficacy of Axert. The most common side effects experienced by those taking Axert include:

• Nausea
• Headache
• Dry mouth
• Pain or tight feeling in the chest, throat, jaw, or neck
• Feeling weak, drowsy, or tired
• Pressure or heavy feeling in any part of your body
• Numbness or tingling in the fingers and toes (paresthesia)
• Feeling hot or cold in the extremities

This is not an exhaustive list of all potential side effects of Axert. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Axert, contact your doctor or healthcare provider immediately.

Things to note about Axert

Axert tablets are taken by mouth. Before starting Axert talk with your doctor if you:

• Have a history of hypersensitivity to almotriptan malate
• Have a history of coronary artery disease (CAD), angina or heart attacks
• Have a history of high blood pressure or high cholesterol
• Have a history of hemiplegic or basilar migraine
• Have a history of stroke, transient ischemic attacks (TIAs), or circulatory problems
• Are a female who has gone through menopause
• Are a man over 40
• Are overweight, smoke, or have diabetes
• Have taken ergot-containing medication or other triptans within the 24 hours prior to migraine
• Have taken a CYP3A4 inhibitor such as ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir
• Have taken a MAO-A inhibitor within 2 weeks prior to your 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
• Have severe renal (kidney) problems
• Have peripheral vascular disease including ischemic bowel disease
• Are pregnant or planning to get pregnant, as there is limited information on the use of Axert in pregnancy. It should be used only if the potential benefit of Axert therapy exceeds risk to the fetus.

Individuals with the above conditions should be monitored closely while taking Axert.

Additional safety information about Axert

If there is no response to the first migraine attack treated with the Axert, 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 Axert. For those with a cardiac history, the first dose of Axert should be administered in a medically supervised setting, and an electrocardiogram (ECG) should be performed immediately following the dose.

Keep track of when you have migraine and when you take Axert so you can monitor its effectiveness, and communicate with your doctor about how the medication is working for you.

Before taking Axert make sure to tell your doctor about all the medicines you take, including prescription and nonprescription, vitamins, and herbal supplements. Axert and other medicines may impact each other, causing side effects.

Because Axert can cause dizziness, weakness, and drowsiness, do not drive a car, use machinery, or do anything requiring you to be fully alert when taking this medication.

For additional details, read the full prescribing information of Axert.