Axert (almotriptan)

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Axert (almotriptan) for migraines: an introduction

Axert, almotriptan, launched in the U.S. in 2001. It is a prescription triptan medication for migraine. Like other triptans, Axert is approved for the acute treatment of migraines with or without aura in adults.

Axert is also approved to treat migraine headache pain in adolescents ages 12 to 17 years old, who have a history of migraine attacks with or without aura that last at least four hours when not treated. Axert’s effectiveness has not been established for relieving other migraine symptoms in teens, such as nausea, sensitivity to light and sensitivity to sound.

It is not used to reduce the number of migraine attacks and it does not prevent migraines.

How Axert for migraines works

Axert is a member of the triptan class of migraine medications. It is thought that Axert, as well as other triptans, relieve migraine symptoms by reducing swelling of the blood vessels around the brain and reducing the presence of other pain-causing substances in the brain.

Axert’s effectiveness

Patients have differing levels of success with each drug. Some feel their symptoms ease quickly, others may find complete relief.

Forms of Axert available to treat migraines

Axert is available in a single form: conventional tablets that are swallowed.

Most common side effects of Axert tablets

  • Nausea and vomiting
  • Dry mouth
  • Tingling or burning feeling
  • Dizziness
  • Drowsiness

If any of the above side effects are serious or don’t go away, please tell your healthcare professional.

Axert Generic Overview

Axert is the brand name for almotriptan. That means that the brand was named by the first manufacturer of Axert which was Ortho McNeil Janssen. The branded version of Axert became available in 2001. Each branded prescription drug also has a generic name, which you will often see in parentheses following the brand name.

When the patent exclusivity for a brand name product expires, often times multiple generic manufacturers will seek approval from the FDA to manufacture and sell generic versions of the branded drug. When a drug like Axert becomes generic it is typical for the generic products to be priced much lower than the branded product. As such, most insurance plans will offer lower patient co-pays for generic drugs, like Axert, than they do for branded drugs.

Even though a prescription drug has a generic name, this does not always mean it is available in a generic form at the pharmacy. Often prescription medicines are referred to either by their brand name (only one manufacturer holds the exclusive right to make and market the product using the brand name) like Axert or by the generic name in this case, almotriptan.

Are generic drugs the same as brand name drugs?

Generic drugs are not exactly the same as the original branded drug, although they are very similar and are widely viewed to be as effective as their branded counterparts.  They are also tested and approved by the FDA.

Is Axert available as a generic?

Yes. Current available formulations of Axert in the generic form include:

  • Generic Axert 6.25 mg oral tablets
  • Generic Axert 12.5 mg oral tablets

How Axert Works

Doses of Axert work differently in different people. The dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with increased risk of side effects.  

Keep a migraine journal of what doses of Axert you are taking when you experience a migraine. This will help you know if the medicine is working for you at the dose you are taking and can help you be prepared to talk about how well the drug works during your visits to your doctor.

Axert Dosage

  • In adults, the recommended Axert starting dose is 6.25 mg to 12.5 mg to be taken with or without food.
  • In children (ages 12 to 17) the recommended Axert starting dose is 6.25 mg to 12.5 mg.
  • The maximum daily dose of Axert is 25 mg in a 24-hour period.
  • If your headache goes away after the first dose of Axert but then returns, you can take another dose after 2 hours.
  • Note: the effectiveness of taking a second dose in this way has not been established.
  • The safety of using Axert to treat more than 4 migraines in a 30-day period has not been established.

Axert Dose in People with Liver Damage

  • The recommended starting dose in people with liver problems of Axert is 6.25 mg.
  • The maximum daily dose is 12.5 mg over a 24-hour period. 

Axert Dose in People with Kidney Damage

  • The recommended starting dose of Axert in patients with severe kidney problems is 6.25 mg.
  • The maximum daily dose is 12.5 mg over a 24-hour period.
  • Axert is not recommended for people who have

  • Heart disease, stroke, or peripheral vascular disease (a disease of arteries and veins outside of the heart and brain)
  • High blood pressure that is not under control
  • Hemiplegic migraine (migraine with stroke-like symptoms of extreme muscle weakness and paralysis) or basilar migraine (migraine with throbbing pain at the back of the head); if you are not sure, ask your doctor
  • Taken another migraine headache medication in the last 24 hours
  • Had an allergic reaction to Axert
  • Allergic reactions to sulfonamides, also known as sulfa drugs (ask your doctor if you are not sure what sulfonamide drugs are).
  • Axert Dose in Children

    • The recommended dose of Axert children ages 12 to 17 is 6.25 mg to 12.5 mg.
    • The safety and efficacy of Axert in people under age 12 have not been established.

    Axert Dose in Older Adults

    • Studies of Axert in people over age 65 were not large enough to show that older adults respond differently from younger people.
    • In general, older adults should be started on a low dose of Axert and watched because older adults are more likely to have lower liver, kidney, or heart function and take additional medications that may interact with Axert.
    • The recommended dose of Axert for older adults with normal working kidneys is the same as for younger adults.

    Axert Side Effects Overview

    As with any medicine, Axert can cause side effects. Generally, Axert is tolerated well by most people; however certain people may not be able to safely use Axert because they have certain medical conditions.

    Axert Side Effects in Adults

    The most common reported side effects include:

    • Nausea and vomiting
    • Dry mouth
    • Tingling or burning feeling
    • Dizziness
    • Drowsiness

    Axert Side Effects in Children (ages 12 to 17)

    The most common reported side effects include:

    • Dizziness
    • Sleepiness
    • Nausea
    • Headache
    • Tingling or burning feeling
    • Vomiting

    Talk to your doctor about using Axert if you are pregnant, planning to become pregnant, or breastfeeding.

    If you have any of these conditions or take any of these medicines, you may need to have your dose adjusted or have special tests to safely use Axert.

    Serious side effects

    Seek immediate medical attention if you experience any of the following serious side effects:

    • Chest pain, tightness, heaviness or pressure
    • Tightness or pressure spreading to the throat, neck and jaw
    • Shortness of breath
    • Difficulty breathing
    • Sudden, severe stomach pain
    • Faintness or dizziness
    • Bloody diarrhea
    • Paleness or blue color in the fingers or toes
    • Slow or difficult speech
    • Pain, burning or tingling in the hands or feet
    • Rash or itching

    Axert side effects may change depending on the dose you take. If you develop these or other serious side effects after using Axert, contact your doctor immediately.

    Axert is one of a class of drugs called triptans. Chest pain, heart attack, irregular heartbeat, stroke, and death have occurred rarely with triptans. Triptans are not recommended for use by people with heart disease, high blood pressure, or any disease affecting the blood vessels.

    Ask your doctor if you are not sure whether you have one of these health conditions. As with other triptans, people taking Axert have very rarely experienced a severe allergic reaction or, also rarely, a reaction similar to hives.

    Do not take Axert if you have:

    • Ever had heart disease.
    • Uncontrolled high blood pressure.
    • Hemiplegic or basilar migraine. If you are not sure, ask your doctor.
    • Taken another migraine medication within the last 24 hours.
    • Had an allergic reaction to Axert or any of its ingredients.
    • Allergic reactions to sulfonamides, also known as sulfa drugs (ask your doctor if you are not sure what sulfonamide drugs are).

    Tell your doctor if you take:

    • Monoamine oxidase inhibitors (MAOI) for depression or another condition, or if it has been less than 2 weeks since you stopped taking an MAOI such as Nardil.
    • Ketoconazole (NIZORAL®), itraconazole (SPORANOX®), ritonavir (NORVIR®), or erythromycin (EMYCIN®), or if it has been less than 1 week since you stopped taking one of these drugs.
    • Selective serotonin reuptake inhibitors (SSRIs such as Paxil, Zoloft or Prozac) or serotonin norepinephrine reuptake inhibitors (SNRIs such as Effexor), two types of drugs for depression or other disorders.
    • These medicines may affect how Axert works, or Axert may affect how these medicines work.

    Before you use Axert, tell your doctor if you have:

    • Past or present medical problems.
    • Past or present high blood pressure, chest pain, shortness of breath, or heart disease.
    • Liver or kidney problems.
    • Heart disease risk factors, such as:
    • High blood pressure
    • Diabetes
    • High cholesterol
    • Overweight
    • Smoking
    • Family members with heart disease
    • You are past menopause
    • You are a male over 40 years old.
    • Allergic reactions to sulfonamides, also known as sulfa drugs (ask your doctor if you are not sure what sulfonamide drugs are).
    • Medicines you take or plan to take, including prescription and non-prescription medicines and herbal supplements.

    Have you experienced side effects using Axert? You are encouraged to report your side effects of any prescription drugs to the FDA (Food and Drug Administration). If you would like to report your side effects while taking Axert, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Axert Drug Interactions Overview

    Axert may interact with other medicines. It is extremely important for you to tell your doctor about all the medications you are currently taking, including your over-the-counter (non-prescription) medications. The migraine journal can help you keep a list of all of your medicines. It is also important to tell your doctor if you are taking any dietary supplements, such as herbs or vitamins. Your prescriber can best help you avoid any unpleasant side effects if he or she knows about everything that you are taking. Do not stop taking any medication without telling your doctor. 

    Axert Drug Interactions with Other Migraine Medicines

    Axert should not be used within 24 hours after another drug containing a triptan (found in some similar migraine medications) or ergotamine (found in some migraine and cluster headache medications) because this could cause your blood vessels to constrict too much.

    Axert Drug Interactions with Antidepressants

    Axert is not recommended for people taking an MAOI (monoamine oxidase inhibitor — a class of antidepressants such as Nardil) or within 2 weeks of stopping one.
    Before using Axert, tell your doctor if you are also taking an antidepressant, such as:

    • Celexa (citalopram)
    • Cymbalta (duloxetine)
    • Effexor (venlafaxine)
    • Lexapro (escitalopram)
    • Luvox (fluvoxamine)
    • Paxil (paroxetine)
    • Prozac (fluoxetine)
    • Sarafem (fluoxetine)
    • oloft (sertraline)

    Taking Axert with an SSRI (selective serotonin reuptake inhibitor — a class of antidepressants) or an SNRI (serotonin-norepinephrine reuptake inhibitor — a class of antidepressants) may cause a potentially life-threatening reaction called serotonin syndrome. Serotonin syndrome symptoms may include:

    • Changes in your thinking, behavior, or level of alertness (including agitation, hallucinations, coma)
    • Changes in your heart rate, blood pressure, or body temperature (including fast heart beat, high or low blood pressure, fever)
    • Changes in your muscles and/or nervous system (including sensitive reflexes, lack of coordination)
    • Nausea, vomiting, and/or diarrhea.

    Axert Drug Interactions with Ketoconazole and Other Drugs that Affect Liver Enzymes ( CYP3A4 Inhibitors)

    Inhibitors of CYP3A4 (such as ketoconazole and itraconazole) taken along with Axert can cause 60% more Axert to stay in your body.
    When taking CYP3A4 inhibitors, the starting dose of Axert should be 6.25 mg and the maximum daily dose is 12.5 mg in a 24-hour period. If you have kidney or liver problems you should not take Axert and CYP3A4 inhibitors at the same time.

    Axert Special Warnings Overview

    Overusing Axert

    Using Axert and other medications like Axert 2 or more days a week for more than 3 months can cause medication-overuse headache, a dull or migraine-like headache that is present at least 15 days per month. You can prevent medication-overuse headache by not using Axert as often (per attack, per week, and per month) and starting preventive treatment when necessary. Talk with your doctor about whether or not you would benefit from trying a medicine that prevents migraines.

    By keeping a migraine journal of what doses you are taking when you experience a migraine, you can be prepared to discuss if you might be experiencing overuse headaches. Be sure to share your headache log with your doctor at your next appointment.

    Axert and Blood Pressure

    Axert has been reported to raise blood pressure on rare occasions in patients with and without high blood pressure. You should not use Axert if you have high blood pressure that is not under control.

    What is your blood pressure? Keeping a blood pressure log if you have been diagnosed with high blood pressure is a very good way to be prepared to speak with your doctor and be aware of any changes in your condition.

    Axert and Heart Disease

    Although extremely rare, serious heart problems, including some that have been fatal, have occurred after taking Axert tablets. These problems have occurred most often in patients with risk factors for heart disease and it is strongly recommended that such patients not take Axert.  

    If you have any heart disease risk factors, have your doctor evaluate your heart and physical condition to determine if you are reasonably free of heart disease and risk of stroke, before taking Axert.

    If you do have risk factors and your doctor decides you can take Axert, it is strongly recommended that you take your first dose of Axert in your doctor’s office or a similar setting with medical staff present unless you have previously taken Axert.

    Because stroke can occur your doctor may choose to do an electrocardiogram (ECG) immediately following a dose of Axert if you have heart disease risk factors.

    What should you do if you experience possible cardiac symptoms while taking Axert?

    If you feel shortness of breath, heart throbbing, persistent pain, tightness or pressure in the chest, or throat shortly after taking Axert, call your doctor right away.

    As always, the best source for advice on treating your migraines is your own migraine specialist. These medication descriptions are provided only for informational purposes. You should begin no medication regimen without first checking with your physician. Again, this information should in no way substitute or be mistaken for medical advice.