RizaFilm is a prescription medicine used for the treatment of migraine.

RizaFilm is an oral film that contains the drug rizatriptan, which belongs to the class of medicines called serotonin receptor agonists (triptans).

Rizatriptan works by binding to serotonin (5-hydroxytryptamine or 5-HT) receptors in the brain to reduce vasodilation and inflammation of the blood vessels associated with migraine.

Rizatriptan was first approved by the FDA in oral tablet form under the brand name Maxalt in 1998.

What is RizaFilm used to treat?

RizaFilm is used to treat migraine attacks with or without aura in adults and in children 12 to 17 years of age who weigh 40 kg or more.

Migraine is a type of headache characterized by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head. At the onset of migraine, the trigeminal nerve releases a chemical called calcitonin gene-related peptide (CGRP) which relaxes the blood vessel walls causing vasodilation.

RizaFilm works to reduce the vasodilation in migraine by constricting the blood vessels.

RizaFilm is not to be used to prevent migraine attacks.

It is not known if this medicine is safe and effective for the treatment of cluster headaches.

It is not known if this medicine is safe and effective in children under 12 years of age and who weigh less than 40 kg.

Take RizaFilm exactly as your doctor tells you to take it.

Your doctor will tell you how much to take and when to take it.

Leave the oral film in the aluminum pouch it comes in until you are ready to take it.

When you are ready to take it, remove the oral film from the aluminum pouch by folding the pouch on the dotted line and tearing it open at the tear notch.

Place the oral film on the tongue. The oral film will disintegrate in about 2 minutes and can be swallowed with saliva. No liquid is required to take the oral film.

If your headache comes back after your first dose:

• For adults: a second dose may be taken at least 2 hours after the first dose. Do not take more than 30 mg in a 24-hour period (for example, do not take more than three 10 mg oral films in a 24-hour period).
• For children 12 to 17 years of age: It is not known if taking more than one dose in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back.

If you take too much or overdose, call your doctor or go to the nearest hospital emergency room right away.

Usual Adult Dose for Migraine

10 mg single dose; separate repeat doses by at least two hours; maximum cumulative dosage in a 24-hour period is 30 mg

Use: for the acute treatment of migraine with or without aura in adults.

Usual Pediatric Dose for Migraine

10 mg single dose

Use: for the acute treatment of migraine with or without aura in pediatric patients 12 to 17 years of age weighing 40 kg or more.

Do not take RizaFilm if you:

• have or have had heart problems.
• have or have had a stroke or a transient ischemic attack (TIA).
• have or have had blood vessel problems including ischemic bowel disease, or narrowing of blood vessels in your legs, arms, and stomach, or kidney (peripheral vascular disease)
• have uncontrolled high blood pressure.
• have taken other triptan medicines in the last 24 hours.
• have taken ergot-containing medicines in the last 24 hours.
• have hemiplegic or basilar migraines.
• take a monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks.
• take propranolol.
• are allergic to rizatriptan or any of the incative ingredients. See the end of this page for a complete list of ingredients.

Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines.

Before you take RizaFilm

Before you take RizaFilm, tell your doctor about all of your medical conditions, including if you:

• have or have had heart problems, high blood pressure, chest pain, or shortness of breath.
• have any risk factors for heart problems or blood vessel problems such as:
  • high blood pressure.
  • high cholesterol.
  • smoking.
  • obesity.
  • diabetes.
  • family history of heart problems.
  • you are post-menopausal.
• have kidney or liver problems.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.

If you become pregnant while taking RizaFilm, talk to your healthcare provider.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby if you take RizaFilm.

RizaFilm may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert.

RizaFilm may cause serious side effects. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects including:

• heart attack and other heart problems. Symptoms of a heart attack may include:
  • chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
• stroke. Symptoms of a stroke may include the following sudden symptoms:
  • numbness or weakness in your face, arm or leg, especially on one side of your body
  • confusion, problems speaking or understanding
  • problems seeing in one or both of your eyes
  • problems walking, dizziness, loss of balance or coordination
  • severe headache with no known cause
• blood vessel problems. Symptoms of blood vessel problems may include:
  • stomach pain
  • bloody diarrhea
  • vision problems
  • coldness and numbness of hands and feet
• allergic reactions. Allergic reactions that can lead to death have happened in people who take rizatriptan. Symptoms of an allergic reaction may include:
  • swelling of your face, eyes, lips, mouth, or tongue
  • trouble breathing
  • hives (itchy bumps)
• medication overuse headache. Some people who use too much migraine medicine for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment.
• serotonin syndrome. A condition called serotonin syndrome can happen when triptan medicines are taken with certain other medicines. Symptoms of serotonin syndrome may include:
  • agitation
  • hallucinations
  • coma
  • fast heartbeat
  • fast changes in your blood pressure
  • increased body temperature
  • muscle spasm
  • loss of coordination
  • nausea, vomiting or diarrhea
• increased blood pressure.

The most common side effects in adults include:

• having a lack of energy
• feeling sleepy or tired
• pain or pressure in your chest or throat
• dizziness
• nausea

Adverse reactions in children are expected to be similar to those in adults.

Tell your doctor if you have any side effect that bothers you or that does not go away.

If you take RizaFilm too often, this may result in you getting chronic (lasting a long time) headaches. In such cases, you should contact your doctor, as you may have to stop taking RizaFilm.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

RizaFilm and other medicines may affect each other causing side effects. It may affect the way other medicines work, and vice versa.

Especially tell your doctor if you take:

• propranolol
• ergot drugs (ergotamine, dihydroergotamine)
• other triptans (sumatriptan, zolmitriptan, naratriptan, frovatriptan, eletriptan, almotriptan)
• SSRIs - selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone)
• SNRIs - serotonin norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine, milnacipran, levomilnacipran)
• monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine).

 Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.