Maxalt-MLT

Rizatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Rizatriptan does not prevent migraine attacks or reduce the number of headaches you have.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not remove tablets from the blister pack until just before use. Store the medication at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor. Your blood pressure should be checked regularly.

You should keep a headache diary by writing down when you have headaches and when you take rizatriptan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Maxalt^®
• Maxalt-MLT^®

Dosage Forms & Strengths

tablet

• 5mg
• 10mg

tablet, oral disintegrating

• 5mg
• 10mg

Migraine Headache

Acute treatment of migraine with or without aura

5-10 mg PO at onset of symptoms; repeat dose after 2 hours if necessary; not to exceed 30 mg/24 hr

Dosing considerations

• Patients taking propranolol: Limit dose to 5 mg PO and do not exceed 15 mg/24 hr

Dosage Forms & Strengths

tablet

• 5mg
• 10mg

tablet, oral disintegrating

• 5mg
• 10mg

Migraine Headache

Acute treatment of migraine with or without aura

<6 years: Safety and efficacy not established

6-17 years (<40 kg): 5 mg PO once q24hr

6-17 years: (40 kg or greater): 10 mg PO once q24hr

Dosing considerations

• Efficacy and safety of treatment with more than 1 dose within 24 hours in pediatric patients has not been established
• 6-17 years (<40 kg) taking propranolol: Do not administer rizatriptan
• 6-17 years (≥40 kg) taking propranolol: Limit dose to 5 mg PO once q24hr as necessary; not to exceed 5 mg/24hr

Taking rizatriptan while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may interact with rizatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Maxalt
• Maxalt-MLT

Available Dosage Forms:

• Tablet, Disintegrating
• Tablet

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad headache or if headache is not better after the first dose.
• Change in eyesight.
• Loss of eyesight. This can be long-lasting.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Very upset stomach or throwing up.
• Very bad belly pain or bloody loose stools.
• Fever.
• Weight loss.
• Leg cramps.
• Feeling of heaviness or tightness in the leg muscles.
• Feeling cold.
• Burning or aching pain in the feet or toes.
• Shortness of breath.
• Mood changes.
• Change in color of skin.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take Maxalt-MLT (rizatriptan orally disintegrating tablets) with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this medicine. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out.
• Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with Maxalt-MLT. Call your doctor right away if you have a change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

No overdoses of MAXALT were reported during clinical trials in adults.

Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence.

In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.

In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea.

In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed.

The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

MAXALT®(max-awlt) and MAXALT-MLT®
rizatriptan benzoate
Tablets and Orally Disintegrating Tablets

Read this Patient Information before you start taking MAXALT® and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Unless otherwise stated, the information in this Patient Information leaflet applies to both MAXALT Tablets and to MAXALT-MLT® Orally Disintegrating Tablets.


What is MAXALT?

MAXALT is a prescription medicine that belongs to a class of medicines called Triptans. MAXALT is available as a traditional tablet (MAXALT) and as an orally disintegrating tablet (MAXALT-MLT).

MAXALT and MAXALT-MLT are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age.

MAXALT is not to be used to prevent migraine attacks.

MAXALT is not for the treatment of hemiplegic or basilar migraines.

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

It is not known if taking more than 1 dose of MAXALT in 24 hours is safe and effective in children 6 to 17 years of age.

It is not known if MAXALT is safe and effective in children under 6 years of age.


Who should not take MAXALT?

Do not take MAXALT 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 • 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 monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks • are allergic to rizatriptan benzoate or any of the ingredients in MAXALT. See the end of this leaflet for a complete list of ingredients in MAXALT.

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.


What should I tell my doctor before taking MAXALT?

Before you take MAXALT, tell your doctor 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: o high blood pressure o high cholesterol o smoking o obesity o diabetes o family history of heart problems o you are post menopausal o you are a male over 40 • have phenylketonuria (PKU). MAXALT-MLT orally disintegrating tablets contain phenylalanine. • have kidney or liver problems • have any other medical condition • are pregnant or plan to become pregnant. It is not known if MAXALT will harm your unborn baby. If you become pregnant while taking MAXALT, talk to your healthcare provider about registering with the pregnancy registry at the Merck National Service Center. You can enroll in this registry by calling 1-800-986-8999. The purpose of this registry is to collect information about the safety of MAXALT in pregnancy. • are breastfeeding or plan to breastfeed. It is not known if MAXALT passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAXALT.

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

MAXALT and other medicines may affect each other causing side effects. MAXALT may affect the way other medicines work, and other medicines may affect how MAXALT works.

Especially tell your doctor if you take:

• propranolol containing medicines such as Inderal®, Inderal® LA, or Innopran® XL • medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

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.


How should I take MAXALT?

• Take MAXALT exactly as your doctor tells you to take it. • Your doctor will tell you how much MAXALT to take and when to take it. • To take MAXALT-MLT: o Leave MAXALT-MLT orally disintegrating tablets in the package it comes in until you are ready to take it. When you are ready to take it: ▪ Remove the blister from the foil pouch. Do not push the MAXALT-MLT orally disintegrating tablet through the blister. ▪ Peel open the blister pack with dry hands and place the MAXALT-MLT orally disintegrating tablet on your tongue. The tablet will dissolve and be swallowed with your saliva. No liquid is needed to take the orally disintegrating tablet. • If your headache comes back after your first MAXALT dose: o For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of MAXALT in a 24-hour period (for example, do not take more than 3 10-mg tablets in a 24-hour period). o For children 6 to 17 years of age: It is not known if taking more than 1 dose of MAXALT 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 MAXALT, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking MAXALT?

MAXALT 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.


What are the possible side effects of MAXALT?

MAXALT 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 of MAXALT including:

• heart attack. Symptoms of a heart attack may include: o chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back o chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain o pain or discomfort in your arms, back, neck, jaw or stomach o shortness of breath with or without chest discomfort o breaking out in a cold sweat o nausea or vomiting o feeling lightheaded • stroke. Symptoms of a stroke may include the following sudden symptoms: o numbness or weakness in your face, arm or leg, especially on one side of your body o confusion, problems speaking or understanding o problems seeing in 1 or both of your eyes o problems walking, dizziness, loss of balance or coordination o severe headache with no known cause • blood vessel problems. Symptoms of blood vessel problems may include: o stomach pain o bloody diarrhea o vision problems o coldness and numbness of hands and feet • serotonin syndrome. A condition called serotonin syndrome can happen when Triptan medicines such as MAXALT are taken with certain other medicines. Symptoms of serotonin syndrome may include: o agitation o hallucinations o coma o fast heartbeat o fast changes in your blood pressure o increased body temperature o muscle spasm o loss of coordination o nausea, vomiting or diarrhea • increased blood pressure.

The most common side effects of MAXALT in adults include:

• feeling sleepy or tired • pain or pressure in your chest or throat • dizziness

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

If you take MAXALT too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking MAXALT.

These are not all the possible side effects of MAXALT. 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.


How should I store MAXALT?

• Store MAXALT at room temperature between 59°F to 86°F (15°C to 30°C). • Safely throw away medicine that is out of date or no longer needed.

Keep MAXALT and all medicines out of the reach of children.


General Information about the safe and effective use of MAXALT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MAXALT for a condition for which it was not prescribed. Do not give MAXALT to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about MAXALT. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about MAXALT that is written for health professionals.

For more information, go to www.maxalt.com or call 1-800-986-8999.


What are the ingredients in MAXALT?

Active ingredient in MAXALT and MAXALT-MLT orally disintegrating tablets:

rizatriptan benzoate.

Inactive ingredients in MAXALT: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate.

Inactive ingredients in MAXALT-MLT orally disintegrating tablets: gelatin, mannitol, glycine, aspartame, and peppermint flavor.

MAXALT-MLT orally disintegrating tablets contain aspartame, a source of phenylalanine.


Phenylketonurics:

MAXALT-MLT orally disintegrating tablets 5-mg contain 1.1 mg of phenylalanine. MAXALT-MLT orally disintegrating tablets 10-mg contain 2.1 mg of phenylalanine.

This Patient Information has been approved by the U.S. Food and Drug Administration.


MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are manufactured for:
Merck Sharp & Dohme Corp., a subsidiary of

Whitehouse Station, NJ 08889, USA

MAXALT Tablets are manufactured by:
Merck Sharp & Dohme Ltd.
Cramlington, Northumberland NE23 3JU,
United Kingdom

MAXALT-MLT Orally Disintegrating Tablets are manufactured by:
Catalent UK Swindon, Zydis Ltd.
Swindon, Wiltshire, SN5 8RU, United Kingdom

The brands listed are the trademarks of their respective owners.
Copyright © 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 01/2013

USPPI-T-MLT-04621301R011