Pronunciation:

ra-SA-ji-leen

Brand Names:

• Azilect

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiparkinsonian

Pharmacologic—

Monoamine Oxidase Inhibitor, Type B

Uses of This Medicine:

Rasagiline is used alone or together with levodopa for the treatment of Parkinson's disease. Parkinson's disease is a condition of the brain that becomes worse over time and may cause movement problems, rigidity, tremors, and slowed physical movement.

This medicine is only available with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of rasagiline in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rasagiline in the elderly.

Breast-feeding—

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amphetamine
• Apraclonidine
• Atomoxetine
• Benzphetamine
• Brimonidine
• Bupropion
• Carbamazepine
• Carbinoxamine
• Citalopram
• Clomipramine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Doxylamine
• Duloxetine
• Ephedrine
• Escitalopram
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Gepirone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Levomethadyl
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Maprotiline
• Mazindol
• Meperidine
• Methadone
• Methamphetamine
• Methyldopa
• Methylphenidate
• Milnacipran
• Mirtazapine
• Nefopam
• Nortriptyline
• Opipramol
• Ozanimod
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Propoxyphene
• Pseudoephedrine
• Reserpine
• Safinamide
• Selegiline
• Serdexmethylphenidate
• Sertraline
• Solriamfetol
• St John's Wort
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Viloxazine
• Vortioxetine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol
• Alfentanil
• Amitriptyline
• Amoxapine
• Atropine
• Balofloxacin
• Benzhydrocodone
• Besifloxacin
• Buprenorphine
• Butalbital
• Butorphanol
• Ciprofloxacin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Dothiepin
• Doxepin
• Droperidol
• Enoxacin
• Epinephrine
• Ethchlorvynol
• Fentanyl
• Flumequine
• Formoterol
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Guarana
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Iobenguane I 131
• Kava
• Lasmiditan
• Levofloxacin
• Levorphanol
• Licorice
• Lithium
• Lofepramine
• Lomefloxacin
• Lorcaserin
• Ma Huang
• Mate
• Metaxalone
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nadifloxacin
• Nalbuphine
• Naratriptan
• Nefazodone
• Norepinephrine
• Norfloxacin
• Ofloxacin
• Ondansetron
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pazufloxacin
• Pefloxacin
• Peginterferon Alfa-2b
• Pentazocine
• Pixantrone
• Protriptyline
• Prulifloxacin
• Reboxetine
• Remifentanil
• Rufloxacin
• Sibutramine
• Sparfloxacin
• Sufentanil
• Tyrosine
• Valbenazine
• Vilanterol
• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Chlorpropamide
• Ginseng
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange
• Tobacco
• Tyramine Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dyskinesia (abnormal muscle movements) or
• Hypertension (high blood pressure) or
• Psychosis (mental disorder), or history of—Use with caution. May make these conditions worse.

• Liver disease, mild—Use with caution. The effects may be increased because of a slower removal of the medicine from the body.

• Liver problems, moderate or severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Take this medicine with or without food.

If you take this medicine and consume tyramine-rich foods, beverages, or dietary supplements or amines (from over-the-counter medicines), you could experience a hypertensive crisis or "cheese reaction". A hypertensive crisis (increase in blood pressure) is very serious and requires immediate medical attention. It is very important that you restrict dietary tyramine by avoiding the following tyramine-rich foods and beverages:

• Aged cheese
• Air dried, aged and fermented meats, sausages and salamis (eg, cacciatore, hard salami and mortadella)
• Animal livers that are spoiled or improperly stored
• Beers and tap beers, all varieties that have not been pasteurized so as to allow for ongoing fermentation
• Broad bean pods (eg, fava bean pods)
• Meat, poultry, or fish that is spoiled or stored improperly (eg, foods with changes in coloration, odor, or mold)
• OTC supplements containing tyramine
• Pickled herring
• Red wine
• Sauerkraut
• Soybean products including soy sauce and tofu
• Yeast extract, concentrated.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of Parkinson's disease:
  • For oral dosage form (tablets):
    • For patients taking rasagiline alone:
      • Adults—1 milligram (mg) once a day.
      • Children—Use and dose must be determined by your doctor.
    • For patients taking rasagiline with levodopa:
      • Adults—At first, 0.5 milligram (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not use this medicine if you are using St. John's wort, cyclobenzaprine, dextromethorphan, meperidine, methadone, propoxyphene, tramadol, or used a MAO inhibitor within the past 14 days.

If you experience signs and symptoms of high blood pressure, you should seek immediate medical attention. Signs and symptoms include severe headache, blurred vision or visual disturbances, difficulty thinking, stupor or coma, seizures, chest pain, unexplained nausea or vomiting.

Make sure your doctor knows about all the other medicines you are using. Rasagiline may cause a serious condition called serotonin syndrome when used with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.

This medicine may make you dizzy or drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

If you are taking this medicine with levodopa, you may experience increased dyskinesia (eg, twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs). Check with your doctor if you have any of these symptoms.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If you should have this problem, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Do not stop taking rasagiline without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abdominal or stomach pain

arm, back, or jaw pain

black, tarry stools

chest pain or discomfort

chest tightness or heaviness

chills

cloudy urine

cough

diarrhea

difficulty swallowing

dizziness

fainting

fast or irregular heartbeat

fever

hives, itching, or skin rash

loss of appetite

nausea

painful or difficult urination

persistent, non-healing sore

pink growth on the skin

puffiness or swelling of the eyelids or around the eyes

reddish patch or irritated area

redness, blistering, peeling, or loosening of the skin

seeing, hearing, or feeling things that are not there

shiny bump

sore throat

sores, ulcers, or white spots on lips or in mouth

sweating

swollen glands

tests that show problems with the liver

tightness in the chest

unusual bleeding or bruising

unusual tiredness or weakness

weakness

white, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

difficulty with moving

headache

heartburn

indigestion

muscle pain or stiffness

pain in the joints

stomach discomfort or upset

Less common

Bruising

burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings

burning, dry, or itching eyes

decreased interest in sexual intercourse

difficulty breathing

difficulty with moving

discouragement

excessive tearing

eye discharge

fall

feeling of constant movement of self or surroundings

feeling sad or empty

general feeling of discomfort or illness

hair loss

inability to have or keep an erection

irritability

joint pain

lack of appetite

large, flat, blue or purplish patches in the skin

lightheadedness

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

muscle aches

neck pain

noisy breathing

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

runny nose

sensation of spinning

shivering

sneezing

stuffy nose

swelling or redness in the joints

thinning of the hair

tiredness

trouble concentrating

trouble sleeping

vomiting

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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