NOTICE TO PATIENTS AND HEALTH CARE PROFESSIONALS: Validus is currently not manufacturing or marketing this product. This website is maintained solely for reference purposes. Patients -- Validus recommends that you talk to your Health Care Professional about alternative therapies.

HOW SHOULD THIS MEDICINE BE USED?

Anzemet® (dolasetron mesylate) Tablets come in tablet form, which can be taken by the mouth.

TAKE EXACTLY AS PRESCRIBED BY YOUR DOCTOR. DO NOT TAKE LARGER OR SMALLER AMOUNTS OF THIS MEDICINE, OR FOR LONGER THAN RECOMMENDED, UNLESS DIRECTED BY YOUR DOCTOR.

Adults

The recommended dose of Anzemet Tablets is 100 mg, taken by mouth within 1 hour before chemotherapy.

Pediatric Patients

The recommended dose for pediatric patients 2 to 16 years of age is 1.8 mg/kg, taken within one hour before chemotherapy, up to a maximum of 100 mg, based on weight.

For children who do not meet the weight requirements for taking Anzemet 100 mg Tablets or children unable to swallow tablets, Anzemet Injection solution may be used instead by mixing it into apple or apple-grape juice for oral dosing.

Elderly Patients & Patients with Kidney Impairment or Failure

These patients should be monitored with ECG while taking Anzemet Tablets, but no dosage adjustment is needed.

WHO SHOULD NOT TAKE ANZEMET?

You should not take Anzemet Tablets if you are allergic to dolasetron mesylate (the active ingredient in Anzemet Tablets) or have any of the following conditions:

  • A personal or family history of abnormal heart rhythms, such as congenital long QT syndrome
  • Take medications, such as diuretics, that may cause an electrolyte imbalance (for example, low potassium or magnesium levels in your blood) or medications for irregular heartbeat (for example, anti-arrhythmic medications)
  • A serious heart condition called “sick sinus syndrome”
  • Slow heartbeat or fast, irregular heartbeat (atrial fibrillation), or heart disease that prevents enough blood from reaching your heart (myocardial ischemia)
  • You are 65 years or older (consult your physician)
  • Kidney disease

You should also be aware that Anzemet Tablets can cause serious heart conditions such as QT syndrome, Toursade de Pointes, or heart block, all of which can lead to loss of heart function, breathing and consciousness.

TELL YOUR DOCTOR ABOUT ALL MEDICINES THAT YOU USE. THERE ARE MANY OTHER MEDICINES THAT CAN INCREASE YOUR RISK OF HEART RHYTHM PROBLEMS IF YOU USE THEM TOGETHER WITH ANZEMET.

Anzemet Tablets can also cause what is known as “serotonin syndrome”, which can occur in patients who are taking Anzemet Tablets along with other medicines known to increase serotonin levels in the body (such as certain antidepressants and migraine medicines).

ANZEMET TABLETS ARE USUALLY TAKEN 1 HOUR BEFORE CHEMOTHERAPY. TELL YOUR DOCTOR IF YOU FORGET TO TAKE THE MEDICATION WITHIN THE SPECIFIED TIME PERIOD BEFORE YOUR CHEMOTHERAPY.

If any of the following symptoms occur, you should get immediate medical help:

  • Changes in mental status
  • Changes in blood pressure, heart rate, sweating, and digestion of your food

Anzemet Tablets also contain inactive ingredients, including carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, synthetic red iron oxide, titanium dioxide, and white wax that can cause allergic reactions or other problems.

TELL YOUR HEALTHCARE PROVIDER IF YOU HAVE ANY OF THE CONDITIONS:

  • Congestive heart failure
  • Heart rhythm condition causing fast, irregular heartbeat (congenital long QT syndrome)
  • Slow heartbeat (bradycardia)
  • Sick sinus syndrome
  • Kidney disease
  • Heart disease that prevents enough blood from reaching your heart (myocardial ischemia)
  • You are taking heartbeat regulating medications to prolong PR interval (such as verapamil) and QRS interval (e.g., flecainide or quinidine)
  • You are taking a serotonin and norepinephrine reuptake inhibitor (SNRI), a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor, mirtazapine, fentanyl, lithium, tramadol, or intravenous methylene blue
  • If you notice a change in your heart rate, feel lightheaded, or have an irregular heartbeat or fainting episode.

Patients under 2 years old should not take Anzemet Tablets because its safety and effectiveness for children under 2 has not been established.

CANCER: Anzemet Tablets have been shown to cause liver cancer in mice at 4, 7, and 14 times the recommended doses.

FERTILITY: Anzemet Tablets do not affect fertility and reproduction at up to 8 times the recommended dose

PREGNANCY WARNINGS:

Anzemet Tablets have not been shown to affect fertility or cause harm to the fetus in animal studies. There have been no studies in pregnant women, so Anzemet should be prescribed only if clearly needed. You should tell your doctor if you are pregnant before taking Anzemet.

NURSING MOTHERS: It is unknown if Anzemet passes through to human milk.  If you are nursing or considering nursing, tell your doctor.

PEDIATRIC USE: Safety and effectiveness in children under the age of 2 has not been studied.

GERIATRIC USE: Older patients are at risk for serious cardiac arrhythmias. ECG monitoring should be done for older patients taking Anzemet Tablets.

TAKING OTHER MEDICINES:

Tell your doctor if you are taking Anzemet Tablets with other medicines used for chemotherapy, particularly those that prolong ECG intervals and/or cause low levels of potassium or magnesium in the blood, or medicines used to treat depression or migraines.

The following medicines are known to have interactions with Anzemet Tablets:

  • Arsenic trioxide (Trisenox)
  • Cimetidine (Tagamet)
  • Digoxin (digitalis, Lanoxin)
  • Tacrolimus (Prograf)
  • Tramadol (Ultram)
  • Verapamil (Calan, Covera, Isoptin, Verelan, Tarka)
  • An antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levoflaxin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater), pentamidine (NebuPent, Pentam), or antibiotics given by injection
  • An antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin)
  • Anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam)
  • Cancer medications (chemotherapy) such as daunorubicin (Cerubidine, Daunoxome), doxorubicin (Adriamycin, Doxil), epirubicin (Ellence), idarubicin (Idamycin), mitoxantrone (Novantrone), and others
  • A diuretic (water pill)
  • Heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Trambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace)
  • HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), ritonavir (Norvir), or nelfinavir (Viracept)
  • Medicines to treat psychiatric disorders such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon)
  • Migraine headache such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig)
  • Narcotic medication such as methadone (Methadose, Diskets, Dolophine)
  • Other medicines to prevent or treat nausea and vomiting such as ondansetron (Zofran) or droperidol (Inapsine)
  • Seizure medicine such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal)

THIS LIST IS NOT COMPLETE AND OTHER DRUGS MAY INTERACT WITH ANZEMET TABLETS. TELL YOUR DOCTORS ABOUT ALL MEDICINES YOU USE.  THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN AND HERBAL PRODUCTS.  DO NOT START ANY NEW MEDICATIONS WITHOUT TELLING YOUR DOCTOR.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Anzemet® (dolasetron mesylate) Tablets

WHAT ARE ANZEMET TABLETS USED FOR?

Anzemet® (dolasetron mesylate) Tablets are used to prevent nausea and vomiting associated with chemotherapy.

WHEN SHOULD I NOT TAKE THE DRUG?

DO NOT USE Anzemet Tablets if you have ever had a bad reaction to any form of Anzemet (tablets or injection) in the past.

WHAT WARNINGS SHOULD I KNOW ABOUT ANZEMET TABLETS?

QT, PR, and QRS Interval Prolongation

The QT, PR, and QRS Intervals reflect separate measures of time in the heart’s electrical cycle.

QT Interval: A lengthened QT Interval can be associated with rapid heartbeat and can increase your risk for sudden death. Anzemet Tablets can increase the QT Interval in a dose-dependent fashion. If you are prescribed Anzemet Tablets and have congestive heart failure, very slow heart rate, liver impairment, or if you are older, your doctor may suggest ECG monitoring.

PR and QRS Interval: Lengthened PR and QRS Intervals are associated with heart block, heart attack, irregular heart beat, and serious slow heart rate in adults and children. Anzemet Tablets can increase these conditions in a dose-dependent fashion and can result in death. If you have any of these conditions, or if you are taking other drugs that impact the PR or QRS Intervals, your doctor will require ECG monitoring.

Serotonin Syndrome

Serotonin syndrome occurs when there is excess serotonin in the body. This can have serious, potentially life-threatening and sometime fatal consequences. Anzemet Tablets can cause excess serotonin levels in the body.  If you are taking Anzemet Tablets, watch for the following symptoms:

If you are taking Anzemet Tablets and any other serotogenic drugs such as certain antidepressants, then you may be at a higher risk for developing serotonin syndrome. If any of these symptoms occur, stop taking Anzemet and seek emergency treatment.

Pediatric Use

Safety and effectiveness in pediatric patients (2 years and older) is based on studies in adults. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Anzemet Tablets can be used with children old enough to swallow tablets. For children that do not meet the weight requirements for taking Anzemet 100 mg Tablets or children unable to swallow, Anzemet Injection solution may be mixed into apple or apple-grape juice for oral dosing. (See Anzemet Injection).

Geriatric Use

Older patients are at particular risk for prolongation of the PR, QRS, and QT interval. Caution should be exercised and ECG monitoring should be performed when using Anzemet Tablets in older patients.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

If you are prescribed Anzemet Tablets and have congestive heart failure, very slow heart rate, QT syndrome, liver impairment, have hypokalemia (potassium deficiency in bloodstream) or hypo-magnesemia (magnesium deficiency in bloodstream), take diuretics,  anti-arrhythmic drugs or other drugs which lead to QT prolongation, or take high doses of anthracycline, your doctor will monitor you closely.

You should tell your doctor if you are pregnant, thinking of becoming pregnant, or nursing.

Anzemet Tablets have been shown to  cause liver cancer in mice at 3,6, and 12 times the recommended doses.

Anzemet Tablets do not have an effect on fertility and reproduction in rats at up to 9 times the recommended dose.

However there have been no studies in pregnant women, so your doctor will only prescribe Anzemet Tablets if clearly needed.

It is not known whether Anzemet Tablets pass through to human milk. If you are nursing or considering nursing, tell your doctor.

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH ANZEMET TABLETS?

Very few drugs interact with Anzemet Tablets. However, if you are going to take Anzemet Tablets with any other drugs, make sure you tell your doctor. Your doctor may monitor you if you are taking Anzemet Tablets with certain chemotherapy drugs, drugs that may cause serotonin syndrome, or drugs that affect your QT Interval and/or cause low blood potassium or magnesium.

WHAT ARE THE SIDE EFFECTS OF ANZEMET TABLETS?

Get immediate medical help if you notice any of the following side effects:

Less serious side effects may include:

The most common side effects reported in patients taking Anzemet Tablets were headache, fatigue, diarrhea, abnormally slow heartbeat (bradycardia), dizziness, pain, abnormally rapid heartbeat (tachycardia), indigestion, and chills/shivering.

THIS IS NOT A COMPLETE LIST OF SIDE EFFECTS AND OTHERS MAY OCCUR. TELL YOUR DOCTOR ABOUT ALL MEDICINES YOU USE.  THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN AND HERBAL PRODUCTS.  DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR. YOU MAY REPORT SIDE EFFECTS TO VALIDUS PHARMACEUTICALS LLC AT
1-866-982-5438.

OVERDOSAGE:

There is no known specific antidote for dolasetron mesylate, and patients with suspected overdose should be managed with supportive therapy. If overdose is suspected, seek emergency medical assistance or call the Poison Help Line at 1-800-222-1222.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch