HOW SHOULD THIS MEDICINE BE USED?

Anzemet® (dolasetron mesylate) Injection is injected into a vein through an IV and is prescribed intravenously by your doctor prior to anesthesia for prevention of nausea and vomiting before surgery or as soon as you become nauseous or begin vomiting after surgery.

YOUR DOCTOR WILL NOT EXCEED THE RECOMMENDED DOSE OF ANZEMET INJECTION.

YOUR DOCTOR WILL NOT MIX ANZEMET INJECTION WITH OTHER DRUGS.

Adults

In most cases, only one dose of Anzemet Injection is given while you are still under anesthesia or as soon as you have symptoms of nausea or vomiting post surgery.

The recommended dose of Anzemet injection is 12.5 mg given as a single dose approximately 15 minutes before anesthesia (for prevention) or as soon as nausea or vomiting begins (after surgery).  Anzemet Injection can be safely infused as rapidly as 30 seconds or diluted in a compatible IV solution to 50 ml and infused over a period up to 15 minutes.

ANZEMET INJECTION IS NOT FOR PREVENTING NAUSEA OR VOMITING THAT IS CAUSED BY CHEMOTHERAPY OR OTHER CONDITIONS NOT RELATED TO SURGERY.

WHEN INITIAL TREATMENT WITH ANZEMET INJECTION HAS NOT WORKED TO REDUCE NAUSEA AND VOMITING, REPEATED DOSES OF ANZEMET INJECTION SHOULD NOT BE GIVEN.

Children

Anzemet Injection can be given to children 2 years old or older either through an IV into a vein, or it can be mixed with apple or apple-grape juice and given orally.

IV Administration

The recommended IV dose in children 2 to 16 years old is 0.35 mg/kg, with a maximum dose of 12.5 mg given as a single dose approximately 15 minutes before anesthesia (for prevention) or as soon as nausea or vomiting begins (a treatment for nausea and vomiting).  Anzemet Injection can be safely infused as rapidly as 30 seconds or diluted in a compatible IV solution to 50 ml and infused over a period up to 15 minutes.

SAFETY AND EFFECTIVENESS IN CHILDREN UNDER 2 YEARS OLD HAS NOT BEEN STUDIED.

Oral Administration of IV Product

Anzemet Injection solution may be mixed into apple or apple-grape juice for oral dosing.  With this mode of administration, the recommended dose for children 2 to 16 years old is 1.2 mg/kg up to a maximum 100-mg dose given within 2 hours before surgery.  The diluted product may be kept up to 2 hours at room temperature before use.

WHO SHOULD NOT TAKE ANZEMET INJECTION?

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

  • A history of abnormal heart rhythms, such as congenital QT syndrome
  • Low levels of potassium or magnesium in your blood or take medicines, that may cause an electrolyte imbalance
  • If you are elderly AND have a serious heart condition called “sick sinus syndrome”

ANZEMET INJECTION CAN CAUSE SERIOUS HEART RHYTHM PROBLEMS.  YOU SHOULD NOT USE ANZEMET INJECTION IF YOU HAVE A HISTORY OF SERIOUS HEART CONDITIONS SUCH AS LONG QT SYNDROME, OR LOW BLOOD LEVELS OF POTASSIUM OR MAGNESIUM.  IF YOU HAVE ANY OF THESE CONDITIONS, ANZEMET INJECTION MAY LEAD TO LOSS OF HEART FUNCTION, BREATHING AND CONSCIOUSNESS.  TELL YOUR DOCTOR IF YOU OR ANYONE IN YOUR FAMILY HAS EVER HAD ANY OF THESE CONDITIONS.

IF YOU ARE OLDER YOU CANNOT RECEIVE ANZEMET INJECTION FOR THE TREATMENT OF NAUSEA OR VOMITING ASSOCIATED WITH CHEMOTHERAPY.

To make sure that you can safely receive Anzemet Injection, tell your doctor if you have any of these conditions:

  • Congestive heart failure and slow heart rate
  • Heart disease, heart abnormalities,  and pre-existing problems with your heart
  • History of irregular heart beat or atrial  fibrillation
  • Heart attack
    • Receive drugs known to prolong the PR and/or QRS interval (verapamil, flecainide or quinidine)
  • Kidney disease

Your doctor may have you undergo ECG monitoring if you receive Anzemet Injection with any of these conditions.

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 Injection can also cause what is known as “serotonin syndrome”, which can occur if you receive Anzemet Injection alone or in combination with other medications known to increase serotonin levels in the body (such as certain antidepressants and migraine medicines).

TELL YOUR DOCTOR ABOUT ALL MEDICATIONS YOU ARE TAKING, INCLUDING OVER-THE-COUNTER MEDICINES, VITAMINS, AND SUPPLEMENTS.  DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR

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

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

PREGNANCY WARNINGS:

While Anzemet Injection has 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 Injection should be prescribed only if clearly needed. Tell your doctor if you are pregnant.

NURSING MOTHERS:  It is unknown if Anzemet Injection 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 conducted if you are an older patient receiving Anzemet Injection.

TAKING OTHER MEDICINES:

Tell your doctor about all other medicines you use, especially:

  • 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)

MAKE SURE THAT YOU INFORM YOUR DOCTOR ABOUT ALL MEDICATIONS YOU ARE TAKING SO THAT YOU CAN BE MONITORED FOR POSSIBLE DRUG INTERACTIONS.

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IMPORTANT SAFETY INFORMATION

Anzemet® (dolasetron mesylate) Injection

WHAT IS ANZEMET INJECTION USED FOR?

Anzemet® (dolasetron mesylate) Injection is used to prevent and treat post-operative nausea and vomiting in adults and children 2 years and older.

WHEN SHOULD I NOT TAKE THE DRUG?

DO NOT USE ANZEMET INJECTION IF:

WHAT WARNINGS SHOULD I KNOW ABOUT ANZEMET?

QT, PR and QRS Interval Prolongation

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

QT Interval:  A lengthened QT interval can be associated with rapid/slow heartbeat and can increase your risk for sudden death.  Anzemet Injection can increase the QT Interval in a dose-dependent fashion.  If you have a prolonged QT Interval or low levels of potassium or magnesium in your bloodstream you should avoid receiving Anzemet Injection.  Low levels of potassium and magnesium in the bloodstream must be corrected prior to starting Anzemet Injection therapy and should be monitored once Anzemet Injection therapy has begun.  If you are prescribed Anzemet Injection and have congestive heart failure and very slow heart rate, 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 Injection can increase these conditions and result in death.   Patients having underlying heart disease and heart abnormalities are at particular risk, as are elderly patients, patients with irregular heart beat, patients with atrial fibrillation (irregular or quivering heartbeat) with slow heart response, patients who have had heart attack or patients receiving drugs (such as verapamil, flecainide or quinidine) known to prolong the PR and/or QRS interval.  If you have one of these conditions, your doctor will prescribe Anzemet Injection with ECG monitoring.  If you have or are at risk for complete heart block, your doctor will only prescribe Anzemet Injection if you have an implanted pacemaker.

Serotonin Syndrome

Serotonin syndrome occurs when there is excess serotonin in the body.  This has been reported for drugs, such as Anzemet Injection, that are known as 5-HT3  receptor antagonists.  You can develop serotonin syndrome from use of a 5-HT3 receptor antagonist alone, or from use of other serotogenic drugs used for depression and migraine and other disorders such as serotonin reuptake inhibitors (SSRI’s), serotonin and norepinephrine reuptake inhibitors (SNRI’s), monoamine oxidase inhibitors (MAOI’s), mirtazepine, fentanyl, lithium, tramadol and intravenous methylene blue3, in combination with Anzemet Injection.

Serotonin syndrome can have serious, potentially life-threatening and sometimes fatal consequences.  If you are receiving Anzemet Injection and have any of the following symptoms, seek immediate medical attention: changes in your mental status (agitation, hallucinations, delirium and coma), changes in basic body functions (irregular heart beat, increased or decreased blood pressure, dizziness, flushing, sweating, high body temperature), neuromuscular symptoms (tremor, rigidity, unusual muscle jerking and/or spasms, in-coordination), seizures, nausea, vomiting, diarrhea.

ANZEMET INJECTION IS ADMINISTERED WITH CAUTION IN PATIENTS WHO HAVE OR MAY DEVELOP PROLONGED CARDIAC INTERVALS, PARTICULARLY PROLONGATION OF THE QT INTERVAL.  THIS INCLUDES PATIENTS WHO HAVE LOW BLOOD LEVELS OF POTASSIUM AND MAGNESIUM, PATIENTS TAKING DIURETICS WITH THE POTENTIAL OF CAUSING ELECTROLYTE ABNORMALITIES, PATIENTS WITH CONGENITAL QT SYNDROME (PROLONGED QT INTERVALS), PATIENTS TAKING ANTIARRHYTHMIC DRUGS OR OTHER DRUGS THAT CAN LEAD TO QT PROLONGATION, AND CUMULATIVE HIGH DOSE ANTHRACYCLINE THERAPY.

Pediatric Use

Prevention of chemotherapy induced nausea and vomiting

ANZEMET INJECTION SHOULD NOT BE USED IN CHILDREN UNDERGOING CANCER CHEMOTHERAPY

Prevention and treatment of post-operative nausea and vomiting

ANZEMET INJECTION SHOULD NOT BE USED IN CHILDREN UNDER 2 YEARS OLD FOR POST-OPERATIVE NAUSEA AND VOMITING

Geriatric Use

Prevention of chemotherapy induced nausea and vomiting

ANZEMET INJECTION SHOULD NOT BE USED FOR GERIATRIC PATIENTS UNDERGOING CANCER CHEMOTHERAPY

Prevention and treatment of post-operative nausea and vomiting

There have been no studies of the use of Anzemet Injection for post-operative nausea and vomiting in older patients.

Older patients are at risk for prolongation of the PR, QRS and QT interval, so if you are an older patient and receiving Anzemet Injection, your doctor will exercise caution  and should require ECG monitoring.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

If you are prescribed Anzemet Injection and have congestive heart failure, very slow heart rate, QT syndrome, liver impairment, have hypokalemia (potassium deficiency in bloodstream) or hypomagnesemia (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 Injection has been shown to  cause liver cancer in mice at 4,7, and 14 times the recommended doses.

Anzemet Injection does not have an effect on fertility and reproduction at up to 9 times the recommended dose.

There is no evidence of impaired fertility or harm to the fetus caused by Anzemet Injection in rats and rabbits. However, there have been no studies in pregnant women so your doctor will only prescribe Anzemet Injection if clearly needed.

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

WHAT OTHER MEDICATIONS MIGHT INTREACT WITH ANZEMET INJECTION?

There are few drugs that interact with Anzemet Injection.  However, if you are going to receive Anzemet Injection with any other drugs make sure you tell your doctor.  Your doctor may monitor you if you are receiving Anzemet Injection in combination 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 INJECTION?

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 Injection were headache, fatigue, diarrhea, abnormally slow heartbeat (bradycardia), dizziness, pain, abnormally rapid heartbeat (tachycardia), indigestion, and chills/shivering.

Very rapid heart rate and cardiac arrest have been reported following administration of Anzemet Injection.

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 (1-866-9VALIDUS).

OVERDOSAGE:

There is no known specific antidote for Anzemet Injection, and patients with suspected overdose should be managed with supportive therapy.

Doses as large as 5 mg IV have safely been given to healthy volunteers and cancer patients.

Following a suspected overdose of Anzemet Injection, if a patient is found to have second-degree or higher heart block, he or she should undergo cardiac telemetry monitoring.