IMPORTANT SAFETY INFORMATION
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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:
- Change in your mental status
- Changes in basic body functions such as blood pressure, heart rate, sweating and digestion
- Tremors
- Rigidity
- Seizures
- Lack of coordination, or overactive reflexes
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:
- Change in your heart rate
- Lightheadedness
- Irregular heartbeat, weak pulse, slow breathing
- Swelling in your hands or feet
- Headache with chest pain and severe dizziness, fainting, fast or slow pounding heartbeats
- Urinating less than usual or not at all
- Agitation, hallucinations, delirium, and coma
- Dizziness
- Tremors
- Muscle stiffness, muscle spasms, overactive reflexes, lack of coordination
- Seizures, with or without nausea, vomiting, diarrhea
Less serious side effects may include:
- Mild headache
- Tired feeling, mild dizziness
- Diarrhea, constipation, upset stomach, loss of appetite
- Chills, shivering, numbness or tingly feeling
- Fever, sweating
- Rash
- Joint or muscle pain
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
