Trisenox

Trisenox is a prescription medication used to treat acute promyelocytic leukemia (APL). APL is a type of cancer in which there are too many immature blood cells in the blood and bone marrow. Trisenox belongs to a group of drugs called antineoplastics. These work by slowing or stopping the growth of cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include nausea, tiredeness, fever, and swelling. Do not drive or operate heavy machinery until you know how Trisenox will affect you.

Trisenox is used to treat acute promyelocytic leukemia (APL) in those who have not been helped by other types of chemotherapy or whose condition has improved but then worsened following treatment with other types of chemotherapy. APL is a type of cancer in which there are too many immature blood cells in the blood and bone marrow.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cephalon, Inc.

• Teva Oncology

Common side effects of Trisenox include the following:

• nausea
• tiredness
• fever
• swelling
• tremors
• chest pain
• diarrhea
• vomiting
• stomach pain
• sore throat
• constipation
• imbalance of electrolytes
• headache
• difficulty falling asleep
• sensations of burning or tingling in arms, hands, fingers, feet, legs, or toes
• cough
• difficulty breathing
• nosebleeds
• skin inflammation
• itch
• abnormal heart rhythm
• fast heart beat
• muscle and joint pain
• high white blood cell count
• anxiety
• low blood pressure

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

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

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

No formal drug interactions tests have been completed. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with use of Trisenox:

Trisenox should be given only under the supervision of a doctor who has experience in treating people who have leukemia (cancer of the white blood cells).

Trisenox may cause a serious or life-threatening group of symptoms called APL differentiation syndrome. Your doctor will monitor you carefully to see whether you are developing this syndrome. Your doctor may ask you to weigh yourself every day during the first few weeks of your treatment because weight gain is a symptom of APL differentiation syndrome.

• If you experience any of the following symptoms, call your doctor immediately: fever, weight gain, shortness of breath, labored breathing, chest pain, or cough. At the first sign that you are developing APL differentiation syndrome, your doctor will prescribe one or more medications to treat the syndrome.

Trisenox may cause QT prolongation (heart muscles take longer to recharge between beats due to an electrical disturbance), which can cause serious or life-threatening heart rhythm problems.

• Before you begin treatment with Trisenox, your doctor will order an electrocardiogram (ECG; test that records the electrical activity of the heart) and other tests to see whether you already have an electrical disturbance in your heart or are at higher than usual risk of developing this condition.
• Your doctor will monitor you closely and will order an ECG and other tests during your treatment with Trisenox.
• Tell your doctor if you have or have ever had QT prolongation, heart failure, irregular heartbeat, or low levels of potassium or magnesium in your blood. Also tell your doctor if you are taking any of the following medications: amiodarone (Cordarone), amphotericin (Abelcet, Amphotec, Fungizone), cisapride (Propulsid), disopyramide (Norpace), diuretics ('water pills'), dofetilide (Tikosyn), erythromycin (E.E.S., E-Mycin, Erythrocin), moxifloxacin (Avelox), pimozide (Orap), procainamide (Procanbid, Pronestyl), quinidine (Quinidex), sotalol (Betapace, Betapace AF), sparfloxacin (Zagam), thioridazine (Mellaril), and ziprasidone (Geodon). Call your doctor immediately if you have an irregular or fast heartbeat or if you faint during your treatment with Trisenox.

Do not take this medication if you are allergic to Trisenox or to any of the inactive ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before receiving Trisenox injection,

• tell your doctor and pharmacist if you are allergic to Trisenox or any other medications
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had kidney disease
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Talk to your doctor about using birth control to prevent pregnancy during your treatment with Trisenox. If you become pregnant while receiving Trisenox, call your doctor. Trisenox may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving Trisenox.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. One patient who became pregnant while receiving Trisenox had a miscarriage. It is advisable to avoid pregnancy while on this medication. Trisenox may cause harm the the fetus (unborn baby).

Tell your doctor if you are breastfeeding or plan to breastfeed.

Trisenox has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Trisenox, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Induction Treatment Schedule: Trisenox should be administered into the vein at a dose of 0.15 mg/kg daily until response is achieved. Total induction dose should not exceed 60 doses.

Consolidation Treatment Schedule: Consolidation treatment should begin 3 to 6 weeks after completion of induction therapy. Trisenox should be administered into the vein at a dose of 0.15 mg/kg daily for 25 doses over a period up to 5 weeks.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to Trisenox.

Experienced Physician and Institution: Trisenox injection should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia.

APL Differentiation Syndrome: Some patients with APL treated with Trisenox have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This syndrome can be fatal. The management of the syndrome has not been fully studied, but high-dose steroids have been used at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously BID) should be immediately initiated, irrespective of the leukocyte count, and continued for at least 3 days or longer until signs and symptoms have abated. The majority of patients do not require termination of Trisenox therapy during treatment of the APL differentiation syndrome.

ECG Abnormalities: Trisenox can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient (also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with Trisenox.

ECG and Electrolyte Monitoring Recommendations: Prior to initiating therapy with Trisenox, a 12-lead ECG should be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine should be assessed; preexisting electrolyte abnormalities should be corrected and, if possible, drugs that are known to prolong the QT interval should be discontinued. For QTc greater than 500 msec, corrective measures should be completed and the QTc reassessed with serial ECGs prior to considering using Trisenox. During therapy with Trisenox, potassium concentrations should be kept above 4 mEq/L and magnesium concentrations should be kept above 1.8 mg/dL. Patients who reach an absolute QT interval value > 500 msec should be reassessed and immediate action should be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending Trisenox therapy should be considered. If syncope, rapid or irregular heartbeat develops, the patient should be hospitalized for monitoring, serum electrolytes should be assessed, Trisenox therapy should be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease. There are no data on the effect of Trisenox on the QTc interval during the infusion.