Trisenox Side Effects

Generic Name: arsenic trioxide

Please note - some side effects for Trisenox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Trisenox - for the Consumer

Trisenox

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trisenox:

Agitation; blurred vision; chills; constipation; cough; darkening of skin; diarrhea; dizziness; drowsiness; dry eyes, mouth, or skin; earache; eye pain or irritation; flushing; headache; increased sweating; indigestion; loss of appetite; mouth sores; muscle, joint, or bone pain; nausea; nosebleed; numbness or tingling of the skin; pain, swelling, or redness at the injection site; pale skin; postnasal drip; ringing in the ears; skin lesions; sore throat; stomach pain, tenderness, or bloating; swelling of the eyelid; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching, difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety, confusion, or depression; black or bloody stools; bleeding between menstrual periods; chest pain; convulsions; decreased urination; fainting; fast heartbeat; fever; increased thirst or urination; irregular heart rate; loss of bowel or bladder control; loss of consciousness; rapid breathing; seizures; severe dizziness; severe weakness; skin shedding at the injection site; spitting up of blood; sudden weight gain; swelling of ankles, feet, or hands; tremors; trouble breathing; unusual bruising or bleeding; vaginal bleeding; wheezing.

Trisenox Side Effects - for the Professional

Trisenox

Clinical Studies Experience

Safety information was available for 52 patients with relapsed or refractory APL who participated in clinical trials of Trisenox. Forty patients in the Phase 2 study received the recommended dose of 0.15 mg/kg of which 28 completed both induction and consolidation treatment cycles. An additional 12 patients with relapsed or refractory APL received doses generally similar to the recommended dose. Most patients experienced some drug-related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. These adverse effects have not been observed to be permanent or irreversible nor do they usually require interruption of therapy.

Serious adverse events (SAEs), grade 3 or 4 according to version 2 of the NCI Common Toxicity Criteria, were common. Those SAEs attributed to Trisenox in the Phase 2 study of 40 patients with refractory or relapsed APL included APL differentiation syndrome (n=3), hyperleukocytosis (n=3), QTc interval ≥ 500 msec (n=16, 1 with torsade de pointes), atrial dysrhythmias (n=2), and hyperglycemia (n=2).

The following table describes the adverse events that were observed in patients treated for APL with Trisenox at the recommended dose at a rate of 5% or more. Similar adverse event profiles were seen in the other patient populations who received Trisenox.

Post-Marketing Experience

The following reactions have been reported from clinical trials and/or world-wide post-marketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.

Cardiac disorders: ventricular extrasystoles in association with QT prolongation, and ventricular tachycardia in association with QT prolongation

Nervous system disorders: peripheral neuropathy

Hematologic disorders: pancytopenia

Respiratory, thoracic, and mediastinal disorders: A differentiation syndrome, like retinoic acid syndrome, has been reported with the use of Trisenox for the treatment of malignancies other than APL.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects can include QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. Tachycardia (up to 55%), ECG QT corrected interval prolonged > 500 msec (up to 38%), palpitations (up to 10%), and ECG abnormalities other than QT interval prolongation (up to 7%) have been reported. One patient (also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.

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

Other

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 arsenic trioxide therapy during treatment of the APL differentiation syndrome.

Other side effects similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome have been reported. This syndrome is characterized by fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions (with or without leukocytosis). The syndrome can be fatal.

General

General side effects including fatigue (up to 63%), fever (up to 63%), edema (up to 40%), rigors (up to 38%), chest pain (up to 25% ), pain (up to 15%), weight gain (up to 13%), weakness (up to 10%), weight loss (up to 8%) and hemorrhage (up to 8%) have been reported.

Local

Local side effects including injection site pain (up to 20%), injection site erythema (up to 13%), and injection site edema (up to 10%) have been reported.

Hypersensitivity

Hypersensitivity side effects have been reported in up to 5% of treated patients.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 75%), vomiting (up to 58%), abdominal pain (up to 58%), diarrhea (up to 53%), sore throat (up to 40%), constipation (up to 28%), anorexia (up to 23%), decreased appetite (up to 15%), loose stools (up to 10%), dyspepsia (up to 10%), oral blistering (up to 8%), fecal incontinence (up to 8%), gastrointestinal hemorrhage (up to 8%), dry mouth (up to 8%), abdominal tenderness (up to 8%), hemorrhagic diarrhea (up to 8%), and abdominal distension (up to 8%) have been reported.

Metabolic

Metabolic side effects including hypokalemia (up to 50%), hypomagnesemia (up to 45%), hyperglycemia (up to 45%), hyperkalemia (up to 18%), hypocalcemia (up to 10%), hypoglycemia (up to 8%) and acidosis (up to 5%) have been reported.

Hepatic

Hepatic side effects including increased ALT (up to 20%) and increased AST (up to 13%) have been reported.

Nervous system

Nervous system side effects including headache (up to 60%), insomnia (up to 43%), paresthesia (up to 33%), dizziness (up to 23%), tremor (up to 13%), convulsion (up to 8%), somnolence (up to 8%), and coma (up to 5%) have been reported.

Respiratory

Respiratory side effects including cough (up to 65%), dyspnea (up to 53%), epistaxis (up to 25%), hypoxia (up to 23%), pleural effusion (up to 20%), post nasal drip (up to 13%), wheezing (up to 13%), decreased breath sounds (up to 10%), crepitations (up to 10%), rales (up to 10%), hemoptysis (up to 8%), tachypnea (up to 8%), and rhonchi (up to 8%) have been reported.

Dermatologic

Dermatologic side effects including dermatitis (up to 43%), pruritus (up to 33%), ecchymosis (up to 20%), dry skin (up to 13%), erythema (up to 10%), increased sweating (up to 10%), facial edema (up to 8%), night sweats (up to 8%), petechiae (up to 8%), hyperpigmentation (up to 8%), skin lesions (up to 8%), urticaria (up to 8%), local exfoliation (up to 5%), and eyelid edema have been reported. A case of iatrogenic arsenic induced Mees' lines has also been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 33%), myalgia (up to 25%), bone pain (up to 23%), back pain (up to 18%), neck pain (up to 13%), and pain in a limb (up to 13%) have been reported.

Hematologic

Hematologic side effects including leukocytosis (up to 50%), anemia (up to 14%), thrombocytopenia (up to 19%), febrile neutropenia (up to 13%), neutropenia (up to 10%), disseminated intravascular coagulation (up to 8%), and lymphadenopathy (up to 8%) have been reported.

Other

Vascular side effects including hypotension (up to 25%), flushing (up to 10%), hypertension (up to 10%), and pallor (up to 10%) have been reported.

Psychiatric

Psychiatric side effects including anxiety (up to 30%), depression (up to 20%), agitation (up to 5%), and confusion (up to 5%) have been reported.

Ocular

Ocular side effects including eye irritation (up to 10%), blurred vision (up to 10%), dry eye (up to 8%), and painful red eye (up to 5%) have been reported.

Renal

Renal side effects including renal failure (up to 8%), renal impairment (up to 8%), oliguria (up to 5%), and incontinence (up to 5%) have been reported.

Genitourinary

Genitourinary side effects including vaginal hemorrhage (up to 13%) and intermenstrual bleeding (up to 8%) have been reported.

Other

Otic side effects including earache (up to 8%) and tinnitus (up to 5%) have been reported.

Other

Infections reported in patients receiving arsenic trioxide include sinusitis (up to 20%), herpes simplex (up to 13%), upper respiratory tract infection (up to 13%), nonspecific bacterial infection (up to 8%), herpes zoster (up to 8%), nasopharyngitis (up to 5%), oral candidiasis (up to 5%), and sepsis (up to 5%).

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