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Trisenox

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Trisenox

Trisenox Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Trisenox (arsenic trioxide) is used to treat a cancer of the blood and bone marrow called acute promyelocytic leukemia, or APL. It is a cancer medication. Common side effects include pain/redness/swelling at the injection site, nausea, vomiting, diarrhea, stomach/abdominal pain, tiredness, cough, headache, or dizziness.

Trisenox is given intravenously under physician supervision at a dose of 0.15 mg/kg daily until bone marrow remission. Total induction dose should not exceed 60 doses. Consolidation treatment begins 3 to 6 weeks after completion of induction therapy and Trisenox is administered intravenously at a dose of 0.15 mg/kg daily for 25 doses for up to 5 weeks. Trisenox may interact with droperidol, diuretics (water pills), antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, or narcotics. Tell your doctor all medications you use. Trisenox should not be used during pregnancy. It may harm the fetus. If you become pregnant or think you may be pregnant, tell your doctor. Consult your doctor about birth control. This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended.

Our Trisenox (arsenic trioxide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Trisenox in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • sharp chest pain, wheezing, rapid breathing, feeling short of breath;
  • dry cough, feeling weak, tired, or ill;
  • fever, chills, swelling in your ankles or feet, weight gain;
  • dizziness, fainting, fast or pounding heartbeat;
  • pale skin, easy bruising or bleeding (nosebleeds);
  • high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin); or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

  • nausea, vomiting, stomach pain, diarrhea, constipation;
  • headache;
  • anxiety, depressed mood;
  • mild rash or itching;
  • sleep problems (insomnia);
  • numbness or tingly feeling;
  • joint or muscle pain;
  • abnormal vaginal bleeding; or
  • pain, redness or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Trisenox (Arsenic Trioxide Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Trisenox Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Pain/redness/swelling at the injection site, nausea, vomiting, diarrhea, stomach/abdominal pain, tiredness, cough, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Both leukemia and this medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as unexplained fever, chills, or persistent sore throat.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising, nosebleed, increased thirst, change in the amount of urine, blurred vision, bone/joint pain, decreased appetite, unusual weight loss, muscle pain/stiffness/spasm, numbness/tingling, swollen hands/legs/feet.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness/fainting, fast/irregular heartbeat, coughing up blood, mental/mood changes (e.g., confusion), muscle weakness, seizures, bloody/black/tarry stool, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Trisenox (Arsenic Trioxide Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Trisenox FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Safety information was available for 52 patients with relapsed or refractory APL who participated in clinical trials of TRISENOX (arsenic trioxide injection) . 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 (arsenic trioxide injection) 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 between the ages of 5 - 73 years treated for APL with TRISENOX (arsenic trioxide injection) 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 (arsenic trioxide injection) .

Adverse Events (any grade) Occurring in ≥ 5% of 40 Patients with APL who Received TRISENOX (arsenic trioxide) injection at a dose of 0.15 mg/kg/day

System organ class/Adverse Event All Adverse Events, Any Grade Grade 3 & 4 Events
n % n %
General disorders and administration site conditions
  Fatigue 25 63 2 5
  Pyrexia (fever) 25 63 2 5
  Edema - non-specific 16 40    
  Rigors 15 38    
  Chest pain 10 25 2 5
  Injection site pain 8 20    
  Pain - non-specific 6 15 1 3
  Injection site erythema 5 13    
  Injection site edema 4 10    
  Weakness 4 10 2 5
  Hemorrhage 3 8    
  Weight gain 5 13    
  Weight loss 3 8    
  Drug hypersensitivity 2 5 1 3
Gastrointestinal disorders
  Nausea 30 75    
  Anorexia 9 23    
  Appetite decreased 6 15    
  Diarrhea 21 53    
  Vomiting 23 58    
  Abdominal pain (lower & upper) 23 58 4 10
  Sore throat 14 35    
  Constipation 11 28 1 3
  Loose stools 4 10    
  Dyspepsia 4 10    
  Oral blistering 3 8    
  Fecal incontinence 3 8    
  Gastrointestinal hemorrhage 3 8    
  Dry mouth 3 8    
  Abdominal tenderness 3 8    
  Diarrhea hemorrhagic 3 8    
  Abdominal distension 3 8    
Metabolism and nutrition disorders
  Hypokalemia 20 50 5 13
  Hypomagnesemia 18 45 5 13
  Hyperglycemia 18 45 5 13
  ALT increased 8 20 2 5
  Hyperkalemia 7 18 2 5
  AST increased 5 13 1 3
  Hypocalcemia 4 10    
  Hypoglycemia 3 8    
  Acidosis 2 5    
Nervous system disorders
  Headache 24 60 1 3
  Insomnia 17 43 1 3
  Paresthesia 13 33 2 5
  Dizziness (excluding vertigo) 9 23    
  Tremor 5 13    
  Convulsion 3 8 2 5
  Somnolence 3 8    
  Coma 2 5 2 5
Respiratory
  Cough 26 65    
  Dyspnea 21 53 4 10
  Epistaxis 10 25    
  Hypoxia 9 23 4 10
  Pleural effusion 8 20 1 3
  Post nasal drip 5 13    
  Wheezing 5 13    
  Decreased breath sounds 4 10    
  Crepitations 4 10    
  Rales 4 10    
  Hemoptysis 3 8    
  Tachypnea 3 8    
  Rhonchi 3 8    
Skin & subcutaneous tissue disorders
  Dermatitis 17 43    
  Pruritus 13 33 1 3
  Ecchymosis 8 20    
  Dry skin 6 15    
  Erythema - non-specific 5 13    
  Increased sweating 5 13    
  Facial edema 3 8    
  Night sweats 3 8    
  Petechiae 3 8    
  Hyperpigmentation 3 8    
  Non-specific skin lesions 3 8    
  Urticaria 3 8    
  Local exfoliation 2 5    
  Eyelid edema 2 5    
Cardiac disorders
  Tachycardia 22 55    
  ECG QT corrected interval prolonged > 500 msec 16 40    
  Palpitations 4 10    
  ECG abnormal other than QT interval prolongation 3 8    
Infections and infestations
  Sinusitis 8 20    
  Herpes simplex 5 13    
  Upper respiratory tract infection 5 13 1 3
  Bacterial infection - non-specific 3 8 1 3
  Herpes zoster 3 8    
  Nasopharyngitis 2 5    
  Oral candidiasis 2 5    
  Sepsis 2 5 2 5
Musculoskeletal, connective tissue and bone disorders
  Arthralgia 13 33 3 8
  Myalgia 10 25 2 5
  Bone pain 9 23 4 10
  Back pain 7 18 1 3
  Neck pain 5 13    
  Pain in limb 5 13 2 5
Hematologic disorders
  Leukocytosis 20 50 1 3
  Anemia 8 20 2 5
  Thrombocytopenia 7 18 5 13
  Febrile neutropenia 5 13 3 8
  Neutropenia 4 10 4 10
  Disseminated intravascular coagulation 3 8 3 8
  Lymphadenopathy 3 8    
Vascular disorders
  Hypotension 10 25 2 5
  Flushing 4 10    
  Hypertension 4 10    
  Pallor 4 10    
Psychiatric disorders
  Anxiety 12 30    
  Depression 8 20    
  Agitation 2 5    
  Confusion 2 5    
Ocular disorders
  Eye irritation 4 10    
  Blurred vision 4 10    
  Dry eye 3 8    
  Painful red eye 2 5    
Renal and urinary disorders
  Renal failure 3 8 1 3
  Renal impairment 3 8    
  Oliguria 2 5    
  Incontinence 2 5    
Reproductive system disorders
  Vaginal hemorrhage 5 13    
  Intermenstrual bleeding 3 8    
Ear disorders
  Earache 3 8    
  Tinnitus 2 5    

The following additional adverse events were reported as related to TRISENOX (arsenic trioxide injection) treatment in 13 pediatric patients (defined as ages 4 through 20): gastrointestinal (dysphagia, mucosal inflammation/stomatitis, oropharyngeal pain, caecitis), metabolic and nutrition disorders (hyponatremia, hypoalbuminemia, hypophosphatemia, and lipase increased), cardiac failure congestive, respiratory (acute respiratory distress syndrome, lung infiltration, pneumonitis, pulmonary edema, respiratory distress, capillary leak syndrome), neuralgia, and enuresis. Pulmonary edema (n=l) and caecitis (n=l) were considered serious reactions.

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 (arsenic trioxide injection) for the treatment of malignancies other than APL. See BOXED WARNING.

Read the entire FDA prescribing information for Trisenox (Arsenic Trioxide Injection) »

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Trisenox - User Reviews

Trisenox User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Trisenox sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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