Description
Arsenic trioxide injection is used together with another medicine (eg, tretinoin) to treat newly-diagnosed low-risk acute promyelocytic leukemia (APL), a type of leukemia (cancer of the blood cells). It is also used to treat APL in patients who have not responded to other medication regimens. It may also be used to treat other kinds of cancer, as determined by your doctor.
Arsenic trioxide belongs to the general group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by arsenic trioxide, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
Before you begin treatment with arsenic trioxide injection, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of arsenic trioxide injection in children. However, safety and efficacy have not been established in children younger than 4 years of age receiving arsenic trioxide alone and in children receiving arsenic trioxide injection with tretinoin.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of arsenic trioxide injection in the elderly.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Foscarnet
- Levoketoconazole
- Lidoflazine
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Acetazolamide
- Adagrasib
- Ajmaline
- Alfuzosin
- Amiloride
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Amphotericin B
- Anagrelide
- Apomorphine
- Aprindine
- Aripiprazole
- Aripiprazole Lauroxil
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Azimilide
- Azithromycin
- Azosemide
- Bedaquiline
- Bemetizide
- Bendroflumethiazide
- Benzthiazide
- Bretylium
- Bumetanide
- Buprenorphine
- Buserelin
- Buthiazide
- Canrenoate
- Canrenone
- Ceritinib
- Chloral Hydrate
- Chloroquine
- Chlorothiazide
- Chlorpromazine
- Chlorthalidone
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol use, chronic or
- Malabsorption or
- Poor nutrition or
- Thiamine (vitamin B1) deficiency—Use with caution. May increase risk of having a brain disease called encephalopathy.
- Congestive heart failure or
- Heart block or
- Heart rhythm problems (eg, prolonged QT interval or torsade de pointes), history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—Use with caution. May increase the risk for a more serious heart rhythm problem while taking arsenic trioxide.
- Kidney disease, severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins.
Arsenic trioxide often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you have an upset stomach. Ask your doctor for ways to lessen these effects.
Precautions
It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
You should not receive this medicine if you are pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment with this medicine and for 3 months after the last dose. If you think you or your sexual partner have become pregnant while using the medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Tell your doctor right away if you have chest pain or discomfort, chills, cough, difficulty with breathing, eye pain, fever, general feeling of illness, headache, sore throat, unusual tiredness or weakness, or weight gain while using this medicine. These may be symptoms of a serious condition called retinoic-acid-APL (RA-APL) or APL differentiation syndrome.
This medicine can cause serious heart rhythm problems, including arrhythmias. Your doctor will monitor you during treatment to assess for heart rhythm problems. Talk to your doctor if you have concerns about this.
This medicine may cause a brain disease called encephalopathy. It may also increase your risk for Wernicke’s encephalopathy, especially if you have vitamin B1 (thiamine) deficiency. This is more likely in patients who have been drinking alcohol for a long time, who also use a diuretic (eg, furosemide), or who have malabsorption and nutritional deficiency. Check with your doctor right away if you have blurred vision, loss of consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, a stiff neck, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Using this medicine may increase your risk of getting other cancers. Talk to your doctor if you have concerns about this risk.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Chills
- cough
- decreased urine output
- dry mouth
- eye pain
- general feeling of illness
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in hands, feet, or lips
- seizures
- sore throat
- trouble breathing
- unusual tiredness or weakness
- vomiting
Less common
- Black, tarry stools
- bluish lips or skin
- blurred vision
- chest pain
- dizziness or lightheadedness
- fever
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased urine output
- irregular or pounding heartbeat or pulse
- painful or difficult urination
- sores, ulcers, or white spots on the lips or in the mouth
- stomach ache or cramps
- sweating
- swollen glands
- unexplained weight loss
- unusual bleeding or bruising
- unusual weight gain
Incidence not known
- Agitation
- anxiety
- back pain
- behavior changes similar to drunkenness
- bleeding
- blistering, peeling, or loosening of the skin
- bloating
- blood in the urine or stools
- bluish fingernails, palms, or nailbeds
- bruising
- change in size, shape, or color of existing mole
- cloudy urine
- cold sweats
- cool, pale skin
- confusion
- constipation
- coughing that sometimes produces a pink frothy sputum
- coughing or spitting up blood
- dark urine
- diarrhea
- difficult, fast, noisy breathing
- dilated neck veins
- drowsiness
- extreme tiredness or weakness
- fainting
- fast heartbeat
- high fever
- indigestion
- irregular heartbeat, recurrent
- irritability
- joint pain
- large hives, itching, or skin rash
- loss of consciousness
- mole that leaks fluid or bleeds new mole
- painful blisters on the trunk of the body
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- persistent bleeding or oozing from puncture sites, mouth, or nose
- rapid, shallow breathing
- red skin lesions, often with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- severe nausea
- shakiness
- stiff neck
- sudden weight gain
- tightness in the chest
- swelling of the eyelids, lips, face, fingers, or lower legs
- unsteadiness or awkwardness
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Confusion
- muscle weakness, severe
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Belching
- bone pain
- feeling of warmth
- heartburn
- heavy non-menstrual vaginal bleeding
- injection site pain, redness, or swelling
- limb pain
- mental depression
- neck pain
- nosebleeds
- redness of the face, neck, arms, and occasionally, upper chest
- trouble sleeping or getting to sleep
Incidence not known
- Deafness
- difficulty moving
- earache
- eye dryness, redness, or pain
- loss of bowel or bladder control
- night sweats
- ringing in the ears
- small red or purple spots on the skin
- swelling of the abdominal or stomach area
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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