Arsenic trioxide

Arsenic trioxide

Arsenic trioxide

What is arsenic trioxide?

Arsenic trioxide is sometimes given in combination with another medicine called tretinoin.

Arsenic trioxide may also be used for other purposes not listed in this medication guide.

Side effects of arsenic trioxide

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Arsenic trioxide can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if left untreated. This condition can occur within 1 day to 2 months after you start taking arsenic trioxide.

If necessary, seek medical attention immediatelySymptoms of differentiation syndrome:

• fever, cough, difficulty breathing;

• Dizziness;

• rash;

• decreased urination;

• rapid weight gain; or

• Swelling in your arms or legs.

Also call your doctor immediately if you have:

• fast or pounding heartbeat, fluttering in the chest, shortness of breath, and sudden dizziness (as if you might faint);

• confusion, decreased consciousness;

• problems with vision, balance, or muscle movement;

• a seizure;

• fever, fatigue, night sweats;

• easy bruising or bleeding;

• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath smell;

• low magnesium – dizziness, irregular heartbeat, nervousness, muscle spasms, muscle spasms, coughing, or choking feeling; or

• low potassium – leg cramps, constipation, irregular heartbeat, fluttering in the chest, increased thirst or need to urinate, numbness or tingling, muscle weakness or feeling weak.

Common arsenic trioxide side effects may include:

• stomach pain, nausea, vomiting, diarrhea;

• cough, sore throat, difficulty breathing;

• fever, chills, fatigue, headache, joint pain;

• fast or irregular heartbeat;

• numbness or tingling;

• low magnesium or potassium deficiency, high blood sugar;

• itching, rash;

• Swelling;

• joint or muscle pain; or

• Sleep disorders.

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

Warnings

Arsenic trioxide can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if left untreated. This condition may occur within 1 day to 2 months after you start taking this medication.

If necessary, seek medical attention immediatelySymptoms of differentiation syndrome:Fever, dizziness, cough, difficulty breathing, swelling, rapid weight gain, or decreased urination.

Arsenic trioxide can cause serious heart problems. Your risk may be higher if you also take certain other medicines. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

Get emergency medical help if you experience fast or pounding heartbeat, fluttering in the chest, shortness of breath, and sudden dizziness.

Before you take this medicine

You should not be treated with arsenic trioxide if you are allergic to it.

Tell your doctor if you have ever had:

• heart problems or a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (e.g. low levels of potassium or magnesium in your blood);

• kidney disease; or

• Liver disease.

Arsenic trioxide can harm an unborn childif the mother or father uses arsenic trioxide.

• If you are a woman,Do not use arsenic trioxide if you are pregnant. Use effective contraception to prevent pregnancy while you are using this medication and for at least 6 months after your last dose.

• If you are a man,Use effective contraception if your sexual partner may become pregnant. Continue using contraception for at least 3 months after the last dose.

• Tell your doctor immediately if pregnancy occurs while the mother or father is taking arsenic trioxide.

It may be more difficult for you to get a woman pregnant while you are taking this medicine.You should still use contraception to prevent pregnancy because the medicine can harm an unborn baby.

Do not breast-feed while using this medicine.and for at least 2 weeks after your last dose.

How is arsenic trioxide administered?

Arsenic trioxide is given as an infusion into a vein. A doctor will give you this injection.

Frequent medical tests may be needed to make sure this medicine is not causing harmful effects. Because of the results, your cancer treatment may be delayed.

You may be given other medications to prevent serious side effects or allergic reactions. Take these medicines for as long as your doctor tells you.

You must remain under the care of a doctor while using arsenic trioxide.

Arsenic trioxide dosage information

Usual Adult Dose for Acute Promyelocytic Leukemia:

INDUCTION CYCLE: 0.15 mg/kg i.v. for 1 to 2 hours once daily until bone marrow remission or up to a maximum of 60 days
CONSOLIDATION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once daily for 25 doses for up to 5 weeks; Begin consolidation 3 to 6 weeks after completion of induction therapy

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are unresponsive or have relapsed to retinoid and anthracycline chemotherapy and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

Usual pediatric dose for acute promyelocytic leukemia:

4 YEARS AND OLDER:
INDUCTION CYCLE: 0.15 mg/kg i.v. for 1 to 2 hours once daily until bone marrow remission or up to a maximum of 60 days
CONSOLIDATION CYCLE: 0.15 mg/kg IV over 1 to 2 hours once daily for 25 doses for up to 5 weeks; Begin consolidation 3 to 6 weeks after completion of induction therapy

Use: Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are unresponsive or have relapsed to retinoid and anthracycline chemotherapy and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking arsenic trioxide?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect arsenic trioxide?

Arsenic trioxide can cause serious heart problems.Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria or HIV.

Other medications can affect arsenic trioxide, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.