Treosulfan

Treosulfan is used for adults and children who are at least 1 year old with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) to prepare for a stem cell transplant.

Treosulfan is given together with other cancer treatments.

Treosulfan may also be used for reasons not mentioned in this medication guide.

Treosulfan is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your medical caregivers if you feel any burning or pain when treosulfan is injected.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing.

Clean "sweaty" skin areas (armpits, genital area) with a disposable washcloth and clear water. Keep your skin clean and dry on the days you receive the infusion. Change occlusive dressings and do not cover your skin with tight clothing after receiving the infusion. Change wet and soiled diapers as soon as possible during the 12 hours after each infusion.

You may need frequent medical tests after you stop using this medicine.

You may get infections, even serious infections, or bleed more easily. Call your doctor if you have flu symptoms, fever, skin sores, cough, night sweats, neck stiffness, confusion, or vision problems.

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

Tell your doctor if you have or have ever had:

• an active or recent infection;
• seizures;
• an organ transplant, or a stem cell transplant from a donor; or
• chemotherapy or radiation.

Using treosulfan may increase your risk of developing other cancers. Ask your doctor about this risk.

Treosulfan can harm an unborn baby if the mother or the father is receiving treosulfan.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Treosulfan may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

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

Treosulfan may cause serious side effects. Call your doctor right away if you experience:

• swelling, pain, burning, irritation, or changes in the skin where the injection was given;
• severe itching, rash, or dry skin;
• unusual bruising or bleeding, or new signs of infection (fever, weakness, cough, diarrhea, burning during urination); or
• seizures.

Common side effects of treosulfan may include:

• infections, fever;
• mouth sores;
• muscle, bone, or joint pain;
• nausea or vomiting;
• swelling; or
• abnormal lab results.

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Stem Cell Transplant Conditioning:

Treosulfan: 10 g/m2 IV once a day for 3 days (day -4, -3, -2) before stem cell infusion (day 0)Fludarabine: 30 mg/m2 IV infusion once a day, for 5 days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0)Comments:-This drug is administered as a 2-hour IV infusion.-This drug should be administered before fludarabine on days -4, -3, -2.-Premedicate the patients with antiemetics before administering this drug.-This drug is used in combination with fludarabine. Consult the manufacturer product information of fludarabine for more information.-Monitor for extravasation, if extravasation occurs, stop the infusion.Use: In combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in patients with acute myeloid leukemia and myelodysplastic syndrome

Usual Pediatric Dose for Stem Cell Transplant Conditioning:

1 Year and Older:Treosulfan: 10 g/m2 IV once a day for 3 days (day -4, -3, -2) before stem cell infusion (day 0)Fludarabine: 30 mg/m2 IV infusion once a day, for 5 days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0)Comments:-This drug is administered as a 2-hour IV infusion.-This drug should be administered before fludarabine on days -4, -3, -2.-Premedicate the patients with antiemetics before administering this drug.-This drug is used in combination with fludarabine. Consult the manufacturer product information of fludarabine for more information.-Monitor for extravasation, if extravasation occurs, stop the infusion.Use: In combination with fludarabine as a preparative regimen for allogeneic HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome

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

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

Treosulfan may cause skin reactions. Avoid applying creams or wearing tight clothing on days you receive treosulfan.

Other drugs may affect treosulfan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.