Description
Treosulfan injection is used in combination with another medicine (eg, fludarabine) to treat patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) before receiving allogeneic hematopoietic stem cell transplant (HSCT).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for 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 have not been performed on the relationship of age to the effects of treosulfan injection in children younger than 1 year of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of treosulfan injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 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.
- Abemaciclib
- Acalabrutinib
- Alfentanil
- Aprepitant
- Astemizole
- Axitinib
- Bosutinib
- Brigatinib
- Ceritinib
- Cisapride
- Clindamycin
- Cobimetinib
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
- Dasatinib
- Dihydroergotamine
- Docetaxel
- Dofetilide
- Dronedarone
- Entrectinib
- Ergotamine
- Everolimus
- Fentanyl
- Flibanserin
- Fosaprepitant
- Fosphenytoin
- Ivosidenib
- Levomethadyl
- Lomitapide
- Lurbinectedin
- Midostaurin
- Neratinib
- Nilotinib
- Olaparib
- Oxycodone
- Paclitaxel
- Palovarotene
- Pazopanib
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:
- Anemia or
- Infection or
- Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 2 hours.
Your doctor will give you other medicines (medicine to prevent vomiting) before you receive and during treatment with this medicine.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant within 7 days before receiving this medicine. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Treosulfan can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness.
This medicine may cause skin reactions (eg, rash, dermatitis). Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, or swelling. Always clean sweaty areas (eg, armpit, groin, genital area, inframammary line) with a washcloth and clean water. Do not apply any cream during treatment. Do not wear tight clothing.
Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site. These may be symptoms of injection site reactions and tissue necrosis.
This medicine may increased your risk of secondary cancer. Talk to your doctor if you have concerns about this.
Some men and women who receive this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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
- Agitation
- black, tarry stools
- bleeding gums
- blurred vision
- chest pain or discomfort
- chills
- coma
- confusion
- cough
- coughing up blood
- decreased urine output
- depression
- difficulty in swallowing
- dilated neck veins
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- fever
- general feeling of discomfort or illness
- headache
- hostility
- increased menstrual flow or vaginal bleeding
- irritability
- lethargy
- loss of appetite
- lower back or side pain
- muscle or bone pain
- muscle twitching
- nausea or vomiting
- nervousness
- nosebleeds
- painful or difficult urination
- pale skin
- paralysis
- prolonged bleeding from cuts
- pounding in the ears
- red or dark brown urine
- redness, swelling, pain of the skin
- scaling of skin on the hands and feet
- seizures
- slow or fast heartbeat
- sore throat
- stomach pain, severe
- stupor
- swelling
- swelling of the face, fingers, feet, or lower legs
- thickening of bronchial secretions
- tingling of the hands and feet
- trouble breathing
- ulceration of the skin
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- drowsiness
- muscle tremors
- pinpoint red spots on the skin
- restlessness
- stomach cramps
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:
More common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning feeling in the chest or stomach
- constipation
- darkening of the skin
- diarrhea
- dry mouth
- feeling of constant movement of self or surroundings
- hiccups
- hoarseness
- indigestion
- sensation of spinning
- swelling or inflammation of the mouth
- tenderness in the stomach area
- trouble sleeping
- voice changes
Incidence not known
- Unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
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.
CON-XXXXXXXX
