Eflornithine (ef-LOR-ni-theen)

Reduces the risk of relapse (coming back) in patients with high-risk neuroblastoma (a type of cancer that most often occurs in young children).

Brand Name(s):

Iwilfin

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• If you are unable to swallow the tablet whole, you may crush and mix it with 2 tablespoons of soft food or liquid. Mix and eat the mixture. If any crushed tablet pieces remain, mix it with another 2 tablespoons of soft food or liquid. Take all mixture within 1 hour of mixing. Throw away unused mixture 1 hour after mixing.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take the missed dose as soon as you remember. If you miss a dose and it is within 7 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• Tell your doctor if you liver disease or hearing problems.
• This medicine may cause the following problems:
  • Liver problems
  • Hearing loss
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Hearing loss
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

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