Pronunciation:

ef-LOR-ni-theen

Brand Names:

• Iwilfin

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Ornithine Decarboxylase Inhibitor

Uses of This Medicine:

Eflornithine is used to reduce the risk of relapse (coming back) in patients with high-risk neuroblastoma (a type of cancer that most often occurs in young children) who have had at least a partial response to previous treatment (eg, anti-GD2 immunotherapy).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of eflornithine in the pediatric population. Safety and efficacy have been established.

Older adults—

No information is available on the relationship of age to the effects of eflornithine in geriatric patients.

Other medicines—

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 taking 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.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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:

• Hearing problems or
• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • To reduce the risk of relapse (coming back) in patients with high-risk neuroblastoma:
    • Adults and children—Dose is based on body surface area (BSA) and must be determined by your doctor. Your doctor may adjust your dose as needed and tolerated.
      • BSA of more than 1.5 meter squared (m2)—768 milligrams (mg) or 4 tablets 2 times a day.
      • BSA of 0.75 to 1.5 m2—576 mg or 3 tablets 2 times a day.
      • BSA of 0.5 to less than 0.75 m2—384 mg or 2 tablets 2 times a day.
      • BSA of 0.25 to less than 0.5 m2—192 mg or 1 tablet 2 times a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you 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. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

This medicine can temporarily lower the number of white blood cells in your blood, which will increase 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause hearing loss. Check with your doctor right away if you have continuing ringing or buzzing or other unexplained noise in the ears. Your doctor will check your hearing before you start and during treatment with this medicine.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

body aches or pain

chest pain or tightness

continuing ringing or buzzing or other unexplained noise in the ears

cough

difficult, burning, or painful urination

earache

ear congestion

fever or chills

frequent urge to urinate

headache

hearing loss

loss of voice

lower back or side pain

redness or swelling in the ear

sneezing

sore throat

stuffy or runny nose

trouble breathing

unusual tiredness or weakness

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

clay colored stools

dark urine

decreased appetite

loss of appetite

nausea and vomiting

pale skin

pinpoint red spots on the skin

skin rash

stomach pain or tenderness

swelling of the feet or lower legs

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

yellow eyes or skin

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, dry, or itching eyes

diarrhea

discharge, excessive tearing

itching, pain, redness, swelling, tenderness, or warmth on the skin

pain or tenderness around eyes and cheekbones

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

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.