Eflornithine (Injection)

Eflornithine (Injection) is used to treat African sleeping sickness, a disease caused by protozoa (tiny one-celled animals).

Eflornithine (Injection) is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems.

Eflornithine can lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take to reduce the risk of infection or bleeding:

• Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in 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.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits. For this medicine, please think about the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adults, and there is no specific information comparing the use of eflornithine in children to its use in other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work in the same way as they do in younger adults or if they cause different side effects or problems in older adults. There is no specific information comparing the use of eflornithine in elderly patients to its use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if interactions could happen. In these situations, your doctor might need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Anemia or other blood problems—Eflornithine may worsen existing blood problems.

• Hearing loss—Long-term treatment with eflornithine may increase the risk of hearing loss.

• Kidney disease—Patients with kidney disease may have a higher chance of side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Sore throat and fever
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Rare

• Convulsions (seizures)
• Loss of hearing

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• Nausea
• Stomach pain
• Vomiting

Rare

• Hair loss
• Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

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

Pharmacologic Class: Ornithine Decarboxylase Inhibitor

To ensure the best response, eflornithine must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, eflornithine must be given on a regular schedule.

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 injection dosage form: For the treatment of African sleeping sickness: Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 100 milligrams (mg) per kilogram (kg) (45 mg per pound) of body weight injected slowly into a vein over a period of at least forty-five minutes. This dose is given every six hours for fourteen days. Children—Use and dose must be determined by your doctor.