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|Ornidyl

EFLORNITHINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Ornidyl

† Not commercially available in Canada.

Category

• Antiprotozoal, systemic

Description

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

Eflornithine is available only with your doctor"s prescription, in the following dosage form:

• Parenteral
• Injection (U.S.)

Before Receiving 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 eflornithine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to eflornithine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. However, studies in animals have shown that eflornithine causes death of the fetus and birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether eflornithine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are receiving this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of eflornithine in children with use in other age groups.

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

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 receiving eflornithine, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)—Caution should be used if these medicines and eflornithine are used together; receiving eflornithine while you are using these medicines may make anemia and other blood problems worse

• Anti-infectives by mouth or by injection (medicine for infection) or
• Chloroquine (e.g., Aralen) or
• Cisplatin (e.g., Platinol) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Inflammation or pain medicine, except narcotics, or
• Quinine (e.g., Quinamm)—Use of any of these medicines with eflornithine may increase the chance of hearing loss

Other medical problems—The presence of other medical problems may affect the use of eflornithine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or other blood problems—Eflornithine may cause blood problems, making the problems you already have worse

• Hearing loss—Long-term treatment with eflornithine may increase your chance of hearing loss

• Kidney disease—Patients with kidney disease may have an increased chance of side effects

Proper Use of This Medicine

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 eflornithine will be different for different patients. The following information includes only the average dose of eflornithine.

• 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.

Precautions After Receiving This Medicine

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, 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 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.

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:

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Revised: 06/26/1995

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