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USP DI Vol. II - EFLORNITHINE (Systemic)

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 Africansleeping sickness, a disease caused by protozoa (tinyone-celled animals).

Eflornithine is available only with your doctor's prescription, in thefollowing dosage form:

    Parenteral
  • Injection (U.S.)


Before Receiving This Medicine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For eflornithine, the following should be considered:

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

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

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

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of eflornithinein children with use in other age groups.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are receivingeflornithine, it is especially important that your health care professionalknow 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 ifthese medicines and eflornithine are used together; receiving eflornithinewhile you are using these medicines may make anemia and other blood problemsworse
  • 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 witheflornithine may increase the chance of hearing loss

Other medical problems?The presence of other medicalproblems may affect the use of eflornithine. Make sure you tell your doctorif you have any other medical problems, especially:

  • Anemia or other blood problems?Eflornithine may cause bloodproblems, making the problems you already have worse
  • Hearing loss?Long-term treatment with eflornithine may increaseyour chance of hearing loss
  • Kidney disease?Patients with kidney disease may have an increasedchance of side effects

Proper Use of This Medicine

To ensurethe 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 regularschedule.

Dosing?The dose of eflornithine will be differentfor different patients. The following information includes only the averagedose of eflornithine.

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

Precautions After Receiving This Medicine

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

Eflornithine can lower the number of white blood cells in your blood, increasingthe 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 certainprecautions you can take to reduce the risk of infection or bleeding:

  • Check with your doctor immediately ifyou think you are getting an infection or if you get a fever or chills.
  • Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
  • Be careful not to cut yourself when you are using sharp objects suchas 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

    More common

      Sore throat and fever; unusual bleedingor bruising; unusual tiredness or weakness

    Rare

      Convulsions (seizures); loss of hearing

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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    More common

      Diarrhea; nausea; stomach pain; vomiting

    Rare

      Hair loss; headache

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


Revised: 06/26/1995