Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
No information is available on the relationship of age to the effects of eflornithine in geriatric patients.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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—Use with caution. May make this condition worse.
Proper Use
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.
- 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.
- To reduce the risk of relapse (coming back) in patients with high-risk neuroblastoma:
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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. 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. 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
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.
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