Pronunciation:

oh-PREL-ve-kin

Brand Names:

• Neumega

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Thrombopoietic Growth Factor

Uses of This Medicine:

Oprelvekin is a synthetic (man-made) version of a substance called interleukin-11. Naturally occurring interleukin-11 is produced by bone marrow cells in the body and helps to make platelets, which are necessary for proper clotting of blood. Oprelvekin is used to help prevent low platelet counts caused by treatment with some cancer medicines.

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—

Oprelvekin has caused joint and tendon problems in animals and there is a possibility it could also cause these effects in children receiving it. Discuss these possible effects with your doctor.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

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

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. 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:

• Congestive heart failure—May be worsened because oprelvekin causes the body to retain water
• Atrial arrhythmias (heart rhythm problems)—This medicine may cause heart rhythm problems
• Fluid build-up in the abdomen or lungs—May be worsened by oprelvekin
• Myeloablative chemotherapy— May lead to serious side effects

Proper Use of This Medicine:

If you are injecting this medicine yourself, each package of oprelvekin will contain a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable.

If you have any questions about any of this, check with your health care professional.

This medicine works best if it is given at the same time every day.

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.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store in the refrigerator. Do not freeze.

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 that this medicine is working properly and to check for unwanted effects.

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.

The side effects listed below include only those that might be caused by oprelvekin. To find out about other side effects that may be caused by the cancer medicines you are also receiving, see the information about those medicines.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Fast heartbeat

fluid retention

irregular heartbeat

shortness of breath

sore mouth or tongue

swelling of feet or lower legs

white patches in mouth and/or on tongue

Less common

Bloody eye

blurred vision

severe redness and peeling of skin

Incidence not determined

(—Observed during clinical practice with levofloxacin; estimates of frequency cannot be determined)

bleeding

blistering

bloody urine

blurred vision

burning

change in ability to see colors, especially blue or yellow

cloudy urine

coldness

cough

decrease or increase in amount of urine

difficulty swallowing

discoloration of skin

dizziness

fainting or lightheadedness

fast heartbeat

feeling of pressure

hives

increased blood pressure

increased thirst

infection

inflammation

itching

loss of appetite

lower back/side pain

lumps

nausea

numbness

pain

puffiness or swelling of the eyelids or around the eyes face, lips or tongue

rash

redness

scarring

shortness of breath

skin rash

soreness

stinging

stomach pain;

swelling

tenderness

tightness in chest

tingling

troubled breathing

ulceration

unusual tiredness or weakness

vomiting

warmth at site

weight gain

wheezing

This medicine may also cause the following side effect that your doctor will watch for:

More common

Heart rhythm problems

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

Red eyes

weakness

Less common

Numbness or tingling of hands or feet

skin discoloration

skin rash at place of injection

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.