Oprelvekin (Subcutaneous)

Oprelvekin is a man-made version of a substance called interleukin-11. The body naturally produces interleukin-11 in bone marrow cells, and it helps to create platelets, which are needed for proper blood clotting. Oprelvekin is used to help prevent low platelet counts that may happen due to some cancer treatments.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress at regular visits to ensure that this medicine is working correctly and to check for any side effects.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Oprelvekin has caused joint and tendon issues in animals, and it may also cause these effects in children who receive it. Talk to your doctor about these possible effects.

Geriatric

This medicine has been studied and does not appear to cause different side effects or problems in older adults compared to younger adults.

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 using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken near the time of eating food or specific types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Congestive heart failure—May get worse because oprelvekin causes the body to hold onto water
• Atrial arrhythmias (heart rhythm problems)—This medicine may lead to heart rhythm issues
• Fluid build-up in the abdomen or lungs—May be exacerbated by oprelvekin
• Myeloablative chemotherapy—May result in serious side effects

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

The side effects listed below include only those that might be caused by oprelvekin. To learn 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 the 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.

In the U.S.

• Neumega

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Thrombopoietic Growth Factor

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.