Neumega (Subcutaneous)

Oprelvekin is a man-made version of a substance called interleukin-11. The body naturally makes interleukin-11 in bone marrow cells, and it helps produce platelets, which are needed for proper blood clotting. Oprelvekin is used to help prevent low platelet counts that can occur from treatment with certain cancer medicines.

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

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to look for any unwanted effects.

In deciding to use a medicine, you and your doctor must weigh the risks of taking it against the benefits it may provide. For this medicine, consider the following:

Allergies

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

Pediatric

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

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if interactions could 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]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using 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

Other medical problems may impact the use of this medicine. Be sure to tell your doctor about any other medical issues, particularly:

• 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 issues.
• Fluid build-up in the abdomen or lungs—May be worsened by oprelvekin.
• Myeloablative chemotherapy—May lead to serious side effects.

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

The side effects listed below include only those that could be caused by oprelvekin. To learn about other side effects that might be caused by the cancer medicines you are also taking, refer to 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 monitor 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. Your health care professional may also have suggestions to help prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 injection site

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your health care 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.