Oprelvekin

Oprelvekin is a prescription medication used to prevent low platelet levels in the blood after certain types of chemotherapy. Oprelvekin belongs to a group of drugs called thrombopoietic growth factors, which help the body make more platelets.

This medication comes in an injectable form and is given just under the skin once daily.

Common side effects include slight water weight gain, shortness of breath, and low red blood cell count (anemia).

Oprelvekin is a prescription medication for people who have received certain types of chemotherapy and is used to stimulate the bone marrow to produce platelets to prevent the number of platelets circulating in the blood from dropping dangerously low. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oprelvekin may be found in some form under the following brand names:

• Neumega

The most common, but less serious side effects, are:

• Slight water weight gain
• Some swelling in the arms and/or legs
• Shortness of breath when walking or moving around
• Anemia (low red blood cell count)

These side effects may be caused by water retention. For most people, the water weight gain will go away a few days after the last injection of oprelvekin. Make sure you have read and understand the section called “Drug Precautions”, because many of these side effects could develop into a more serious condition.

Other side effects that you should tell your doctor about are:

• Blurred vision, headaches, or redness of the eyes
• Any swelling or bruising that doesn't go away in the location where you have injected oprelvekin

This is not a complete list of oprelvekin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

If you have any other problems, whether or not you think they are related to oprelvekin, you should call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No oprelvekin drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Oprelvekin may have side effects; some of these side effects may be serious. The most serious possible side effects of treatment with oprelvekin include:

Allergic Reactions. Oprelvekin can cause serious allergic reactions in some patients. Signs that you are having a serious allergic reaction include: swelling of your face, tongue or throat; difficulty breathing, swallowing or talking; shortness of breath; wheezing; chest pain; a tightness in your throat; feeling lightheaded; loss of consciousness; confusion; drowsiness; rash; itching; hives; flushing and/or fever. You or your caregiver should call your doctor immediately if you develop any of these signs or symptoms.

Heart Problems. Oprelvekin can cause heart problems in some patients. If you feel like your heart is pounding, beating fast or skipping a beat, or you have chest pains or are short of breath, you should call your doctor immediately. If you have ever had heart problems, you should tell your doctor before you start treatment with oprelvekin.

If you are taking a water pill (diuretic), you should tell your doctor, because the diuretic can cause your body to lose potassium. This is very important, because oprelvekin can cause heart problems and these heart problems could be more serious when the potassium in your blood is too low. Your doctor will be checking your blood for the amount of potassium in it. If your potassium level is low, your doctor may prescribe a potassium replacement medication to correct it.

Water Weight Gain. Oprelvekin may cause you to retain water and gain weight from the extra fluid in your body. For some patients, water weight gain may cause serious problems that require medicine or hospitalization. A small amount of water weight gain will usually go away within several days after you stop taking oprelvekin. But, if you have a rapid weight gain over a few days, swelling of the legs and feet, dizziness, shortness of breath or chest pain, it could mean that you have a serious condition with fluid around the lungs and heart. If you have ever had heart failure or are taking medicine that may cause you to retain water, you should tell your doctor before you start treatment with oprelvekin.

Eye Problem. Oprelvekin can cause or worsen an eye problem called papilledema. Papilledema is swelling of the optic (eye) nerve. Papilledema can cause changes in your eyesight from blurred vision to blindness.

Children Receiving Oprelvekin. Because oprelvekin is approved only for use in adults, you should talk to your child's doctor about the reasons why oprelvekin has been prescribed for your child. You should talk to your child's doctor about the risks and side effects of using this medication in children. One of the side effects seen in children taking oprelvekin is a serious eye condition called papilledema which is a form of swelling of the nerve that enters the back of the eye. Many children may not show any signs of papilledema. If your child complains that they have a headache or are having difficulty seeing, call your child's doctor right away. Other side effects that have been seen in children are fast heartbeat, redness of the eye, changes to the heart, and changes to bones that can be seen on x-ray.

Stop taking oprelvekin and call your doctor or healthcare provider immediately if you develop any of these symptoms:

• Shortness of breath or trouble breathing
• Chest pains
• Swelling in your face, hands, or feet
• Rapid weight gain over a few days
• You feel like your heart is pounding or beating out of your chest or skipping a beat, also referred to as palpitations
• Changes in your eyesight including blurred vision and blindness

Do not take oprelvekin if you have ever had or think you have had an allergic reaction to oprelvekin. Talk to your doctor if you have any questions about this information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of oprelvekin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you start taking oprelvekin, you should tell your doctor the names of all of the medications you are taking including prescription and non-prescription drugs, vitamins, and nutritional supplements. If you have any of the following conditions or medical problems, tell your doctor or healthcare provider:

• You are pregnant or planning to become pregnant
• Breastfeeding
• You have heart problems
• You have kidney disease
• You have eye problems

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. Oprelvekin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding. It is not known if oprelvekin is excreted in human breast milk or if it will harm your nursing baby. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using oprelvekin.

To see if oprelvekin is working, your doctor will ask you to have blood tests done to measure the number of platelets in your body. After starting oprelvekin, it may take 10 to 21 days for your platelet numbers to increase. The amount of time it takes to increase the number of platelets varies from patient to patient. Oprelvekin may not work for everyone and you may still need platelet transfusions or have bleeding even if you take oprelvekin as directed by your doctor. You should always follow your doctor's instructions.

If your doctor has recommended that you receive oprelvekin at home, then you and/or your caregiver should be instructed on how to prepare oprelvekin, how much oprelvekin to use, how to inject it, how often it should be injected, and how to dispose of the unused portions of each bottle. Do not inject oprelvekin until you are comfortable with the steps to prepare and inject oprelvekin at home.

You should always change the site of your injections each day to avoid soreness at any one site. Your injections should be given about the same time each day. If you miss an injection on one day, you should not try to add it on the next day. Tell your doctor that you missed a dose and continue as usual with your next scheduled dose. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how you respond to this medication
• your weight
• your renal function

The recommended dose of oprelvekin to stimulate the bone marrow, in patients without severe renal impairment, is 50 mcg/kg once daily.

If you take too much oprelvekin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If oprelvekin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

It is important that you do not take any more or less of the amount of oprelvekin that your doctor prescribed. Too much oprelvekin might put you at risk for irregular heartbeats and water retention (including fluid around the heart and lungs).

The kit containing the bottle of powdered oprelvekin and the pre-filled syringe should be kept in a refrigerator. Do not freeze. 

The oprelvekin powder must be protected from light.

Every time you give yourself a dose of oprelvekin, you must use a new bottle of oprelvekin powder and a new pre-filled syringe of Sterile Water for Injection, USP. There is an expiration date printed on the bottle of the oprelvekin powder and on the pre-filled syringe. Do not use the oprelvekin or the pre-filled syringe if it is past the expiration date (month and year).

After you mix the oprelvekin with the Sterile Water for Injection, USP, you must use it as soon as possible. Do not let more than three (3) hours go by between the time you mix the oprelvekin and the water, and the time that you use it. The oprelvekin and Sterile Water for Injection, USP mixture can be stored in the oprelvekin bottle for up to three (3) hours either at room temperature or in the refrigerator. Remember to keep the bottle out of the light. Do not store the oprelvekin and Sterile Water for Injection, USP mixture in a syringe.

After you give yourself an injection of oprelvekin, discard the oprelvekin bottle and syringe with the needle attached into the “Sharps Container”.

Do not dispose of the Sharps Containers in household trash. Do not recycle.

Allergic Reactions Including Anaphylaxis

Oprelvekin has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of oprelvekin should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction.