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Oprelvekin

 
  Generic Name: Oprelvekin (injectable) (oh PERL ve kin)
 
  Brand Names: Neumega  
     
   
 

What is oprelvekin?

Oprelvekin is a protein that stimulates production of platelets in the blood. Platelets are important for proper clotting of the blood and for wound healing.

Oprelvekin is used to prevent platelets from becoming dangerously low in certain people receiving chemotherapy that can result in bone marrow suppression or the need for blood platelet transfusions.

Oprelvekin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about oprelvekin?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have congestive heart failure, kidney disease, a heart rhythm disorder, a seizure disorder, or a history of heart disease, stroke, or fluid retention around your liver, heart, or lungs.

Stop using oprelvekin and get emergency medical help if you have any of these signs of an allergic reaction: fever, rash, shortness of breath, chest pain, wheezing, confusion, fainting, hives, or swelling of your face, lips, tongue, or throat. Once you have had an allergic reaction to oprelvekin, you must never use it again. Other serious side effects of oprelvekin include swelling or rapid weight gain, chest pain, uneven heartbeats, sudden numbness or weakness, confusion, problems with speech or balance, and sudden vision loss or pain behind your eyes. Call your doctor at once if you have any of these side effects.

Treatment with oprelvekin is usually started 6 to 24 hours after chemotherapy is completed. Your blood will then need to be tested on a regular basis. Do not miss any scheduled appointments.

It may take up to 21 days of using this medicine before your platelets increase. For best results, keep using the medication as directed.

What should I discuss with my healthcare provider before using oprelvekin?

Do not use this medication if you are allergic to oprelvekin.

Before using oprelvekin, tell your doctor if you are allergic to any drugs, or if you have:

  • congestive heart failure;

  • a heart rhythm disorder;

  • a history of heart disease or stroke;

  • a history of fluid around your liver, heart, or lungs;

  • a seizure disorder; or

  • kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use oprelvekin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether oprelvekin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use oprelvekin?

Oprelvekin is given as an injection under the skin of your stomach, thigh, hip, or upper arm. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Avoid shaking the medication vial (bottle). You may gently swirl the vial, but vigorous shaking can ruin the medicine.

Use a different skin area each time you give yourself an injection. Do not inject this medicine into the same place on your body twice in a row.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Treatment with oprelvekin is usually started 6 to 24 hours after chemotherapy is completed. Your blood will then need to be tested on a regular basis. Do not miss any scheduled appointments..

It may take up to 21 days of using this medicine before your platelets increase. For best results, keep using the medication as directed.

Oprelvekin must be mixed with a liquid (diluent) before injecting it. Do not draw your dose into a syringe until you are ready to give yourself an injection. The prepared dose must be used within 3 hours after mixing it.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store unused oprelvekin vials and diluent syringes in the refrigerator. Do not freeze.

A vial of oprelvekin should be used only once. Throw away any medicine still in the vial after mixing your dose.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include shortness of breath, swelling, uneven heartbeats, and chest pain.

What should I avoid while using oprelvekin?

Avoid making any changes in your diet while using this medication. Oprelvekin can cause fluid retention and swelling. Your doctor may recommend a low-salt diet to prevent this condition.

Oprelvekin side effects

Stop using oprelvekin and get emergency medical help if you have any of these signs of an allergic reaction: fever, rash, shortness of breath, chest pain, wheezing, confusion, fainting, hives, or swelling of your face, lips, tongue, or throat. Once you have had an allergic reaction to oprelvekin, you must never use it again. Stop using oprelvekin and call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;

  • swelling, rapid weight gain;

  • chest pain, fast or uneven heartbeats;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with speech, or balance;

  • feeling light-headed, fainting;

  • fever, chills, tingling, body aches, flu symptoms;

  • urinating less than usual, or not at all;

  • dry mouth, increased thirst, drowsiness, confusion, nausea, vomiting, muscle pain or weakness;

  • sudden vision loss, headache or pain behind your eyes, with vomiting; or

  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • redness of your eyes;

  • headache, dizziness, sleep problems (insomnia);

  • nausea, vomiting, diarrhea;

  • skin redness, pain, or irritation where the medicine was injected; or

  • runny or stuffy nose, cough, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Oprelvekin Dosing Information

Usual Adult Dose for Thrombocytopenia Drug Induced:

Nonmyeloid malignancy:
50 mcg/kg subcutaneously once daily following myelosuppressive chemotherapy

Usual Pediatric Dose for Thrombocytopenia Drug Induced:

Study-Phase 1, (n=43) - Nonmyeloid malignancy:
25 to 100 mcg/kg/day following myelosuppressive chemotherapy.

What other drugs will affect oprelvekin?

There may be other drugs that can affect oprelvekin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about oprelvekin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.09. Revision Date: 4/12/2009 4:43:04 PM.;
 
 
 
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