Neumega

DRUG DESCRIPTION

Interleukin eleven (IL-11) is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production. IL-11 is a member of a family of human growth factors which includes human growth hormone, granulocyte colonystimulating factor (G-CSF), and other growth factors.

Oprelvekin, the active ingredient in Neumega (oprelvekin) , is produced in Escherichia coli (E. coli) by recombinant DNA technology. The protein has a molecular mass of approximately 19,000 daltons, and is non-glycosylated. The polypeptide is 177 amino acids in length and differs from the 178 amino acid length of native IL-11 only in lacking the amino-terminal proline residue. This alteration has not resulted in measurable differences in bioactivity either in vitro or in vivo.

Neumega (oprelvekin) is formulated in single-use vials containing 5 mg of oprelvekin (specific activity approximately 8 x 106 Units/mg) as a sterile, lyophilized powder with 23 mg Glycine, USP, 1.6 mg Dibasic Sodium Phosphate Heptahydrate, USP, and 0.55 mg Monobasic Sodium Phosphate Monohydrate, USP. When reconstituted with 1 mL of Sterile Water for Injection, USP, the resulting solution has a pH of 7.0 and a concentration of 5 mg/mL.

What are the possible side effects of oprelvekin (Neumega)?

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...

Read All Potential Side Effects and See Pictures of Neumega

What are the precautions when taking oprelvekin (Neumega)?

Before using oprelvekin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart/blood vessel disease (e.g., congestive heart failure, irregular heartbeat, stroke), unusual fluid retention (e.g., swelling of the ankles/feet, ascites, pleural effusion), eye problems (e.g., papilledema), brain/spinal cord tumors, high blood pressure (hypertension).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

Read All Potential Precautions of Neumega


Neumega Consumer (continued)

SIDE EFFECTS: Pain at the injection site, red eyes, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fever, flushing, headache, severe weakness, sudden/unexplained weight gain, swelling of the hands/ankles/feet, shortness of breath, muscle/bone pain, fast/pounding/irregular heartbeat, white patches in the mouth, unusual tiredness, change in the amount of urine, vision changes (e.g., blurred vision, loss of vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, confusion, weakness on one side of the body, slurred speech, chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing/swallowing/talking.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using oprelvekin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart/blood vessel disease (e.g., congestive heart failure, irregular heartbeat, stroke), unusual fluid retention (e.g., swelling of the ankles/feet, ascites, pleural effusion), eye problems (e.g., papilledema), brain/spinal cord tumors, high blood pressure (hypertension).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Children may be at greater risk for eye/heart problems and bone changes while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Neumega Patient Information Including Side Effects

Brand Names: Neumega

Generic Name: oprelvekin (injectable) (Pronunciation: oh PERL ve kin)

  • What is oprelvekin (Neumega)?
  • What are the possible side effects of oprelvekin (Neumega)?
  • What is the most important information I should know about oprelvekin (Neumega)?
  • What should I discuss with my healthcare provider before using oprelvekin (Neumega)?
  • How should I use oprelvekin (Neumega)?
  • What happens if I miss a dose (Neumega)?
  • What happens if I overdose (Neumega)?
  • What should I avoid while using oprelvekin (Neumega)?
  • What other drugs will affect oprelvekin (Neumega)?
  • Where can I get more information?

What is oprelvekin (Neumega)?

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 are the possible side effects of oprelvekin (Neumega)?

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.

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

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.

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