Neumega®

Posted on October 18th, 2010 by

Class: Supportive Care

Generic Name: Oprelvekin (oh PREL ve kin), IL-11, interleukin-11
Trade Name: Neumega®

How is this drug used? Oprelvekin is FDA approved for the prevention of low platelet levels (thrombocytopenia) and reduction of the need for platelet transfusions following chemotherapy in patients with nonmyeloid cancers who are at a high risk of developing thrombocytopenia. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Oprelvekin belongs to a class of drugs called growth factors. Oprelvekin stimulates the bone marrow to produce more platelets, thereby reducing the risk of thrombocytopenia and bleeding from too few platelets.

How is oprelvekin given (administered)? Oprelvekin is administered as an injection under the skin (subcutaneous) and the dose depends on the size of the patient. Patients may be taught to administer these injections by themselves.

How are patients monitored? Patients will have scheduled meetings with their healthcare provider while they are being treated with oprelvekin.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

Patients will be closely monitored for fluid retention, which may be characterized by swelling of the ankles, feet, hands or face. Patients experiencing difficulty breathing, little or no urine output for 8 – 12 hours, chest pain, dizziness, swelling of the hands, feet, ankles, face, or sudden weight gain should contact their healthcare provider immediately.

Patients will also be monitored for an allergic-type reaction to oprelvekin which causes fever, rash, hives, drowsiness, shortness of breath, wheezing, low blood pressure, rash, reddening of the skin, swelling of facial features, swelling of the tongue, difficulty speaking or swallowing, and changes in mental status. Patients experiencing any of these symptoms should tell their healthcare provider immediately.

Patients will also be monitored for a condition called papilledema, a condition in which there is swelling of the optic nerve.  Patients with visual disturbances or pain around the eye should contact their healthcare provider.

What are the common (occur in 30% or more of patients) side effects of treatment with oprelvekin?

• Fluid retention, which will cause swelling of the hands, feet and ankles
• Fever
• Headache
• Insomnia
• Dizziness
• Fatigue
• Nausea and vomiting
• Mouth sores
• Diarrhea
• Shortness of breath
• Runny nose

What are the less common (occur in 10% to 29% of patients) side effects of treatment with oprelvekin?

• Changes in heart rate
• Abnormalities of heart rhythm
• Infection in mouth (thrush)
• Sore throat
• Cough
• Fluid retention around lungs
• Redness of eye
• Bone pain
• Hair loss
• Nervousness
• Chills
• Pain
• Abdominal pain
• Infection
• Loss of appetite accompanied by extreme weight loss
• Constipation
• Heartburn
• Muscle pain
• Weakness
• Skin abnormalities, rash

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
• Eat small meals frequently to help alleviate nausea.
• Rotate injection sites each day to avoid soreness at any one site.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• If patients experience dizziness, they should avoid driving or operating heavy machinery.

When should patients notify their physician?

• Signs of an allergic-type reaction - fever, rash, hives, shortness of breath, low blood pressure, reddening of the skin, swelling of facial features, swelling of the tongue, difficulty speaking, and changes in mental status
• Chest pain
• Difficulty breathing
• Noticeable changes in heart rate or rhythm
• Swelling of the ankles, feet or hands
• Rapid weight gain
• Eye infection
• Visual disturbances or pain around the eye
• Headache
• Dizziness
• Mouth sores
• Prolonged or severe nausea or vomiting
• Prolonged or severe diarrhea
• Swelling or bruising that doesn’t go away at injection site

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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Tags: N, Supportive

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