"Nov. 29, 2012 (Chicago) -- For cancer patients undergoing chemotherapy who have found their complaints of general mental fogginess and haziness dismissed by their doctors as not being a real medical condition, vindication has arrived.
Neumega Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Neumega (oprelvekin) is a protein that stimulates production of platelets in the blood 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. Common side effects of Neumega include injection site reactions (pain redness, or irritation), red eyes, dizziness, headache, sleep problems (insomnia), nausea, vomiting, diarrhea, runny or stuffy nose, cough, or sore throat.
The recommended dose of Neumega in adults without severe renal impairment is 50 µg/kg given once daily, administered subcutaneously (under the skin) as a single injection. Other drugs may interact with Neumega. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Neumega should be used only when prescribed. It is unknown if this drug passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Neumega (oprelvekin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Neumega in Detail - Patient Information: 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.
Read the entire detailed patient monograph for Neumega (Oprelvekin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Neumega Overview - Patient Information: Side Effects
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.
Read the entire patient information overview for Neumega (Oprelvekin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Neumega FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Three hundred twenty-four subjects, with ages ranging from eight months to 75 years, have been exposed to Neumega treatment in clinical studies. Subjects have received up to six (eight in pediatric patients) sequential courses of Neumega treatment, with each course lasting from one to 28 days. Apart from the sequelae of the underlying malignancy or cytotoxic chemotherapy, most adverse events were mild or moderate in severity and reversible after discontinuation of Neumega dosing.
In general, the incidence and type of adverse events were similar between Neumega 50 mcg/kg and placebo groups. The most frequently reported serious adverse events were neutropenic fever, syncope, atrial fibrillation, fever and pneumonia. The most commonly reported adverse events were edema, dyspnea, tachycardia, conjunctival injection, palpitations, atrial arrhythmias, and pleural effusions. The most frequently reported adverse reactions resulting in clinical intervention (eg, discontinuation of Neumega, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction symptom) were atrial arrhythmias, syncope, dyspnea, congestive heart failure, and pulmonary edema (see WARNINGS, Fluid Retention and WARNINGS, Cardiovascular Events). Selected adverse events that occurred in ≥ 10% of Neumega-treated patients are listed in Table 3.
TABLE 3 : SELECTED ADVERSE EVENTS
|Body Bas Whole|
|Skin and Appendages|
|*Occurred in significantly more Neumega-treated patients than in placebo-treated patients.|
The following adverse events also occurred more frequently in cancer patients receiving Neumega than in those receiving placebo: blurred vision, paresthesia, dehydration, skin discoloration, exfoliative dermatitis, and eye hemorrhage. Other than a higher incidence of severe asthenia in Neumega treated patients (10 [14%] in Neumega patients versus two [3%] in placebo patients), the incidence of severe or lifethreatening adverse events was comparable in the Neumega and placebo treatment groups.
Two patients with cancer treated with Neumega experienced sudden death that the investigator considered possibly or probably related to Neumega. Both deaths occurred in patients with severe hypokalemia ( < 3.0 mEq/L) who had received high doses of ifosfamide and were receiving daily doses of a diuretic (see WARNINGS, Cardiovascular Events).
The following adverse events, occurring in ≥ 10% of patients, were observed at equal or greater frequency in placebo-treated patients: asthenia, pain, chills, abdominal pain, infection, anorexia, constipation, dyspepsia, ecchymosis, myalgia, bone pain, nervousness, and alopecia. The incidence of fever, neutropenic fever, flu-like symptoms, thrombocytosis, thrombotic events, the average number of units of red blood cells transfused per patient, and the duration of neutropenia < 500 cells/μL were similar in the Neumega 50 mcg/kg and placebo groups.
In clinical studies that evaluated the immunogenicity of Neumega, two of 181 patients (1%) developed antibodies to Neumega. In one of these two patients, neutralizing antibodies to Neumega were detected in an unvalidated assay. The clinical relevance of the presence of these antibodies is unknown. In the post-marketing setting, cases of allergic reactions, including anaphylaxis have been reported (see WARNINGS, Allergic Reactions Including Anaphylaxis). The presence of antibodies to Neumega was not assessed in these patients.
The data reflect the percentage of patients whose test results were considered positive for antibodies to Neumega and are highly dependent on the sensitivity and specificity of the assay. Additionally the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparisons of the incidence of antibodies to Neumega with incidence of antibodies to other products may be misleading.
Abnormal Laboratory Values
The most common laboratory abnormality reported in patients in clinical trials was a decrease in hemoglobin concentration predominantly as a result of expansion of the plasma volume (see WARNINGS, Fluid Retention). The increase in plasma volume is also associated with a decrease in the serum concentration of albumin and several other proteins (eg, transferrin and gamma globulins). A parallel decrease in calcium without clinical effects has been documented.
After daily SC injections, treatment with Neumega resulted in a two-fold increase in plasma fibrinogen. Other acute-phase proteins also increased. These protein levels returned to normal after dosing with Neumega was discontinued. Von Willebrand factor (vWF) concentrations increased with a normal multimer pattern in healthy subjects receiving Neumega.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reactions, (2) frequency of reporting, or (3) strength of causal connection to Neumega.
The following adverse reactions have been reported during the post-marketing use of Neumega:
- allergic reactions and anaphylaxis/anaphylactoid reactions
- visual disturbances ranging from blurred vision to blindness
- optic neuropathy
- ventricular arrhythmias
- capillary leak syndrome
- renal failure
- injection site reactions (dermatitis, pain, and discoloration) (see BOXED WARNING, WARNINGS, and CONTRAINDICATIONS).
Read the entire FDA prescribing information for Neumega (Oprelvekin)
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