Adverse Reaction:
Adverse reactions-
Cardiovascular - atrial fibrillation/flutter 1% palpitations 3% syncope 6%
tachycardia 3% vasodilation 9%
CNS- dizziness 28% headache 36% insomnia 27%
Dermatologic- rash 16%
GI - diarrhea 33% mucosistis 37% nausea/vomiting 70%
oral monoliasis 1%
Respiratory - cough increased 22% dyspnea 22% pharyngitis 16%
pleural effusion 0% rhinitis 31%
Special senses- conjuntivial injection 3%
Miscellaneous- edema 15% fever 28% neutropenic fever 42%
Contra-Indications:
Hypersensitivity to any of the components or the product
Special precautions-
Myeloblastic chemotherapy- oprelverkin is not indicated following myleblstic chemotherapy.
In phase 2 clinical studies significantly increased incidence in edema, conjuntivial bleeding,
hypotension, and tachycardia was observed in patients receiving oprelvenkin as compared to
placebo.
Fluid retention- use with caution in patients with clinically evident congestive heart failure, patients
receiving aggresive hydration,patients who are susceptible to developing congestive heart
failure, patients with a history of heart failure who are well compensated and receiving appropiate
medical therapy and patients who may develop fluid retention as a result of associated medical
conditions or whose conditions may be excaberted by fluid retention.
Cardiovascular effects-oprelvenkin use is associated withcardiovascular reactions.
Use with caution in patients with a history of artial arrhythmias, and only after consideration of the
potential risks in relation to the anticipated benefit
CNS effects- stroke has been reported in the setting of patients who develop fibrillation/ flutter
while receiving oprelvekin. Patients with a history of stroke or ischemic attack may be at increased
risk of these reactions.
Papilledema - changes in visual acutity and or/ visual field defects ranging from blurred vision
to blindness can occur in patients with papilledema taking opevelkin.
Hypersensitivity reactions- such as, edema of the face, tongue, or larynx, shortness of breath,
wheezing, chest pain, hypotension, including shock, dysarthias, loss of consciousness,
mental status changes rash, urticaria, fushing fever, have occured.
If hypersensitivity reactions occur,seek medical attentions
Renal function impairment- fluid retention associated with oprelvekin treatment have not been
studied in patients with renal function impairment, but carefully monitor fluid balance in these
patients
Pregnancy- use operlvekin during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation- decide whether to discontinue breast feeding or the drug depending on the importance
of the drug to the mother.
Children- a safe and effective dose of oprelvekin has not been established in children.
Monitoring- obtain a complete blood cell count prior to chemotherapy and at regular intervals
during operlvekin therapy. Monitor platelet counts
Patient Information:
1. Use oprelvekin under the guidelines and supervision of a heath care provider.
2. Inform patients of the most serious and common adverse reactions associated with oprelvekin.
administration, including those symptoms related to allergic and hypersensitivity reactions
3. Advice patients who have preexisting pleural or other effusions or a history of congestive
heart failure to contact their health care provider for worsening of dyspnea.
4. Most patients who receive oprevelkin develop anemia. Advice patients to contact their
healthcare provider if symptoms attributable to atrial arrhythmias, develop.
Manufacturer Details