- Powder for injection 5 mg
Interleukin–11 (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.
C max is 17.4 ng/mL. T max is 3.2 h.
The bioavailability is more than 80%.
Renal. The t ½ (terminal) is 6.9 h.
Special PopulationsRenal Function Impairment
C max was 2.2-fold higher. AUC was 2.6-fold higher. Cl was approximately 40% of the value seen in healthy renal function patients.Elderly
Cl decreases with age.Children
AUC for children was approximately half that in adults.
Indications and Usage
Prevention of severe thrombocytopenia and reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies.
Dosage and AdministrationAdults
Subcutaneous 50 mcg/kg once daily, starting 6 to 24 h after completion of chemotherapy. Continue therapy until the post-nadir platelet count is at least 50,000/mm 3 or for a max of 21 days. Discontinue oprelvekin at least 2 days before starting the next chemotherapy cycle.Severe Renal Function Impairment
Subcutaneous CrCl less than 30 mL/min: 25 mcg/kg.
- Administer as a single dose in the abdomen, thigh, or hip (or upper arm if not self-injecting).
- During reconstitution, avoid excessive or vigorous agitation of product.
- Inspect visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, do not administer.
- Dosing beyond 21 days per treatment course is not recommended.
Store powder for injection and diluent in refrigerator (36° to 46°F). Protect from light and freezing. Use reconstituted solution within 3 h of reconstitution and store vial in refrigerator or at controlled room temperature (at or below 77°F). Do not freeze or shake reconstituted solution.
None well documented.
Laboratory Test Interactions
None well documented.
Tachycardia (20%); vasodilatation (19%); palpitations (14%); syncope (13%); atrial fibrillation/flutter (12%); arrhythmias, capillary leak syndrome, cardiomegaly, ventricular arrhythmias (postmarketing).
Headache (41%); dizziness (38%); insomnia (33%); asthenia (14%).
Rash (25%); exfoliative dermatitis, paresthesia, skin discoloration.
Rhinitis (42%); pharyngitis (25%); conjunctival injection (19%); blurred vision, eye hemorrhage, optic neuropathy, papilledema, visual disturbances ranging from blurred vision to blindness (postmarketing).
Nausea/vomiting (77%); diarrhea, mucositis (43%); oral moniliasis (14%).
Renal failure (postmarketing).
Decreased albumin, calcium, Hgb, transferrin and gamma globulins; increased plasma fibrinogen and Von Willebrand factor concentrations.
Injection-site reactions, including dermatitis, discoloration, and pain (postmarketing).
Dyspnea (48%); increased cough (29%); pleural effusions (10%).
Edema (59%); neutropenic fever (48%); fever (36%); allergic reaction, anaphylaxis/anaphylactoid reactions (postmarketing); dehydration, sudden death.
Allergic or hypersensitivity reactions, including anaphylaxis, can occur. Permanently discontinue product in any patient who develops an allergic or hypersensitivity reaction.
Monitor fluid balance and electrolyte status. Obtain CBC prior to and at regular intervals during therapy. Monitor platelet counts during time of expected nadir and until adequate recovery (post–nadir counts at least 50,000 mcL).
Category C .
Safety and efficacy not established.
Use with caution; monitor fluid balance carefully.
Moderate decreases in Hgb concentration, hematocrit, and RBC count, without a decrease in RBC mass, can occur.
Antibody formation/allergic reactions
A small proportion (1%) of patients developed antibodies to oprelvekin.
The safety and efficacy of administering oprelvekin before or concurrently with chemotherapy have not been evaluated.
Oprelvekin has been administered safely using the recommended dosing schedule for no more than 6 cycles following chemotherapy. Continuous dosing (2 to 13 wk) in primates produced joint capsule, tendon fibrosis, and periosteal hyperostosis.
Use with caution in patients with a history of atrial arrhythmia. Transient atrial arrhythmias (atrial fibrillation or flutter) have occurred in approximately 15% of patients following treatment with oprelvekin.
Oprelvekin is known to cause fluid retention; use with caution in patients with clinically evident CHF, patients who may be susceptible to developing CHF, and patients with a history of heart failure. Sudden deaths have occurred in oprelvekin-treated patients receiving chronic diuretic therapy and ifosfamide who developed severe hypokalemia.
May occur; use with caution in patients with preexisting papilledema or with tumors involving the CNS. Changes in visual acuity and/or visual field defects can occur.
Stroke has been reported in patients who experienced atrial fibrillation/flutter. Patients with a history of stroke or transient ischemic attack may be at increased risk.
Doses of oprelvekin more than 50 mcg/kg may be associated with an increased incidence of CV events in adult patients.
- Instruct patient or caregiver who will be administering oprelvekin as to the proper dose and the method for reconstituting and administering oprelvekin. Instruct patients in the importance of proper disposal and caution against the reuse of needles, syringes, drug product, and diluent.
- Inform patients of the most common adverse reactions associated with oprelvekin administration, including those symptoms related to fluid retention. Mild to moderate peripheral edema and shortness of breath on exertion can occur within the first week of treatment and may continue for the duration of administration. Advise patients who have preexisting pleural or other effusions or a history of CHF to contact health care provider if dyspnea worsens.
- Advise that most patients who receive oprelvekin develop anemia.
- Contact health care provider if symptoms attributable to atrial arrhythmia develop and are not transient.
- Advise women of childbearing potential of the possible risks of oprelvekin to the fetus.
Copyright © 2009 Wolters Kluwer Health.