(oh PREL ve kin)
Thrombocytopenia: Prevention of severe thrombocytopenia and to reduce the need for platelet transfusions following myelosuppressive chemotherapy for nonmyeloid malignancy in adults who are at high risk for thrombocytopenia
Hypersensitivity to oprelvekin or any component of the formulation
Oprelvekin has caused allergic or hypersensitivity reactions, including anaphylaxis. Permanently discontinue administration of oprelvekin in any patient who develops an allergic or hypersensitivity reaction.
Thrombocytopenia: SubQ: 50 mcg/kg once daily until postnadir platelet count ≥50,000/mm3. Begin ~6 to 24 hours after the end of chemotherapy. In studies, doses were administered for 10 to 21 days (do not administer for more than 21 days). Discontinue at least 2 days prior to the next planned chemotherapy cycle.
Refer to adult dosing.
For dosage adjustment purposes, renal function may be estimated using the Cockcroft-Gault formula.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Reduce dose to 25 mcg/kg once daily.
There are no dosage adjustments provided in the manufacturer 's labeling.
Reconstitute with 1 mL provided sterile water for injection (without preservative) to a final concentration of 5 mg/mL; direct diluent down side of vial; swirl gently, avoid excessive or vigorous agitation.
For subcutaneous administration in the abdomen, thigh, or hip; outer upper arm may also be used (if not self-injecting). Rotate injection sites each day.
Store intact vials (and prefilled diluent syringe) refrigerated between 2 ‚ °C and 8 ‚ °C (36 ‚ °F and 46 ‚ °F); do not freeze. Protect from light. Store reconstituted solution in the vial at either 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F) or room temperature of ≤25 ‚ °C (77 ‚ °F); use within 3 hours of reconstitution. Do not freeze or shake reconstituted solution.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Subcutaneous [preservative free]:
Neumega: 5 mg (1 ea [DSC])
There are no known significant interactions.
Monitor electrolytes and fluid balance during therapy (including persisting fluid collections [pericardial effusions or ascites]); obtain a complete blood cell count (CBC) at baseline and at regular intervals during therapy; monitor platelet counts during the time of expected nadir and until adequate recovery has occurred; renal function (at baseline)
>10%:
Cardiovascular: Tachycardia (children 84%; adults 20%), edema (59%), cardiomegaly (children 21%), vasodilation (19%), atrial arrhythmia (12% to 15%), palpitation (14%), syncope (13%)
Central nervous system: Neutropenic fever (48%), headache (41%), dizziness (38%), fever (36%), insomnia (33%)
Dermatologic: Rash (25%)
Endocrine & metabolic: Fluid retention
Gastrointestinal: Nausea/vomiting (77%), diarrhea (43%), mucositis (43%), oral moniliasis (14%), weight gain (due to fluid retention)
Hematologic: Anemia (dilutional; onset: 3-5 days; duration: ≤1 week)
Neuromuscular & skeletal: Weakness (severe 14%), periostitis (children 11%), arthralgia
Ocular: Conjunctival injection/redness/swelling (children 57%; adults 19%), papilledema (children 16%; adults 1%)
Respiratory: Dyspnea (48%), rhinitis (42%), cough (29%), pharyngitis (25%)
1% to 10%: Respiratory: Pleural effusion (10%)
<1% (Limited to important or life-threatening): Allergic reaction, amblyopia, anaphylaxis/anaphylactoid reactions, blindness, blurred vision, capillary leak syndrome, cardiac arrest, chest pain, dehydration, dysarthria, exfoliative dermatitis, eye hemorrhage, facial edema, fibrinogen increased, fluid overload, HF, hypoalbuminemia, hypocalcemia, hypokalemia, hypotension, injection site reactions (dermatitis, pain, discoloration), loss of consciousness, mental status changes, optic neuropathy, paresthesia, pericardial effusion, peripheral edema, pneumonia, pulmonary edema, renal failure, shock, skin discoloration, stroke, urticaria, ventricular arrhythmia, visual acuity changes, visual field defect, von Willebrand factor concentration increased, wheezing
Exposure to oprelvekin increases as renal function decreases.
Concerns related to adverse effects:
- Anemia (dilutional): Dilutional anemia may occur due to increased plasma volume, presenting as moderate decreases in hemoglobin concentration, hematocrit, and red blood cells without a decrease in red blood cell mass; effect generally appears within 3 to 5 days of initiation of therapy and resolves over ~1 week following oprelvekin discontinuation.
- Cardiovascular effects: Arrhythmias (usually brief in duration), pulmonary edema, and cardiac arrest have been reported; use in patients with a history of atrial arrhythmia only if the potential benefit exceeds possible risks. Stroke has been reported in patients who develop atrial fibrillation/flutter while receiving oprelvekin (patients with a history of stroke or transient ischemic attack may be at risk for atrial fibrillation/flutter). Ventricular arrhythmia has also been reported, occurring within 2 to 7 days of treatment initiation.
- Fluid retention: May cause serious fluid retention (reversible within several days after discontinuation), which may result in peripheral edema, dyspnea, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation of preexisting pleural effusion. Serious fluid retention (sometimes fatal) has been reported. Use with caution in patients with clinically evident heart failure or who may be susceptible to developing heart failure, patients receiving aggressive hydration, patients with a history of heart failure who are well compensated and receiving appropriate medical therapy, and patients who may develop fluid retention as a result of associated medical conditions or whose medical condition may be exacerbated by fluid retention. Monitor fluid and electrolyte status; preexisting fluid collections, including pericardial effusions or ascites, should also be monitored (may require drainage).
- Hypersensitivity reactions: [US Boxed Warning]: Allergic or hypersensitivity reactions, including anaphylaxis, have been reported. Permanently discontinue in any patient developing an allergic or hypersensitivity reaction. Reaction may occur with the first or with subsequent doses. Allergic reactions included facial/tongue/larynx edema, dyspnea, wheezing, chest pain, hypotension (including shock), rash, urticaria, flushing, fever, loss of consciousness, mental status changes, and/or dysarthria.
- Papilledema: Papilledema has occurred, usually following repeated cycles. The incidence of papilledema occurred more frequently in children. Use with caution in patients with preexisting papilledema or with CNS tumors; may worsen or develop during treatment. Patients experiencing oprelvekin-related papilledema may be at risk for visual acuity changes and/or visual field defects, ranging from blurred vision to blindness.
Disease-related concerns:
- Renal impairment: Use with caution in patients with renal impairment (oprelvekin is renally eliminated); dosage adjustment required in severe renal impairment. Monitor fluid balance.
Other warnings/precautions:
- Appropriate use: Begin 6 to 24 hours following completion of chemotherapy; safety and efficacy of oprelvekin administered immediately before or during cytotoxic chemotherapy or initiated at the time of expected nadir has not been established. Not indicated following myeloablative chemotherapy; increased toxicities (hypotension, tachycardia, edema, and conjunctival bleeding) were reported and efficacy was not demonstrated. A higher incidence of adverse events (fluid retention/overload, facial/pulmonary edema, capillary leak syndrome) has also been reported when used following bone marrow transplantation. Efficacy has not been evaluated with chemotherapy regimens >5 days duration or with regimens associated with delayed myelosuppression (eg, nitrosoureas, mitomycin). Safety and efficacy have not been established with chronic administration.
C
Adverse events have been observed in animal reproduction studies
Oprelvekin is a thrombopoietic growth factor that stimulates megakaryocytopoiesis and thrombopoiesis, resulting in proliferation of megakaryocyte progenitors and megakaryocyte maturation, thereby increasing platelet production.
Vd: Adults: 112 to 152 mL/kg
Urine (primarily; predominantly as metabolites); Clearance: Adults: 2.2 to 2.7 mL/min/kg; clearance decreases with age and is about 1.2 to 1.6 times faster in children than in adults
Onset of action: 5 to 9 days; Maximum effect: 14 to 19 days
Serum: 3.2 ‚ ± 2.4 hours
Up to 7 days after discontinuation
Terminal: 6.9 ‚ ± 1.7 hours
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience mouth sores, insomnia, or rhinorrhea. Have patient report immediately to prescriber rash, severe fatigue, severe nausea, vomiting, severe diarrhea, severe abdominal pain, flu-like symptoms, pharyngitis, difficulty breathing, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, severe dizziness, passing out, flushing, arrhythmia, severe headache, bruising, bleeding, vision changes, eye pain, severe eye irritation, blindness, loss of strength and energy, urinary retention, change in amount of urine passed, dysphagia, or illogical thinking (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.