Oprelvekin
Also known as: IL-11, Neumega, recombinant human IL-11, recombinant human interleukin‑11, rhIL-11, rHuIL‑11
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Summary
Oprelvekin is a recombinant form of human interleukin‑11 (IL‑11) approved in the United States in 1997 for the prevention of severe chemotherapy‑induced thrombocytopenia and to reduce platelet‑transfusion requirements in patients with non‑myeloid malignancies. It is administered by subcutaneous injection and acts as a platelet‑growth factor, shortening the duration of low platelet counts after myelosuppressive chemotherapy.
Mechanism of Action
IL‑11 binds to the IL‑11 receptor complex on megakaryocyte progenitors, activating the associated gp130 signaling subunit. This triggers the JAK/STAT cascade, leading to transcription of genes that promote megakaryocyte maturation, platelet production, and also exert anti‑inflammatory effects on stromal cells. The net result is an accelerated recovery of platelet numbers after chemotherapy‑induced marrow suppression.
What the Research Shows
Placebo‑controlled trials in solid‑tumour patients receiving dose‑intensive chemotherapy reported that 68% of oprelvekin recipients avoided platelet transfusion compared with 41% of placebo recipients, demonstrating a clear reduction in transfusion need. The product received FDA clearance in 1997 for this indication, but was voluntarily withdrawn from the market later, leaving no FDA‑approved drug for chemotherapy‑induced thrombocytopenia. Subsequent investigations explored oprelvekin for Crohn's disease, colitis, rheumatoid arthritis and psoriasis, but these studies did not lead to additional approvals. Recent reviews emphasize that, while oprelvekin showed efficacy, newer thrombopoietin‑receptor agonists are now the focus of clinical trials for this problem.
Reported Benefits
Clinical data indicate that oprelvekin can substantially lower the proportion of patients requiring platelet transfusions after intensive chemotherapy, thereby reducing transfusion‑related costs and potential complications. The drug also shortens the duration of severe thrombocytopenia, helping to maintain chemotherapy dose intensity and schedule, which may improve overall oncologic outcomes when used in appropriate patients.
Limitations of the Evidence
Oprelvekin is no longer marketed in the United States after voluntary withdrawal, limiting its practical availability. Evidence is confined to older trials; head‑to‑head comparisons with newer thrombopoietin‑receptor agonists are lacking. The studies provide limited guidance on which patient subgroups derive the greatest benefit, and long‑term safety data are sparse. Ongoing research has shifted toward alternative agents, leaving oprelvekin with an uncertain role in current practice.
Safety Considerations
The most frequently reported adverse effects are fluid retention, peripheral edema, and weight gain, which are generally mild and reversible after discontinuation. In some patients, excessive fluid overload can exacerbate cardiac or renal conditions, so caution is advised in those with pre‑existing heart failure or renal impairment. Other reported events include mild nausea and transient elevation of liver enzymes, but serious toxicities were uncommon in trial populations.
How It Is Administered
Oprelvekin is supplied as a sterile aqueous solution for subcutaneous injection. The usual regimen in clinical trials involved daily injections for several days following each chemotherapy cycle, with dose adjustments based on body surface area. The formulation does not contain preservatives and must be stored refrigerated until use.
Routes of Administration
Goals & Uses
- Reduction of platelet transfusion needTransfusion MedicineHigh
- Platelet count recoveryHematologyHigh
- Chemotherapy‑induced thrombocytopeniaHematologyHigh
- Prevention of severe thrombocytopenia after chemotherapyHematology / Oncology Supportive CareHigh
Contraindications
- Congestive heart failureCardiovascularHigh
- Hypersensitivity to oprelvekin or any componentAllergy / ImmunologyHigh
- Myeloid malignanciesOncologyHigh
- Severe fluid overload or uncontrolled cardiac diseaseCardiovascularModerate
- History of atrial arrhythmiasCardiovascularModerate
- Hypersensitivity to oprelvekin or any excipientAllergyHigh
Adverse Effects
- Fluid retention/edemaCardiovascularCommon
- AnaphylaxisImmunologicRareSevere life-threatening allergic reaction
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Conjunctival injection / papilledemaOphthalmologicUncommon
- Fluid retention / edemaFluid / ElectrolyteCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- FeverSystemicCommonElevated body temperature
- Atrial arrhythmias (flutter/fibrillation)CardiovascularUncommon
- ThrombosisHematologicRareFormation of a blood clot
Drug Interactions
- Antiarrhythmic agentsModerate
- other cytokine therapiesLow
- DiureticsModerateMay worsen dehydration or electrolyte imbalance
- Anticoagulants (e.g., warfarin, heparin)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pediatric patients (<12 y)AgeRelative
- Elderly patients with congestive heart failureCardiovascularRelative
- Elderly patientsAgeRelative
Regulatory Status
- European UnionUnapprovedNot authorized in the European Union.
- United StatesApprovedApproved: Chemotherapy‑induced thrombocytopeniaFDA‑approved; marketed as Neumega.
- United KingdomUnapprovedNot approved by MHRA; not commercially available in the UK.
Approved by FDA (2001) for thrombocytopenia; not approved in the EU; withdrawn in some markets due to safety concerns (fluid retention).
Evidence & Sources
- Journal ArticleModerateAl-Samkari H, Soff GA2021-01-01T00:00:00.000000Z
- Journal ArticleModerateSitaraman SV, Gewirtz AT2001-01-01T00:00:00.000000Z
- Journal ArticleModerateRubenstein EB, Elting L1998-01-01T00:00:00.000000Z
- Journal ArticleModerateAl-Samkari H2022-01-01T00:00:00.000000Z
Frequently Asked Questions
What condition was oprelvekin originally approved to treat?
It was approved to prevent severe thrombocytopenia and reduce the need for platelet transfusions in patients receiving myelosuppressive chemotherapy for non‑myeloid cancers.
How does oprelvekin help increase platelet counts?
The recombinant IL‑11 binds to its receptor on megakaryocyte precursors, activates JAK/STAT signaling, and accelerates maturation of megakaryocytes, leading to faster platelet production after chemotherapy‑induced marrow suppression.
Why is oprelvekin no longer available in the United States?
The manufacturer voluntarily withdrew the product from the market after its initial approval, leaving no FDA‑approved therapy for chemotherapy‑induced thrombocytopenia at present.
What are the main side effects patients should be aware of?
Fluid retention and peripheral edema are the most common adverse effects; they are usually mild and reversible but can be problematic in patients with heart or kidney disease, requiring monitoring during treatment.
What is Oprelvekin?
Oprelvekin is a recombinant form of human interleukin‑11 (IL‑11) approved in the United States in 1997 for the prevention of severe chemotherapy‑induced thrombocytopenia and to reduce platelet‑transfusion requirements in patients with non‑myeloid malignancies. It is administered by subcutaneous injection and acts as a platelet‑growth factor, shortening the duration of low platelet counts after myelosuppressive chemotherapy.
What is Oprelvekin used for?
Oprelvekin is educationally associated with: Reduction of platelet transfusion need, Platelet count recovery, Chemotherapy‑induced thrombocytopenia, Prevention of severe thrombocytopenia after chemotherapy. Educational only — not medical advice.
How is Oprelvekin administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Oprelvekin?
Reported adverse effects include: Fluid retention/edema, Anaphylaxis, Injection site reactions, Headache, Conjunctival injection / papilledema, Fluid retention / edema, Nausea, Fever, Atrial arrhythmias (flutter/fibrillation), Thrombosis. This list is not exhaustive — consult a qualified clinician.
Who should avoid Oprelvekin?
Recorded contraindications: Congestive heart failure, Hypersensitivity to oprelvekin or any component, Myeloid malignancies, Severe fluid overload or uncontrolled cardiac disease, History of atrial arrhythmias, Hypersensitivity to oprelvekin or any excipient. Consult a qualified clinician before use.