Oprelvekin


Generic Medicine Info
Indications and Dosage
Subcutaneous
Prophylaxis of severe thrombocytopenia after myelosuppressive chemotherapy
Adult: To reduce the need for platelet transfusions after myelosuppressive chemotherapy in patients with non-myeloid malignancies who are at high risk of severe thrombocytopenia: 50 mcg/kg once daily, start dosing 6-24 hours following the completion of chemotherapy. Continue treatment until the post-nadir platelet count is ≥50,000/mm3. Max duration of therapy: 21 days for each treatment course. Discontinue treatment at least 2 days prior to initiating the next planned chemotherapy cycle.
Renal Impairment
CrCl (mL/min) Dosage
<30 25 mcg/kg daily.
Reconstitution
Reconstitute vial labelled as 5 mg with 1 mL of sterile water for inj (preservative-free) to make a final concentration of 5 mg/mL. During reconstitution, direct the sterile water for inj toward the side of the vial. Gently swirl to dissolve the contents. Avoid vigorous agitation. Use immediately or within 3 hours after reconstitution.
Contraindications
Hypersensitivity.
Special Precautions
Patient with clinically evident CHF or at risk of developing heart failure (e.g. history of heart failure who are well-compensated and receiving appropriate treatment); susceptibility to develop fluid retention or whose medical condition may be exacerbated by fluid retention, pre-existing fluid collections (including pleural or pericardial effusions, and ascites); history of cardiac arrhythmias (including atrial or ventricular arrhythmias), stroke or TIA; pre-existing papilloedema, tumours involving the CNS; pre-existing visual disturbances. Patient receiving aggressive hydration or chronic diuretic therapy. Not indicated for use after myeloablative chemotherapy. Severe renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Fluid retention resulting in peripheral oedema or dyspnoea on exertion; dilutional anaemia (moderately lowered Hb, haematocrit and RBC count without decreased RBC mass); CV events, including atrial arrhythmias (e.g. atrial flutter or fibrillation) and ventricular arrhythmias; stroke (in patients who developed atrial fibrillation/flutter during treatment); papilloedema.
Cardiac disorders: Tachycardia, palpitations, syncope.
Eye disorders: Conjunctival injection, blurred vision, eye haemorrhage.
Gastrointestinal disorders: Nausea, vomiting, mucositis, diarrhoea, oral moniliasis.
General disorders and administration site conditions: Oedema, neutropenic fever, fever.
Metabolism and nutrition disorders: Dehydration.
Nervous system disorders: Headache, dizziness, paraesthesia.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Rhinitis, increased cough, pharyngitis.
Skin and subcutaneous tissue disorders: Rash, skin discolouration, exfoliative dermatitis.
Vascular disorders: Vasodilatation.
Potentially Fatal: Following recent bone marrow transplantation: Severe fluid retention or overload (e.g. pulmonary oedema, capillary leak syndrome, pericardial or pleural effusion), renal failure; hypersensitivity reactions, including anaphylaxis.
Parenteral/SC: C
Monitoring Parameters
Monitor CBC prior to chemotherapy and regularly during oprelvekin therapy; platelet counts periodically during treatment; fluid status. Closely monitor fluid and electrolytes in patients receiving chronic diuretic therapy.
Drug Interactions
Potentially Fatal: May cause severe hypokalaemia when given in patients receiving oprelvekin with chronic diuretic therapy and ifosfamide.
Action
Description: Oprelvekin, a recombinant human interleukin-11 (IL-11), is a platelet growth factor that predominantly affects megakaryocytopoiesis. It directly binds to IL-11 receptors on myeloid progenitor cell surfaces and stimulates the production of platelets, neutrophils, erythrocytes, and macrophages within the bone marrow.
Onset: Increase in platelet counts: 5-9 days after daily administration (dose-dependent).
Duration: Continued increase in platelet counts: Up to 7 days after therapy discontinuation, then platelet counts return to baseline within 14 days.
Pharmacokinetics:
Absorption: Bioavailability: >80%. Time to peak plasma concentration: 3.2 ± 2.4 hours.
Distribution: Distributed rapidly into highly perfused organs.
Excretion: Mainly via urine (small amounts as unchanged drug). Terminal half-life: Approx 7 hours.
Storage
Store intact vial between 2-8°C. Protect from light. Do not freeze. Reconstituted solution: Store between 2-8°C or below 25°C. Do not freeze or shake the solution.
MIMS Class
Haematopoietic Agents
ATC Classification
L03AC02 - oprelvekin ; Belongs to the class of interleukins. Used as immunostimulants.
References
Anon. Oprelvekin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/07/2021.

Buckingham R (ed). Oprelvekin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/07/2021.

Neumega (Wyeth Pharmaceuticals Inc.). U.S. FDA. https://www.fda.gov. Accessed 08/07/2021.

Oprelvekin, rh-IL-11. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 16/07/2021.

Disclaimer: This information is independently developed by MIMS based on Oprelvekin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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