SubcutaneousProphylaxis of severe thrombocytopenia after myelosuppressive chemotherapyAdult: 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.
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| CrCl (mL/min) |
Dosage |
| <30 |
25 mcg/kg daily. |
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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.
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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.
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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.
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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.
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Potentially Fatal: May cause severe hypokalaemia when given in patients receiving oprelvekin with chronic diuretic therapy and ifosfamide.
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Description:
Mechanism of Action: 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.
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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.
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L03AC02 - oprelvekin ; Belongs to the class of interleukins. Used as immunostimulants.
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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.
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