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CEPLENE

Package:
VIALS: 14 x 0.5 mg/0.5 ml.
Dosage:
See prescribing information for full details.
Prescribing Restrictions:  None


Indications:
Maintenance therapy for adult patients with acute myeloid leukemia in first remission, concomitantly treated with Interleukin- 2 (IL-2). The efficacy has not been fully demonstrated in patients older than 60 years.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients. Patients with significantly compromised cardiac function, e.g., NYHA Class III/IV. Patients receiving systemic steroid therapy, clonidine and H₂ blocking agents. Patients who have received an allogenic stem cell transplant. Pregnancy and lactation.
Special Precautions:
The injection should be administered 1-3 minutes after IL-2 administration, and not concomitantly. Rapid subcutaneous injection or injection into a vascular space may result in severe hypotension, tachycardia or syncope. Treatment in conjunction with IL-2 should be used with caution in patients with poorly compensated cardiac function. Patients with cardiac disease should be evaluated for ventricular ejection fraction and wall function by echocardiography or nuclear medicine stress test and then treated with caution. Patients should be monitored for possible clinical complications due to hypotension or hypovolemia. The product should be administered in the clinic under supervision of the physician on day 1 of the initial treatment cycle. Patient monitoring on day 1 should include vital signs, including pulse, blood pressure and respiratory rate. Patient monitoring during subsequent treatment days or cycles should be performed as long as the patient continues to experience significant changes in vital signs during administration. If significant hypotension or related symptoms are observed in subsequent treatment cycles, dose reduction should be initiated and if required, administered in hospital until responses to treatment allow for home administration. Caution should be used for patients with any of the following: symptomatic peripheral arterial disease, past or present peptic or esophageal ulcer disease with a history of bleeding, clinically significant renal disease and stroke within the last 12 months. Where appropriate, consideration should be made to providing concomitant treatment with a proton pump inhibitor. Patients with clinically significant infection requiring the use of antibiotics, antifungals or antivirals, or who have completed prior anti-infectious therapy within 14 days of starting treatment should be treated with caution unless the use of antibiotics and antivirals were for prophylaxis purposes. Patients with a prior history of autoimmune disease (including systemic lupus, inflammatory bowel disease, psoriasis and rheumatoid arthritis) should be treated with caution. Monitoring of laboratory test results is recommended, including standard hematological and blood chemistry tests. Patients receiving the following medicinal products should be treated with caution: Beta-blockers or other anti hypertensive agents; H₁ blocking agents and neuroleptics (anti-psychotics) with H₁ receptor blocking properties; tricyclic anti-depressants that may have H₁ and H₂receptor blocking properties; monoamine oxidase inhibitors, anti-malarial and anti-trypanosomal agents; neuromuscular blocking agents, narcotic analgesics, and various contrast media. See prescribing information for full details.
Side Effects:
See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.