Darbepoetin alfa is available in 25, 40 mcg dose strengths. 25mcg/0.42 ml, 40mcg/0.40ml
Detailed composition of each strength is as under:
| S. No | Ingredient | 25mcg/0.42 ml
|
40mcg/0.40ml |
| 1 | Darbepoetin alfa (r-DNA origin) | 25 mcg | 40 mcg |
| 2 | Sodium Phosphate Monobasic Monohydrate USP | 0.89 mg | 0.85 mg |
| 3 | odium Phosphate Dibasic Anhydrous USP | 0.28 mg | 0.26 mg |
| 4 | Sodium Chloride USP | 3.44 mg | 3.27 mg |
| 5 | Polysorbate 80 USP | 0.021 mg | 0.020 mg |
| 6 | Water for Injection USP/EP | q.s. to 0.42 mL | q.s. to 0.40 mL |
Darbepoetin alfa injection is indicated for the treatment of
Chronic Renal Failure Patients
Adult Patients
Adverse reactions occurring in patients treated with Darbepoetin alfa are: Hypertension, dyspnea, peripheral edema, cough, procedural hypotension, angina pectoris, vascular access complications, Fluid overload, rash/erythema and arteriovenous graft thrombosis
Pediatric Patients
The most frequently reported serious adverse reactions with Darbepoetin alfa in clinical trials were hypertension and convulsions. The most commonly reported adverse reactions were hypertension, injection site pain, rash, and convulsions. Studies have not evaluated the effects of Darbepoetin alfa when administered to pediatric patients as the initial treatment for the anemia associated with CKD.
Cancer Patients Receiving Chemotherapy
The adverse reactions from controlled clinical studies and post-marketing experience are hypersensitivity, convulsions, hypertension, thromboembolic events, including pulmonary embolism, myocardial infarction, cerebrovascular disorders encompasses CNS hemorrhages and cerebrovascular accidents (ischemic and hemorrhagic), rash/erythema, Oedema and injection site pain.
