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methoxy polyethylene glycol-epoetin beta |
| Mircera |
Pharmaceutical
company:
Hoffman LaRoche www.roche.com |
Pharmacologic classification: erythropoeisis-stimulating agent
Therapeutic classification: antianemic
Pregnancy risk category: C
AVAILABLE FORMS
Single use vial: 50, 100, 200, 300, 400, 600, 1,000 mcg/ml
Prefilled syringes: 50, 75, 100, 150, 200, 250 mcg/0.3 ml; 400, 600, 800 mcg/0.6 ml
INDICATIONS AND DOSAGES
Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis--
Adults: Initially, 0.6 mcg/kg once every 2 weeks by subcutaneous or I.V. injection; dosage should be adjusted to maintain a hemoglobin level between 10 to 12 g/dl. Once hemoglobin has been maintained, may be given once a month, using twice the dose given every 2 weeks.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients who are hypersensitive to any component of the drug or drugs in this class, patients with uncontrolled hypertension, and patients with anemia caused by cancer chemotherapy.
Use cautiously in patients with hypertension or history of seizures, and in pregnant and breast-feeding women.
INTERACTIONS
None reported.
ADVERSE REACTIONS
CNS: headache, seizures.
CV: hypertension, postural hypotension, serious CV events, thromboembolic events, septic shock, fluid overload.
GI: diarrhea, vomiting, constipation.
GU: urinary tract infection.
Hematologic: pure red cell aplasia.
Musculoskeletal: muscle spasm, back pain, pain in extremity.
Respiratory: nasopharyngitis, URI, cough.
Other: increased mortality and tumor progression in patient with cancer, injection site reactions.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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