Unifer IV

Iron deficiency anemia, in pregnancy and in non-dialysis dependent chronic kidney disease (CKD) patients, hemodialysis dependent CKD patients or peritoneal dialysis CKD patients

Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given. As injection: Iron Sucrose can also be administered undiluted by slow IV injection at a rate of 1 ml Iron Sucrose (20 mg Iron) in at least 1 minute a maximum of 10 ml Iron Sucrose (200 mg Iron) can be administered per injection in at least 10 minutes. As infusion: Iron Sucrose should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Iron Sucrose in maximum 20 ml 0.9% NaCl etc up to 25 ml Iron Sucrose in maximum 500 ml 0.9% NaCl. Dilution must take place immediately prior to infusion and solution must be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes ete. Normal posology is to use 5-10 ml Iron Sucrose 1-3 times a week depending on the Hemoglobin level. For the administration of the maximum tolerable dose of 7 mg Iron/kg body weight an infusion time of at least 3.5 hours has to be respected, independently of the total dose. IV Administration HD-dependent CKD May be administered via dialysis line as the undiluted solution or by diluting 100 mg (5 mL) in 100 mL NS Administer either by slow IV injection over 2-5 min or IV infusion over at least 15 min Non-dialysis-dependent CKD Administer undiluted by slow IV inj over 2-5 min PD-dependent CKD Dilute dose in a maximum of 250 mL NS 300 mg doses: infuse IV over 1.5 hr 400 mg dose: infuse IV over 2.5 hr Pediatric Undiluted: Administer by slow IV injection over 5 minutes Diluted in 25 mL of 0.9% NaCl: Administer IV over 5-60 minutes

Adults and the Elderly: Iron-deficiency Anemia in Chronic Kidney Disease Hemodialysis-dependent CKD: 100 mg elemental iron IV (injection or infusion over 2-5 min) per dialysis session not to exceed total cumulative dose of 1000 mg divided in 3 doses/week Non-dialysis-dependent CKD: 200 mg IV injection for 5 doses in over 14 days (cumulative 1000 mg in 14-day period) Peritoneal dialysis-dependent CKD: 300 mg IV infusion (1.5 hr) for 2 doses 14 days apart, THEN 400 mg IV infusion (2.5 hr) 14 days later (cumulative 1000 mg divided in 3 doses/week)

Iron-deficiency Anemia in Chronic Kidney Disease Indicated for maintenance treatment of iron-deficient anemia associated with chronic kidney disease <2 years: Safety and efficacy not established Hemodialysis-dependent: 0.5 mg/kg IV q2weeks for 12 weeks; not to exceed 100 mg/dose Non-dialysis dependent or peritoneal-dependent (on erythropoietin): 0.5 mg/kg IV q4weeks for 12 weeks; not to exceed 100 mg/dose

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload e.g. Haemochromatosis, thalassemia or haemosiderosis and in patients with known hypersensitivity to Iron preparations or any components preparation, in patients with anemia not caused by Iron deficiency.

Iron: Essential component in the formation of hemoglobin; adequate amounts of iron are necessary for effective erythropoiesis; also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin.

Iron Sucrose should be administered with caution in patients with asthma, eczema, other atopic allergies or allergic reaction to other parenteral Iron preparations, low binding capacity and/or folic acid deficiency, liver dysfunction, acute or chronic infection. Baseline tests: Ensure Hgb, Hct, serum ferritin and transferrin saturation is determined before starting therapy and periodically during treatment. Note that serum Iron levels may be reliably obtained 48 hours after IV dosing. Blood Pressure: Monitor Blood Pressure during infusion. If hypotension occurs, slow the rate of infusion. If hypotension continues, discontinue infusion and be prepared to treat appropriately. Discontinue oral Iron preparations before administering parenteral Iron products. Co-administration of parenteral Iron preparations may reduce absorption of oral Iron.The dose will be in terms of elemental Iron. For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration. Medication is administered 1 to 3 times/ week. Do not administer more than 3 times/week. Discard any unused diluted solution. Do not save unused solution for future use. Do not administer if particulate matter or discoloration noted. Lactation: Not known if excreted in breast milk, use caution

>10% Hypotension (36%),Muscle cramps (23%),Headache,Nausea 1-10% Dizziness,Fatigue,Arthralgia,Back pain,Hypertension,Fluid overload,Peripheral edema,Cough,Vomiting,Diarrhea,Constipation,Pruritus Frequency Not Defined Potentially fatal anaphylaxis (rare)

Pregnancy Published studies on intravenous iron sucrose treatment after first trimester of pregnancy not shown adverse maternal or fetal outcomes; available reports of intravenous iron sucrose use in pregnant women during first trimester are insufficient to assess risk of major birth defects and miscarriage; iron deficiency anemia during pregnancy should be treated because there are risks to mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy Animal data Animal reproduction studies of iron sucrose administered to rats and rabbits during period of organogenesis at elemental iron doses equivalent to maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus; adverse outcomes in pregnancy occur regardless of health of mother or use of medications Iron deficiency anemia during pregnancy should be treated; untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia; adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight Lactation Iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants; there are no data on effects on milk production Developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for treatment and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

May reduce the serum levels of cefdinir; stools may appear red due to the formation of an insoluble iron-cefdinir complex. May reduce the serum levels of eltrombopag. May decrease absorption of phosphate supplements. Concurrent use with trientine may result in reduction of serum levels of iron sucrose and/or trientine. Potentially Fatal: Dimercaprol may increase the nephrotoxic effect of iron salts when used concurrently.