Ferrospey

Composition

Each 5 ml contains:  ferric hydroxide in complex with sucrose eq. to elemental Iron – 100 mg

Water for injection USP q.s.

Indications for use

For the treatment of iron deficiency in the following indications:

• where there is a clinical need to deliver iron rapidly to iron stores
• in patients who cannot tolerate oral iron therapy or who are non-compliant
• in active inflammatory bowel disease where oral iron preparations are ineffective.

Mode of application

Must be administered only by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Before administering the first dose to a new patient, should be given a test dose of Ferrospey. Must not be used for intramuscular injection. If during the period of observation emerged the phenomenon of intolerance, the introduction of the drug should be discontinued immediately. Before opening the ampoule, first should inspect it for any possible sediment and damage.

Intravenous drip infusion:

The drug is preferably added during drip infusion in order to reduce the risk of significant decrease of blood pressure and the risk of solution into paravenous space. Immediately before infusion the drug must be diluted only in sterile 0.9% sodium chloride solution in a ratio of 1:20 – e.g. 1 ml (20 mg Fe) in 20 ml 0.9% sodium chloride solution. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg iron (5 ml Ferrospey) in at least 15 minutes, 200 mg iron (10 ml Ferrospey) in at least 30 minutes, 300 mg (15 ml Ferrospey) – in at least 1.5 hours, 400 mg – in at least 2.5 hours, 500 mg – in at least 3.5 hours. Introduction of maximum tolerated single dose is 7 mg Fe / kg, must be carried out in at least 3.5 hours, regardless of the total dose. The first 20 mg of iron (i.e. 1 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 100 mg in 15 minutes.

Intravenous injection: also may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml the drug (200 mg iron) per injection. 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. After injection, to patient is recommended to fix the arm in an extended position. Injection into dialyser: may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.

Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease: 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Ferrospey should be administered early during the dialysis session. The usual total treatment course of Ferrospey is 1000 mg. Ferrospey treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease: 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 ml of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Ferrospey, diluted in a maximum of 250 ml of 0.9% NaCl, over a period of 3.5 to 4 hours on day 1 and day 14. Ferrospey treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease: In 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Ferrospey in a maximum of 250 ml of 0.9% NaCl. Ferrospey treatment may be repeated if iron deficiency reoccurs.

Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment: The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.

For iron maintenance treatment: Administer Ferrospey at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 ml of 0.9% NaCl and administered over 5 to 60 minutes. Ferrospey treatment may be repeated if necessary.

Pediatric Patients (2 years of age and older) with NDD-CKD or PDD-CKD who are on erythropoietin therapy for iron maintenance treatment: The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.  For iron maintenance treatment: Administer Ferrospey at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 ml of 0.9% NaCl and administered over 5 to 60 minutes.  Ferrospey treatment may be repeated if necessary.