CosmoFer. Dose Selection and Calculation Guide for intravenous administration. Low molecular weight iron dextran. Revised TDI tables

Transcription

1 CosmoFer Low molecular weight iron dextran Dose Selection and Calculation Guide for intravenous administration Revised TDI tables low Mw iron dextran Before prescribing CosmoFer please refer to full local approved data sheet.

2 How to use the tables to select the correct dose of CosmoFer The tables opposite provide dosage information for four haemaglobin target levels: 11 g/dl, 12 g/dl, 13 g/dl and 14 g/dl. Choose the table for the target haemaglobin that you require. In the left hand column, find the body weight that most closely matches the patient s body weight. Read across this row to the column headed by the haemoglobin concentration that matches the patient s current state. The reading at this point is the dose required, expressed as 2 ml ampoules of CosmoFer (50 mg/ml). If the dose that you arrive at is printed in red, then it must be divided for administration because it is above the upper limit for Total Dose Infusion (TDI) of 20 mg/kg body weight. All dosages printed in black may be added to 500 ml 0,9% saline and infused over 4-6 hours. Continue to observe the patient for 1 hour after the infusion. Test dose: (all routes of administration) Before administering the first dose to a new patient, a test dose of CosmoFer corresponding to 25 mg iron or equal to 1/2 ml solution is recommended. If no adverse reactions are seen after 60 minutes, the remaining dose can be given. Please read the Prescribing Information on the inside page.

3 How to calculate the dose of CosmoFer individually The dose of CosmoFer required to correct iron deficiency anaemia is dependent on the patient s body weight and haemoglobin status. To calculate the appropriate dose you will need to determine: The target haemoglobin concentration (g/l) The actual haemoglobin concentration (g/l) The patient s weight (kg) The required dose of iron in milligrams, is given by the formula: ((Target Hb Actual Hb) x Body Weight x 0.24) mg* * (Please note: This additional 500 mg is only applicable to patients with a body weight of more than 35 kg) Test dose: (all routes of administration) Before administering the first dose to a new patient, a test dose of CosmoFer corresponding to 25 mg iron or equal to 1/2 ml solution is recommended. If no adverse reactions are seen after 60 minutes, the remaining dose can be given.

4 The doses of CosmoFer given in these tables Target Haemoglobin of 11 g/dl Body Actual Haemoglobin Weight Concentration (g/dl) (kg) Target Haemoglobin of 12 g/dl Body Actual Haemoglobin Weight Concentration (g/dl) (kg) Please note: These tables are only for patients with iron deficiency anaemia. They are not appropriate for patients requiring iron replacement for blood loss.

5 are expressed as milligrams of iron Target Haemoglobin of 13 g/dl Body Actual Haemoglobin Weight Concentration (g/dl) (kg) Target Haemoglobin of 14 g/dl Body Actual Haemoglobin Weight Concentration (g/dl) (kg) The doses given in these tables are based on iron stores of 500 mg. In calculating these doses, the values have been rounded down to the nearest 25 mg iron (0.5 ml CosmoFer ). Please use these tables in conjunction with the SPC.

6 Effective and flexible... CosmoFer IV iron therapy significantly increases the response to rhuepo, compared to oral iron supplementation 1,2 CosmoFer is the only globally available parenteral iron formulation that can be administered both IV, IM and as total dose infusion (TDI) 1,3,4 CosmoFer administered as TDI, improves compliance and reduces the number of injections and hospital visits 5 With a well documented safety profile Clinical experience from > 60 mio. doses 6 CosmoFer is characterized by significantly less adverse events compared to high Mw iron dextran 7,8,9,10,11,12 CosmoFer is a tightly bound iron complex, more stable than iron sucrose and iron gluconate, and is therefore less likely to lead to toxicity 13,14,15,16,17

7 CosmoFer abbreviated prescribing information Before prescribing CosmoFer (low Mw iron dextran) please refer to full local approved data sheet. Presentation: Solution for infusion and injection in the form of 2ml ampoules containing a solution of Iron (III)-hydroxide dextran complex 312.5mg equivalent to 50mg elemental iron (III) per ml. Indications: Iron deficiency anaemia when oral iron therapy is impossible or inadequate in patients above 14 years of age. Dosage: The normal recommended dosage schedule is mg corresponding to 2-4ml, two or three times a week depending on the haemoglobin level. If clinical circumstances require rapid delivery of iron to the body iron stores, CosmoFer may be administered as a total dose infusion up to a total replacement dose corresponding to 20mg iron/kg body weight. Administration: CosmoFer solution for injection can be administered by an intravenous drip infusion or by a slow intravenous injection. Intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes. CosmoFer may also be administered as undiluted solution intramuscularly. Intravenous drip infusion: CosmoFer must be diluted only in 0.9% sodium chloride or in 5% glucose solution. CosmoFer in a dose of mg iron (2-4ml) may be diluted in 100 ml. On each occasion the first 25 mg of iron should be infused over a period of 15 minutes. If no adverse reactions occur during this time the remaining portion of the infusion should be given at an infusion rate not more then 100 ml in 30 minutes. Slow intravenous injection: CosmoFer may be administered in a dose of mg iron by slow intravenous injection (0.2 ml/min) preferably diluted in ml 0.9% sodium chloride or 5% glucose solution. On each occasion before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given. Intramuscular injection: For intramuscular injection, the amount of CosmoFer required is determined either from the dosage table or by calculation; it is administered as a series of undiluted injections of up to 100mg iron (2.0ml) each, determined by the patient s body weight. CosmoFer must be given by deep intramuscular injection to minimise the risk of subcutaneous staining, it is recommended to use the Z-track technique. Total dose infusion: For total dose infusion the amount of CosmoFer required is determined either from the dosage table or by calculation, it is added to the required volume (usually 500 ml) of 0.9% sodium chloride or 5% glucose solution and infused intravenously over 4-6 hours. On each occasion the first 25 mg of iron should be infused over a period of 15 minutes. If no adverse reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to drops per minute. BEFORE ADMINISTERING THE FIRST DOSE TO A NEW PATIENT, a test dose of CosmoFer corresponding to 25 mg iron or equal to 1/2 ml solution is recommended for all routes of administration. If no adverse reactions are seen after 60 minutes, the remaining dose can be given. Contraindications: Non-iron deficiency anaemia, iron overload or disturbances in utilisation of iron, patients with a history of asthma, eczema or other atopic allergy, drug hypersensitivity, decompensated liver cirrhosis and hepatitis, acute or chronic infection, rheumatoid arthritis with symptoms or signs of active inflammation, acute renal failure. Pregnancy and lactation: CosmoFer should not be used during the first trimester but can be used during second and third trimester and during lactation if oral iron therapy is ineffective or impracticable. Warnings/ Precautions: The use of CosmoFer as with the parenteral use of other iron-carbohydrate complexes carries a risk of immediate severe Pharmacosmos A/S Roervangsvej 30 DK-4300 Holbaek Tel: Fax: pharmacosmos@pharmacosmos.com

8 and potentially lethal anaphylactoid reactions. Patients should be closely observed during and for 1 hour after administration. The risk is enhanced for patients with known (medical) allergy. CosmoFer may only be administered when anaphylactic emergency measures, including an injectable 1:1000 adrenaline solution are available. Additional treatment with antihistamine and/or corticosteroids should be given as appropriate. Administration to patients with (auto) immune disorder or inflammatory conditions may cause a type III allergic reaction. Hypotensive episodes may occur if intravenous injection is administered too rapidly. Drug interactions: CosmoFer should not be administered concomitantly with oral iron preparations, as the absorption of oral iron will be reduced. Oral iron therapy should not be started earlier than 5 days after the last injection of CosmoFer. The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Incompatibilities: CosmoFer must only be mixed with 0.9% sodium chloride or 5% glucose solution. No other intravenous dilution solutions or therapeutic agents should be used. Side effects: Acute, severe anaphylactoid reactions which are uncommon occur usually within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and/or cardiovascular collapse. Other less severe manifestations include urticaria, rashes, itching, nausea and shivering. Delayed reactions are well described and may be severe and are characterised by arthralgia, myalgia and sometimes fever. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics. Other uncommon to rare adverse reactions are loss of consciousness, altered mental status, seizure, dizziness, restlessness, fatigue, hypotension, angioedema, arrythmia, chest pain, diarrhoea, diaphoresis, myalagia, tremors, dyspnoea, nausea, emesis, abdominal pain, flushing, puritus, rash, blurred vision, feeling hot, cramps and numbness. Exacerbation of joint pain in rheumatoid arthritis can occur. Local reactions reported are soreness and inflammation at or near injection site and local phlebitic reaction. After intramuscular injection local complications such as staining of the skin, bleeding, formation of sterile abscesses, tissue necrosis or atrophy and pain are observed. Legal Category: POM. Pharmaceutical Precautions: CosmoFer is for single use only and any unused solution should be discarded. The reconstituted solution for injection is to be visually inspected prior to use. Only clear solutions without particles should be used. Package Quantities 5 ampoules per pack. Date of preparation: January References: 1) Auerbach M. J Clint Once 2004, 22 No 7: ) Fishbane S. AJKD 1995, Vol 26, No 1: pp ) Summery of products charateristics. 4) Auerbach M et al, AJKD 1998: 31, 1; ) Peebles G. and Stanley Stewert, Journal of outcomes Research 2004; 8: ) IMS data and data on file. 7) Peck, SN et al, Journal of Pediatric Gastroenterology and Nutrition: Volume 27 (4) October 1998 p ) Case G. ANNA Journal; Feb. 1998; 25, 1 pp ) McCarthy et al, Am J Nephrol 2000;20: ) Fletes R. et al, American Journal of Kidney Diseases, Vol 37, No 4 (April), 2001: pp ) Coyne D.W. et al, Kidney International (2003) Vol. 63, pp ) Chertow GM et al,nephrol Dial Transplant 2004; 19: ) Geisser P et al, Structure/Histotoxicity relationship of parenteral iron preparations. Arzneimittel-forschung/Drug Research (1992). 42 (II), 12, ) Zager RA et al, AJKD 2002, 40, (1): ) Zager RA et al, Kidney International 2004, 66: ) Agarwal R, Kidney International, Vol. 65 (2004), pp ) Hörl W.H., Macdougall I.C, Rossert J., Schaefer R.M.: Therapy with intravenous iron and recombinant human erythropoietin in chronic kidney disease. OPTA update low Mw iron dextran