Synhafm L

Uses

This is used for the treatment of Iron deficiency in the following indications:

• Where there is a clinical need for a rapid Iron supply
• In patients who can not tolerate oral Iron therapy or who are non-compliant
• In active inflammatory bowel disease where oral Iron preparations are ineffective
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
• Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
• Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin

It is also used for the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.

Synhafm L is also used to associated treatment for these conditions: Hyperphosphataemia

How Synhafm L works

Following intravenous administration, iron sucrose is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron is then incorporated into hemoglobin as the cells mature into red blood cells.

Dosage

Synhafm L dosage

Adults and Elderly: 5-10 ml (100-200 mg Iron) once to three times a week depending on the hemoglobin level.

Synhafm L has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyzer. Synhafm L must not be used for intramuscular injection.

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

As injection: Synhafm L can also be administered undiluted by slow IV injection at a rate of 1 ml Synhafm L (20 mg Iron) in at least 1 minute a maximum of 10 ml Synhafm L (200 mg Iron) can be administered per injection in at least 10 minutes.

As infusion: Synhafm L should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Synhafm L in maximum 20 ml 0.9% NaCl etc up to 25 ml Synhafm L 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 Synhafm L 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.

Side Effects

Synhafm L is generally well tolerated. However, occasionally metallic taste, headache, nausea, vomiting and hypotension may occur. Less frequently side-effects are paresthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactic (pseudoallergic) reactions and in the region of the punctured vein, phlebitis and venous spasm have been observed.

Toxicity

Hypersensitivity reactions, including anaphylactic shock, loss of consciousness, collapse, hypotension, dyspnea, and seizure. Monitor iron toxicity through the periodic evaluation of lab works which monitor the body concentration of iron. Lab monitoring of the following parameters: transferrin saturation, serum ferritin concentrations, hemoglobin, and hematocrit could be helpful to avoid iron overload. Severe allergic symptoms include: rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning or pain at the injection site; burning, numbness, or tingling; chest pain; fainting; loss of consciousness; severe or persistent dizziness, headache, or light-headedness; seizures; shortness of breath; swelling of the hands, ankles, or feet.

Precaution

Synhafm L 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.

Interaction

Drug-drug interactions involving Synhafm L have not been studied. Synhafm L Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.

Food Interaction

• Take with food. Take with meals to maximize phosphate binding capacity and reduce phosphate absorption.

Volume of Distribution

Vd is 7.3 L

Elimination Route

The intravensously administered iron sucrose injection would result rapidly in high serum iron levels. Maximum measured levels occured after 10 min of injection with an average of 30.00 mg/l.

Half Life

6 hours.

Clearance

Total body clearance is 20.5 ml/min.

Elimination Route

Renal elimination of iron contributed very little to the total elimination (in average less than 5%). While, renal elimination of sucrose accounts for 68-75% of the administered dose after 4 and 24 hours respectively.

Pregnancy & Breastfeeding use

Pregnant women: FDA pregnancy category B.

Lactating mothers: It is not known whether this drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Synhafm L is administered to a nursing woman.

Contraindication

The use of Synhafm L is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Synhafm L or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.

Acute Overdose

Overdosage can cause acute iron overloading wich may manifests itself as haemosiderosis. Symptoms associated with overdosage or infusing Synhafm L too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. Overdosage should be treated with supportive measures and, if required, an Iron chelating agent. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Storage Condition

Store below 25° C. Do not freeze. Use immediately after dilution in saline.

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