Febrate

Febrate Uses, Dosage, Side Effects, Food Interaction and all others data.

Following intravenous administration, this is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency.The converse is true when Iron is plentiful.

Significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.

Trade Name Febrate
Generic Iron Sucrose
Iron Sucrose Other Names Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide
Type Injection, Tablet, Syrup
Formula C12H29Fe5Na2O23
Weight Average: 866.546
Monoisotopic: 866.764181
Protein binding

It binds with transferrin.

Groups Approved
Therapeutic Class Parenteral Iron Preparations
Manufacturer Iva Healthcare Pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Febrate
Febrate

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.

Febrate is also used to associated treatment for these conditions: Hyperphosphataemia

How Febrate 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

Febrate dosage

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

Febrate has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyzer. Febrate 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: Febrate can also be administered undiluted by slow IV injection at a rate of 1 ml Febrate (20 mg Iron) in at least 1 minute a maximum of 10 ml Febrate (200 mg Iron) can be administered per injection in at least 10 minutes.

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

Febrate 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

Febrate 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 Febrate have not been studied. Febrate 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 Febrate is administered to a nursing woman.

Contraindication

The use of Febrate is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Febrate 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 Febrate 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.

Innovators Monograph

You find simplified version here Febrate

Febrate contains Iron Sucrose see full prescribing information from innovator Febrate Monograph, Febrate MSDS, Febrate FDA label

FAQ

What is Febrate used for?

Febrate injection is an iron replacement product used to treat iron deficiency anemia in people with kidney disease. Febrate is usually given with another medication to promote the growth of red blood cells.

How safe is Febrate?

Febrate has been reported to be safe with an excellent profile in clinical use.

How does Febrate work?

Febrate works by replenishing iron stores so that the body can make more red blood cells.

What are the common side effects of Febrate?

Common side effects of Febrate are include:

  • Bloating or swelling of the face, arms, hands, lower legs, or feet.
  • chest pain or tightness in the chest.
  • difficult or labored breathing.
  • headache.
  • slow or fast heartbeat.
  • tingling of the hands or feet.
  • unusual tiredness or weakness.


Is Febrate safe during pregnancy?

Febrate has been reported to be safe and effective during pregnancy.

Is Febrate safe during breastfeeding?

Febrate supplements are perfectly safe to take when you're breastfeeding. Your provider may give you a prescription, or recommend an over-the-counter supplement that's right for you

Can I drink alcohol with Febrate?

drinking alcohol increases the risk of cancer and is linked to other health concerns, you shouldn't start drinking alcohol to increase iron absorption.

When should I take Febrate ?

Administer Febrate early during the dialysis session. The usual total treatment course of Febrate is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs.

How is Febrate given?

Febrate is given by injection into a vein as directed by your doctor. It is usually given slowly over 2 to 5 minutes or as directed by your doctor. Febrate can also be mixed in a saline solution and given through an IV over a longer time.

How long does Febrate take to work?

Febrate complex is effective because of the rapid removal from the plasma and the availability of iron for erythropoiesis. After a bolus dose of iron sucrose, the plasma peak occurs in 10 minutes.

How often can I give Febrate ?

Febrate can be given as a maximum of 200mg not more than 3 times per week; doses must be 24 hours apart.

Who should not take Febrate?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your iron sucrose injection.

What happens if I overdose?

Seek emergency medical attention

Can too much Febrate cause infertility?

Haemochromatosis is well established as a cause of infertility in both men and women, usually because iron deposition in the pituitary or the gonads leads to hypogonadism.

Is iron hard on my heart?

Febrate has a big job in our bodies as a crucial part of the proteins that deliver oxygen to our tissues. With low iron, the heart must pump harder, which can lead to fatigue, shortness of breath, and a higher risk of heart attacks and strokes.

Can Febrate affects my kidney?

Febrate increased proteinuria, the long-term effects of repeated non-dextran iron on kidney function requires further study.

Does Febrate increase hemoglobin?

One way of treating anemia is with intravenous Febrate, which is delivered into the vein through a needle to increase the levels of iron and hemoglobin in the body.

*** Taking medicines without doctor's advice can cause long-term problems.
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