Indications & Uses
OXYFER 1 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Ferric Carboxymaltose is dosed in three steps. First you work out the iron need, then you calculate and give the dose or doses, and finally you assess the patient after iron repletion.
Step 1: Determining the iron need. The iron need for repletion with Ferric Carboxymaltose depends on the patient's body weight and haemoglobin (Hb) level. It is set out as follows.
If Hb is <10 g/dl: below 35 kg, 500 mg. From 35 kg to <70 kg, 1500 mg. At 70 kg and over, 2000 mg.
If Hb is 10 to 14 g/dl: below 35 kg, 500 mg. From 35 kg to <70 kg, 1000 mg. At 70 kg and over, 1500 mg.
If Hb is >14 g/dl: below 35 kg, 500 mg. From 35 kg to <70 kg, 500 mg. At 70 kg and over, 500 mg.
Step 2: Calculating and giving the maximum individual iron dose(s). Once the iron need is known, give the appropriate dose or doses of Ferric Carboxymaltose with these limits in mind. A single administration should not exceed 15 mg iron/kg body weight when given by intravenous injection, or 20 mg iron/kg body weight when given by intravenous infusion. It should also not exceed 1,000 mg of iron (20 ml Ferric Carboxymaltose). The maximum recommended cumulative dose is 1000 mg of iron per week.
Step 3: Assessment after iron repletion. The clinician should re-assess the patient based on the individual patient's condition. The Hb level should be checked again no earlier than 4 weeks after the final Ferric Carboxymaltose administration, so there is enough time for erythropoiesis and iron utilisation. If the patient needs more iron, recalculate the iron need using the list above.
Side Effects
Side effects of Ferric Carboxymaltose are infrequent and usually mild, and most patients don't need to stop treatment because of them. The most common one is nausea. After that come headache, dizziness, hypertension, injection site reactions, nausea, alanine aminotransferase increased and hypophosphataemia. Uncommon side effects are hypersensitivity, dysgeusia, tachycardia, hypotension, flushing, dyspnoea, dyspepsia, abdominal pain, constipation, diarrhea, pruritus, urticaria, erythema, rash, myalgia, back pain, arthralgia, muscle spasms, pyrexia, fatigue, chest pain, oedema peripheral and chills. Some lab values may also rise, namely aspartate aminotransferase, gamma glutamyl transferase, blood lactate dehydrogenase and blood alkaline phosphatase. Rare side effects with Ferric Carboxymaltose are anaphylactoid reactions, loss of consciousness, anxiety, phlebitis, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, face oedema, rigors, malaise and influenza like illness.
Cautions & Contraindications
Warnings & Precautions
Serious hypersensitivity reactions have been reported in patients receiving Ferric Carboxymaltose, including anaphylactic-type reactions. Some of these have been life-threatening and some have been fatal. Patients may present with shock, clinically significant hypotension, loss of consciousness and collapse. So the patient should be watched for signs and symptoms of hypersensitivity during the administration and afterwards, for at least 30 minutes and until clinically stable following completion of the infusion. Give Ferric Carboxymaltose only when staff and treatments are immediately available to deal with serious hypersensitivity reactions. Other serious or severe adverse reactions that may be linked to hypersensitivity can also occur, and these include, but are not limited to, pruritus, rash, urticaria, wheezing or hypotension. Hypertension Transient rises in systolic blood pressure may occur, sometimes with facial flushing, dizziness or nausea. These rises generally appeared immediately after dosing and settled within 30 minutes. Monitor patients for signs and symptoms of hypertension after each administration of Ferric Carboxymaltose. Laboratory Test Alterations In the 24 hours after Ferric Carboxymaltose is given, laboratory assays may overestimate serum iron and transferrin bound iron, because they also measure the iron in Ferric Carboxymaltose.
Contraindications
Ferric Carboxymaltose must not be used in these cases: hypersensitivity to the active substance, to Ferric Carboxymaltose itself or to any of its excipients, known serious hypersensitivity to other parenteral iron products, anaemia that is not due to iron deficiency (for example other microcytic anaemia), and evidence of iron overload or disturbances in how the body uses iron.
Pregnancy & Breastfeeding
There are no adequate and well-controlled trials of Ferric Carboxymaltose in pregnant women. So a careful benefit and risk check is needed before it is used in pregnancy, and it should not be used unless clearly necessary.
Animal data suggest that iron released from Ferric Carboxymaltose can cross the placental barrier, and that using it during pregnancy may influence skeletal development in the fetus. If the benefit is judged to outweigh the potential risk for both the mother and the fetus, treatment should be confined to the second and third trimester.
For women who are breast-feeding, the data are limited. Based on them, Ferric Carboxymaltose is unlikely to be a risk to the breast-fed child.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Patients with haemodialysis-dependent chronic kidney disease
For haemodialysis-dependent chronic kidney disease patients, a single injection of Ferric Carboxymaltose should not go above a maximum daily dose of 200 mg iron.
Paediatric population
Ferric Carboxymaltose has not been studied in children, so it is not recommended for children under 14 years.
Overdose
Giving Ferric Carboxymaltose in excessive doses can cause iron to build up in the body's storage sites, and this may lead to hemosiderosis. Checking iron parameters such as serum ferritin and transferrin saturation can help show whether iron is accumulating. If it has built up, treat it according to standard medical practice, for example by considering an iron chelator.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Ferric Carboxymaltose in a cool, dry place where the temperature stays below 30°C, and away from light. Don't freeze it. Keep it out of the reach of children.
Common questions about OXYFER 1 1000 mg
What is OXYFER 1 1000 mg Injection?
OXYFER 1 1000 mg Injection is a medicine that contains Ferric Carboxymaltose. It is made by Ibn Sina Pharmaceutical Ind. Ltd. It belongs to the Parenteral Iron Preparations group of medicines.
What is OXYFER 1 used for?
OXYFER 1 is used for: Anemia.
What are the side effects of OXYFER 1?
Side effects of Ferric Carboxymaltose are infrequent and usually mild, and most patients don't need to stop treatment because of them. The most common one is nausea.
Can I take OXYFER 1 during pregnancy or while breastfeeding?
There are no adequate and well-controlled trials of Ferric Carboxymaltose in pregnant women. So a careful benefit and risk check is needed before it is used in pregnancy, and it should not be used unless clearly necessary. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much OXYFER 1?
Giving Ferric Carboxymaltose in excessive doses can cause iron to build up in the body's storage sites, and this may lead to hemosiderosis. Checking iron parameters such as serum ferritin and transferrin saturation can help show whether iron is accumulating. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store OXYFER 1?
Keep Ferric Carboxymaltose in a cool, dry place where the temperature stays below 30°C, and away from light. Don't freeze it.
Do I need a prescription for OXYFER 1?
OXYFER 1 is a prescription (Rx) medicine. Take it as your doctor advises.