Revofer750 mg/15 ml
IV Injection
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Medicine overview
Indications of Revofer 750 mg/15 ml
Revofer 750 mg/15 ml is indicated for the treatment of iron deficiency anemia in adult patients-
Who have intolerance to oral iron or have had unsatisfactory response to oral iron
Who have non-dialysis dependent chronic kidney disease.
Theropeutic Class
Parenteral Iron Preparations
Pharmacology
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release.
Metabolism
Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
Dosage & Administration of Revofer 750 mg/15 ml
For patients weighing 50 kg or more
Dosage:Give Revofer 750 mg/15 ml in two doses separated by at least 7 days
Notes:Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course
For patients weighing less than 50 kg
Dosage:Give Revofer 750 mg/15 ml in two doses separated by at least 7 days
Notes:Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. The dosage of Revofer 750 mg/15 ml is expressed in mg of elemental iron. Each mL of Revofer 750 mg/15 ml contains 50 mg of elemental iron. Revofer 750 mg/15 ml treatment may be repeated if iron deficiency anemia reoccurs. Administer Revofer 750 mg/15 ml intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Revofer 750 mg/15 ml solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Revofer 750 mg/15 ml is intended for single use only. Any unused drug remaining after injection must be discarded. Avoid extravasation of Revofer 750 mg/15 ml since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Revofer 750 mg/15 ml administration at that site
| Condition | Dosage | Notes |
|---|---|---|
| For patients weighing 50 kg or more | Give Revofer 750 mg/15 ml in two doses separated by at least 7 days | Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course |
| For patients weighing less than 50 kg | Give Revofer 750 mg/15 ml in two doses separated by at least 7 days | Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. The dosage of Revofer 750 mg/15 ml is expressed in mg of elemental iron. Each mL of Revofer 750 mg/15 ml contains 50 mg of elemental iron. Revofer 750 mg/15 ml treatment may be repeated if iron deficiency anemia reoccurs. Administer Revofer 750 mg/15 ml intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Revofer 750 mg/15 ml solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Revofer 750 mg/15 ml is intended for single use only. Any unused drug remaining after injection must be discarded. Avoid extravasation of Revofer 750 mg/15 ml since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Revofer 750 mg/15 ml administration at that site |
Dosage of Revofer 750 mg/15 ml
For patients weighing 50 kg or more
Dosage:Give Revofer 750 mg/15 ml in two doses separated by at least 7 days
Notes:Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course
For patients weighing less than 50 kg
Dosage:Give Revofer 750 mg/15 ml in two doses separated by at least 7 days
Notes:Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. The dosage of Revofer 750 mg/15 ml is expressed in mg of elemental iron. Each mL of Revofer 750 mg/15 ml contains 50 mg of elemental iron. Revofer 750 mg/15 ml treatment may be repeated if iron deficiency anemia reoccurs. Administer Revofer 750 mg/15 ml intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Revofer 750 mg/15 ml solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Revofer 750 mg/15 ml is intended for single use only. Any unused drug remaining after injection must be discarded. Avoid extravasation of Revofer 750 mg/15 ml since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Revofer 750 mg/15 ml administration at that site
| Condition | Dosage | Notes |
|---|---|---|
| For patients weighing 50 kg or more | Give Revofer 750 mg/15 ml in two doses separated by at least 7 days | Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course |
| For patients weighing less than 50 kg | Give Revofer 750 mg/15 ml in two doses separated by at least 7 days | Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. The dosage of Revofer 750 mg/15 ml is expressed in mg of elemental iron. Each mL of Revofer 750 mg/15 ml contains 50 mg of elemental iron. Revofer 750 mg/15 ml treatment may be repeated if iron deficiency anemia reoccurs. Administer Revofer 750 mg/15 ml intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Revofer 750 mg/15 ml solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Revofer 750 mg/15 ml is intended for single use only. Any unused drug remaining after injection must be discarded. Avoid extravasation of Revofer 750 mg/15 ml since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Revofer 750 mg/15 ml administration at that site |
Interaction of Revofer 750 mg/15 ml
There are no known drug interactions and none well documented.
Contraindications
Hypersensitivity to any of its components.
Side Effects of Revofer 750 mg/15 ml
Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
Pregnancy & Lactation
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Precautions & Warnings
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension may occur.Hypertension: Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration.
Storage Conditions
Do not store above 30°C. Do not freeze.
Drug Classes
Parenteral Iron Preparations
Mode Of Action
Non-dextran, IV is a colloidal iron hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron; replaces iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Macrophage engulf FCM from blood and control iron release. Transferrin saturates and, Iron into the liver, spleen and Bone marrow.
Pregnancy
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Frequently Asked Questions
What is Revofer 750 mg/15 ml used for?
Ferric Carboxymaltose is indicated for the treatment of iron deficiency anemia in adult patients- Who have intolerance to oral iron or have had unsatisfactory response to oral iron Who have non-dialysis dependent chronic kidney disease.
What is the dosage of Revofer 750 mg/15 ml?
For patients weighing 50 kg or more: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.For patients weighing less than 50 kg: Give Ferric Carboxymaltose in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg o…
What are the side effects of Revofer 750 mg/15 ml?
Nausea, Hypertension, Flushing, Decreased blood phosphorus, Dizziness, Vomiting, Pruritus, Rash, Urticaria, Wheezing, Injection site discoloration, Headache, Increased alanine aminotransferase), Dysgeusia, Hypotension, Constipation, Serious anaphylactic/anaphylactoid reactions
Who should not take Revofer 750 mg/15 ml?
Hypersensitivity to any of its components.
What precautions should be taken with Revofer 750 mg/15 ml?
Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and a…
Is Revofer 750 mg/15 ml safe during pregnancy and breastfeeding?
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.