G-Ferric IV Injection or Infusion 500 mg/10 ml

Uses

G-Ferric IV Injection or Infusion 500 mg/10 ml is used 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.

G-Ferric IV Injection or Infusion 500 mg/10 ml is also used to associated treatment for these conditions: Iron Deficiency Anemia (IDA)

How G-Ferric IV Injection or Infusion 500 mg/10 ml works

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.

Dosage

G-Ferric IV Injection or Infusion 500 mg/10 ml dosage

For patients weighing 50 kg or more: Give G-Ferric IV Injection or Infusion 500 mg/10 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 G-Ferric IV Injection or Infusion 500 mg/10 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 G-Ferric IV Injection or Infusion 500 mg/10 ml is expressed in mg of elemental iron. Each mL of G-Ferric IV Injection or Infusion 500 mg/10 ml contains 50 mg of elemental iron. G-Ferric IV Injection or Infusion 500 mg/10 ml treatment may be repeated if iron deficiencyanemiareoccurs.

Administer G-Ferric IV Injection or Infusion 500 mg/10 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, G-Ferric IV Injection or Infusion 500 mg/10 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.

Inspectparenteraldrug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of G-Ferric IV Injection or Infusion 500 mg/10 ml is intended for single use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of G-Ferric IV Injection or Infusion 500 mg/10 ml since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the G-Ferric IV Injection or Infusion 500 mg/10 ml administration at that site.

Side Effects

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

Toxicity

The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.

Precaution

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.

Interaction

There are no known drug interactions and none well documented.

Food Interaction

Volume of Distribution

3 L

Elimination Route

When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).

Half Life

7 to 12 hours.

Elimination Route

Renal elimination of iron was negligible.

Pregnancy & Breastfeeding use

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

Contraindication

Hypersensitivity to any of its components.

Storage Condition

Do not store above 30°C. Do not freeze.

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