Injectafer

Injectable Iron Supplements
Iron Supplements

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Administer as an undiluted slow IV push or by intermittent IV infusion.
Each vial is for single use only. Discard any unused portion; contains no preservatives.
Avoid extravasation since brown discoloration of the extravasation site may be long-lasting. If extravasation occurs, discontinue administration at that site.

Slow IV Push
No dilution necessary.
Doses up to 750 mg: Administer at a rate of approximately 100 mg/minute (2 mL/minute).
1,000 mg doses: Administer over 15 minutes.
 
Intermittent IV Infusion
Dilute in 0.9% NaCl Injection to a concentration of 2 to 4 mg/mL and infuse over at least 15 minutes. Do not dilute to concentrations less than 2 mg/mL in order to maintain stability.
Storage: The solution is physically and chemically stable at room temperature for 72 hours when added to an infusion bag containing 0.9% NaCl Injection at concentrations ranging from 2 to 4 mg/mL.

anaphylactoid reactions / Rapid / 0.1-0.1
anaphylactic shock / Rapid / Incidence not known
bone fractures / Delayed / Incidence not known

hypophosphatemia / Delayed / 1.0-27.0
hypertension / Early / 1.0-4.0
erythema / Early / 0.3-3.0
wheezing / Rapid / 1.5-1.5
elevated hepatic enzymes / Delayed / 1.2-1.2
hypotension / Rapid / 0-1.0
osteomalacia / Delayed / 0-1.0
constipation / Delayed / 0.5-0.5
sinus tachycardia / Rapid / Incidence not known
chest pain (unspecified) / Early / Incidence not known
dyspnea / Early / Incidence not known

rash / Early / 1.0-8.0
injection site reaction / Rapid / 3.0-8.0
nausea / Early / 1.0-7.2
vomiting / Early / 0.2-5.0
headache / Early / 1.0-5.0
flushing / Rapid / 0.3-4.0
pharyngitis / Delayed / 3.0-3.0
dizziness / Early / 1.0-2.1
urticaria / Rapid / 1.5-1.5
pruritus / Rapid / 1.5-1.5
skin discoloration / Delayed / 1.0-1.4
dysgeusia / Early / 1.0-1.2
abdominal pain / Early / 0.5
diarrhea / Early / 0.5
paresthesias / Delayed / 0.5
sneezing / Early / 0.5
back pain / Delayed / Incidence not known
syncope / Early / Incidence not known
fever / Early / Incidence not known
chills / Rapid / Incidence not known
arthralgia / Delayed / Incidence not known

Injectafer

Rx

Parenteral iron replacement product
For iron-deficiency anemia (IDA) in adults and pediatric patients 1 year and older who have intolerance to or an unsatisfactory response to oral iron and adults with non-dialysis dependent chronic kidney disease; also indicated for iron deficiency in adult patients with NYHA class II and III heart failure to improve exercise capacity
Anaphylactic-type reactions, including life-threatening and fatal, have been reported with use of ferric carboxymaltose

750 mg IV every 7 days or more for 2 doses for a cumulative dose of 1,500 mg or 15 mg/kg/dose (Max: 1,000 mg/dose) IV as a single dose. Treatment may be repeated if iron deficiency recurs.

15 mg/kg/dose IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.

15 mg/kg/dose (Max: 750 mg/dose) IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.

750 mg IV every 7 days or more for 2 doses for a cumulative dose of 1,500 mg or 15 mg/kg/dose (Max: 1,000 mg/dose) IV as a single dose. Treatment may be repeated if iron deficiency recurs.

15 mg/kg/dose IV every 7 days or more for 2 doses. Treatment may be repeated if iron deficiency recurs.

1,000 mg IV on day 1, followed by 500 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

1,000 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

500 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

1,000 mg IV on day 1, followed by 1,000 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

1,000 mg IV on day 1, followed by 500 mg IV at week 6. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

500 mg IV on day 1. Administer a maintenance dose of 500 mg IV at 12, 24, and 36 weeks if serum ferritin is less than 100 ng/mL or serum ferritin is 100 to 300 ng/mL with transferrin saturation less than 20%.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Dimercaprol: (Contraindicated) Dimercaprol forms toxic chelates with iron. These dimercaprol-iron complexes are more toxic than the metal alone, especially to the kidneys. Do not administer iron during dimercaprol treatment. Therapy with iron should generally be delayed until 24 hours after the cessation of dimercaprol therapy.
Iron: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.

Injectafer Intravenous Inj Sol: 1mL, 50mg

weighing 50 kg or more: 15 mg/kg/dose IV (Max: 1,000 mg/dose) when given as a single-dose or 750 mg IV when given as a 2-dose course (Max: 1,500 mg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
weighing less than 50 kg: 15 mg/kg/dose IV for 2 doses (Max: 30 mg/kg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.

weighing 50 kg or more: 15 mg/kg/dose IV (Max: 1,000 mg/dose) when given as a single-dose or 750 mg IV when given as a 2-dose course (Max: 1,500 mg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.
weighing less than 50 kg: 15 mg/kg/dose IV for 2 doses (Max: 30 mg/kg total cumulative dose) for iron-deficiency anemia; 1,000 mg IV for iron deficiency in heart failure.

15 mg/kg/dose IV (Max: 750 mg/dose) for 2 doses (Max: 30 mg/kg total cumulative dose).

15 mg/kg/dose IV (Max: 750 mg/dose) for 2 doses (Max: 30 mg/kg total cumulative dose).

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Normal erythropoiesis is dependent on the concentration of iron and erythropoietin available in the plasma. Administration of iron does not stimulate the production of red blood cells, nor does it correct abnormalities not caused by iron deficiency. A therapeutic response to treatment with iron products is dependent on the patient's ability to absorb and use the iron, and it is influenced by the cause of the deficiency as well as other illnesses that can affect normal erythropoiesis.
 
Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Iron is a component of myoglobin and several heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an essential component of the metalloflavoprotein enzymes and the mitochondrial enzyme alpha-glycerophosphate oxidase. Iron-containing proteins and enzymes are important in oxidation-reduction reactions, especially those of the mitochondria. Furthermore, iron is a cofactor for enzymes such as aconitase and tryptophan pyrrolase. Iron deficiency not only causes anemia and decreased oxygen delivery, it also reduces the metabolism of muscle and decreases mitochondrial activity. Iron deficiency can also lead to defects in learning or thermoregulation. Thus iron is important to several metabolic functions which are independent of its importance to erythropoiesis.

Ferric carboxymaltose is administered intravenously. After administration of a single dose of ferric carboxymaltose 100 to 1,000 mg IV in iron deficient adult patients, the iron was rapidly cleared from the plasma with a terminal half-life of 7 to 12 hours. Renal elimination of iron was negligible.

After administration of a single dose of ferric carboxymaltose 100 to 1,000 mg IV in iron deficient adult patients, the maximum iron concentrations of 37 to 333 mcg/mL were obtained after 15 minutes to 1.21 hours, respectively, post dose. The estimated volume of distribution was 3 L.

Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions, especially during the second and third trimester of pregnancy. Advise pregnant women of the potential risk to a fetus. Studies of ferric carboxymaltose use in pregnant women have not reported an association with ferric carboxymaltose and major birth defects and miscarriage; however, these studies cannot establish or exclude the absence or any drug-related risk during pregnancy. In animal studies, administration of ferric carboxymaltose during organogenesis caused adverse developmental outcomes, including malformations and increased implantation loss, at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area).
 

The available published data on the use of ferric carboxymaltose in lactating women demonstrate that iron is present in breast milk. While iron is excreted into breast milk, the iron content of breast milk is not readily affected by the iron content of the maternal diet or the maternal serum iron concentration. Among the breastfed infants, adverse reactions included constipation and diarrhea but none of the adverse reactions reported were considered related to ferric carboxymaltose exposure through breast milk. There are no data available on the effects of ferric carboxymaltose on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for ferric carboxymaltose and any potential adverse effects on the breast-fed infant from ferric carboxymaltose or the underlying maternal condition.