infed
Pharmaranks rates Infed 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Infed (Iron Dextran) is a parenteral iron replacement.
Iron Dextran · by Allergan
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Iron Dextran
- Drug class
- Parenteral Iron Replacement
- Form
- Injectable
- Strength
- Iron Dextran EQ 100MG IRON/2ML (EQ 50MG IRON/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Allergan
- FDA application
- NDA017441
- FDA boxed warning
- Yes — see the boxed warning
What is Infed?
From the FDA label:INFeD (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 4.5 to 7.0.
How to use
See Full Prescribing Information for weight-based dosing and administration information. ( 2 ) Weight in Kg Weight in Kg INFeD dose volume 2.1 Important Pre-Treatment Information Discontinue administration of any iron-containing products prior to administration of INFeD. Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. Administer a test dose of INFeD prior to administration of therapeutic dose [see Dosage and Administration ( 2.4 )] . 2. 2 Recommended Dosage for Iron Deficiency Anemia Calculate the INFeD dose based upon Table 1 and formulas below. Continue INFeD until hemoglobin is within the normal range and iron stores are replete. Administer daily doses of no more than 2 mL of INFeD until the total required dose is administered. Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). Iron storage parameters may improve prior to hematologic parameters. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Table 1: Total INFeD Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* P A T I E…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Delayed Reactions [see Warnings and Precautions ( 5.2 )] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions ( 5.3 )] Iron Overload [see Warnings and Precautions ( 5.4 ) ] Fetal bradycardia [see Use in Specific Populations ( 8.1 )] The following adverse reactions associated with the use of INFeD were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders : Leukocytosis, lymphadenopathy. Gastrointestinal disorders : Abdominal pain, nausea, vomiting, diarrhea. General disorders and administration site conditions : chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. Musculoskeletal and connective tissue disorders : Arthralgia, arthritis (may represent reactivation in patients with quiescent…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS See full prescribing information for complete boxed warning. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. ( 5.1 ) Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD. ( 5.3 )
Warnings
Important safety information
Delayed Reactions: May occur with large intravenous doses. ( 5.2 ) Increased Risk of Toxicity in Patients with Underlying Conditions: Monitor for toxicity in these patients. ( 5.3 ) Iron Overload: Excessive therapy can lead to iatrogenic hemosiderosis. Do not administer to patients with iron overload. Periodically monitor hematologic and iron parameters. ( 5.4 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including INFeD. Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Administer only in a setting where resuscitation equipment and medications are available. Administer a test dose of INFeD prior to the first therapeutic dose [see Dosage and Administration ( 2.4 ) ]. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. If hypersensitivity reactions occur during administration, stop INFeD immediately and manage reaction medically. 5.2 Delayed Reactions Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. The adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. The etiology of these reactions is not known. Do not exceed a total daily dose of 2 mL undiluted INFeD. 5. 3 Increased Risk of Toxicity in Patients with Underlying Conditions Monitor for iron toxicity when INFeD is used in patients with serious impairment of liver function. It should not be used during the acute phase of infectious kidney disease. Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration ( 5.1 )]. 5. 4 Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving INFeD require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer INFeD to patients with evidence of iron overload.
Who should not take Infed
INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions ( 5.1 ) ] . Known hypersensitivity to INFeD ( 4 )
Overdose — what happens if you take too much
Excessive dosages of INFeD may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer INFeD to patients with iron overload [see Warnings and Precautions ( 5.4 )] . INFeD is not removed by hemodialysis [see Clinical Pharmacology ( 12.3 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Drug/Laboratory Test Interactions Drug interactions involving INFeD have not been studied. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. INFeD may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of INFeD. Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of INFeD. Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following INFeD infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.
Drug class
How this class works, per Iron Dextran - StatPearls - NCBI Bookshelf.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How does Infed work?
- Infed is a parenteral iron replacement. Given by injection or IV, these supply iron directly into the bloodstream wrapped in a protective carbohydrate shell. The iron is gradually released, picked up by the protein transferrin, and delivered to the bone marrow, where it is used to build hemoglobin and treat iron-deficiency anemia.
- How is Infed rated?
- pharmaranks gives Infed a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Infed?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Infed. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Infed?
- Infed is marketed by Allergan. You can see Allergan's full profile, rating, and other products on pharmaranks.
- Is Infed a brand-name or generic drug?
- Infed is a brand-name product with the active ingredient Iron Dextran.
- Is Infed available over the counter?
- No. Infed is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Infed come in?
- Infed is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Infed?
- Infed is classified as parenteral iron replacement, phosphate binder, per the FDA's Established Pharmacologic Class.
- Is Infed FDA-registered?
- Infed is on record with the U.S. FDA under application number NDA017441. You can verify this on its official FDA label.
- Has Infed been recalled by the FDA?
- Infed has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Infed safe?
- There's no single safe-or-not verdict. pharmaranks gives Infed a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Infed?
- Infed's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Delayed Reactions [see Warnings and Precautions ( 5.2 )] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings a… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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infed
72/100