INFED- iron dextran injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611)

Disponible depuis:

Allergan, Inc.

DCI (Dénomination commune internationale):

IRON DEXTRAN

Composition:

FERRIC CATION 50 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions ( 5.1 ) ] . Risk Summary   Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant persons of the potential risk to the fetus. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations   Disease-Associated Maternal and/or Embryo/Fetal Risk    Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal /Neonatal Adverse Reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as INFeD) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. Data Animal Data No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. The animals used in these tests were not iron deficient. Risk Summary Trace amounts of unmetabolized iron dextran are present in human milk. There are no data on the effects of iron dextran in breastfed infants or effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for INFeD in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. INFeD is not recommended for use in infants under 4 months of age [s ee Dosage and Administration ( 2.2 ) ]. Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.

Descriptif du produit:

INFeD (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

INFED- IRON DEXTRAN INJECTION
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFED SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFED.
INFED (IRON DEXTRAN INJECTION), FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1974
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)
INDICATIONS AND USAGE
INFeD, an iron replacement product, is indicated for treatment of
adult and pediatric patients of age 4
months and older with documented iron deficiency who have intolerance
to oral iron or an unsatisfactory
response to oral iron. (1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for weight-based dosing and
administration information. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/2 mL (50 mg/mL) in single-dose vials (3)
CONTRAINDICATIONS
Known hypersensitivity to INFeD (4)
WARNINGS AND PRECAUTIONS
Delayed Reactions: Ma