MONOFERRIC- ferric derisomaltose injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

FERRIC DERISOMALTOSE (UNII: AHU547PI9H) (FERRIC DERISOMALTOSE - UNII:AHU547PI9H)

Tillgänglig från:

Pharmacosmos Therapeutics Inc.

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1), Description (11)) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Risk Summary There are no available data on Monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see Data) . There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations) . Iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. The findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. Animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (MRHD) of 1000 mg, respectively, based on body surface area ( see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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 includes 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 women with parenteral iron products (such as Monoferric) which may cause fetal bradycardia, especially during the second and third trimester. Data Animal Data Iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. The highest recommended dose in human clinical use is 20 mg iron/kg body weight. In a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (GD) 17 at doses of 3, 11, and 32 mg Fe/kg/day. The doses of 11 and 32 mg Fe/kg/day (approximately 0.1 and 0.3 times the MRHD of 1000 mg, based on body surface area (BSA)) resulted in an increase in the incidence of skeletal developmental delays. Ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from GD7 to GD20, at doses of 11, 25 and 43 mg Fe/kg/day. The dose of 43 mg Fe/kg/day (approximately 0.8 times the MRHD of 1000 mg, based on BSA) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. Adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). Fetal malformations and reduced fetal weights were also noted in the 25 mg Fe/kg/day group (approximately 0.5 times the MRHD based on BSA). Risk Summary The available data on the use of Monoferric in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Monoferric in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Clinical Considerations Monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea). Safety and effectiveness have not been established in pediatric patients. Of the 3934 patients in clinical studies of Monoferric, 29% were 65 years and over, while 13% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Produktsammanfattning:

Monoferric injection is a sterile, dark brown, non-transparent aqueous solution supplied in cartons as single-dose vials (10 mL, 5 mL or 1 mL) in the following configurations: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). See the USP controlled room temperature. Do not freeze. When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.

Bemyndigande status:

New Drug Application

Produktens egenskaper

MONOFERRIC- FERRIC DERISOMALTOSE INJECTION, SOLUTION
PHARMACOSMOS THERAPEUTICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONOFERRIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MONOFERRIC.
MONOFERRIC (FERRIC DERISOMALTOSE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
MONOFERRIC is an iron replacement product 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. ( 1)
who have non-hemodialysis dependent chronic kidney disease. ( 1)
DOSAGE AND ADMINISTRATION
For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric
as an intravenous infusion.
For patients weighing less than 50 kg: Administer Monoferric as 20
mg/kg actual body weight as an
intravenous infusion.
Repeat Monoferric treatment if iron deficiency anemia reoccurs. ( 2)
DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg iron /10 mL (100 mg/mL) single-dose vial ( 3)
Injection: 500 mg iron/5 mL (100 mg/mL) single-dose vial ( 3)
Injection: 100 mg iron/mL single-dose vial ( 3)
CONTRAINDICATIONS
Serious hypersensitivity to Monoferric or any of its components. ( 4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Monitor patients for signs and symptoms of
hypersensitivity during and after
Monoferric administration for at least 30 minutes and until clinically
stable following completion of the
infusion. ( 5.1)
Iron Overload: Do not administer Monoferric to patients with iron
overload. ( 5.2)
ADVERSE REACTIONS
Most commonly reported adverse reactions (incidence ≥1%) are rash
and nausea. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PHARMACOSMOS AT
1-888-828-0655 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2