MONOFERRIC- ferric derisomaltose solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Ferric derisomaltose (UNII: AHU547PI9H) (Ferric derisomaltose - UNII:AHU547PI9H)

Dostupné z:

Pharmacosmos A/S

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 ass

Prehľad produktov:

Monoferric injection is a sterile, dark brown, non-transparent aqueous solution supplied in cartons as single-dose vials (10 mL, 5mL 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.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

MONOFERRIC- FERRIC DERISOMALTOSE SOLUTION
PHARMACOSMOS A/S
----------
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: 1/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Preparation and Administration