ACCRUFER- ferric maltol capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERRIC MALTOL (UNII: MA10QYF1Z0) (FERRIC CATION - UNII:91O4LML611)

Available from:

Shield TX (UK) Ltd

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ACCRUFER is indicated for the treatment of iron deficiency in adults. ACCRUFER is contraindicated in patients with a history of: - Hypersensitivity to the active substance or to any of the excipients [see Description ( 11)] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. - Hemochromatosis and other iron overload syndromes [see Warnings and Precautions ( 5.1)] . Use may result in iron overdose [see Overdosage ( 10)]. - Receiving repeated blood transfusions. Use may result in iron overload [see Warnings and Precautions ( 5.2) and Overdosage ( 10)]. Risk Summary ACCRUFER is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3)] . In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. In animal reproduction studies, oral administration of maltol to pregnant Crl: COBS-CD (SD) BR rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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. Data Animal Data In embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. Administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. In a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. Administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. Risk Summary There are no data on the presence of ACCRUFER in human milk, the effects on the breastfed child, or the effects on milk production. ACCRUFER is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to ACCRUFER. Safety and effectiveness of ACCRUFER have not been established in pediatric patients. Of the 295 patients in the randomized trials of ACCRUFER, 39% of patients were aged 65 and older, while 23% were aged 75 and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

Product summary:

ACCRUFER (ferric maltol) 30 mg iron capsules are supplied as 60 capsules in HDPE bottles with a child-proof polypropylene push-lock. 1 Bottle of 60-count 30 mg ferric iron capsules (NDC 73059-001-60). 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].

Authorization status:

New Drug Application

Summary of Product characteristics

ACCRUFER- FERRIC MALTOL CAPSULE
SHIELD TX (UK) LTD
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACCRUFER
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACCRUFER.
ACCRUFER (FERRIC MALTOL) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
ACCRUFER is an iron replacement product indicated for the treatment of
iron deficiency in adults. ( 1)
DOSAGE AND ADMINISTRATION
30 mg twice daily on an empty stomach ( 2.1)
Continue as long as necessary to replenish body iron stores ( 2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: 30 mg ( 3)
CONTRAINDICATIONS
Hypersensitivity to the active substance or any excipient ( 4)
Hemochromatosis and other iron overload syndromes ( 4)
Patients receiving repeated blood transfusions ( 4)
WARNINGS AND PRECAUTIONS
IBD FLARE:Avoid use in patients with IBD flare ( 5.1)
IRON OVERLOAD:Accidental overdose of iron products is a leading cause
of fatal poisoning in children
under 6. Keep out of reach of children. ( 5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 1%) are flatulence,
diarrhea, constipation, feces discolored,
abdominal pain, nausea, vomiting and abdominal discomfort/distension.
( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SHIELD THERAPEUTICS INC
AT 1-888-963-
6267 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Dimercaprol: Avoid concomitant use. ( 7.2)
Oral Medications: Separate administration of ACCRUFER from certain
oral medications. Monitor clinical
responses as appropriate. ( 7.1, 7.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Risk of Inflammatory Bowel Disease (IBD) Flare
5.2 Iron Overload
®
5.3 Risk of Overdosage in Children Due to Accidental Ingestion
6 ADVERSE REACTIONS
6.1 Cl