Accrufer
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami Ardakani
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Overview
Accrufer is an Oral Iron Replacement Therapy that is FDA approved for the treatment of iron deficiency in adults.. Common adverse reactions include Flatulence, diarrhea, constipation, discolored stools, abdominal pain, nausea, vomiting, and abdominal discomfort or bloating..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage is 30 mg orally twice daily, taken 1 hour before or 2 hours after a meal.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Accrufer FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Patients with a history of hypersensitivity to Accrufer or any of its inactive components. Patients with hemochromatosis and other iron overload syndromes. Patients receiving repeated blood transfusions, as this may result in iron overload.
Warnings
Increased Risk of Inflammatory Bowel Disease (IBD) Flares.
Adverse Reactions
Clinical Trials Experience
Flatulence Diarrhea Constipation Discolored stools Abdominal pain Nausea Vomiting Abdominal discomfort or bloating
Postmarketing Experience
Adverse reactions identified during post-approval use include gastrointestinal disorders consistent with those observed in clinical trials.
Drug Interactions
Calcium and magnesium salts: May reduce iron absorption. Tetracycline antibiotics: May reduce the absorption of both iron and the antibiotic.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Accrufer in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Accrufer in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Accrufer during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Accrufer in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Accrufer in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Accrufer in geriatric settings.
Gender
There is no FDA guidance on the use of Accrufer with respect to specific gender populations.
Race
There is no FDA guidance on the use of Accrufer with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Accrufer in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Accrufer in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Accrufer in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Accrufer in patients who are immunocompromised.
Administration and Monitoring
Administration
Accrufer is administered orally. Capsules should be swallowed whole with water, taken 1 hour before or 2 hours after a meal. Do not open, break, or chew Accrufer capsules.
Monitoring
Monitor serum ferritin and transferrin saturation to assess response to therapy.
IV Compatibility
There is limited information regarding the compatibility of Accrufer and IV administrations.
Overdosage
Symptoms of overdose may include gastrointestinal discomfort and iron overload. In case of overdose, discontinue Accrufer and provide appropriate supportive measures.
Pharmacology
There is limited information regarding Accrufer Pharmacology in the drug label.
Mechanism of Action
Ferric maltol acts as a source of iron, which is essential for oxygen transport in the blood and other processes in the human body.
Structure
There is limited information regarding Accrufer Structure in the drug label.
Pharmacodynamics
Ferric maltol provides bioavailable iron for incorporation into hemoglobin and other iron-containing components.
Pharmacokinetics
After oral administration, ferric maltol dissociates, releasing iron and maltol separately into the bloodstream. Iron is bound to transferrin and reaches its highest concentrations in the blood plasma one to three hours after ingestion.
Nonclinical Toxicology
There is limited information regarding Accrufer Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Accrufer Clinical Studies in the drug label.
How Supplied
Accrufer is supplied as 30 mg capsules. The capsules are available in bottles containing 56 or 112 capsules. Each capsule is dark red and imprinted with the dosage strength.
Storage
Accrufer should be stored at room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and keep the bottle tightly closed when not in use.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Take Accrufer 1 hour before or 2 hours after meals for optimal absorption. Be aware of possible gastrointestinal side effects, such as constipation or discolored stools. Continue therapy as directed by their healthcare provider, even if they feel better before the course is completed. Notify their healthcare provider if they experience any signs of iron overload or worsening gastrointestinal discomfort.
Precautions with Alcohol
No specific interactions between Accrufer and alcohol have been identified. However, alcohol can impact the absorption of iron and may exacerbate gastrointestinal side effects. Patients are advised to limit alcohol intake during treatment to optimize efficacy.
Brand Names
Accrufer
Look-Alike Drug Names
There is limited information regarding Accrufer Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.