Accrufer Drug Information
Generic name: FERRIC MALTOL
Uses of Accrufer
ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
Dosage & Administration of Accrufer
Recommended Dosage Adults and Children Aged 10 Years and Above The recommended dosage of ACCRUFER is 30 mg orally twice daily, on an empty stomach 1 hour before or 2 hours after meals. Swallow capsules whole. Do not open, break, or chew capsules.
Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.
Side Effects of Accrufer
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to ACCRUFER in 175 adult patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3). The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian.
Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo. Table 1. Adverse Reactions Reported by ≥1% of Patients Treated with ACCRUFER During Placebo-Controlled Period of Pooled Studies (Studies AEGIS1/2 and AEGIS 3) The proportion of patients who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies was 4.6% for patients taking ACCRUFER.
The most common adverse reaction leading to discontinuation of ACCRUFER in these studies was abdominal pain (1.7% of patients). Pediatric Patients with Iron Deficiency Anemia The safety profile of ACCRUFER in pediatric patients was assessed in 24 patients aged 10 to <18 years of age enrolled to the FORTIS trial and treated with ACCRUFER. Overall, the safety profile reported in pediatric patients was consistent with the safety profile reported in adult patients with iron deficiency anemia.
| ACCRUFER 30 mg Twice Daily (N = 175) | Placebo (N = 120) | ||
|---|---|---|---|
| Body System | |||
| Adverse Reaction | |||
| Gastrointestinal | |||
| Flatulence | 4.6% | 0.0% | |
| Diarrhea | 4.0% | 1.7% | |
| Constipation | 4.0% | 0.8% | |
| Feces discolored | 4.0% | 0.8% | |
| Abdominal pain | 2.9% | 2.5% | |
| Nausea | 1.7% | 0.8% | |
| Vomiting | 1.7% | 0.0% | |
| Abdominal discomfort | 1.1% | 0.0% | |
| Abdominal distension | 1.1% | 0.0% | |
Warnings & Cautions for Accrufer
Increased Risk of Inflammatory Bowel Disease (IBD) Flare
Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract.
Iron Overload
Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron. Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy.
Risk of Overdosage in Children Due to Accidental Ingestion
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Drug Interactions with Accrufer
Effect of Other Drugs on ACCRUFER Oral Medications There are no empirical data on avoiding drug interactions between ACCRUFER and concomitant oral medications. Concomitant use of some drugs may reduce the bioavailability of iron after administration of ACCRUFER. Separate the administration of ACCRUFER from these drugs.
The duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate or extended release product. Monitor clinical response to ACCRUFER.
Effect of ACCRUFER on Other Drugs Dimercaprol
Concomitant use of iron products with dimercaprol may increase the risk of nephrotoxicity. Avoid concomitant use of ACCRUFER with dimercaprol. Oral Medications Concomitant use of ACCRUFER may decrease the bioavailability of some drugs, including mycophenolate, ethinyl estradiol, ciprofloxacin and doxycycline.
For oral drugs where reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate the administration of ACCRUFER by at least 4 hours. Monitor clinical responses to concomitant drugs as appropriate.
Contraindications for Accrufer
ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients. Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. Hemochromatosis and other iron overload syndromes.
Use may result in iron overdose. Receiving repeated blood transfusions. Use may result in iron overload.
Hypersensitivity to the active substance or any excipient Hemochromatosis and other iron overload syndromes Patients receiving repeated blood transfusions
Overdosage Information for Accrufer
No data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea.
In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation.
Do not administer ACCRUFER to patients with iron overload. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Clinical Studies of Accrufer
Patients with Inflammatory Bowel Disease (IBD)
The safety and efficacy of ACCRUFER for the treatment of iron deficiency anemia was studied in two randomized, placebo-controlled trials: AEGIS 1 ( NCT01252221 ) and AEGIS 2 ( NCT01340872 ). All patients had discontinued prior oral ferrous product treatment due to lack of efficacy or inability to tolerate oral iron replacement products. Subjects were randomized 1:1 to receive either 30 mg ACCRUFER twice daily or a matched placebo control for 12 weeks.
The major efficacy outcome was the mean difference in Hb concentration from baseline to week 12 between ACCRUFER and placebo. The Least Square mean difference from baseline was 2.18 g/dL (p<0.0001)(see Table 2). Table 2.
Summary of Hemoglobin Concentration (g/dL) and Change from Baseline to Week 12 AEGIS 1 & 2 - Analysis Using Multiple Imputation - Full Analysis Set Population Note: Multiple imputation was based on treatment, gender, disease, and Hb concentration at baseline, Week 4, and 8. The mean ferritin (mcg/L) levels in ACCRUFER subjects at baseline were 8.6 mcg/L and the mean ferritin (mcg/L) levels at Week 12 were 26.0 mcg/L with a mean overall improvement of 17.3 mcg/L. Following completion of the 12-week placebo-controlled phase of the studies, eligible patients transitioned to ACCRUFER 30 mg twice daily open-label treatment for an additional 52 weeks.
ACCRUFER was administered at a dose of 30 mg twice daily. The LS mean difference was 0.52 g/dL (p= 0.0149) (see Table 3). Table 3.
Summary of Hemoglobin Concentration (g/dL) and Change from Baseline to Week 16 Analysis Using Multiple Imputation Intent-to-Treat Population The LS mean difference in change from baseline Hb to Week 4 and 8 between ACCRUFER and placebo were 0.13 g/dl and 0.46 g/dl, respectively. The mean change in ferritin concentration from baseline to Week 16 was 49.3 mcg/L for the ACCRUFER group and 6.3 mcg/L for the placebo group. Efficacy was assessed based on mean change from baseline to week 12 in Hb (g/dL) (descriptive statistics).
A clinically significant increase in Hb was observed in children 10 years and above receiving ACCRUFER orally twice daily for 12 weeks (see Table 4). The results are presented for the pooled population who received either 15 mg twice daily or 30 mg orally twice daily (based on age). The 15 mg twice daily dose is not approved and not recommended for use.
The recommended dosage of ACCRUFER in pediatric patients aged 10 years and over is 30 mg orally twice daily. Table 4.
| Visit (Week) Statistic | ACCRUFER (N = 64) | Placebo (N =64) | |
|---|---|---|---|
| Baseline | |||
| Mean (SD) | 11.0 (1.03) | 11.10 (0.85) | |
| Mean change from baseline to Week 12 | |||
| LS Mean (SE) | 2.25 (0.12) | 0.06 (0.13) | |
| Treatment Comparison | Difference in Change from Baseline | ||
| LSM Difference (SE) ACCRUFER Placebo) | 1-sided lower 97.5%CI | p-value | |
| ACCRUFER versus placebo | 2.18 (0.19) | (1.81) | <0.0001 |
| Note: Multiple imputation was based on treatment, gender, disease [UC or CD], and Hb concentration at baseline, Week 4, and 8. For each imputed dataset, the change from baseline to Week 12 was analyzed using an ANCOVA model with treatment as the factor and gender, disease, baseline Hb concentration as covariates. | |||
| Visit (Week) Statistic | ACCRUFER (N = 111) | Placebo (N = 56) | |
|---|---|---|---|
| Baseline | |||
| Mean (SD) | 10.06 (0.77) | 10.03 (0.82) | |
| Mean change from baseline to Week 16 | |||
| LS Mean (SE) | 0.50 (0.12) | -0.02 (0.16) | |
| Treatment Comparison | Difference in Change from Baseline | ||
| LSM Difference (SE) ACCRUFER – Placebo | 95% CI | p-value | |
| ACCRUFER versus placebo | 0.52 (0.21) | (0.10, 0.93) | 0.0149 |
| Note: Multiple imputation was based on treatment, gender, eGFR at baseline, and Hb concentration at baseline, Week 4 and 8. For each imputed dataset, the change from baseline to Week 16 was analyzed using an ANCOVA model with treatment as the factor and baseline Hb concentration, baseline eGFR as covariates. | |||
| Endpoint | ACCRUFER 10 to <18 years (N=24) |
|---|---|
| Hb concentrations (g/dL) | |
| Baseline (SD) | 10.73 (0.89) |
| Mean change from baseline to week 12 b | 1.10 (1.06) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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