16/19. Ferric Maltol- (ACCRUFER)-@- (July 2019)- 2019)- Iron deficiency Anemia
Drug Name:16/19. Ferric Maltol- (ACCRUFER)-@- (July 2019)- 2019)- Iron deficiency Anemia
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
• Dimercaprol: Avoid concomitant use.
• Oral Medications: Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate.
DRUG INTERACTIONS
The following information is based upon published case reports and clinical studies that could not be confirmed by an adequately controlled study with ACCRUFER, but still warrant consideration given the potential risks involved with iron products.
1. 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.
2. 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 There are no empirical data on avoiding drug interactions between ACCRUFER and concomitant oral medications.
Concomitant use of ACCRUFER may decrease the bioavailability of some drugs.
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.
Indication:
WARNINGS- • IBD flare: Avoid use in patients with IBD flare • Iron overload: Accidental overdose of iron products is a leading cause of fatal poisoning in children under 6.
Adverse Reactions- Advise patients that may cause, flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting or abdominal bloating or discomfort.
Adverse Reaction:
ADVERSE REACTIONS
Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension.
Contra-Indications:
CONTRAINDICATIONS
• Hypersensitivity to the active substance or any excipient • Hemochromatosis and other iron overload syndromes • Patients receiving repeated blood transfusions
WARNINGS AND PRECAUTIONS
• IBD flare: Avoid use in patients with IBD flare
• Iron overload: Accidental overdose of iron products is a leading cause of fatal poisoning in children under 6.
Keep out of reach of children.
Dosages/ Overdosage Etc:
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dosing Recommendations
Inform patients to take ACCRUFER as directed on an empty stomach, at least 1 hour before or 2 hours after meals. Instruct patients on concomitant medications that should be dosed apart from ACCRUFER
Adverse Reactions
Advise patients that ACCRUFER may cause, flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting or abdominal bloating or discomfort.
Advise patients to report severe or persistent gastrointestinal symptoms or any allergic reactions to their physician
Increased Risk of IBD Flare
Advise patients that they should not use ACCRUFER if they are experiencing an IBD flare
Iron Overload and Risk of Accidental Overdose in Children
Inform patients to keep this product out of reach of children as accidental over dose of iron products is a leading cause of fatal poisonings in children.
In case of accidental overdose, advise them to call a doctor or poison control center immediately
Patient Information
ACCRUFERTM (ak-roo-fer) (ferric maltol) capsules
What is ACCRUFER?
ACCRUFER is a prescription medicine used in adults to treat low iron stores in your body.
It is not known if ACCRUFER is safe and effective for use in children.
Do not take ACCRUFER if you: • are allergic to ferric maltol or any of the ingredients in ACCRUFER. See the end of this leafelet for a complete list of ingredients in ACCRUFER.
• have any illness that causes you to store too much iron in your body or if you have a problem with how your body uses iron.
• are receiving repeated blood transfusions.
Before taking ACCRUFER, tell your healthcare provider about all your medical conditions, including if you:
• have inflammatory bowel disease (IBD).
• are pregnant or plan to become pregnant.
It is not known if ACCRUFER will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ACCRUFER passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ACCRUFER.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking ACCRUFER with certain other medicines may affect each other causing serious side effects.
Some medicines may need to be taken at least 4 hours before or 4 hours after you have taken your ACCRUFER dose.
Ask your healthcare provider for a list of these medicines if you are not sure if you take one of these medicines.
Especially tell your healthcare provider if you take:
• dimercaprol
• other oral iron tablets or health supplements containing iron Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.
2.Pharmacodynamics
ACCRUFER has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT).
3.Pharmacokinetics
The pharmacokinetic properties of serum iron after administration of ACCRUFER was assessed in subjects with iron deficiency (with or without anemia) following a single dose and at steady state (after 1 week) of ACCRUFER 30 mg, 60 mg, or 90 mg twice daily (1 to 3 times the approved recommended dosage
Total serum iron concentrations increase in a less than dose proportional manner with increasing ACCRUFER doses.
Absorption
ACCRUFER dissociates upon uptake from the gastrointestinal tract allowing iron and maltol to be absorbed separately. Total serum iron peak values were reached 1.5 to 3 hours after administration of ACCRUFER, and were comparable between Day 1 and Day 8.
Effect of Food
Food has been shown to decrease the bioavailability of iron after administration of ferric maltol.
Drug Interaction Studies
No clinical studies evaluating the drug interaction potential of ACCRUFER have been conducted.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy 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
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.
2. Lactation 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.
3.Pediatric Use
Safety and effectiveness of ACCRUFER have not been established in pediatric patients.
4.Geriatric Use
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.
OVERDOSAGE
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