OROFeR-M30 mg

Ferric maltol is an oral iron replacement therapy indicated for the treatment of iron deficiency in adults (and, per current approved labeling in some regions, adolescents 10 years and older), including in patients with inflammatory bowel disease who have not tolerated or responded adequately to standard oral ferrous iron preparations.

Contains OROFeR-M 30 mg as the active ingredient, available as oral capsules, commonly in 30 mg strength (providing 30 mg elemental iron per capsule).

Ferric maltol is a stable complex of ferric iron and maltol, a naturally occurring flavour compound, developed specifically to overcome the poor tolerability that limits many patients' ability to take standard oral iron supplements. It is used to treat iron deficiency anaemia, and has been studied particularly in patients with inflammatory bowel disease, a population in which iron deficiency is common but standard high-dose ferrous iron preparations are often poorly tolerated or can worsen gut symptoms. Unlike hemochromatosis-related iron overload risk with any iron product, OROFeR-M 30 mg is specifically contraindicated in patients with existing iron overload conditions, and caution is needed during active flares of inflammatory bowel disease.

Therapeutic Class: Oral Iron Replacement Therapy

The maltol component forms a stable complex with ferric iron that keeps the iron in a soluble, biologically available form as it passes through the gastrointestinal tract, allowing uptake onto transferrin and ferritin for use in red blood cell production (haematopoiesis) and iron storage. This design is intended to provide effective iron absorption while causing less gastrointestinal irritation than standard ferrous iron salts.

• Take 1 hour before or 2 hours after a meal, on an empty stomach, since food reduces absorption
• Swallow the capsule whole; do not open, break, or chew it
• Space other medicines apart from OROFeR-M 30 mg, since iron can reduce the absorption of certain other drugs
• If a dose is missed, take it as soon as remembered, unless it is close to the time of the next dose, in which case skip the missed dose

The following should be assessed by a healthcare professional before combining with OROFeR-M 30 mg:

• Other oral medications generally: as with other oral iron products, OROFeR-M 30 mg can reduce the absorption of certain other drugs (such as tetracyclines, fluoroquinolones, levothyroxine, and bisphosphonates) if taken at the same time; space these medicines apart from OROFeR-M 30 mg dosing.
• Antacids and acid-reducing medicines: may reduce iron absorption if taken close together; separate dosing where possible.

Common side effects

• Flatulence
• Diarrhoea or constipation
• Discoloration of stool (dark or black stools - an expected, harmless effect of oral iron)
• Abdominal pain, discomfort, or distension
• Nausea, vomiting

Serious effects (seek medical attention)

• Signs of worsening inflammatory bowel disease: increased abdominal pain, bloody diarrhoea, fever - iron products, including OROFeR-M 30 mg, may be associated with increased IBD activity in some patients; report any such symptoms promptly.
• Signs of a severe allergic reaction: rash, swelling, difficulty breathing.
• Signs of iron overload with inappropriate or excessive use: unusual fatigue, joint pain, abdominal pain, bronze or grey skin discoloration.

Pregnancy

Ferric maltol is absorbed in a way that is not expected to be harmful to a developing baby, and untreated iron deficiency during pregnancy can itself increase the risk of anaemia, premature birth, or low birth weight; the benefit of treating iron deficiency during pregnancy is generally considered to outweigh potential risks, but discuss use with your doctor.

Breastfeeding

Ferric maltol is not expected to pass into breast milk in significant amounts; ask your doctor about use while breastfeeding.

• Avoid during an active flare of inflammatory bowel disease - oral iron, including OROFeR-M 30 mg, is generally avoided during a significant flare, given the risk of worsening gastrointestinal symptoms.
• Use with care in intestinal stricture or diverticular disease, given the general caution with any oral capsule formulation in patients with narrowed or diverticular bowel segments.
• Diagnosis of iron deficiency anaemia should be confirmed by iron studies before starting treatment, and monitored during treatment to assess response and avoid inadvertent iron overload.
• Take on an empty stomach as directed, since food significantly reduces absorption and effectiveness.
• In chronic kidney disease, OROFeR-M 30 mg is not recommended for patients on dialysis or receiving erythropoiesis-stimulating agents or hypoxia-inducible factor prolyl hydroxylase inhibitors - these patients generally require intravenous iron instead.

Iron overdose, including from excessive OROFeR-M 30 mg intake, can be serious, particularly in young children, and may cause nausea, vomiting, abdominal pain, and, in significant overdose, more severe systemic toxicity including metabolic acidosis and organ damage. Suspected significant overdose, especially in a child, is a medical emergency - seek immediate medical attention or contact a poison control center. Keep this medicine securely out of reach of children given the seriousness of iron overdose in this population.

Store at room temperature, away from moisture and heat, as directed on the product label. Keep securely out of reach of children, given the serious risk of iron overdose with accidental ingestion.

• Children under 10 years: Not approved for use in this age group; safety and effectiveness have not been established.
• Adolescents 10 years and older: Approved for use in some regions at the same adult dose, under the supervision of a healthcare professional experienced in managing iron deficiency anaemia.
• Renal impairment: No dose adjustment recommended for an eGFR of 15 mL/min/1.73m² or higher; not recommended for patients on dialysis or receiving certain other anaemia treatments, who generally require IV iron instead.
• Inflammatory bowel disease patients: A key population for this therapy, given its generally better tolerability than standard ferrous iron, though it should be avoided during an active flare.

Treatment duration depends on the severity of iron deficiency, but generally requires at least 12 weeks to adequately replenish iron stores; treatment is continued, and periodically reassessed with blood tests, until ferritin levels are within the normal range, as directed by the treating physician. Clinical trials have shown OROFeR-M 30 mg to be well tolerated for continuous use up to 64 weeks in appropriate patients requiring longer-term maintenance.

Drug Class: Ferric iron-maltol complex

Ferric maltol delivers iron in a chemically stable, soluble form to the gastrointestinal tract, where the iron is taken up and transported onto transferrin in the blood, then used by the bone marrow to produce haemoglobin for new red blood cells, or stored as ferritin. This corrects the underlying iron deficiency responsible for iron deficiency anaemia and its associated symptoms (fatigue, pallor, and reduced exercise tolerance).

Ferric maltol is approved for use in adolescents 10 years and older in some regions, at the same 30 mg twice-daily dose as adults, for treatment of iron deficiency, initiated and monitored under the supervision of a healthcare professional experienced in managing iron deficiency anaemia. It is not approved for children under 10 years.