Nuvifer®

Ferric Maltol INN equivalent to elemental Iron 30 mg

Dosage Form: Capsule
Pack Size: 3 X 10's
Composition:

Ferric Maltol INN equivalent to elemental Iron 30 mg.

Description:

Nuvifer® is used to provide supplemental iron to patients with an iron deficiency. It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity. Ferric Maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, 6 in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin.

Pharmacokinetics:

1. Absorption: Nuvifer® dissociates in the gastrointestinal tract, leading to a Tmax of 1.5-3.0 hours for iron concentrations. Mean serum iron increases by 14±6 µmol/L in iron deficient patients following a single dose.
2. Distribution: 60mg dose is approximately 14% bioavailable. 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 18±1% is present in the liver, and 2.6±1% is in the urine. 
3. Metabolism: In vitro, ferric maltol metabolism is predominantly glucuronidation of Maltol by UGT1A6 and sulfation.
4. Elimination: 39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate.Iron and ferric maltol are not excreted in the urine and unabsorbed ferric Maltol is eliminated in the feces

Indications:

Nuvifer® is indicated for the treatment of iron deficiency in adults.

Dosage & Administration:

30 mg twice daily on an empty stomach and continue as long as necessary to replenish body iron stores

The recommended dosage is 30 mg twice daily, taken 1 hour before or 2 hours after a meal. Do not open, break, or chew Nuvifer® 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.

Contraindications:

• 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
• Receiving repeated blood transfusions. Use may result result in iron overload

Warning & Precautions:

1. Increased Risk of Inflammatory Bowel Disease: Avoid use of this drug in patients with an active inflammatory bowel disease, as there is potential risk of increased inflammation in the gastrointestinal tract. The following clinically significant adverse reactions are described elsewhere in the labeling:

• Increased Risk of Inflammatory Bowel Disease
• Iron Overload

Risk of Overdosage in Children Due to Accidental Injestion

Overdose:

No data are available regarding overdose of Nuvifer® 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 Nuvifer® 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 Nuvifer® to patients with iron overload.

Storage Conditions:

Store below 25⁰C. & dry place. Keep away from light and out of the reach of children.

Commercial Pack:

Nuvifer® Capsule: Each pack contains 3x10 capsules in Alu-Alu blister strips.