MONOFERRIC 100 MG — DIN 02477777

What is MONOFERRIC?

MONOFERRIC 100 MG contains IRON (FERRIC DERISOMALTOSE) : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02477777, held by Pfizer Canada Ulc, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 14-Jan-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MONOFERRIC used for?

MONOFERRIC is indicated for the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy. The diagnosis must be based on laboratory tests.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The dose of MONOFERRIC is expressed in terms of mg of elemental iron, with each mL containing 100 mg. The iron dose and administration schedule must be individually established. Clinicians may calculate the cumulative dose based on patient's Hb and body weight using the Simplified Table or Ganzoni formula, or treat with a fixed dose. A single MONOFERRIC infusion should not exceed 20 mg iron/kg body weight, and single doses above 1500 mg are not recommended. For pregnant patients, maximum single dose is 1000 mg and maximum cumulative dose is 2000 mg, confined to gestation week 16 and beyond. For NDD-CKD patients and IDA patients (non-CKD) weighing more than 50 kg, a fixed dose of 1000 mg can be given. For patients weighing less than 50 kg, 20 mg/kg actual body weight should be administered. MONOFERRIC can be administered as an intravenous drip infusion, an intravenous bolus injection, or a direct injection into the venous limb of the dialyzer. Intravenous drip infusion: up to 20 mg iron/kg body weight in a single infusion or weekly infusions. Single doses above 1500 mg are not recommended. If cumulative iron need exceeds 20 mg iron/kg body weight, split into two administrations with at least one week interval. Recommended administration rates: ≤1000 mg over 20 minutes, >1000 mg over 30 minutes. Dilute only in sterile 0.9% sodium chloride solution, not to concentrations less than 1 mg iron/mL, and never in more than 500 mL. Intravenous bolus injection: up to 500 mg once a week at up to 250 mg iron/minute. May be administered undiluted or diluted in maximum 20 mL sterile 0.9% sodium chloride. Injection into dialyzer: directly into the venous limb of the dialyzer during hemodialysis session.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

MONOFERRIC is contraindicated in patients who are hypersensitive to this drug or any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. It is also contraindicated in patients with known serious hypersensitivity to other parenteral iron products, non-iron deficiency anemia (e.g., hemolytic anemia), iron overload or disturbances in utilization of iron (e.g., hemochromatosis, hemosiderosis), and decompensated liver cirrhosis or active hepatitis.

Warnings and precautions

MONOFERRIC is contraindicated in patients with any allergy to this drug or known serious hypersensitivity to other parenteral iron products. Serious hypersensitivity reactions, including life-threatening and fatal anaphylaxis/anaphylactoid reactions, have been reported with intravenous iron products, including MONOFERRIC. Serious cases of hypotension have also been reported. MONOFERRIC should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions, including blood pressure and pulse, during and for at least 30 minutes following each administration. Each IV iron administration is associated with a risk of a hypersensitivity reaction; minimize the number of single IV iron administrations. Excessive therapy can lead to iron overload and iatrogenic hemosiderosis. Do not administer to patients with iron overload. Hypotensive episodes may occur if intravenous injection is administered too rapidly. Parenteral iron should be used with caution in case of severe acute or chronic infection and should not be used in patients with ongoing bacteraemia. There is an increased risk of hypersensitivity reactions in patients with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).