MonoFer

MonoFer

Manufacturer:

Pharmacosmos

Distributor:

DCH Auriga

Marketer:

Compai Pharma
Concise Prescribing Info
Contents
Ferric derisomaltose
Indications/Uses
Fe deficiency in adult when oral Fe prep is ineffective or cannot be used; where there is a clinical need to deliver Fe rapidly.
Dosage/Direction for Use
IV Fe deficiency Individualized dose. Determine cumulative Fe need (Ganzoni formula is recommended for patient w/ anorexia nervosa, cachexia, obesity, pregnancy or anaemia due to bleeding). Patient weighing ≥70 kg w/ Hb ≥100 g/L 1,500 mg, Hb <100 g/L 2,000 mg. Patient weighing 50 to <70 kg w/ Hb ≥100 g/L 1,000 mg, Hb <100 g/L 1,500 mg. IV bolus inj Max: 500 mg at administration rate up to 250 mg/min, up to 3 times wkly. IV drip infusion Max: 20 mg/kg single infusion. Cumulative Fe dose >20 mg/kg: Split in 2 administrations w/ at least 1-wk interval; give 20 mg/kg in the 1st administration whenever possible. Doses ≤1,000 mg: Administer over 20 min. Doses >1,000 mg: Administer ≥30 min.
Contraindications
Hypersensitivity. Known serious hypersensitivity to other parenteral Fe products. Non-Fe deficiency anaemia (eg, haemolytic anaemia). Fe overload or utilization disturbances (eg, haemochromatosis, haemosiderosis). Decompensated liver cirrhosis, active hepatitis.
Special Precautions
Hypersensitivity including serious & potentially fatal anaphylactic reactions; enhanced risk for patients w/ multi allergies (including drug allergies), history of severe asthma, eczema or other atopic allergies, immune or inflammatory conditions (eg, SLE, RA). Observe patients for ARs for at least 30 min following each inj. Immediately discontinue if hypersensitivity reactions or intolerance signs occur. Not recommended to be given in single IV drip infusion doses >1,500 mg. Acute or chronic infection, asthma, eczema or atopic allergies. Discontinue use in patients w/ ongoing bacteraemia. Perform a risk/benefit evaluation in patients w/ chronic infection. Avoid paravenous leakage when administrating; may lead to skin irritation & potentially long-lasting brown discoloration at the inj site; immediately discontinue in case of paravenous leakage. May cause falsely elevated serum bilirubin values & falsely decreased serum Ca values. Patients w/ compensated liver dysfunction. Avoid in patients w/ hepatic dysfunction (ALT &/or AST >3 x ULN) where Fe overload is a precipitating factor particularly in porphyria cutanea tarda. Carefully monitor Fe status to avoid Fe overload. Pregnancy & lactation. Not recommended for childn & adolescents <18 yr. Carefully perform risk/benefit assessment prior to use & closely monitor for adverse events in patients >65 yr.
Adverse Reactions
Drug Interactions
Reduced oral Fe absorption; do not start oral Fe therapy <5 days after the last inj. Possible brown-colored serum from a blood sample drawn 4 hr after large doses of parenteral Fe administration (≥5 mL).
MIMS Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Presentation/Packing
Form
MonoFer soln for inj/infusion 100 mg/mL
Packing/Price
5 mL x 5 × 1's
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