Monoferric

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For patients weighing 50 kg or more:
• Administer 1,000 mg of Monoferric as an intravenous infusion.
• For patients weighing less than 50 kg:
• Administer Monoferric as 20 mg/kg actual body weight as an intravenous infusion.
• Repeat Monoferric treatment if iron deficiency anemia reoccurs.
• ( 2 )
• 2.1 Recommended Dosage For patients weighing 50 kg or more:
• Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose.
• Repeat dose if iron deficiency anemia reoccurs.
• For patients weighing less than 50 kg:
• Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose.
• Repeat dose if iron deficiency anemia reoccurs.
• The dosage of Monoferric is expressed in mg of elemental iron.
• Each mL of Monoferric contains 100 mg of elemental iron.
• Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions ( Warnings and Precautions (5.1) ) .
• 2.2 Preparation and Administration Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.
• The product contains no preservatives.
• Each vial of Monoferric is single-dose only.
• Discard unused portion.
• Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Monoferric with other drugs has not been established.
• Monoferric should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored at room temperature for up to 8 hours.
• Extravasation of Monoferric may cause brown discoloration at the extravasation site which may be long lasting.
• Monitor for extravasation.
• If extravasation occurs, discontinue the Monoferric administration at that site.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 3934 patients in clinical studies of Monoferric, 29% were 65 years and over, while 13% were 75 years and over.
• No overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
• Hypersensitivity Reactions (see Warnings and Precautions (5.1) ) .
• Iron Overload (see Warnings and Precautions (5.2) ) .
• Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
• The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials.
• Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores.
• Eligible subjects were required to have a baseline hemoglobin of ≤11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL.
• Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia ( see Clinical Studies (14) ).
• Eligible subjects also had to have serum ferritin ≤100 ng/mL or ≤300 ng/mL if TSAT ≤30%.
• Trial 1 and Trial 2 In the two randomized, actively-controlled clinical trials, Trial 1 and Trial 2 (see Clinical Studies (14) ) , patients were randomized in a 2:1 ratio to intravenous Monoferric (n = 2008) or intravenous iron sucrose (n = 1000) respectively.
• Monoferric was administered as a single intravenous infusion of 1000 mg diluted in 100 mL 0.9 % sodium chloride and given over approximately 20 minutes (approximately 50 mg iron/min).
• Iron sucrose was administered as 200 mg undiluted intravenous injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times (1000 mg) within the first two weeks starting at baseline.
• The data described below reflect exposure to Monoferric in 2008 patients exposed to a 1000 mg single intravenous dose of Monoferric.
• The mean cumulative intravenous Iron exposure was 984 mg.
• Trial 1 included 1483 patients with iron deficiency anemia in the safety analysis that had intolerance to oral iron or have had unsatisfactory response to oral iron or with a clinical need for rapid repletion of iron stores.
• Trial 2 included 1525 patients in the safety analysis who had non-dialysis dependent CKD.
• The mean (SD) age of the combined study population was 56.4 (18.3) years.
• The majority of patients were women (75.7%).
• Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric.
• Adverse reactions related to treatment and reported by ≥1% of the treated patients in the combined analysis of Trial 1 and 2 are listed in Table 1.
• Table 1.
• Adverse Reactions (≥1%) in Patients Receiving Monoferric in Clinical Trials 1 and 2 Monoferric (N = 2008) N (%) Iron sucrose (N = 1000) N (%) Adverse Reaction Nausea 24 (1.2) 11 (1.1) Rash 21 (1) 1 (0.1) Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group.
• Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.
• 6.2 Post-marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The following adverse reactions have been most commonly reported from the post-marketing spontaneous reports with Monoferric:
• Cardiac disorders:
• Tachycardia Gastrointestinal disorders:
• Abdominal pain, nausea and vomiting, constipation, diarrhea General disorders and administration site conditions:
• Fatigue, pyrexia, chest pain, chills, Fishbane reaction, extravasation, influenza like symptoms, injection site reactions, malaise, pain Immune System disorders:
• Anaphylactic/anaphylactoid reaction, hypersensitivity Investigations:
• Hepatic enzymes increased Musculoskeletal and connective tissue disorders:
• Back pain, muscle spasms, arthralgia, myalgia Nervous system disorders:
• Dizziness, headache, paresthesia, dysgeusia, seizure, loss of consciousness, syncope Psychiatric disorders:
• Anxiety Respiratory, thoracic and mediastinal disorders:
• Dyspnea, cough, bronchospasm Skin and subcutaneous tissue disorders:
• Erythema, urticaria, discoloration skin, rash, pruritus, skin exfoliation, angioedema, sweating Vascular disorders:
• Hypertension, hypotension, flushing, phlebitis Extravasation of Monoferric at the injection site that may lead to irritation of the skin and potentially long lasting brown discoloration at the site of injection has also been reported.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Prior History of Allergies to Parenteral Iron Products Question patients regarding any prior history of reactions to parenteral iron products (see Warnings and Precautions (5.1) ) .
• Hypersensitivity Reactions Advise patients to report any signs and symptoms of hypersensitivity that may develop during and following Monoferric administration, such as rash, itching, dizziness, lightheadedness, swelling and breathing problems (see Warnings and Precautions (5.1) ) .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Monoferric is a sterile, dark brown, non-transparent aqueous solution available as:
• Injection:
• 1,000 mg iron/10 mL (100 mg/mL) single-dose vial Injection:
• 500 mg iron/5 mL (100 mg/mL) single-dose vial Injection:
• 100 mg iron/mL single-dose vial Injection:
• 1,000 mg iron /10 mL (100 mg/mL) single-dose vial ( 3 ) Injection:
• 500 mg iron/5 mL (100 mg/mL) single-dose vial ( 3 ) Injection:
• 100 mg iron/mL single-dose vial ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Monoferric injection is a sterile, dark brown, non-transparent aqueous solution supplied in cartons as single-dose vials (10 mL, 5 mL or 1 mL) in the following configurations:
• Vial size Number of vials per carton NDC 1,000 mg/10 mL 1 73594-9310-1 500 mg/5 mL 1 73594-9305-1 100 mg/mL 5 73594-9301-2
• Storage and Handling
• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• See the USP controlled room temperature.
• Do not freeze.
• When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.

Quoted from the official label, section “How Supplied”.

How to store it

• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• See the USP controlled room temperature.
• Do not freeze.
• When added to an infusion bag containing 0.9% Sodium Chloride Injection, USP, Monoferric solution may be stored for up to 8 hours at room temperature.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion.
• Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose.
• Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
• Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:
• {FeO (1-3X) (OH) (1+3X) (C 6 H 5 O 7 3- ) X }, (H 2 0) T , - (C 6 H 10 O 6 ) R (-C 6 H 10 O 5 -) Z (C 6 H 13 O 5 ) R , (NaCl) Y X = 0.0311;
• T = 0.25;
• R = 0.14;
• Z = 0.49;
• Y =
• 0.14 Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules.
• A schematic representation is presented below Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.
• Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection, hydrochloric acid and sodium hydroxide may be used to adjust pH.
• Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Ferric Derisomaltose