Monoferric

What is Monoferric?

Monoferric is a prescription iron replacement medicine used to treat iron deficiency anemia in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron
• non-dialysis dependent chronic kidney disease

It is not known if Monoferric is safe and effective for use in children less than 18 years old.

Description

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 6H 5O 73-) X}, (H 20) T, –

(C 6H 10O 6) R(-C 6H 10O 5-) Z(C 6H 13O 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.

Mechanism of Action

Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

Who should not use Monoferric?

Do not receive Monoferric if you are allergic to ferric derisomaltose or any of the ingredients in Monoferric.

See the end of this guide for a complete list of ingredients in Monoferric.

What should I tell my healthcare provider before using Monoferric?

Before receiving Monoferric, tell your healthcare provider about all of your medical conditions, including if you:

• have had an allergic reaction to IV iron
• are pregnant or plan to become pregnant. It is not known if Monoferric will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Monoferric passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Monoferric.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I usee Monoferric?

Monoferric is given into your vein (intravenously) by your healthcare provider over at least 20 minutes.

What are the possible side effects of Monoferric?

Monoferric may cause serious side effects, including:

• Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive Monoferric. Symptoms of an allergic reaction including rash, itching, hives, dizziness, lightheadedness, breathing problems and low blood pressure have also happened during treatment with Monoferric. Tell your healthcare provider right away if you develop any of the above symptoms of a serious allergic reaction or if you have ever had any unusual or allergic reaction to any IV iron in the past.
• Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start and during treatment with Monoferric.

The most common side effects of Monoferric include rash and nausea, chest pain.
These are not all the possible side effects of Monoferric.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Label

100 MG/ML VIAL BOX

• PHARMACOSMOS
• MonoFerric ®
  (ferric derisomaltose) injection
• 100 mg / mL
• FOR INTRAVENOUS INFUSION AFTER DILUTION
  Discard unused portion
  Sterile
  Rx Only
• 5 x 1 mL Single-Dose Vials

PRINCIPAL DISPLAY PANEL – 500 MG/5 ML VIAL BOX

• MonoFerric ®
  (ferric derisomaltose)
  injection
• 500 mg / 5 mL
  (100 mg/mL)
• FOR INTRAVENOUS INFUSION
  AFTER DILUTION
  One single-dose vial
  Discard unused portion
  Sterile
• Rx Only

1000 MG/10 ML VIAL BOX

• MonoFerric ®
  (ferric derisomaltose)
  injection
• 1000 mg / 10 mL
  (100 mg/mL)
• FOR INTRAVENOUS INFUSION
  AFTER DILUTION
  One single-dose vial
  Discard unused portion
  Sterile
• Rx Only

10 ML VIAL SINGLE DOSE

General information about the safe and effective use of Monoferric

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. You can ask your pharmacist or healthcare provider for information about Monoferric that is written for health professionals.

What are the ingredients in Monoferric?

Active ingredient: ferric derisomaltose

Inactive ingredients: water for injection