What is Monoferric?
Monoferric (ferric derisomaltose) is a prescription iron treatment given through a vein (IV) to treat iron deficiency anemia in adults who:
- cannot tolerate oral iron or who have not responded well to treatment with oral iron
- have non-dialysis dependent chronic kidney disease
IMPORTANT SAFETY INFORMATION
Who should not receive Monoferric?
Do not receive Monoferric if you have had serious allergic reactions to ferric derisomaltose or any of its ingredients.
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.
These are not all the possible side effects of Monoferric. Call your doctor for medical advice about side effects.
What should I tell my doctor or healthcare provider before receiving Monoferric?
Before receiving Monoferric, tell your healthcare provider about all 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. Untreated iron deficiency anemia during pregnancy may increase risks for you and your baby.
- are breastfeeding or plan to breastfeed. Data from women treated with Monoferric show that iron is present in breast milk. It is not known how Monoferric may affect your breastfed baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information including information for patients.
IMPORTANT SAFETY INFORMATION
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.
What is Monoferric?
Monoferric (ferric derisomaltose) is a prescription iron treatment given through a vein (IV) to treat iron deficiency anemia in adults who:
- cannot tolerate oral iron or who have not responded well to treatment with oral iron
- have non-dialysis dependent chronic kidney disease
IMPORTANT SAFETY INFORMATION
Who should not receive Monoferric?
Do not receive Monoferric if you have had serious allergic reactions to ferric derisomaltose or any of its ingredients.
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.
These are not all the possible side effects of Monoferric. Call your doctor for medical advice about side effects.
What should I tell my doctor or healthcare provider before receiving Monoferric?
Before receiving Monoferric, tell your healthcare provider about all 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. Untreated iron deficiency anemia during pregnancy may increase risks for you and your baby.
- are breastfeeding or plan to breastfeed. Data from women treated with Monoferric show that iron is present in breast milk. It is not known how Monoferric may affect your breastfed baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information including information for patients.
