Ferric Derisomaltose

Ferric Derisomaltose is a prescription medication used for the treatment of Iron Deficiency Anemia.

• Ferric Derisomaltose is available under the following different brand names: Monoferric.

Common side effects of Ferric Derisomaltose include:

• Rash, and
• Nausea

Serious side effects of Ferric Derisomaltose include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat, and
• Dizziness

Rare side effects of Ferric Derisomaltose include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 100 mg elemental iron/mL (1-mL5-mL10-mL single-dose vials)

Iron Deficiency Anemia

Adult dosage

• Below 50 kg: 20 mg/kg actual body weight Intravenous infusion
• Above 50 kg: 1000 mg intravenous infusion
• Repeat dose if iron deficiency anemia reoccurs,

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ferric Derisomaltose has no noted severe interactions with any other drugs.
• Ferric Derisomaltose has no noted serious interactions with any other drugs.
• Ferric Derisomaltose has no noted moderate interactions with any other drugs.
• Ferric Derisomaltose has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Hypersensitivity to Ferric Derisomaltose or any of its components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ferric Derisomaltose?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ferric Derisomaltose?”

Cautions

• Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, were reported.
• Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis; monitor hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during therapy; do not administer to patients with iron overload.

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Published studies on the use of IV iron products in pregnant women have not reported an association with adverse developmental outcomes; these studies cannot exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess the risk of major birth defects.
  • Clinical considerations
  • Untreated iron deficiency anemia in pregnancy is associated with adverse maternal outcomes (. g, postpartum anemia)
  • Adverse pregnancy outcomes associated with iron deficiency anemia include increased risk for preterm delivery and low birth weight.
  • Risks to the fetus associated with maternal severe hypersensitivity reactions.
  • Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products which may cause fetal bradycardia, especially during the second and third trimesters.
• Lactation
  • Available data on use in lactating women demonstrate that iron is present in breast milk.
  • Data do not inform the potential exposure of iron for the breastfed child or the effects on milk production.
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or the underlying maternal condition.
  • Clinical considerations
    • Monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea)