Myofer

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Myofer

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Myofer

Quick Facts: Myofer (Iron Dextran)

Property Description
Active Ingredient Iron Dextran Complex
Form Sterile Injectable Solution
Pharmacological Class Hematinic, Parenteral Iron Supplement
General Purpose Iron replenishment to support hemoglobin production
Origin Synthetic colloidal complex

What is Myofer and What Class of Drug is it?

Myofer is a prescription-only medicine containing the active ingredient Iron Dextran Complex, classifying it as a Parenteral Iron Supplement within the pharmacological group of Hematinics. This medicinal entity is a specialized synthetic colloidal complex where the inorganic iron is chemically bound and stabilized by the polysaccharide dextran. The complex structure is key to its delivery method.

Iron Dextran is an iron replacement therapy intended for use when the oral route is ineffective or impractical. This affirms the medicine's role when there is a recognized clinical need for reliable iron delivery that bypasses the limitations of the digestive system. The physical form is a sterile injectable solution, which dictates its definitive route of delivery via injection.

What is the General Purpose of This Iron Supplement?

The overall purpose of Myofer is to facilitate reliable and efficient iron replenishment when an individual is clinically diagnosed with severe iron deficiency, often due to issues that prevent successful oral treatment. By supplying a readily available source of iron directly to the system, the medicine supports the necessary biological process of producing hemoglobin.

Iron is an essential component of hemoglobin, which carries oxygen from the lungs throughout the body. The benefit lies in correcting the mineral imbalance underlying iron-deficiency anemia, thereby helping to restore the body’s essential oxygen transport function, a process clinically recognized as vital for energy metabolism and overall health.

Regulatory References

  1. NIH Iron Fact Sheet for Health Professionals
  2. NIH Iron Fact Sheet

What side effects are possible with Myofer?

Myofer: Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of Myofer (Mycophenolic Acid) based primarily on risks associated with its immunosuppressive effects. Adverse reactions are grouped by frequency and affected System-Organ Class (SOC), with Infections and Blood and Lymphatic System Disorders being major categories.


Frequency-Classified Adverse Reactions

The most commonly documented adverse events are in the Very Common (ge 1/10) category, which includes viral, bacterial, and fungal infections, leukopenia (low white blood cell count), and diarrhoea. Reactions classified as Common (ge 1/100 to < 1/10) include anaemia, thrombocytopenia, nausea, vomiting, and hypertension.


Serious Adverse Reactions

The use of this medication carries a documented risk of serious opportunistic infections, which can be fatal, such as Progressive Multifocal Leukoencephalopathy (PML) and sepsis. Treatment is also associated with an increased incidence of lymphomas and other malignancies, especially non-melanoma skin carcinomas. Severe gastrointestinal events, including ulceration, haemorrhage, and perforation, are also listed.


Population-Specific Safety Considerations and Restrictions

Official labeling defines significant safety constraints for specific groups. The medicine is associated with a high risk of pregnancy loss (miscarriage) and congenital malformations if used during pregnancy. Caution is advised for patients with severe renal impairment or those with active serious digestive system disease. Use is formally contraindicated in patients with a rare inherited deficiency of HGPRT (Lesch-Nyhan/Kelley-Seegmiller syndromes). The risks of overall immunosuppression are related to the intensity and duration of the treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Myofer (mycophenolic acid) may result in the exaggerated manifestation of known effects. Documented clinical signs primarily involve the gastrointestinal system, including severe stomach pain, nausea, vomiting, heartburn, and diarrhea. A critical outcome noted in regulatory documents is the appearance of signs of infection, such as fever, sore throat, chills, and cough, due to the medicine's immunosuppressive nature.


Official Management and Considerations

Treatment for overexposure is required to be symptomatic and supportive. Regulatory information states that no specific antidote is known for mycophenolic acid. Furthermore, hemodialysis is unlikely to remove clinically significant amounts of the active ingredient. A specific consideration exists for patients with severely impaired renal function or anuria, who may experience a markedly increased exposure to the inactive metabolite (MPAG).


Mandated Emergency Action

Immediate medical attention is required upon the suspicion of an overdose or the manifestation of any severe symptoms or signs of infection. Officially documented guidance mandates that patients contact emergency services or a Poison Control Center without delay.

Therapeutic Uses of Myofer

Quick Facts: Myofer Uses

Therapeutic Domain Purpose
Kidney Transplant May help with the prophylaxis of organ rejection
Pediatric Kidney Transplant Prescribed for specific pediatric patients at least six months post-transplant

What Myofer Treats: Main Uses and Benefits

Myofer (mycophenolic acid) is a prescription medication used to manage certain immune responses following a kidney transplant. The primary role of this medication is to assist in the prophylaxis of organ rejection in adult patients who have received a kidney transplant. Prophylaxis, in this context, refers to managing the risk of the body's natural defense system from rejecting the new organ.

This medicine is typically prescribed as part of a combination regimen that includes other immunosuppressant agents, such as cyclosporine and corticosteroids. Using Myofer as part of a medical regimen may help to reduce the incidence of organ rejection. It is also used in specific pediatric patients five years of age and older who are at least six months post-kidney transplant, to support the same objective.

It is important that patients consult with a qualified physician experienced in immunosuppressive therapy, as treatment with Myofer requires careful management and monitoring.

Eligibility and Restrictions for Use

Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults who have received an allogeneic kidney transplant.
  • Pediatric patients ge 5 years of age who are at least six months post-kidney transplant.

Populations for whom use is contraindicated:

  • Patients with a known history of hypersensitivity to mycophenolic acid or any component of the formulation.
  • Pregnant women and women of childbearing potential not using highly effective contraception.
  • Breastfeeding women.

Age-related eligibility rules:

  • Use in children younger than 5 years of age is not established by regulatory documents.
  • Older adults (ge 65 years) do not require specific dose adjustments but may have increased susceptibility to adverse reactions.

Condition-specific eligibility rules:

  • Use is not recommended in patients with a rare hereditary deficiency of HGPRT (e.g., Lesch-Nyhan syndrome).
  • Use requires caution in patients with active severe gastrointestinal disease.
  • Use may require interruption or dose reduction if a patient develops significant neutropenia (a blood disorder).

Connection to the overall eligibility profile: Regulatory documents define Myofer eligibility by establishing absolute prohibitions based on reproductive status and hypersensitivity, classifying these as contraindications. Permissible use is officially limited to adult and age-restricted pediatric kidney transplant recipients receiving concomitant immunosuppression. Specific conditions like HGPRT deficiency or active GI disease impose defined restrictions on use, as specified in the medicine's official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures Myofer's interaction profile around pharmacokinetic interference and pharmacodynamic addition. The primary constraint is managing substances that alter the plasma concentration of the active component, Mycophenolic Acid (MPA).

Pharmacokinetic Interaction Constraints

Mechanism Interacting Substances Regulatory Restriction
Reduced Absorption Antacids (Magnesium/Aluminum) Must be administered at least two hours apart.
Enterohepatic Interference Cholestyramine, Telmisartan Co-administration is generally advised against.
Renal Excretion Competition Ganciclovir, Acyclovir Leads to increased plasma concentrations of both medicines.
Enzyme Induction (UGT) Rifampin, St. John's Wort May significantly reduce MPA exposure.

Pharmacodynamic and Other Constraints

Pharmacodynamic Addition: Co-administration with other immunosuppressive or myelosuppressive agents, such as Azathioprine, may result in an additive risk of hematological toxicity.

Vaccines: Use with live attenuated vaccines is cautioned against, as the immunosuppressive nature of Myofer may result in a diminished immune response.

Oral Contraceptives: Myofer co-administration can reduce the systemic exposure (AUC) of the progestin component (e.g., Levonorgestrel).

Mechanism of Action

How Myofer Works: Mechanism of Action


Molecular Target and Enzyme Modulation

Myofer acts by precisely modulating specific receptor or enzyme systems on the cellular level. It initiates its effect cascade through a highly selective interaction with these targets, either blocking an overactive component or adjusting its binding affinity. This foundational step translates the drug's presence into a focused biological signal, modifying the initiation of cellular signaling sequences.

Dampening Dysregulated Signal Transduction

The molecular action results in the dampening of key signal transduction pathways associated with heightened physiological responses. Myofer modifies early molecular steps in these cascades, interrupting the amplification of abnormal signals and influencing the signal transduction flux within the targeted systems. This systemic interference is relevant for the modulation of processes driven by distinct, overactive signaling patterns.

System-Level Activity Adjustment

The effect on molecular pathways ultimately results in changes to systemic activity patterns within central or peripheral biological systems. Myofer engages mechanisms that influence feedback regulation, modifying the effects of excessive mediator activity and adjusting heightened physiological responses, resulting in specific physiological adjustments dictated by the mechanism.

Dosage and Administration Information

How Myofer is Used

Myofer (Mycophenolic Acid) is administered via the oral route using a specific delayed-release tablet formulation, which is available in 180 mg and 360 mg strengths. This medicine is intended for continuous, long-term maintenance therapy as part of an immunosuppressive regimen following a kidney transplant.

The standard adult dosing regimen is 720 mg taken twice daily (BID), establishing a total daily dose of 1,440 mg. The therapy is typically initiated shortly after the transplant procedure, usually within 72 hours.

Procedural Requirements

For proper administration, the tablets must be taken on an empty stomach. This is generally defined as one hour before or two hours after consuming food. It is a critical procedural requirement that the tablets be swallowed whole and must not be crushed, chewed, or cut. Breaking the tablet compromises the integrity of the gastro-resistant coating, which is essential for controlled release.

Population-Specific Dosing

Dosage adjustments are provided for certain patient groups. For pediatric patients (age five years and older who are at least six months post-transplant), dosing is calculated based on body surface area (BSA) at 400 mg/m² twice daily, with the total daily dose capped at 1,440 mg. Furthermore, in cases of severe renal impairment (GFR less than 25 mL/min/1.73 m^2), the maximum total daily dose should not exceed 1,440 mg.

Recent Clinical Evidence

Research evidence / Overview of studies for Myofer


Evidence for use in Adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)

Myofer was studied for adults with B-cell ALL, a condition characterized by periods of heightened symptoms. The research mainly examined single-arm Phase I/II trials where Myofer was the focus of the study. Studies monitored outcomes related to systemic or functional imbalance, such as leukemia cell presence (minimal residual disease) and how symptoms evolved over short defined time intervals.

The findings describe patterns observed in the studies, including the proportion of patients who achieved a complete response. Research highlights changes measured during the study period. The data show patterns related to certain adverse events that were monitored in the studies, some of which were classified as serious. Overall, evidence is limited to small, heavily pre-treated populations. Long-term effects are not fully established, and comparative evidence is lacking.


Evidence for use in Pediatric and young adult patients with relapsed/refractory B-cell ALL

This section will detail the findings from studies conducted specifically in the pediatric and young adult population with relapsed or refractory B-cell ALL.

Myofer was evaluated in research for children and young adults (often up to age 26). The studies monitored outcomes reflecting daily functioning or activity level and measured response rates. Studies report how symptoms evolved in the observed populations, with findings suggesting that some patients achieved a complete remission. Reports included observations of certain adverse events. The sample sizes were modest, and evidence quality varies across studies due to the early phase of the research.


What is still uncertain about Myofer

Sample sizes were modest, and evidence quality varies across studies. Comparative evidence is lacking. The approach to managing side effects, particularly serious ones, has been a topic that research continues to explore across different clinical settings. Evidence highlights what is known — and what is still uncertain.

Frequently Asked Questions (FAQ)

Common questions about Myofer (FAQ)

Q: What are the most common things people feel right after the Myofer infusion?

Official information indicates that immediate reactions, which can occur during or shortly after the infusion, may include sensations like flushing, rash, nausea, or dizziness. Other transient feelings commonly reported right after treatment include facial flushing, back pain, and a feeling of chest oppression.

Q: Is it common to feel tired the day after the Myofer treatment?

Regulatory information notes that some adverse reactions may be delayed, manifesting one to two days after the treatment is complete. These delayed effects may include general feelings of malaise (discomfort), fatigue (tiredness), and headache.

Q: Can Myofer cause long-term side effects?

Regulatory documents state that prolonged or excessive use of this medicine may lead to excess iron storage in the body, a condition known as hemosiderosis. The official label also notes that repeated administration of iron-carbohydrate complexes has been associated with a theoretical risk of carcinogenesis in animal studies, and this risk is noted in official documentation.

Q: Does Myofer interact with common pain relievers like Tylenol or Advil?

Official drug labels generally do not list direct chemical interactions between this iron product and common pain relievers like acetaminophen (Tylenol) or ibuprofen (Advil). However, for patients with existing stomach or bowel issues, the official prescribing information notes a caution regarding the concurrent use of NSAIDs (like Advil) because they carry their own risk of gastrointestinal bleeding.

Q: What is the total time needed for a typical Myofer infusion appointment?

The time required for the actual Myofer infusion typically ranges from one to four hours, depending on the total required dose being given. Official safety guidelines recommend that patients are monitored for at least 30 minutes after the infusion is finished to watch for any signs of an immediate hypersensitivity reaction.

Q: Does Myofer affect blood sugar levels?

Official information suggests that intravenous iron products may affect the measurement of long-term blood sugar control, such as the HbA1c test, due to the increased formation of new red blood cells. However, acute infusion of the iron product has not been shown to impair the body's short-term insulin response.

Q: Can I drive after getting the Myofer infusion?

The medicine is associated with adverse reactions that affect the central nervous system, including dizziness, low blood pressure (hypotension), and rarely, loss of consciousness (syncope). Official documents describe these potential effects and recommend considering them before performing activities like driving or operating machinery.

Q: How long does the effect of a Myofer treatment typically last?

Studies and official documents show that levels of ferritin (which measures iron storage) typically remain elevated for at least four weeks or longer after administration. The duration of the therapeutic benefit regarding symptom improvement is understood to vary significantly by individual.

Q: Why is Myofer given as an IV infusion instead of a shot?

The product is formulated as a complex requiring a parenteral (non-oral) route to overcome the limits of digestive absorption. Intravenous (IV) infusion is often preferred over a simple intramuscular (IM) shot because IM use carries a high risk of skin staining and may lead to a greater chance of adverse reactions when large doses are given.

Q: Is it possible to receive too much iron from Myofer?

Yes, it is possible for excessive therapy with parenteral iron to lead to a condition called iatrogenic hemosiderosis, which is the excess storage of iron. This potential risk is why regulatory documents specify that all patients must undergo periodic monitoring of their iron levels.

Q: Can Myofer affect the results of other blood tests?

Official information indicates that the medicine can affect certain laboratory test results. For instance, high doses may cause a brown color to the serum and can lead to falsely high results for serum bilirubin or falsely low results for serum calcium. Serum iron measurements, specifically, may not be reliable for up to three weeks after administration.

Q: Can Myofer be used by people with certain liver conditions?

Official prescribing information describes the need for extreme care when the medicine is used in patients who have a serious impairment of liver function. This caution is in place due to how the body processes iron and potential toxicity risks.

Q: Does Myofer have a black box warning in the US?

Yes, official documents for Iron Dextran products in the U.S. include a Food and Drug Administration (FDA) Boxed Warning. This is the strongest type of warning the FDA requires and concerns the risk of anaphylactic-type reactions, including fatalities, following parenteral administration.

Q: What are the ingredients of Myofer besides the active component?

Regulatory documents list the active ingredient as Iron Dextran Complex. Other inactive ingredients (excipients) typically include Water for Injection and often small amounts of sodium chloride and/or pH adjusters like hydrochloric acid or sodium hydroxide.

Q: Is the Myofer infusion painful?

The infusion itself is not commonly listed as a source of pain, but a complication called extravasation can occur. Extravasation, which is when the solution leaks out of the vein, can cause pain and long-lasting brown discoloration at the injection site.

Q: Does Myofer interact with common blood pressure medications?

Official prescribing information notes a potential interaction with a certain class of blood pressure medications called Angiotensin-Converting Enzyme (ACE) inhibitors. Concomitant use of Myofer with ACE inhibitors may increase the risk of a serious hypersensitivity reaction to the iron product.

Q: Is it described that Myofer can cause changes in taste?

Yes, regulatory documents list a change in taste, medically termed dysgeusia (an alteration in taste), as a reported adverse reaction associated with the use of this medicine.

Q: Can Myofer be given in an outpatient clinic setting?

Official administration guidelines state that the medicine can be given in an outpatient or clinic setting, provided that specific safety precautions are met. It must only be administered where medical personnel and all necessary treatments for serious hypersensitivity reactions are immediately available.

Q: Is Myofer considered a biologic drug?

No, the medicine is not classified as a biologic drug. It is officially described as a Parenteral Iron Supplement and a synthetic colloidal complex, which falls under the pharmacological group of Hematinics.

Q: Can Myofer be given to a person with a history of iron overload?

Official documents state that the medicine is contraindicated (should not be used) in patients who show evidence of iron overload. This includes conditions like hemosiderosis or hemochromatosis, as administering more iron can worsen the existing overload.

Q: What is the typical monitoring process after a Myofer infusion?

Official safety guidelines require that patients are monitored for signs of a hypersensitivity reaction for a minimum of 30 minutes after the infusion is completed. For the long-term safety of the patient, hematologic and iron storage levels require periodic monitoring.

Q: Is there a maximum number of Myofer doses a person can receive?

Official dosing is based on a calculation of the patient's total iron deficit, which considers the patient’s body weight and hemoglobin level. The calculated total iron required dictates the total number of doses administered. The official prescribing information also states that the daily volume administered generally should not exceed 2 mL.

Q: What are the official guidelines for treating infusion-related reactions to Myofer?

Regulatory guidance requires that the medicine be administered only in settings where all equipment and treatments necessary for anaphylactic shock (such as epinephrine) are immediately available. If a severe hypersensitivity reaction begins, the administration must be stopped immediately, and the reaction must be managed medically.

How should Myofer be stored and disposed of?

How to Store and Dispose of Myofer

Storage Conditions: Myofer (iron isomaltoside 1000) must be stored in its original container and be protected from light. The required temperature is controlled room temperature, specifically between 20 C and 25 C ( 68 F to 77 F). The product must not be frozen and should be kept out of the reach of children.

Handling and Stability: The vial is for single-dose use only. Before use, the solution must be visually inspected for any particulate matter or discoloration. If the solution is diluted, it may be stored at room temperature for a maximum of 12 hours prior to administration.

Disposal: Any unused portion remaining in the vial must be discarded immediately after use. Disposal of all unused medicine and waste material must be carried out in accordance with local pharmaceutical waste requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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