MonoFer Adverse Reactions

Acute severe hypersensitivity reactions may occur with parenteral iron preparations. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and/or cardiovascular collapse; fatalities have been reported. Other less severe manifestations of immediate hypersensitivity, such as urticaria and itching may also occur. In pregnancy, associated foetal bradycardia may occur with parenteral iron preparations.
Flushing in the face, acute chest and/or back pain and tightness sometimes with dyspnea in association with intravenous iron treatment may occur (frequency uncommon). This may mimic the early symptoms of an anaphylactoid/anaphylactic reaction. The infusion should be stopped and the patient's vital signs should be assessed. These symptoms disappear shortly after the iron administration is stopped. They typically do not reoccur if the administration is restarted at a lower infusion rate.
The table presents the adverse drug reactions (ADRs) reported during ferric derisomaltose treatment in clinical trials and in-market experience. (See Table 2.)

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Description of selected adverse reactions: Delayed reactions may also occur with parenteral iron preparations and can be severe. They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics.
Other Post-Marketing experience: Because these adverse events are spontaneously reported in a voluntary manner from a population of uncertain size, it is not possible to reliably estimate their frequency.
Cardiac disorders: Cardiac arrest.
General disorders and administration site conditions: Asthenia, chest discomfort, feeling abnormal, feeling hot.
Musculoskeletal and connective tissue disorders: Joint swelling, pain in extremity.
Nervous system disorders: Burning sensation, cerebrovascular accident, generalized tonic-clonic seizure, syncope.
Respiratory, thoracic and mediastinal disorders: Asphyxia, pharyngeal edema, respiratory arrest, respiratory distress, wheezing.
Skin and subcutaneous tissue disorders: Erythema, generalized erythema, purpura, skin discolouration, swelling face.
Vascular disorders: Shock.
Post-marketing experience: Post marketing adverse reactions are included in the previous table.
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.