Applies to ferumoxytol: intravenous solution.
Warning
Intravenous route (Solution)
Risk For Serious Hypersensitivity/Anaphylaxis ReactionsFatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol. Initial symptoms may include hypotension, syncope, unresponsiveness, and cardiac or cardiorespiratory arrest.Only administer ferumoxytol as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following ferumoxytol infusion including monitoring of blood pressure and pulse during and after ferumoxytol administration.Hypersensitivity reactions have occurred in patients in whom a previous ferumoxytol dose was tolerated.
Serious side effects of Ferumoxytol
Along with its needed effects, ferumoxytol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking ferumoxytol:
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain
- confusion
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- rapid weight gain
- sweating
- tightness in the chest
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- chest discomfort
- cough
- decreased urine output
- difficulty with swallowing
- dilated neck veins
- dizziness
- extreme tiredness or weakness
- fainting
- fast, pounding, or irregular heartbeat or pulse
- hives, itching, or skin rash
- irregular breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of consciousness
- nausea
- no blood pressure or pulse
- pain in the shoulders, arms, jaw, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stopping of the heart
- unconsciousness
- unresponsiveness
- vomiting
- weight gain
Other side effects of Ferumoxytol
Some side effects of ferumoxytol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Back pain
- headache
- muscle spasms
- stomach pain
For Healthcare Professionals
Applies to ferumoxytol: intravenous solution.
General
The most common adverse events were injection site reactions, gastrointestinal symptoms, headache, dizziness, and hypotension.[Ref]
Local
Common (1% to 10%): Injection site reactions (infusion/injection site bruising, pain, reaction, swelling, warmth, hemorrhage, irritation, rash)[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, abdominal pain (abdominal distension, abdominal pain upper, abdominal discomfort)
Uncommon (0.1% to 1%): Diarrhea, constipation, feces discolored
Rare (less than 0.1%): Dry mouth, dyspepsia, glossodynia
Frequency not reported: Lip swelling, swollen tongue[Ref]
Cardiovascular
Common (1% to 10%): Hypotension (hypotension, blood pressure decreased)
Uncommon (0.1% to 1%): Flushing (flushing, hot flush), hypertension (hypertension, accelerated hypertension)
Rare (less than 0.1%): Cardiac arrest, cardio-respiratory arrest, myocardial events, congestive heart failure
Frequency not reported: Tachycardia/arrhythmia, myocardial infarction, vasodilation, pulse absent
Postmarketing reports: Cyanosis[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Dysgeusia, somnolence, burning sensation
Rare (less than 0.1%): Paresthesia
Frequency not reported: Syncope, unresponsiveness, loss of consciousness[Ref]
Dermatologic
Common (1% to 10%): Pruritus (pruritus generalized), rash (rash, rash generalized, rash pruritic, urticaria)
Uncommon (0.1% to 1%): Ecchymosis, sweating (hyperhidrosis, night sweats), skin hyperpigmentation, skin reaction
Frequency not reported: Angioedema[Ref]
Respiratory
Common (1% to 10%): Cough, dyspnea
Rare (less than 0.1%): Epistaxis
Frequency not reported: Bronchospasm, hyperventilation, hypoxia, laryngeal edema, pharyngeal edema, respiratory arrest, respiratory failure, throat irritation, throat tightness, wheezing[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, muscle spasms
Uncommon (0.1% to 1%): Muscle/joint pain or stiffness (arthralgia, myalgia, muscular weakness, musculoskeletal stiffness)[Ref]
Metabolic
Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Decreased appetite, increased appetite
Rare (less than 0.1%): Dehydration, gout, hyperkalemia, blood glucose decreased
Frequency not reported: Oxygen saturation decreased[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity (including anaphylaxis)
Postmarketing reports: Life-threatening anaphylactic/anaphylactoid reactions[Ref]
Hematologic
Rare (less than 0.1%): Eosinophilia[Ref]
Hepatic
Rare (less than 0.1%): Hepatic function abnormal[Ref]
Other
Common (1% to 10%): Peripheral edema, chest pain (chest discomfort, chest pain), fever (feeling hot, pyrexia)
Uncommon (0.1% to 1%): Fatigue (asthenia, fatigue), chills, serum ferritin increased, contusion[Ref]
Ocular
Rare (less than 0.1%): Lacrimation increased, vision blurred[Ref]
Renal
Frequency not reported: Chronic renal failure[Ref]
