Clinical Trial Experience
Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
The mean age of the 1272 patients who received MAGNEVIST
Injection in pre-market clinical trials was 46.4 years (range 2 to 93 years).
Of these patients, 55% (700) were male and 45% (572) were female. Of the 1271
patients who received MAGNEVIST Injection and for whom race was reported, 82.1%
(1043) were Caucasian, 9.7% (123) were Black, 5.3% (67) were Hispanic, 2.1% (27)
were Oriental/Asian, and 0.9% (11) were other.
The most common adverse reaction was headache (4.8%). The
majority of headaches were transient and of mild to moderate severity. Other
adverse reactions that occurred in ≥ 1% of patients included: nausea
(2.7%), injection site coldness/localized coldness (2.3%) and dizziness (1%).
The following additional adverse reactions occurred in less
than 1% of the patients:
General Disorders: Injection site reactions,
including phlebitis, pain, localized warmth, localized edema, and burning
sensation; substernal chest pain, back pain, pyrexia, asthenia, feeling cold,
generalized warmth, fatigue, and chest tightness, and anaphylactoid reactions characterized
by cardiovascular, respiratory and/or cutaneous symptoms, such as dyspnea,
bronchospasm, and cough. (See WARNINGS AND PRECAUTIONS.)
Cardiovascular: Hypotension, hypertension,
tachycardia, migraine, syncope, vasodilatation, pallor.
Gastrointestinal: Abdominal discomfort, teeth pain,
increased salivation, abdominal pain, vomiting, diarrhea.
Nervous System: Agitation, anxiety, thirst,
somnolence, diplopia, loss of consciousness, convulsions (including grand mal),
Respiratory System: Throat irritation, rhinitis,
Skin: Rash, sweating (hyperhidrosis), pruritus,
urticaria (hives), facial edema.
Special Senses: Conjunctivitis, taste abnormality,
dry mouth, lacrimation, eye irritation, eye pain, ear pain.
The following additional adverse reactions have been
identified during postmarketing use of Magnevist. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The most serious reactions were nephrogenic systemic
fibrosis (see BOXED WARNING) and acute reactions including cardiac or
respiratory arrest, anaphylactic shock, shock, respiratory distress, and
laryngeal edema. Life threatening and/or fatal adverse reactions have been
reported. The most frequently reported adverse reactions in the postmarketing
experience were nausea, vomiting, urticaria and rash.
General Disorders and Administration Site Conditions:
Nephrogenic systemic fibrosis (see WARNINGS AND PRECAUTIONS), body
temperature decreased, tremor, shivering (chills).
Hypersensitivity Reactions: Anaphylactic/anaphylactoid
reactions that may be fatal and include cardiac or respiratory arrest,
respiratory distress, cyanosis, laryngeal edema, laryngospasm, pharyngeal
edema, and angioedema (see WARNINGS AND PRECAUTIONS).
Delayed hypersensitivity reactions have been reported up to
several hours after administration of Magnevist.
Renal and Urinary: Acute renal failure, worsening
renal impairment (see WARNINGS AND PRECAUTIONS), urinary incontinence,
Vascular: Thrombophlebitis, deep vein
thrombophlebitis, compartment syndrome requiring surgical intervention.
Cardiac: Cardiac arrest, heart rate decreased,
Ear and Labyrinth Disorders: Hearing impaired.
Eye Disorders: Visual disturbance.
Musculoskeletal and Connective Tissue Disorder: Arthralgia.
Nervous System Disorders: Coma, parosmia, speech
Respiratory System: Respiratory arrest, pulmonary
Skin: Erythema multiforme, pustules (rash pustular).
No information provided.