"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Adverse effects reported with 1 mcg/kg or 100 mcg/patient include flushing of the face, neck, and upper chest (16%; 45/276), beginning almost immediately and lasting 3 to 5 minutes. Recipients have also reported an urge to take a deep breath (6%; 3/49), which occurs with a timing similar to, but less frequently than, that of flushing. Higher doses ( > =3mcg/kg) are associated with more prolonged flushing, tachycardia, hypotension, dyspnea, and “chest compression” or tightness. In addition, at doses of > =5 mcg/kg, significant increases in heart rate and decreases in blood pressure were observed. The cardiovascular effects occurred 2-3 minutes after injection and lasted for 30-60 minutes. The facial flushing was more prolonged, lasting up to 4 hours in some subjects. All signs and symptoms could be reduced by administering the drug as a 30-second infusion instead of by bolus injection.
Total doses of up to 200 mcg of corticorelin were administered as a bolus injection to 60 men and women, including both healthy normal subjects and patients with endocrine disorders. In most cases, only minor adverse effects, such as transient flushing and feelings of dyspnea, were noted. However, a few patients with disorders of the pituitary-adrenal axis had major symptoms. One patient had a precipitous fall in blood pressure and pulse rate and developed asystole, which required resuscitation. In two patients with Cushing's disease and in one with secondary adrenal insufficiency, an Ňabsence-likeÓ loss of consciousness occurred, which started within a few seconds after injection of corticorelin and lasted from 10 seconds to 5 minutes. This was accompanied by a slight fall in blood pressure. One patient with a well documented seizure diathesis experienced a grand mal epileptic seizure following ACTHREL® (corticorelin ovine triflutate for injection) administration. The patient had discontinued anti-convulsant therapy the day of the procedure. (See PRECAUTIONS and DRUG INTERACTIONS)
Read the Acthrel (corticorelin ovine triflutate for injection) Side Effects Center for a complete guide to possible side effects »
The plasma ACTH response to corticorelin injection is inhibited or blunted in normal subjects pretreated with dexamethasone. The use of a heparin solution to maintain i.v. cannula patency during the corticorelin test is not recommended. A possible interaction between corticorelin and heparin may have been responsible for a major hypotensive reaction that occurred after corticorelin administration. (See ADVERSE REACTIONS)
Last reviewed on RxList: 11/13/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Acthrel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.