MultiHance

MultiHance Side Effects Center

MultiHance (gadobenate dimeglumine) is a contrast agent used to allow blood vessels, organs, and other tissues to be seen more clearly during an MRI. Common side effects of MultiHance include headache, dizziness, nausea, vomiting, fever, sweating, feeling unusually hot or cold, bad taste in your mouth, tingling in your hands or feet, and skin rash.

The recommended dose of MultiHance is 0.1 mmol/kg (0.2 ML/kg). Cisplatin, doxorubicin, daunorubicin, vincristine, methotrexate, etoposide, tamoxifen, and paclitaxel may interact with MultiHance. Tell your doctor all medications you take. Before taking MultiHance tell your doctor if you have kidney disease or if you are on dialysis. If you are pregnant only use MultiHance if the potential benefit outweighs the potential risk to the fetus. Do not take MultiHance if you are breastfeeding.

Our MultiHance (gadobenate dimeglumine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

MultiHance in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects of gadobenate dimeglumine may occur up to several days after injection.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath;
  • seizure (convulsions);
  • breathing problems;
  • pounding heartbeats or fluttering in your chest; or
  • pain, burning, swelling, blistering, or skin changes where the injection was given (may occur up to several days after injection).

Less serious side effects may include:

  • headache, dizziness;
  • dry mouth, nausea, vomiting;
  • feeling unusually hot;
  • unusual or unpleasant taste in your mouth;
  • numbness or tingly feeling;
  • mild itching or rash; or
  • cold feeling, warmth, pain, or bruising where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for MultiHance (Gadobenate Dimeglumine Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

MultiHance FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials 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.

Adult

In clinical trials, a total of 2982 adult subjects (119 healthy volunteers and 2863 patients) received MultiHance at doses ranging from 0.005 to 0.4 mmol/kg. There were 1724 (58%) men and 1258 (42%) women with a mean age of 55.1 years (range 18 to 92 years). A total of 2644 (89%) subjects were Caucasian, 84 (3%) Black, 162 (5%) Asian, 29 (1%) Hispanic, 18 (1%) in other racial groups, and for 45 (2%) subjects, race was not reported.

The most commonly reported adverse reactions in adult subjects who received MultiHance were headache (1.8%) and nausea (1.6%). Most adverse reactions were mild to moderate in intensity. Four subjects experienced serious adverse reactions. One subject with a history of seizures experienced convulsions 17 minutes after the administration of MultiHance. Another subject with a history of recent myocardial infarction (MI) and congestive heart failure (CHF) experienced acute pulmonary edema within 10 minutes after the administration of 30 mL of MultiHance. The third subject developed acute necrotizing pancreatitis. The fourth subject experienced an anaphylactoid reaction with laryngismus and dyspnea [see WARNINGS AND PRECAUTIONS]. Adverse reactions that occurred in at least 0.5% of 2982 adult subjects who received MultiHance are listed below (Table 1), in decreasing order of occurrence within each system.

TABLE 1: ADVERSE REACTIONS REPORTED IN ≥ 0.5% OF ADULT SUBJECTS WHO RECEIVED MultiHance IN CLINICAL TRIALS

Number of subjects dosed 2982
Number of subjects with any adverse reaction 450 (15.1%)
Gastrointestinal Disorders
Nausea 48 (1.6%)
Vomiting 14(0.5%)
General Disorders and Administration Site Disorders
Feeling Hot 31 (1.0%)
Injection Site Reaction 40 (1.3%)
Nervous System Disorders
Headache 54 (1.8%)
Taste perversion 25 (0.8%)
Paresthesia 23 (0.8%)
Dizziness 22 (0.7%)
Skin and Subcutaneous Tissue Disorders
Rash 19(0.6%)
Vascular Disorders Hypertension 16(0.5%)

The following adverse reactions occurred in less than 0.5% of the 2982 adult subjects who received MultiHance:

Blood and Lymphatic System Disorders: Basophilia, decreased hemoglobin, hemolysis, leukocytosis, leukopenia;

Cardiac Disorders: Arrhythmia, atrial fibrillation, bradycardia, chest discomfort, ECG abnormality (bundle branch block, complete AV block, first-degree AV block, inverted T wave, prolonged PR interval, prolonged QT interval, shortened QT interval), myocardial ischemia, palpitations, supraventricular extrasystoles, tachycardia, ventricular arrhythmia, ventricular extrasystoles;

Ear and Labyrinth Disorders: Ear pain, tinnitus;

Eye Disorders: Eyelid edema, ocular hyperemia, visual disturbance;

Gastrointestinal Disorders: Acute necrotizing pancreatitis, abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, fecal incontinence, increased pruritus in patients with cirrhosis, vomiting;

General Disorders and Administration Site Conditions: Asthenia, back pain, chest pain, chills, fever, infection, injection site extravasation, injection site inflammation, injection site pain, malaise, rigors;

Immune System Disorders: Anaphylactic and anaphylactoid reactions, anaphylactic shock, hypersensitivity reactions;

Investigations: Abnormal laboratory test (includes changes in CPK, creatinine, ferritin, transferrin, total iron binding capacity), bilirubinemia, hyperglycemia, hyperkalemia, hypocalcemia, hypoglycemia, hyponatremia, decreased blood albumin, increased alkaline phosphatase, increased GGT, increased LDH, increased serum iron, increased SGOT, increased SGPT;

Musculoskeletal and Connective Tissue Disorders: Muscle spasms, myalgia, myositis;

Nervous System Disorders: Aphasia, convulsion, hemiplegia, hypertonia, hypoesthesia, paralysis, parosmia, stupor, syncope, tremor;

Renal and Urinary Disorders: Albuminuria, glycosuria, hematuria, proteinuria, urinary frequency, urinary tract infection;

Respiratory, Thoracic and Mediastinal Disorders: Acute pulmonary edema, cough, dyspnea, hyperventilation, laryngospasm, nasal congestion, obstructive airway disorder, pulmonary embolus, wheezing;

Skin and Subcutaneous Tissue Disorders: Facial edema, hyperhidrosis, pruritus, sweating, urticaria;

Vascular Disorders: Hypotension.

Pediatric

In clinical trials, 217 pediatric subjects received MultiHance at a dose of 0.1 mmol/kg. A total of 112 (52%) subjects were male and the overall mean age was 8.3 years (range 4 days to 17 years). A total of 168 (77%) subjects were Caucasian, 12 (6%) Black, 12 (6%) Asian, 24 (11%), Hispanic, and 1 (<1%) in other racial groups.

Adverse reactions were reported for 14 (6.5%) of the subjects. The frequency and the nature of the adverse reactions were similar to those seen in the adult patients. The most commonly reported adverse reactions were vomiting (1.4%), pyrexia (0.9%), and hyperhidrosis (0.9%). No subject died during study participation. A serious adverse reaction of worsening of vomiting was reported for one (0.5%) patient with a brain tumor (glioma) for which a causal relationship to MultiHance could not be excluded.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of MultiHance. 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.

Anaphylactic, anaphylactoid and hypersensitivity reactions manifested with various degrees of severity up to anaphylactic shock, loss of consciousness and death. The reactions generally involved signs or symptoms of respiratory, cardiovascular, and/or mucocutaneous abnormalities. Extravasation of MultiHance may lead to injection site reactions, characterized by local pain or burning sensation, swelling, blistering, and necrosis [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for MultiHance (Gadobenate Dimeglumine Injection) »

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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.


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