Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 02 February 2017

Indication(s)

INDICATIONS AND USAGE Central Nervous System Gadopentetate dimeglumine Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Gadopentetate dimeglumine Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

Extracranial/Extraspinal Tissues Gadopentetate dimeglumine is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.

Body Gadopentetate dimeglumine Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).

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Advisory information

contraindications
CONTRAINDICATIONS Gadopentetate dimeglumine is contraindicated in patients with: •Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), or •Acute kidney injury, or •History of severe hypersensitivity reactions to gadopentetate dimeglumine.
Adverse reactions

ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not 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 Gadopentetate dimeglumine 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 Gadopentetate dimeglumine 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), paresthesia.

Respiratory System: Throat irritation, rhinitis, sneezing.

Skin: Rash, sweating (hyperhidrosis), pruritus, urticaria (hives), facial edema.

Special Senses: Conjunctivitis, taste abnormality, dry mouth, lacrimation, eye irritation, eye pain, ear pain.

Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of gadopentetate dimeglumine.

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 gadopentetate dimeglumine.

Renal and Urinary: Acute renal failure, worsening renal impairment (see Warnings and Precautions), urinary incontinence, urinary urgency.

Vascular: Thrombophlebitis, deep vein thrombophlebitis, compartment syndrome requiring surgical intervention.

Cardiac: Cardiac arrest, heart rate decreased, arrhythmia.

Ear and Labyrinth Disorders: Hearing impaired.

Eye Disorders: Visual disturbance.

Musculoskeletal and Connective Tissue Disorder: Arthralgia.

Nervous System Disorders: Coma, parosmia, speech disorder.

Respiratory

System: Respiratory arrest, pulmonary edema.

Skin: Erythema multiforme, pustules (rash pustular).

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION The recommended dosage of Gadopentetate dimeglumine Injection is 0.2 mL/kg (0.1 mmol/ kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds.

Dosing for patients in excess of 286 lbs has not been studied systematically.

DOSE AND DURATION OF Gadopentetate dimeglumine INJECTION BY BODY WEIGHT BODY WEIGHT Total Volume, mL * lb kg 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 * Rate of injection: 10 mL/15 sec Drug Handling: To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush.

The imaging procedure should be completed within 1 hour of injection of Gadopentetate dimeglumine Injection.

As with other gadolinium contrast agents, Gadopentetate dimeglumine Injection has not been established for use in magnetic resonance angiography.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration.

Do not use the solution if it is discolored or particulate matter is present.

Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.

Pregnancy and lactation

Nursing Mothers Gadopentetate dimeglumine is excreted in human milk.

Gadopentetate dimeglumine Injection was administered intravenously to 18 lactating women with normal renal function at a dose of 0.1 mmol/ kg body weight.

In these women, less than 0.04 % of the administered gadolinium was excreted into the breast milk during the 24-hour period following dosing.

Breast milk obtained during the 24 hours following dosing revealed the average cumulative amount of gadolinium excreted in breast milk was 0.57+/- 0.71 micromoles.

The amount transferred from a 70 kg woman (receiving 0.1 mmol/ kg body weight) to an infant by breastfeeding over a period of 24 hrs translates into less than 3 micromoles of gadolinium.

The overall duration of excretion of gadolinium into breast milk is unknown.

The extent of the absorption of Gadopentetate dimeglumine Injection in infants and its effect on the breast-fed child remains unknown.

More information

Category Value
Authorisation number NDA019596
Orphan designation No
Product NDC 47781-147
Date Last Revised 15-02-2014
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Alvogen, Inc
Warnings

WARNING:

NEPHROGENIC SYSTEMIC FIBROSIS (NSF) Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs.

Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.

NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

• Do not administer gadopentetate dimeglumine to patients with:?

chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or?

acute kidney injury (see CONTRAINDICATIONS).

• Screen patients for acute kidney injury and other conditions that may reduce renal function.

For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

Do not exceed the recommended gadopentetate dimeglumine dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration (see WARNINGS AND PRECAUTIONS).