Hexabrix

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will give Hexabrix.
• Other drugs may be given before this medicine to help avoid side effects.
• You will need to be sure that you are not dehydrated before getting Hexabrix. Check with your doctor to see if you need to drink extra fluids before getting this medicine.
• Drink lots of noncaffeine liquids after using Hexabrix unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Feeling of warmth.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

 NOT FOR INTRATHECAL USE

For Intravascular Use

Sterile Solution

200 mL  5505-21

Hexabrix

Ioxaglate Meglumine 39.3% and Ioxaglate Sodium 19.6% Injection USP

320 mg/mL Organically Bound Iodine

NOT FOR INTRATHECAL USE

Rx Only

†Licensed by Guerbet, S.A. Registered U.S. Patent and Trademark Office.

Protect from light •

Store below 30°C (86°F). Do not freeze.

Each mL contains 393 mg ioxaglate meglumine, 196 mg ioxaglate

sodium and 0.10 mg edetate calcium disodium. The pH is adjusted

with meglumine, sodium hydroxide or ioxaglic acid.

Single dose container • Discard unused portion

Usual Dosage:

See Package Insert.

13010110

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Feeling of warmth.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ioxaglate: injectable solution

General

The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth. These reactions are usually of brief duration. In clinical trials, this drug produced less discomfort (pain and heat) up on injection than other contrast agents.[Ref]

Cardiovascular

Common (1% to 10%): Facial flushing
Uncommon (0.1% to 1%): Thrombosis
Rare (0.01% to 0.1%): Thrombophlebitis; severe cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest
Very rare (less than 0.01%): Disseminated intravascular coagulation
Frequency not reported: Generalized vasodilation, flushing, venospasm. Vascular constriction due to injection rate. Cardiac decompensation, serious arrhythmias, myocardial ischemia or infarction may occur during coronary arteriography and left ventriculography.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)[Ref]

Dermatologic

Frequency not reported: Extravasation with burning pain, hematomas, ecchymosis, tissue necrosis[Ref]

Hypersensitivity

Frequency not reported: Dermal manifestations (urticaria with or without pruritus, erythema, maculopapular rash); dry mouth, sweating, conjunctival symptoms; facial, peripheral, and angioneurotic edema; symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestations of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis[Ref]

Nervous system

Frequency not reported: Headache, trembling, shaking, lightheadedness, spasm, convulsions, aphasia, syncope, paresis, paralysis resulting from spinal cord injury and pathology associated with the syndrome of transverse myelitis, visual field losses which are usually transient but may be permanent, coma, death[Ref]

Other

Frequency not reported: Chills without fever, hyperthermia[Ref]

Renal

Frequency not reported: Temporary renal shutdown or other nephropathy[Ref]

Some side effects of Hexabrix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended unless clearly needed. US FDA pregnancy category: B Comment: This drug cross the placental barrier.

Reproduction studies have been performed in rats, and rabbits at doses up to two times the maximum adult human dose and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Substance Name

Ioxaglate

CAS Registry Number

59017-64-0

Drug Class

Contrast Agents

Diagnostic Agents

LactMed Record Number

529

Last Revision Date

20160226

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.