Gadoteridol (Intravenous)

Gadoteridol helps doctors and other medical specialists to see the patient's body parts during a scan clearly.

Overview

Gadoteridol is a contrast agent that aids in diagnosing specific disorders in the neck and head or spine and brain (central nervous system). It is administered to the body through an injection only by a professional doctor. The medicine can sometimes cause a severe threat to the patients suffering from any kidney disease or those under dialysis. The doctor may, therefore, perform screening tests before infusing the patient. Gadoteridol has some side effects which tend to go away shortly. Also, the injection can cause allergic reactions like Anaphylaxis. It is, however, an essential medicine that helps doctors while carrying out MRA scans.

Conditions Treated

  • MRI scan
  • Brain X-Ray imaging
  • Head and neck diagnostic imaging
  • Spinal Lesions X-Ray imaging

Type Of Medicine

  • Contrast agent

Side Effects

Along the needed results, Gadoteridol may sometimes cause unwanted effects. The effects vary from one patient to another, and not all of them may occur. However, immediate medical attention is needed once they appear.

Inform your doctor right away if you experience any of these effects: chest discomfort and pain, blurred vision, confusion, difficulty when swallowing, decrease responsiveness, fainting, feeling an excess warmth, general discomfort feeling, fainting, loss of consciousness and loss of control in the bladder. It's also important to inform the doctor when you have increased salivation, hoarseness, pulse or low blood pressure, irregular breathing, seizures and throat spasm.

Not all the side effects caused by Gadoteridol need immediate medical help. Most of them disappear with time as the body continues to adjust to the treatment. Also, your doctor may give you a few tips on what to do to reduce the impact of the side effects or prevent them from occurring. Check with your doctor if the symptoms become severe and bothersome. Also, feel free to ask any questions about the effects.

Gadoteridol may sometimes cause effects which are less severe and disappear shortly. Some of them are nausea, vomiting, headache, anxiety, abdominal cramps, diarrhea, dry mouth, watery eyes, sneezing, cough, stuffy nose or warmth at the point of injection. Some patients have also reported these adverse effects although they happen on rare occasions: Bleeding, skin discoloration, blistering, burning sensation, rashes, itching and numbness, unexplained buzzing and ringing sounds in the ears.

No adverse effect should be ignored. Reporting the effects will help the doctor to decide on what to be done. Other effects that are not mentioned here may still occur. Seek the doctor's advice for close monitoring and clarification. The side effects may also be reported to FDA at 1-800-FDA-1088.

Dosage

Gadoteridol is infused into a body vein through an IV. The injection is only done in a hospital setup or clinic before an MRI scan is done. Your healthcare provider or doctor may first watch you shortly after carrying out the test. This will ensure that there are no delayed reactions or unwanted effects occur.

The normal adult dosage for adults is administered as follows;

Central Nervous System:

0.1 mmol/kg (0.2 mL/kg) given as a rapid IV injection (10 mL/min - 60 mL/min) or bolus (greater than 60 mL/min). For the patients who are suspected to have poor enhancing lesions in equivocal or negative scans, the second dosage of 0.2 mmol/kg (0.4 mL/ kg) is added up to 30 minutes after administering the first dose.

Extraspinal and Extracranial Tissues:

0.1 mmol/kg (0.2 mL/kg) is given as an injection (10 mL/min - 60 mL/min) or a bolus greater than 60 mL/min.

The usual dosage for children over the age of 2 years:

0.1 mmol/ kg (0.2 mL/kg) is given as an injection (10 mL/min to 60 mL/min) or a bolus greater than 60 mL/min.

Dose adjustments in the liver and renal impairment have not been studied yet.

To be sure of a complete injection of the contrast medium, a 5ml saline flush should be administered after the dose. The imaging process should be done within one hour after the first Gadoteridol infusion. Parenteral products must be visually inspected for any discoloration and particulate matter before administration. Avoid using the solution if it has particulate, matter or if it is discolored. Any unused solution should be discarded according to the regulations that deal with safe disposal of such substances.

Since a professional doctor only gives the injection in a clinical setup, chances of having an overdose are rare. Gadoteridol is only used during MRA scans hence the patient is not subjected to a particular dosing schedule.

Adequate studies have not been conducted to show the safety of the drug on both pregnant and breastfeeding mothers. It is therefore crucial for the patient to reveal their status so that the doctor can determine their dosage. Also, the efficiency and safety of Gadoteridol on the children below the age of 2 years have not yet been established.

Interactions

Patients are advised to keep a record of the medications they are currently taking. This is because drugs interact with others in the human body regardless of their intake route. It's important to follow the doctor's instructions on food, beverages and activities restrictions.

Gadoteridol can harm the patient's kidneys. This risk is increased when a patient is injected with the drug while still using other kidney medicines. You may need individual tests or dose adjustments if you have used or if you are currently using any of the following drugs:

  • Lithium (Eskalith, Lithobid);
  • Both arthritis and pain drugs like aspirin (Excedrin, Anacin), ibuprofen (Motrin, Advil), acetaminophen (Tylenol), naproxen (Aleve, Naprelan, Naprosyn, and Treximet). Also, drugs like diclofenac (Arthrotec, Cataflam, Flector Patch, and Solareze), meloxicam (Mobic), indomethacin (Indocin), celecoxib (Celebrex) interact with Gadoteridol.
  • Drugs that treat ulcerative colitis-like sulfasalazine (Azulfidine) mesalamine (Pentasa);
  • Medicines that prevent rejection of organ transplants, such as tacrolimus (Prograf), sirolimus (Rapamune) or cyclosporine;
  • IV antibiotics like amphotericin B (AmBisome, Amphotec, (Abelcet), bacitracin (Baci IM), amikacin (Amikin), capreomycin (Capastat), kanamycin (Kantrex), gentamicin (Garamycin) or streptomycin.
  • Antiviral drugs like acyclovir (Zovirax), cidofovir (Vistide), adefovir (Hepsera), foscarnet (Foscavir), valacyclovir (Valtrex), ganciclovir (Cytovene), valganciclovir (Valcyte);
  • Cancer medications like aldesleukin (Proleukin), , ifosfamide (Ifex), carmustine (Gliadel, BiCNU), cisplatin (Platinol), oxaliplatin (Eloxatin), tretinoin (Vesanoid ), streptozocin (Zanosar).

There might be other medicines that are not listed here but affect Gadoteridol. To be on the safe side, tell your doctor all the drugs that you are using. This is inclusive of the prescribed medications, over the counter drugs, vitamins and the herbal medicines. Do not start taking any new medicine without informing the doctor first.

Warnings

Gadoteridol is affected by the presence of the following medical problems. Make sure you inform your doctor if you have:

It is essential for the doctor to keep checking on you to monitor your progress while under this medication or during the scan. This will help the doctor to determine if the drug is working well and ensure it does not bring unwanted effects.

Inform your doctor immediately if you or your patient starts experiencing an itchy and burning skin, joint stiffness, deep bone pains especially in the ribs and hips, muscle weakness, skin hardening or swelling, dark or red skin patches within the first days after receiving this medicine. These could be signs and symptoms of a dangerous disease known as Nephrogenic Systemic Fibrosis (NSF).

High Gadoteridol doses may sometimes increase the chances of Acute Kidney Injury (AKI). This risk has occurred in the past to the patients who suffer from severe kidney problems. Screening is therefore required to the patients who have conditions that can reduce their renal function. Acute kidney injury is characterized by a rapid but reversible decrease of the kidney functions.

This medication can cause severe allergic reactions like anaphylaxis. Anaphylaxis is life-threatening hence it needs immediate medical attention. Inform your nurse or doctor right away when you or your patient experience cold, chest pains, clammy skin, dizziness, confusion, skin rashes, lightheadedness, itching, swelling in the body parts like face, throat, and tongue or breathing trouble after getting this medicine.

Gadoteridol gets cleared from the body through a glomerular filtration process. Although hepato-biliary enteric excretion pathway is not yet established, the dosage should be administered with caution to the patients with either hepatic or renal impairment. The diagnostic processes that use contrast agents should only be carried out by a well-trained physician in a medical setup.

Storage

Gadoteridol injection should be kept at 25°C (77°F). The excursions are permitted to be stored at 1530°C (59-86°F) controlled room temperature. Protect from direct sunlight and out of reach of children. Do not freeze it. Should any freezing occur in the vial, Gadoteridol should be first brought to a room temperature environment before use. Once kept at room temperature for more than one hour, the injection should turn to a bright and colorless slight yellow solution. It should be well examined before use to make sure that the solids are dissolved again and that the closure and the container have not been damaged. If the solids do not dissolve, discard the vial. The frozen syringes should also be discarded.

Summary

Gadoteridol injection is a contrast agent that is used to produce magnetic effects before a magnetic resonance imaging scan is carried out. It provides a clear vision of the body parts especially the brain, neck, head, and spine. This medicine is life-threatening to the patients who are on dialysis due to kidney problems. Patients with high blood pressure and diabetes are advised to reveal their status before they receive the medication. The efficiency and safety of the medicine to both expectant and breastfeeding mothers has not been determined, but it's essential for the doctor to be aware. Just like the other medicines, Gadoteridol causes some side effects and allergic reactions. It is only administered in hospitals by trained health professionals hence not applicable for home storage. The drug may interact with others like antiviral drugs and cancer medications. The patient is therefore required to have a list of the drugs they are taking to help the doctor making a vivid decision before the injection.