Isovue 300 Injection: Uses, Side Effects and Dosage

What is ISOVUE used for?

ISOVUE is for diagnostic use only. It is used only to help identify an illness and not in connection with treatment.

• It can be used for X-rays of your urinary system, spine or blood vessels, including blood vessels of your heart.
• You may be given this medicine before or during a scan of your head or body using ‘computer tomography’ (also called a CT scan). This type of scan uses X-rays.

Your doctor will explain which part of your body will be scanned.

How does ISOVUE work?

ISOVUE is an iodine-based contrast medium. It is given before an X-ray to create contrast in your body. This contrast will help your doctor to more easily identify any issues or irregularities in your body.

What are the ingredients in ISOVUE?

Medicinal ingredients: iopamidol

Non-medicinal ingredients: calcium disodium edetate (EDTA), hydrochloric acid, tromethamine, and water for injection

Serious Warnings and Precautions

• Your doctor will make sure that the right strength is used for you and for the type of procedure to be performed. Serious side effects can happen due to accidental use of the wrong administration route. These serious side effects include: death, convulsions, cerebral hemorrhage (bleeding in the brain), coma, paralysis, arachnoiditis (pain in the lower back or legs), acute renal failure (severe kidney problems), cardiac arrest (heart stops beating), seizures, rhabdomyolysis (breakdown of damaged muscles), hyperthermia (very high body temperature), and brain edema (swelling in the brain).

ISOVUE comes in the following dosage forms:

ISOVUE is a solution for injection that is supplied in three strengths: ISOVUE 200 (iopamidol injection USP 200 mg I/mL), ISOVUE 300 (iopamidol injection USP 300 mg I/mL) and ISOVUE 370 (iopamidol injection USP 370 mg I/mL). ISOVUE is packaged in vials, syringes and/or bottles of various volumes.

Do not use ISOVUE if:

• you are allergic (hypersensitive) to iopamidol, iodinated dye or iodine-containing products or to any of the non-medicinal ingredients of ISOVUE.
• you have severe problems with your liver and/or kidneys.
• you were already given ISOVUE once and the scan needs to be repeated immediately due to technical issues.
• you are taking medicines used to reduce inflammation (corticosteroids) and ISOVUE is going to be injected into your spine.
• it is going to be injected into the space around your brain.
• there is an infection in the area where the scan will be performed or you have a full body (systemic) infection.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ISOVUE. Talk about any health conditions or problems you may have, including if you:

• are pregnant or planning to become pregnant;

• are breastfeeding or planning to breastfeed, since breastfeeding should be stopped for 48 hours following ISOVUE administration;
• have had a previous allergic reaction to contrast media;
• have or have had any allergy (e.g. hay fever, food allergy) or bronchial asthma;
• have heart or blood circulation disease(s);
• have both liver and kidney problems
• have or suspect to have a thyroid gland that is overactive (hyperthyroidism) or have a thyroid nodule;
• have a kidney disease;
• have a condition in which there is the presence of toxins in the blood (endotoxemia);
• have a fever, or elevated body temperature;
• have bursts of high blood pressure caused by a rare tumor of the adrenal gland which sits near the kidney (pheochromocytoma);
• suffer from a cancer of the blood cells (multiple myeloma);
• suffer from a vascular condition in which you have clotting of some small blood vessels in the hands or feet (Buerger's disease or thromboangiitis obliterans);
• suffer from an overproduction of special proteins (paraproteinemia);
• suffer from a harmful accumulation of homocysteine in the body (homocystinuria);
• have diabetes;
• suffer from dehydration;
• have low blood pressure (hypotension);
• have high blood pressure (hypertension);
• are taking medication that can affect your kidney function;
• have or are at risk of having a condition in which you have an increased level of uric acid in the blood (hyperuricemia);
• have high intracranial pressure or suspect a tumor in the skull;
• suffer from brain conditions with seizures;
• have multiple sclerosis;
• have sickle cell disease (not enough healthy red blood cells to carry oxygen throughout your body);
• have had a blood circulation disturbance in the brain;
• suffer from a condition where the blood-brain barrier is disrupted;
• have breathing problems (pulmonary diseases);
• are planning to have a special procedure to allow your doctor to visualize your gallbladder (oral cholecystography).

Other warnings you should know about:

Thyroid Function

Contrast media containing iodine, such as ISOVUE, may change thyroid activity in some patients, both in adults and infants. This may cause:

• hypothyroidism (i.e. too little thyroid hormones in the blood)

  or

• hyperthyroidism (i.e. too much thyroid hormones in the blood)

Thyroid Function in Infants

Contrast media containing iodine may cause hypothyroidism in infants, especially infants born too soon that:

• can continue for several weeks to a month after treatment
• can harm growth and development
• can harm mental growth
• may require treatment

• can cause symptoms such as:

  • fatigue, shortness of breath, low heart rate
  • reduced appetite, feeling cold, weight gain
  • muscle stiffness

Contact your doctor if any of these symptoms happen to your infant.

Your doctor may order blood tests for your infant after treatment to follow thyroid hormone levels in the blood.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ISOVUE:

• Medications used to treat depression (monoamine oxidase (MAO) inhibitors and tricyclic antidepressants);
• Medications used to treat schizophrenia and bipolar disorder (antipsychotics)
• Medications used to treat allergies, as a sedative and/or to prevent vomiting (phenothiazine derivates);
• Medications used to stimulate the brain (CNS stimulants);
• Other agents that contain iodine taken before you have an X-ray of your gall bladder;
• Medications that constrict the blood vessels (vasopressors);
• Beta-blockers, medications used to treat high blood pressure and other heart conditions;
• Biguanides (e.g., metformin), medications to treat diabetes.

Some laboratory tests (e.g. thyroid function test, blood tests for clotting (coagulation) or blood clot breakdown (fibrinolysis)) may be affected by the use of ISOVUE. Tell your doctor if you have any of these tests scheduled.

How to take ISOVUE:

ISOVUE will always be used in a hospital or clinic and will be administered to you by a specially trained and qualified healthcare professional. They will tell you anything you need to know for its safe use.

Usual dose:

Your doctor will decide the dose that is best for you and for the type of procedure to be performed.

Overdose:

What are possible side effects from using ISOVUE?

These are not all the possible side effects you may have when taking ISOVUE. If you experience any side effects not listed here, tell your healthcare professional.

Most side effects to ISOVUE appear within one to 30 minutes after ISOVUE is given.

After injection into an artery or vein:

• Feeling of warmth
• Burning sensation
• Redness (flushing)
• Nausea, vomiting
• Changes in taste

After injection into the space around the spine:

• Headache
• Nausea, vomiting
• Muscle pain

The side effects in the table below may happen several hours or days after ISOVUE is given. If any of these side effects happen after you leave the hospital or clinic, go straight to the emergency department of your nearest hospital.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15°C to 30°C). Protect from light.

Keep out of reach and sight of children.

If you want more information about ISOVUE:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.braccoimaging.com, or by calling 1-800-465-5820.

Last Revised: December 17, 2021