Primovist: Uses, Side Effects and Dosage

Serious warnings and precautions box

What PRIMOVIST is used for:

• PRIMOVIST is used during magnetic resonance imaging (MRI) of the liver. This helps with the diagnosis of various conditions. This medicine is for diagnostic use only.

How PRIMOVIST works:

• MRI is a form of medical diagnostic imaging that creates detailed images of the organs and tissues inside your body.
• PRIMOVIST makes certain areas appear brighter in your MRI. This helps your healthcare professional identify any potential issues.

The ingredients in PRIMOVIST are:

Medicinal ingredients: gadoxetate disodium

Non-medicinal ingredients: caloxetate trisodium, hydrochloric acid, sodium hydroxide, trometamol, water for injection

PRIMOVIST comes in the following dosage forms:

PRIMOVIST is a ready-to-use solution for rapid injection into a vein. It is supplied in a strength of 181.43 milligrams of gadoxetate disodium per millilitre of solution (corresponding to 0.25 mmol/mL). It is packaged in glass vials.

Do not use PRIMOVIST if:

• You are allergic (hypersensitive) to gadoxetate disodium or to any of the other ingredients of PRIMOVIST (see “The ingredients in PRIMOVIST are:” section)
• You have previously had a life-threatening reaction to PRIMOVIST.

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

• have a pacemaker for your heart or if you have another type of implant containing metal
• have or have had a previous reaction to contrast media
• suffer or have suffered from an allergy (eg, hay fever, hives) or asthma
• have a severe disease of the heart and blood vessels
• have very poor kidney function
• have recently had, or shortly expect to have, a liver transplant

• are pregnant or are planning to become pregnant, as it is not known if PRIMOVIST may harm your unborn baby. PRIMOVIST will only be given to you during pregnancy if your doctor decides it is absolutely necessary.

• are breast-feeding or intend to breast-feed, since breast-feeding should be stopped for at least 24 hours following PRIMOVIST administration.

Other warnings you should know about:

Accumulation of Gadolinium in the Brain

Recent information shows that gadolinium (as in PRIMOVIST) may build up in the brain after multiple uses and:

• The effect on the brain is unknown right now.

• Your healthcare professional will:

  • Carefully consider whether to use repeated doses
  • Use the lowest dose

Nephrogenic Systemic Fibrosis

Receiving PRIMOVIST may cause Nephrogenic Systemic Fibrosis (NSF). This is a rare condition which has only been observed so far in patients with severe kidney disease. NSF causes the skin to become thickened, coarse, and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.

Before you receive PRIMOVIST, your healthcare professional will evaluate your kidney function. This will help determine if you should be given PRIMOVIST.

If you have already had an imaging procedure and experience any of the following symptoms, you should seek medical attention as soon as possible:

• Swelling, hardening, and tightening of the skin
• Reddened or darkened patches on the skin
• Burning or itching of the skin
• Yellow spots on the whites of the eyes
• Stiffness in the joints, problems moving or straightening arms, hands, legs, or feet
• Pain deep in the hip bone or ribs
• Weakness of the muscles

Your healthcare professional will monitor your health after administering PRIMOVIST, if you are considered to be at risk for developing NSF.

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 PRIMOVIST:

• rifampicin or rifamycin (medicines used to treat infections, such as tuberculosis)

PRIMOVIST may cause abnormal blood test results for a short period after you receive it. If you need to have blood tests done, tell your healthcare professional that you have been given PRIMOVIST recently.

See also Do not use PRIMOVIST if and Possible side effects from using PRIMOVIST

How to take PRIMOVIST:

• PRIMOVIST will be given to you by a healthcare professional before your MRI.

Usual dose:

Your healthcare professional will determine your dose based on your body weight:

In adults, a single injection of 0.1 mL of PRIMOVIST per kg body weight is generally sufficient (this means, for a person weighing 70 kg the dose would be 7 mL).

PRIMOVIST is not recommended for use in children below 18 years.

Overdose:

No overdosing has been reported so far. If it does happen, the healthcare professional will treat any symptoms and will check whether your kidneys are working normally. If necessary, PRIMOVIST can be removed from the body by hemodialysis.

Possible side effects from using PRIMOVIST:

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

Like all medicines, PRIMOVIST can cause side effects, although not everybody gets them.

Uncommon side effects observed in clinical trials affects 1 to 10 users in 1,000:

• headache, dizziness, disturbed sense of taste (dysgeusia), pins and needles (paresthesia), disturbed sense of smell, sensation of whirling (vertigo)
• flushing
• vomiting, nausea (feeling sick), dry mouth
• rash, severe itching of the skin or eyes (pruritus)
• back pain
• chest pain
• various kinds of injection site reactions (including involuntary leakage of the contrast agent (extravasation) and bleeding, burning, coldness, irritation, pain)
• chills, feeling hot
• feeling abnormal, tiredness (fatigue)

Rare side effects observed in clinical trials (less than 1 in every 1,000 patients is likely to get these):

• tremor, restlessness (akathisia)
• discomfort of the mouth, increased production of saliva (salivary hypersecretion)
• measle-like rash (rash maculopapular), excessive sweating
• discomfort, generally feeling unwell

Side effects reported from postmarketing experience:

• swelling in the tongue or throat (pharyngeal edema, laryngeal edema), hives or nettle-type rash (urticaria), swelling of the face (face edema), runny nose (rhinitis), redness of the eyes (conjunctivitis), stomach pain, reduced feeling or sensitivity in the skin (hypoesthesia), sneezing, cough, pale skin (pallor),
• restlessness

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:

PRIMOVIST should be stored at temperatures between 15°C to 30°C.

If you want more information about PRIMOVIST:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.bayer.ca); or by calling Bayer Medical Information at 1-800-265-7382 or canada.medinfo@bayer.com.

Date of Authorization: 2025-04-16

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