Clariscan

Medical Author: John P. Cunha, DO, FACOEP Last updated on RxList: 1/4/2022
Clariscan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Clariscan?

Clariscan (gadoterate meglumine injection) is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

What Are Side Effects of Clariscan?

Common side effects of Clariscan include:

  • nausea,
  • headache,
  • injection site reactions (pain, coldness), and
  • rash

Dosage for Clariscan

For adult and pediatric patients, the recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients.

Clariscan In Children

The safety and efficacy of Clariscan at a single dose of 0.1 mmol/kg have been established in pediatric patients from 2 to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older. Adverse reactions in pediatric patients were similar to those reported in adults. No dosage adjustment according to age is necessary in pediatric patients.

What Drugs, Substances, or Supplements Interact with Clariscan?

Clariscan may interact with other medicines.

Tell your doctor all medications and supplements you use.

Clariscan During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Clariscan; it is unknown how it would affect a fetus. It is unknown if Clarisca passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Clariscan (gadoterate meglumine injection) Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Clariscan Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects of gadoterate meglumine may occur up to several days after injection.

Gadoterate meglumine can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

  • burning, itching, swelling, scaling, and tightening or hardening of your skin;
  • muscle weakness;
  • joint stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • trouble moving; or
  • skin redness or discoloration.

Also call your doctor at once if you have:

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • headache;
  • nausea;
  • rash; or
  • pain or cold feeling around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Clariscan (Gadoterate Meglumine Injection)

QUESTION

About how much does an adult human brain weigh? See Answer
Clariscan Professional Information

SIDE EFFECTS

GBCAs have been associated with a risk for NSF [see WARNINGS AND PRECAUTIONS]. Confirmed diagnosis of NSF has not been reported in patients with a clear history of exposure to gadoterate meglumine alone.

Hypersensitivity reactions and acute kidney injury are described in other sections of the labeling [see WARNINGS AND PRECAUTIONS].

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect gadoterate meglumine exposure in 2867 patients, representing 2682 adults and 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded, the ethnic distribution was 81% Caucasian, 11% Asian, 4% Black, and 4% others. The average age was 53 years (range from < 1 week to 97 years).

Overall, 4% of patients reported at least one adverse reaction, primarily occurring immediately or within 24 hours following gadoterate meglumine administration. Most adverse reactions were mild or moderate in intensity and transient in nature.

Table 2 lists adverse reactions that occurred in ≥ 0.2% patients who received gadoterate meglumine.

Table 2: Adverse Reactions in Clinical Trials

ReactionRate (%)
n= 2867
Nausea0.6%
Headache0.4%
Injection Site Pain0.4%
Injection Site Coldness0.2%
Rash0.2%

Adverse reactions that occurred with a frequency < 0.2% in patients who received gadoterate meglumine include: feeling cold, feeling hot, burning sensation, somnolence, pain, dizziness, dysgeusia, blood creatinine increased, hypotension, hypertension, asthenia, fatigue, injection site reactions (inflammation, extravasation, pruritus, swelling, warmth), paresthesia, pruritus, laryngeal discomfort, pain in extremity, vomiting, anxiety and palpitations.

Adverse Reactions In Pediatric Patients

During clinical trials, 185 pediatric patients (52 aged < 24 months, 33 aged 2 – 5 years, 57 aged 6 – 11 years and 43 aged 12 – 17 years) received gadoterate meglumine. Overall, 7 pediatric patients (3.8%) reported at least one adverse reaction following gadoterate meglumine administration. The most frequently reported adverse reaction was headache (1.1%). Most adverse events were mild in intensity and transient in nature.

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of gadoterate meglumine. 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.

Table 3: Adverse Reactions in the Postmarketing Experience

System Organ ClassAdverse Reaction
Cardiac Disordersbradycardia, tachycardia, arrhythmia
Immune System Disordershypersensitivity / anaphylactoid reactions including cardiac arrest, respiratory arrest, cyanosis, pharyngeal edema, laryngospasm, bronchospasm, angioedema, conjunctivitis, ocular hyperemia, eyelid edema, lacrimation increased, hyperhidrosis, urticaria
Nervous System Disorderscoma, convulsion, syncope, presyncope, parosmia, tremor
Musculoskeletal and Connective Tissue Disordersmuscle contracture, muscle weakness
Gastrointestinal Disordersdiarrhea, salivary hypersecretion
General Disorders and Administration Site Conditionsmalaise, fever
Adverse events with variable onset and duration have been reported after GBCA administration [see WARNINGS AND PRECAUTIONS]. These include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems.
Skin and Subcutaneous Tissue DisordersNSF, in patients whose reports were confounded by the receipt of other GBCAs or in situations where receipt of other GBCAs could not be ruled out. No unconfounded cases of NSF have been reported with gadoterate meglumine.
Gadolinium-associated plaques.
Vascular Disorderssuperficial phlebitis

Read the entire FDA prescribing information for Clariscan (Gadoterate Meglumine Injection)

© Clariscan Patient Information is supplied by Cerner Multum, Inc. and Clariscan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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