ProHance Multipack

Last updated on RxList: 7/22/2021
ProHance Multipack Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is ProhHance Multipack?

ProhHance Multipack (gadoteridol injection) is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates, and lesions in the head and neck in adults.

What Are Side Effects of ProhHance Multipack?

Side effects of ProhHance Multipack include:

  • nausea,
  • changes in taste,
  • headache,
  • dizziness, and
  • hives.

Dosage for ProhHance Multipack

The recommended dose of ProhHance Multipack in adult and pediatric patients is 0.2 mL/kg (0.1 mmol/kg) body weight administered as rapid intravenous infusion or bolus.

ProhHance Multipack In Children

The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age.

What Drugs, Substances, or Supplements Interact with ProhHance Multipack?
 

ProhHance Multipack may interact with other medicines.

Tell your doctor all medications and supplements you use.


ProhHance Multipack During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using ProhHance Multipack; GBCAs cross the placenta and result in fetal exposure and gadolinium retention. Because of the potential risks of gadolinium to the fetus, ProhHance Multipack should be used only if imaging is essential during pregnancy and cannot be delayed. Lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk and there is limited GBCA gastrointestinal absorption in the breastfed infant. Consult your doctor before breastfeeding.

Additional Information

Our ProhHance Multipack (gadoteridol injection), for Intravenous Use 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.

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ProHance Multipack 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 gadoteridol may occur up to several days after injection.

Gadoteridol 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;
  • a seizure (convulsions); or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nausea; or
  • unusual or unpleasant taste in your mouth.

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 ProHance Multipack (Gadoteridol Injection)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
ProHance Multipack Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information:

  • Nephrogenic systemic fibrosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
  • Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Clinical Trials 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 practice.

The adverse events described in this section were observed in clinical trials involving 3174 subjects (including 2896 adults and 278 pediatric subjects ages 0 to 17 years) exposed to ProHance. Approximately 48% of the subjects were men and ethnic distribution was 78% Caucasian, 6% Black, 3% Hispanic, 6% Asian, and 2% other. In 5% of the subjects, race was not reported. Average age was 47 years (range from 1 day to 91 years) and the exposure ranged from 0.03 to 0.3 mmol/kg.

Overall, approximately 5.8% of subjects reported one or more adverse reactions during a follow-up period that ranged from 24 hours to 7 days after ProHance administration.

Table 2 lists adverse reactions that occurred in ≥ 0.4% subjects who received ProHance.

Table 2: More frequent adverse reactions in clinical trials

Reaction Rate(%)
N = 3174
Nausea 1.4%
Dysgeusia 0.9%
Headache 0.7%
Dizziness 0.4%
Urticaria 0.4%

The following additional adverse events occurred in fewer than 0.4% of the subjects:

General disorders and administration site conditions: Asthenia; chest discomfort, facial edema, feeling hot, injection site coldness, injection site erythema, injection site pain, injection site warmth, pain, pyrexia

Cardiac: Angina pectoris, palpitations, atrio-ventricular block first degree

Ear and labyrinth disorders: Ear discomfort, tinnitus

Eye disorders: Eye pruritis, lacrimation increased

Gastrointestinal disorders: Abdominal discomfort, abdominal pain, diarrhea, dry mouth, gingival pain, oral pruritis, swollen tongue, vomiting

Infections and infestations: Gingivitis, rhinitis

Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, blood chloride increased, blood pressure immeasurable, blood urea decreased, hemoglobin decreased, heart rate increased

Metabolism and nutrition disorders: Decreased appetite, hypoglycemia

Musculoskeletal and connective tissue disorders: Back pain, musculoskeletal stiffness

Nervous system disorders: Formication, hypoesthesia, hypokinesia, lethargy, loss of consciousness, migraine, paresthesia, presyncope, seizure, syncope, taste disorder

Psychiatric disorders: Anxiety, mental status changes

Respiratory, thoracic and mediastinal disorders: Cough, dry throat, dyspnea, nasal discomfort, throat irritation

Skin and subcutaneous tissue disorders: Hyperhidrosis, pruritis, rash, rash morbilliform

Vascular disorders: Flushing, hypotension, peripheral coldness, vascular rupture, vasodilatation, vasospasm

Post-marketing Experience

The following adverse reactions have been identified during post approval use of ProHance that were not observed in the clinical trials. 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.

The following adverse drug reactions have also been reported:

General Disorders and Administration Site Conditions: 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.

Cardiac disorders: Cardiac arrest, bradycardia, hypertension

Immune system disorders: Hypersensitivity/anaphylactoid reactions including cardiac arrest, cyanosis, pharyngeal edema, laryngospasm, bronchospasm, angioedema, cough, sneezing, conjunctivitis, eyelid edema, hyperhidrosis, urticaria [see WARNINGS AND PRECAUTIONS].

Nervous system disorders: Coma, loss of consciousness, vasovagal reaction, tremor

Respiratory, thoracic and mediastinal disorders: Respiratory arrest, pulmonary edema

Renal and urinary system disorders: Acute renal failure *

* Cases of acute renal failure have been reported in patients with pre-existing severe renal impairment.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for ProHance Multipack (Gadoteridol Injection)

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

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