Gadovist - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gadovist

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Gadovist is a drug used in magnetic resonance imaging to increase contrast.

Release form and composition

Gadovist's dosage form is a solution for intravenous administration of 1 mmol / ml: transparent, no foreign inclusions (in colorless glass syringes, 5 or 7.5 ml each, 1 syringe in a blister, in a cardboard box 5 blisters; 15 or 30 ml each colorless glass vials, in a cardboard box 1 or 5 bottles; 15 or 30 ml each in plastic cartridges with a capacity of 65 ml, in a cardboard box 5 cartridges).

Composition of 1 ml solution:

• active substance: gadobutrol - 604.72 mg (equivalent to 1 mmol);
• auxiliary components: sodium calcobutrol - 0.513 mg; hydrochloric acid 0.1M - up to pH 7.2 ± 0.2; trometamol - 1.211 mg; water for injection - up to 1 ml.

Additional characteristics of the solution at 37 ° C:

• osmolarity: 1603 mOsm / kg H ₂ O; 1117 mOsm / L solution;
• viscosity: 4.96 mPa × s.

Indications for use

Gadovist is used only for diagnostic purposes in patients over 7 years of age to increase contrast in magnetic resonance imaging (MRI) of the whole body, including the following studies:

• cranial / spinal MRI;
• MRI of the head, neck, chest, abdomen (including pancreas, liver, and spleen), small pelvis (including prostate, bladder, and uterus), as well as retroperitoneal space (including kidneys), mammary glands, limbs, and musculoskeletal motor system, heart (including imaging for the purpose of diagnosing tissue viability "delayed contrasting" and assessing myocardial perfusion under conditions of pharmacological stress);
• magnetic resonance angiography (MRA).

Special indications for spinal MRI:

• differential diagnosis between intra- and extramedullary tumors;
• determination in the spinal canal of the boundaries of solid tumors and the prevalence of intramedullary tumors.

Gadovist has particular advantages in cases where there are indications for the use of high-dose magnetic resonance imaging, for example, if the identification / exclusion of additional lesions can affect the therapy or medical practice, as well as for visualizing lesions that are difficult to contrast with conventional means, or when identifying minor damage.

Also, the use of Gadovist's solution is possible for perfusion studies in order to assess the blood supply to the tumor, diagnose a stroke, and recognize focal cerebral ischemia.

Contraindications

Absolute:

• age up to 2 years (due to the lack of clinical data on the safety / effectiveness of the drug);
• lactation period (due to the lack of clinical data on the safety / effectiveness of the drug; in cases of using Gadovist, breastfeeding should be interrupted for at least 24 hours).

Relative (diseases / conditions in which the administration of the drug requires caution):

• functional renal disorders in severe course;
• low threshold of convulsive readiness;
• severe cardiovascular disease;
• age 2-7 years (due to the lack of clinical data on the safety / effectiveness of the drug);
• pregnancy (due to the lack of clinical data on the safety / effectiveness of the drug; the use of Gadovist is possible only when absolutely necessary);
• individual intolerance to the components of the drug.

Method of administration and dosage

Gadovist is given as an intravenous bolus.

Magnetic resonance imaging can be started immediately after drug administration (depending on the study protocol and the pulse sequence used).

Optimal contrast enhancement is usually observed in the following situations:

• MRA with contrast enhancement: during the arterial phase;
• other examinations: over a period of time, which is measured in minutes (depends on the type of damage / tissue).

Before administration, it is necessary to assess the condition of the solution and its packaging for discoloration, the presence of visible particles or violations of the integrity of the package.

The solution should be drawn into the syringe immediately before administration. Do not pierce the rubber stopper of the bottle more than 1 time.

Gadovist in a syringe must be prepared for injection, including removal from the package, immediately before administration.

The solution in the cartridges must be administered by a specialist in accordance with the instructions that come with the equipment for using the cartridges.

Do not mix Gadovist with other solutions, which is due to the lack of compatibility data.

The dosage regimen for adults is determined by the indication. As a rule, a single dose of 0.1 ml / kg is sufficient.

The maximum dose is 0.3 ml / kg.

When performing spinal / cranial MRI, in cases where there are suspicions about the presence of lesions, or if more accurate information about the size, number and prevalence of lesions is needed, additional administration of 0.1–0.2 ml / kg of solution is possible within 30 minutes after the first dose.

In order to exclude metastases or tumor recurrence, an increase in the dose to 0.3 ml / kg is shown, which usually helps to increase the diagnostic efficiency of the study.

When conducting perfusion studies of the brain, the use of an injector is recommended. The dose of Gadovist is 0.3 ml / kg, the rate of administration is from 3 to 5 ml / sec.

When conducting MRA, the dose is usually prescribed as follows (patient weight up to / from 75 kg):

• one scan area: 7.5 / 10 ml;
• more than one area: 15/20 ml.

For children from 7 years old, for all indications, Gadovist is administered at a dose of 0.1 ml / kg.

Side effects

Most often (≥ 0.5% of cases), when using Gadovist, the following disorders are observed: dizziness, headache, nausea.

The most serious adverse reactions are cardiac arrest, anaphylactic / anaphylactoid reactions in severe cases.

The development of allergic reactions after a few hours / days (delayed reactions) is observed in rare cases.

As a rule, side effects are mild / moderate in severity.

Possible violations (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):

• digestive system: often - nausea; infrequently - vomiting; rarely - dry mouth;
• nervous system: often - headache; infrequently - dysgeusia, dizziness, paresthesia; rarely - convulsions, loss of consciousness (fainting), parosmia;
• immune system: infrequently - hypersensitivity / anaphylactic and anaphylactoid reactions (pallor, respiratory arrest, anaphylactic shock, cardiovascular insufficiency, cough, sneezing, hot flashes, laryngeal edema, bronchospasm, cyanosis, decreased body temperature, increased blood pressure, chest pain, Quincke's edema, swelling of the face / eyelids, increased sweating, feeling of heat);
• respiratory system: infrequently - shortness of breath;
• cardiovascular system: rarely - tachycardia, palpitations; with an unknown frequency - cardiac arrest;
• skin and subcutaneous structures: infrequently - erythema, rash (including maculopapular rash with itching), pruritus (including generalized form); with an unknown frequency - nephrogenic systemic fibrosis;
• general disorders and changes at the injection site: infrequently - reactions at the injection site (including hemorrhage, burning, sensation of warmth / cold, pain, hematomas, erythema and rash), sensations of heat; rarely - chills, malaise.

special instructions

In the presence of a known hypersensitivity to the components of the solution, before its introduction, it is necessary to carefully correlate the benefits with the possible risk of its use.

The introduction of Gadovist can proceed with hypersensitivity, anaphylactoid reactions and other manifestations of idiosyncrasy, which are characterized by reactions from various body systems (cardiovascular, respiratory) or skin reactions. Their transition to serious conditions, including shock, is possible.

The likelihood of these violations increases in the following cases:

• the presence of a reaction to a contrast agent with a previous administration;
• bronchial asthma;
• burdened history of allergic diseases.

Typically, these reactions occur within 30-60 minutes after the introduction of Gadovist.

After the end of the diagnostic procedure, it is recommended to monitor the patient's condition.

When conducting examinations, it is necessary to have medicines and equipment used for resuscitation measures.

It should be borne in mind that against the background of the use of beta-blockers with the development of hypersensitivity reactions, resistance to the action of beta-adrenergic agonists, which are usually used in such cases, may be observed.

Before the introduction of Gadovist, it is necessary to check the functional state of the kidneys in all patients (collection of anamnestic data, laboratory tests).

Before the appointment of Gadovist, patients with severe impairment of renal function need to carefully balance the possible benefit with the risk, since the excretion of the contrast medium in these cases slows down.

For patients on hemodialysis, to accelerate the elimination of the drug, it is recommended to consider the advisability of immediately starting hemodialysis after administration of the drug.

There is evidence of the development of nephrogenic systemic fibrosis (NSF) due to the administration of gadolinium-containing contrast media, including Gadovist, in patients with the following diseases / conditions:

• acute renal failure of any severity, which is caused by hepatorenal syndrome;
• renal failure in acute or chronic course (with a glomerular filtration rate <30 ml / min / 1.73 m ²);
• period before / after liver transplantation.

Drug interactions

Drug interaction of Gadovist with other drugs / substances has not been identified.

Due to the lack of data on compatibility, Gadovist should not be mixed with other drugs.

Analogs

There is no information on analogues.

Terms and conditions of storage

Store at temperatures up to 30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

After opening the bottle, Gadovist's solution remains stable for 8-24 hours when stored in the range from 20 to 25 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!