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تعداد آیتم قابل مشاهده باقیمانده : 2 مورد

Gadopentetate dimeglumine (United States: Not available): Pediatric drug information

Gadopentetate dimeglumine (United States: Not available): Pediatric drug information
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Brand Names: Canada
  • Magnevist
Therapeutic Category
  • Diagnostic Agent;
  • Gadolinium-Containing Contrast Agent;
  • Radiological/Contrast Media, Ionic;
  • Radiological/Contrast Media, Paramagnetic Agent
Dosing: Pediatric

Dosage guidance:

Safety: Dosing presented in mL/kg and mmol/kg; use caution. Parenteral solution contains 0.5 mmol/mL of gadopentetate dimeglumine.

Dosage form information: Not available in the United States.

Body, CNS, head, and neck MRI

Body, CNS, head, and neck MRI: Infants, Children, and Adolescents: IV: 0.2 mL/kg (0.1 mmol/kg); maximum dose: 20 mL/dose; imaging must be completed within 1 hour of injection.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: IV:

GFR >30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling. Risk for nephrogenic systemic fibrosis (NSF) development increases as kidney function decreases.

GFR <30 mL/minute/1.73 m2: Use contraindicated.

Dialysis: There are no pediatric-specific recommendations; based on experience in adult patients, the following has been observed:

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Ref).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).

Dosing: Liver Impairment: Pediatric

Infants, Children, and Adolescents: IV:

Mild to moderate impairment: There are no pediatric-specific recommendations in the manufacturer's labeling; based on adult data, no dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); does not undergo significant liver metabolism.

Dosing: Adult

(For additional information see "Gadopentetate dimeglumine (United States: Not available): Drug information")

CNS, head, and neck imaging

CNS, head, and neck imaging: IV: 0.1 mmol/kg (0.2 mL/kg) (maximum single dose: 20 mL); may repeat within 30 minutes if clinically indicated.

Dosing: Kidney Impairment: Adult

GFR >30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Risk for NSF development increases as renal function decreases.

GFR <30 mL/minute/1.73 m2: Use contraindicated.

Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has been shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Ref).

Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).

Dosing: Liver Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); does not undergo significant hepatic metabolism.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Gastrointestinal: Nausea (3%), vomiting (1%)

Hypersensitivity: Hypersensitivity reaction (2%)

Local: Discomfort at injection site (7%), local pain (3%)

Nervous system: Dizziness (2%), headache (9%), paresthesia (1%)

Frequency not defined:

Cardiovascular: Edema, hypotension

Dermatologic: Urticaria

Postmarketing:

Cardiovascular: Angina pectoris, bradycardia, cardiac arrhythmia, chest pain, ECG changes, flushing, increased blood pressure, peripheral edema, substernal pain, syncope, tachycardia, thrombophlebitis, vasodilation

Dermatologic: Diaphoresis, pallor

Endocrine & metabolic: Increased serum iron, increased thirst

Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, dysgeusia, mouth pain, oral paresthesia, sialorrhea, stomach discomfort, toothache, xerostomia

Genitourinary: Urinary incontinence, urinary urgency

Hepatic: Increased liver enzymes, increased serum bilirubin

Hypersensitivity: Angioedema, nonimmune anaphylaxis, type IV hypersensitivity reaction

Local: Injection-site reaction (including bleeding at injection site, burning sensation at injection site, erythema at injection site, inflammation at injection site, injection-site coldness, injection-site paresthesia, injection-site phlebitis, irritation at injection site, local thrombophlebitis, localized edema, localized warm feeling, pain at injection site, swelling at injection site, tissue necrosis at injection site)

Nervous system: Agitation, altered sense of smell, anxiety, asthenia, burning sensation, chills, coma, confusion, decreased body temperature, disorientation, drowsiness, fatigue, feeling hot, hyperesthesia, malaise, seizure, sensation of cold, speech disturbance, tremor

Neuromuscular & skeletal: Arthralgia, back pain, limb pain

Ophthalmic: Eye pain, lacrimation, nystagmus disorder, visual disturbance, visual field defect

Otic: Auditory impairment, otalgia, tinnitus

Renal: Acute kidney injury, increased serum creatinine, nephrogenic systemic fibrosis

Respiratory: Apnea, bradypnea, cough, pharyngolaryngeal pain, pulmonary edema, respiratory distress, rhinorrhea, tachypnea, throat irritation

Miscellaneous: Fever

Contraindications

Hypersensitivity to gadopentetate dimeglumine or any component of the formulation; chronic severe kidney disease (GFR <30 mL/minute/1.73 m2); acute kidney injury; neonates up to 4 weeks of age due to their immature renal function.

Warnings/Precautions

Concerns related to adverse effects:

• BP changes: May cause transient decreases or increases in BP; use caution when driving or operating machinery.

• Extravasation: Vesicant; ensure proper needle/catheter/line placement prior to and during administration. Avoid extravasation. Skin and soft tissue necrosis, thrombosis, fasciitis, and compartment syndrome have occurred (rare) at injection site or limb used for injection; phlebitis and thrombophlebitis may be observed usually within 24 hours of injection and resolves with supportive treatment.

• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear GBCAs (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.

• Hypersensitivity reactions: Hypersensitivity, including anaphylactic reactions (rare), may occur; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Delayed reactions may also occur (within several hours of administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.

• Nephrogenic systemic fibrosis: [Canadian Boxed Warning] : Gadolinium-based contrast agents (GBCAs) exposure may increase the risk for nephrogenic systemic fibrosis (NSF) in patients with renal impairment; avoid use unless GBCA enhanced imaging is essential for diagnostic purposes. Use is contraindicated in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2), and neonates up to 4 weeks of age. The risk appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). NSF, a potentially fatal disease, affects the skin, muscle, and internal organs. All patients should be screened for renal dysfunction prior to administration; estimate GFR through laboratory testing in patients at risk for chronic renal disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.

Disease-related concerns:

• Hemolytic disease: Use with caution in patients with hemolytic disease; transient increase in serum iron have occurred.

• Hepatic impairment: Use with caution in patients with hepatic impairment; transient increases in total bilirubin have occurred.

• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency, generally within 48 hours following administration. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.

• Seizures: Use with caution in patients with seizure disorders; may decrease seizure threshold.

• Sickle cell disease: Use with caution in sickle cell disease; may promote sickling in patients homozygous for sickle cell disease.

Other warnings/precautions:

• Scan interpretation: Use caution when interpreting a contrast-enhanced scan in the absence of a companion unenhanced noncontrast MRI.

Product Availability

Not available in the United States.

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Magnevist Intravenous)

469.01 mg/mL (per mL): $5.04

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Magnevist: 469.01 mg/mL (10 mL, 15 mL, 20 mL) [contains meglumine, pentetic acid (dtpa)]

Administration: Pediatric

Parenteral: IV: Administer at 10 mL/minute or as a bolus at a rate not to exceed 10 mL per 15 seconds. Complete imaging procedure within 1 hour of injection. Following administration, flush line with NS 5 mL.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (Ref). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management (Ref) (see Management of Drug Extravasations for more details).

Administration: Adult

IV: Administer at a rate of 10 mL per minute or as a bolus at a rate of 10 mL per 15 seconds. Complete imaging procedure within 1 hour of injection. Following administration, flush line with NS 5 mL.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (Ref). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Ref).

If using hyaluronidase: Intradermal or SUBQ: Dose varies based on the size of infiltration; inject a total of 5 to 250 units (~100 mL contrast reabsorbed per 15 units of hyaluronidase) around the site of extravasation (Ref).

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F). Protect from light. After opening, vial remains stable for 24 hours at ≤30°C (86°F); discard thereafter.

Use

Canadian labeling: Contrast medium for MRI in infants, children, and adults to visualize CNS lesions with abnormal vascularity in the brain, spine, and associated tissues; extracranial/extraspinal lesions with abnormal vascularity in the head and neck; and body lesions with abnormal vascularity.

Medication Safety Issues
Other safety concerns:

ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See "Warnings/Precautions" section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Gadopentetate dimeglumine crosses the placenta (Marcos 1997).

Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 723 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2023).

Monitoring Parameters

Monitor renal function (prior to administration); signs of hypersensitivity (during and for several hours after procedure); injection site for extravasation; short- and long-term monitoring of signs and symptoms of nephrogenic systemic fibrosis (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye).

Mechanism of Action

Exposure to an external magnetic field induces a large local magnetic field in gadopentetate exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 266 ± 43 mL/kg; does not cross intact blood-brain barrier; distribution half-life: 0.2 ± 0.13 hours.

Half-life elimination: 1.6 ± 0.13 hours.

CrCl ≥60 mL/minute: 2.6 ± 1.2 hours.

CrCl 30 to <60 mL/minute: 4.2 ± 2 hours

CrCl <30 mL/minute: 10.8 ± 6.9 hours.

OR

Mild to moderate kidney impairment: 3 to 4 hours.

Severe kidney impairment: ~11 hours.

Excretion: Urine (~91% as gadopentetate within 24 hours).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Magnevist;
  • (AR) Argentina: Gado tec | Gobbilinio | Magnevist | Opacite | Viewgam;
  • (AT) Austria: Magnegita | Magnetolux | Magnevist;
  • (AU) Australia: Magnevist;
  • (BE) Belgium: Magnevist;
  • (BG) Bulgaria: Magnegita | Magnevist;
  • (BR) Brazil: Magnevistan | Viewgam;
  • (CH) Switzerland: Magnevist | Magnograf;
  • (CN) China: Gadopentetate dime | Gadopentetate dimeglumine | Gadopentetic acid | Gadopentetic acid dimeglumine salt | Magnevist | Meglumine gadopent;
  • (CO) Colombia: Magnevist;
  • (DE) Germany: Gadocon | Gadopent | Gadothek | Magnevist | Magnograf;
  • (DO) Dominican Republic: Magnevist | Pentaglubine;
  • (EC) Ecuador: Magnevist;
  • (EE) Estonia: Magnegita | Magnevist;
  • (EG) Egypt: Magnevist;
  • (ES) Spain: Magnevist | Magnograf;
  • (ET) Ethiopia: Gadopentetate dimeglumine;
  • (FI) Finland: Magnevist;
  • (FR) France: Magnevist;
  • (GB) United Kingdom: Magnevist;
  • (GR) Greece: Magnegita | Magnetolux | Magnevist;
  • (HR) Croatia: Magnevist;
  • (HU) Hungary: Magnevist;
  • (ID) Indonesia: Magnevist;
  • (IN) India: Magnevist | Magnilek | Magniscan;
  • (IT) Italy: Magnegita | Magnevist;
  • (JO) Jordan: Magnevist;
  • (JP) Japan: Magnevist;
  • (KE) Kenya: Magnevist | Magnilek;
  • (KR) Korea, Republic of: Magnevist | Mrbester;
  • (LT) Lithuania: Magnegita | Magnevist;
  • (LV) Latvia: Magnegita | Magnevist;
  • (MY) Malaysia: Magnevist;
  • (NL) Netherlands: Magnevist;
  • (NO) Norway: Magnevist;
  • (PH) Philippines: Magnevist;
  • (PK) Pakistan: Magnevist;
  • (PL) Poland: Magnevist;
  • (PR) Puerto Rico: Magnevist;
  • (PT) Portugal: Magnevist;
  • (PY) Paraguay: Magnevist | Viewgam;
  • (QA) Qatar: Magnevist;
  • (RO) Romania: Magnevist;
  • (RU) Russian Federation: Gadopentetic acid tl | Magnevist;
  • (SE) Sweden: Magnevist;
  • (SG) Singapore: Magnevist;
  • (SI) Slovenia: Magnevist;
  • (SK) Slovakia: Magnetolux | Magnevist;
  • (SR) Suriname: Magnevist;
  • (TH) Thailand: Magnevist;
  • (TN) Tunisia: Magnevist;
  • (TR) Turkey: Emaray | Magnevist;
  • (TW) Taiwan: Magnevist;
  • (UA) Ukraine: Magnevist | Tomovist;
  • (ZA) South Africa: Magnevist;
  • (ZW) Zimbabwe: Magnevist
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee Opinion No. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. Erratum in: Obstet Gynecol. 2018;132(3):786. [PubMed 28937575]
  2. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published 2023. Accessed May 17, 2023.
  3. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published 2018. Accessed March 18, 2024.
  4. Bellin MF, Jakobsen JA, Tomassin I, et al; Contrast Media Safety Committee Of The European Society Of Urogenital Radiology. Contrast medium extravasation injury: guidelines for prevention and management. Eur Radiol. 2002;12(11):2807-2812. doi: 10.1007/s00330-002-1630-9. [PubMed 12386778]
  5. Centers for Disease Control, “Nephrogenic Fibrosing Dermopathy Associated with Exposure to Gadolinium-Containing Contrast Agents: St. Louis, Missouri,” MMWR Weekly Rep, 2007, 56(07):137-141.
  6. Expert Panel on MR Safety, "ACR Guidance Document on MR Safe Practices: 2013," J Magn Reson Imaging, 2013, 37(3):501-30. [PubMed 23345200]
  7. Grobner T, “Gadolinium - A Specific Trigger for the Development of Nephrogenic Fibrosing Dermopathy and Nephrogenic Systemic Fibrosis,” Nephrol Dial Transplant, 2006, 21(4):1104-8. [PubMed 16431890]
  8. Joffe P, Thomsen HS, and Meusel M, "Pharmacokinetics of Gadodiamide Injection in Patients with Severe Renal Insufficiency and Patients Undergoing Hemodialysis or Continuous Ambulatory Peritoneal Dialysis," Acad Radiol, 1998, 5(7):491-502. [PubMed 9653466]
  9. Kubik-Huch RA, Gottstein-Aalame NM, Frenzel T, et al. Gadopentetate dimeglumine excretion into human breast milk during lactation. Radiology. 2000;216(2):555-558. [PubMed 10924585]
  10. Kuo PH, Kanal E, Abu-Alfa AK, et al, "Gadolinium-Based MR Contrast Agents and Nephrogenic Systemic Fibrosis," Radiology, 2007, 242(3):647-9. [PubMed 17213364]
  11. MacCara ME. Extravasation: a hazard of intravenous therapy. Drug Intell Clin Pharm. 1983;17(10):713-717. [PubMed 6628223]
  12. Magnevist (gadopentetate dimeglumine) [product monograph]. Mississauga, Ontario, Canada: Bayer Inc; June 2024.
  13. Marcos HB, Semelka RC, and Worawattanakul S, "Normal Placenta: Gadolinium-Enhanced Dynamic MR Imaging," Radiology, 1997, 205(2):493-6. [PubMed 9356634]
  14. Okada S, Katagiri K, Kumazaki T, et al, “Safety of Gadolinium Contrast Agent in Hemodialysis Patients,” Acta Radiol, 2001, 42(3):339-41. [PubMed 11350296]
  15. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Management of extravasation injuries: a focused evaluation of noncytotoxic medications. Pharmacotherapy. 2014;34(6):617-632. doi: 10.1002/phar.1396. [PubMed 24420913]
  16. Rofsky NM, Weinreb JC, Litt AW. Quantitative analysis of gadopentetate dimeglumine excreted in breast milk. J Magn Reson Imaging. 1993;3(1):131-132. [PubMed 8428080]
  17. Rowlett J. Extravasation of contrast media managed with recombinant human hyaluronidase. Am J Emerg Med. 2012;30(9):2102.e1-3. doi: 10.1016/j.ajem.2012.03.005. [PubMed 22633726]
  18. Schmiedl U, Maravilla KR, Gerlach R, Dowling CA. Excretion of gadopentetate dimeglumine in human breast milk. AJR Am J Roentgenol. 1990;154(6):1305-1306. [PubMed 2110745]
  19. Stefanos SS, Kiser TH, MacLaren R, Mueller SW, Reynolds PM. Management of noncytotoxic extravasation injuries: a focused update on medications, treatment strategies, and peripheral administration of vasopressors and hypertonic saline. Pharmacotherapy. 2023;43(4):321-337. doi:10.1002/phar.2794 [PubMed 36938775]
  20. Tremblay E, Thérasse E, Thomassin-Naggara I, et al, "Quality Initiatives: Guidelines for Use of Medical Imaging During Pregnancy and Lactation," Radiographics, 2012, 32(3):897-911. [PubMed 22403117]
  21. Wang PI, Chong ST, Kielar AZ, et al, "Imaging of Pregnant and Lactating Patients: Part 1, Evidence-Based Review and Recommendations," AJR Am J Roentgenol, 2012, 198(4):778-84. [PubMed 22451541]
  22. Wanko SO, Telen MJ, “Transfusion Management in Sickle Cell Disease,” Hematol Oncol Clin N Am, 2005, 19(5):803-26. [PubMed 16214645]
  23. Webb JA, Thomsen HS, and Morcos SK, "The Use of Iodinated and Gadolinium Contrast Media During Pregnancy and Lactation," Eur Radiol, 2005, 15(6):1234-40. [PubMed 15609057]
  24. Widmark JM, “Imaging-related Medications: A Class Overview,” Proc (Bayl Univ Med Cent), 2007, 20(4):408-17. [PubMed 17948119]
  25. Zenk KE. Management of intravenous extravasations. Infusion. 1981;5(4):77-79.
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