Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
GADODIAMIDE (UNII: 84F6U3J2R6) (GADODIAMIDE - UNII:84F6U3J2R6)
GE Healthcare Inc.
INTRAVENOUS
PRESCRIPTION DRUG
OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues [see Clinical Studies (14.1)]. OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [see Clinical Studies (14.2)]. OMNISCAN is contraindicated in patients with: - Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2 ) or acute kidney injury - Prior hypersensitivity to OMNISCAN Risk Summary GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive (see Data) . In animal reproduction studies, no adverse fetal effects were observed with administration of gadodiamide to pregnant rats during organogenesis at doses 1.3 times the maximum human dose based on body surface area (see Data) . Because of the potential risks of gadolinium to the fetus, use OMNISCAN only if imaging is essential during pregnancy and cannot be delayed. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Contrast enhancement is visualized in the human placenta and fetal tissues after maternal GBCA administration. Cohort studies and case reports on exposure to GBCAs during pregnancy have not reported a clear association between GBCAs and adverse effects in the exposed neonates. However, a retrospective cohort study, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI. Overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of GBCAs in pregnancy. Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. Reproductive Toxicology Gadodiamide has been shown to have an adverse effect on embryo-fetal development in rabbits at dosages as low as 0.5 mmol/kg/day for 13 days during gestation (approximately 0.6 times the human dose based on a body surface area comparison). These adverse effects are observed as an increased incidence of flexed appendages and skeletal malformations which may be due to maternal toxicity since the body weight of the dams was reduced in response to gadodiamide administration during pregnancy. In rat studies, fetal abnormalities were not observed at doses up to 2.5 mmol/kg/day for 10 days during gestation (1.3 times the maximum human dose based on a body surface area comparison); however, maternal toxicity was not achieved in these studies and a definitive conclusion about teratogenicity in rats at doses above 2.5 mmol/kg/day cannot be made. Risk Summary There are no data on the presence of gadodiamide in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. Additionally, there is limited GBCA gastrointestinal absorption in the breast-fed infant. Animal data show transfer of gadodiamide into rat milk (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNISCAN and any potential adverse effects on the breastfed infant from OMNISCAN or from the underlying maternal condition. Data Gadodiamide is detected in the breast milk of rats injected intravenously with 0.3 mmol/kg up to 4 hours post dosing and is below the level of quantification after 8 hours. The safety and efficacy of OMNISCAN at a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients over 2 years of age based on adequate and well controlled studies of OMNISCAN in adults, a pediatric CNS imaging study, and safety data in the scientific literature. However, the safety and efficacy of doses greater than 0.1 mmol/kg and of repeated doses have not been studied in pediatric patients. Pharmacokinetics of OMNISCAN have not been studied in pediatrics. The glomerular filtration rate of neonates and infants is much lower than that of adults. The pharmacokinetics volume of distribution is also different. Therefore, the optimal dosing regimen and imaging times in patients under 2 years of age have not been established. In clinical studies of OMNISCAN, 243 patients were between 65 and 80 years of age while 15 were over 80 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity in the elderly cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. OMNISCAN is excreted by the kidney, and the risk of toxic reactions to OMNISCAN may be greater in patients with impaired renal function [see Warnings and Precautions (5.4)]. Because elderly patients are more likely to have decreased renal function, select dose carefully and consider assessment of renal function before OMNISCAN use. Dose adjustments in renal or hepatic impairment have not been studied. Caution should be exercised in patients with impaired renal insufficiency [see Warnings and Precautions (5.2, 5.5)].
OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide in rubber stoppered vials. OMNISCAN is supplied in the following sizes: 10 mL vial, box of 10 (NDC 0407-0690-10) 15 mL fill in 20 mL vial, box of 10 (NDC 0407-0690-15) 20 mL vial, box of 10 (NDC 0407-0690-20) Protect OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small cracks in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen. Store OMNISCAN at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP].
New Drug Application
GE Healthcare Inc. ---------- MEDICATION GUIDE OMNISCAN™ (OMNI-SCAN) (GADODIAMIDE) INJECTION FOR INTRAVENOUS USE This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 1/2024 What is OMNISCAN? • OMNISCAN is a prescription medicine called a gadolinium-based contrast agent (GBCA). OMNISCAN, like other GBCA medicines, is used with a magnetic resonance imaging (MRI) scanner. • An MRI exam with a GBCA, including OMNISCAN, helps your doctor to see problems better than an MRI exam without a GBCA. • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. What is the most important information I should know about OMNISCAN? • GBCAs like OMNISCAN may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if OMNISCAN is safe and effective with intrathecal use. OMNISCAN is not approved for this use. • OMNISCAN contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). • It is not known how gadolinium may affect you, so far, studies have not found harmful effects in patients with normal kidneys. • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance. • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body. • Some people Soma hati kamili
OMNISCAN- GADODIAMIDE INJECTION GE HEALTHCARE INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMNISCAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMNISCAN. OMNISCAN™ (GADODIAMIDE) INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1993 WARNING: RISK ASSOCIATED WITH INTRATHECAL USE AND NEPHROGENIC SYSTEMIC FIBROSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INTRATHECAL ADMINISTRATION OF GADOLINIUM-BASED CONTRAST AGENTS (GBCAS) CAN CAUSE SERIOUS ADVERSE REACTIONS INCLUDING DEATH, COMA, ENCEPHALOPATHY, AND SEIZURES. OMNISCAN IS NOT APPROVED FOR INTRATHECAL USE (5.1). GBCAS INCREASE THE RISK FOR NEPHROGENIC SYSTEMIC FIBROSIS AMONG PATIENTS WITH IMPAIRED ELIMINATION OF THE DRUGS. AVOID USE OF OMNISCAN IN THESE PATIENTS UNLESS THE DIAGNOSTIC INFORMATION IS ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRASTED MRI OR OTHER MODALITIES. DO NOT ADMINISTER OMNISCAN TO PATIENTS WITH: CHRONIC, SEVERE KIDNEY DISEASE (GFR < 30 ML/MIN/1.73M ), OR ACUTE KIDNEY INJURY (4). SCREEN PATIENTS FOR ACUTE KIDNEY INJURY AND OTHER CONDITIONS THAT MAY REDUCE RENAL FUNCTION. FOR PATIENTS AT RISK FOR CHRONICALLY REDUCED RENAL FUNCTION (E.G., AGE > 60 YEARS, HYPERTENSION OR DIABETES), ESTIMATE THE GLOMERULAR FILTRATION RATE (GFR) THROUGH LABORATORY TESTING (5.2). RECENT MAJOR CHANGES Boxed Warning 1/2024 Warnings and Precautions, Risk Associated with Intrathecal Use (5.1) 1/2024 INDICATIONS AND USAGE OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues (1.1) Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space (1.2) DOSAGE AND ADMINISTRATION CNS – Adults and Pediatrics; 2 to 16 years of age: 0.2 mL/kg (0.1 mmol/kg) (2.1, 2.4) Body – Adults and Pediatrics; 2 to 16 years of age: Kidney Soma hati kamili