GADOVIST PFS Injection

GADOVIST PFS Injection is used for: For use in adults and children of all ages (including term newborns) for: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI); Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions; Contrast enhancement in magnetic resonance angiography; MRI of pathologies of the whole body

Administer intravenously as a bolus injection. Dosing is expressed in mL/kg body weight. Cranial and spinal MRI: Adult: 0.1 mL/kg. Administer a second dose of 0.2 mL/kg within 30 minutes if needed to produce adequate contrast Kidneys and liver: Adult: 0.1 mL/kg Angiography: Adult: 0.1 – 0.3 mL/kg NOTE: The vials are single use only. The rubber stopper must be pierced only once. Monitor the patient for at least 30 minutes after administration, to monitor for hypersensitivity reactions. Screen for renal impairment before starting gadobutrol. Use the lowest effective dose. Use with caution due to underdeveloped renal function in infants up to 1 year of age. It may be preferable to use macrocyclic agents in certain patients such as those who may need repeated doses and in vulnerable patients e.g. children and pregnant women

Administer intravenously as a bolus injection. Dosing is expressed in mL/kg body weight. Cranial and spinal MRI: Infant & Child: 0.1 mL/kg Kidneys and liver: Infant & Child: 0.1 mL/kg Angiography: Infant & Child: 0.1 mL/kg NOTE: The vials are single use only. The rubber stopper must be pierced only once. Monitor the patient for at least 30 minutes after administration, to monitor for hypersensitivity reactions. Screen for renal impairment before starting gadobutrol. Use the lowest effective dose. Use with caution due to underdeveloped renal function in infants up to 1 year of age. It may be preferable to use macrocyclic agents in certain patients such as those who may need repeated doses and in vulnerable patients e.g. children and pregnant women

Prepare the medication for injection immediately before the procedure. The vials are single use only. The rubber stopper must be pierced only once. Visually inspect the solution before use. Monitor the patient for at least 30 minutes after administration, to monitor for hypersensitivity reactions. Screen for renal impairment before starting gadobutrol

Hypersensitivity to gadobutrol or any excipients

Conditions that increase the risk of hypersensitivity reactions, such as history of bronchial asthma, history of allergic disorders. Severe renal impairment (GFR <30 mlL/min/1.73 m²). Newborns and infants up to 1 year old. Seizure disorders. Avoid use during pregnancy unless an enhanced MR investigation is necessary, and no suitable alternative is available. Minimal amounts enter the breast milk. Harm to the breast-fed infant is considered unlikely

Recommendations on the use of Gadobutrol in Pregnancy & Lactation: There is limited experience with the use of Gadobutrol during pregnancy and lactation. Gadobutrol is one of the most stable gadolinium-based contrast agents (GBCAs), theoretically making it one of the safer drugs. Till date, no adverse fetal outcome has been reported with gadobutrol. The guidelines so far have recommended that GBCAs should only be used if their usage is considered critical and the potential benefits to the patient or fetus outweigh the possible but unknown risk of fetal exposure to free gadolinium ions. GBCAs with lowest risk of nephrogenic systemic fibrosis (NSF) e.g., Gadobutrol should be used at the lowest possible dose to achieve diagnostic results; high risk agents such as Gadopentetic acid are contraindicated (ACR Committee on Drugs and Contrast Media, 2020; Committee on Obstetric Practice, 2018; Contrast Media Safety Committee, 2018; Patenaude et al., 2014). The amount of GBCA excreted into the breastmilk and absorbed by the infant’s gut is very small; breastfeeding is considered safe after receiving such an agent. However, if the mother is concerned about any potential ill effects to the infant, she may abstain from breastfeeding from the time of contrast administration for a period of 12 to 24 hours (ACR Committee on Drugs and Contrast Media, 2020). ESUR (European Society of Urogenital Radiology) Guidelines on the Use of Gadolinium-Based Contrast Agents during Pregnancy & Lactation (Contrast Media Safety Committee, 2018): When enhanced MR-examination is well-indicated, the smallest possible dose of a macrocyclic gadolinium contrast agent may be given to the pregnant female. These agents have lowest risk of nephrogenic systemic fibrosis (NSF) and include Gadobutrol, Gadoterate meglumine, and Gadoteridol. Following administration of gadolinium-based agents to the mother during pregnancy, no neonatal tests are necessary. Agents with highest risk of NSF (e.g., Gadopentetic acid or Gadopentetate dimeglumine) are contraindicated. Breastfeeding may be continued normally when macrocyclic gadolinium-based contrast agents are given to the mother. With these low-risk agents, discarding the breastmilk in the 24 hours after contrast medium is not considered necessary but the patient can discuss with the doctor if she wishes to do this. Breastfeeding should be avoided for 24 hours after contrast medium if high-risk agents are used. References: 1. ACR Committee on Drugs and Contrast Media. (2020). ACR manual on contrast media. American College of Radiology. http://www.acr.org/~/link.aspx?_id=29C40D1FE0EC4E5EAB6861BD213793E5&_z=z 2. Committee on Obstetric Practice. (2018). Committee Opinion No. 723: Guidelines for Diagnostic Imaging During Pregnancy and Lactation. Obstetrics and Gynecology, 130(4), e210–e216. https://doi.org/10.1097/AOG.0000000000002355 3. Contrast Media Safety Committee. (2018). ESUR Guidelines on contrast agents (10th version). European Society of Urogenital Radiology. http://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf 4. Patenaude, Y., Pugash, D., Lim, K., Morin, L., Diagnostic Imaging Committee, Lim, K., Bly, S., Butt, K., Cargill, Y., Davies, G., Denis, N., Hazlitt, G., Morin, L., Naud, K., Ouellet, A., Salem, S., & Society of Obstetricians and Gynaecologists of Canada. (2014). The use of magnetic resonance imaging in the obstetric patient. Journal of Obstetrics and Gynaecology Canada: JOGC = Journal d’obstetrique et Gynecologie Du Canada: JOGC, 36(4), 349–363. https://doi.org/10.1016/s1701-2163(15)30612-5

Side effects of Gadobutrol : Common adverse effects: - Dizziness, headache - Nausea Uncommon & rare adverse effects: - Cardiac arrest - Dry mouth - Dysgeusia, paraesthesia - Dyspnoea - Erythema, pruritus, rash - Feeling hot, feeling cold - Hypersensitivity/anaphylactoid reactions - Injection site reactions such as extravasation, burning, coldness, warmth, pain, hematoma - Malaise - Nephrogenic Systemic Fibrosis (NSF) - Tachycardia, palpitations - Vomiting

GADOVIST PFS 604.72mg/ml Injection manufactured by BAYER PHARMA AG. Its generic name is Gadobutrol. GADOVIST PFS is availble in United Arab Emirates. Farmaco UAE drug index information on GADOVIST PFS Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.