引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
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| Australia: Ferric carboxymaltose and low blood phosphorous (English only) |
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Therapeutic Goods Administration (TGA) is reminding health professionals that symptomatic hypophosphataemia is a known risk associated with use of ferric carboxymaltose and it is recommended that health professionals routinely evaluate patient risk factors before commencing this medicine and follow up at-risk patients. Ferric carboxymaltose is marketed in Australia under the brand name Ferinject.
Ferric carboxymaltose is known to cause mild asymptomatic transient hypophosphataemia. Ferric carboxymaltose is also associated with a rare risk of severe, symptomatic hypophosphataemia. In clinical trials, the minimum serum phosphate values were obtained after approximately 2 weeks, and in most cases returned to baseline values by 12 weeks following ferric carboxymaltose treatment. The Ferinject Product Information was updated in 2019 to include additional details about this precaution.
Mild hypophosphataemia is usually asymptomatic, but may present with pain, nausea, and asthenia. Severe hypophosphataemia may be associated with symptomatic physiological dysfunction. Acute manifestations include: muscular symptoms (weakness, asthenia, leading to progressive myopathy including cardiorespiratory compromise and death), neurological symptoms (tingling, altered mental status, seizures, paralysis), haematological changes.
The development of clinically significant hypophosphataemia following parenteral iron is more likely in patients on long-term iron replacement, and in those with lower baseline ferritin, gastrointestinal disorders, malnutrition or other causes of phosphate deficiency (low whole body phosphate).
Hypophosphataemia can be the cause of asthenia, fatigue, muscular weakness, breathlessness, tachycardia and headaches, which might otherwise be misdiagnosed as failure to respond to treatment of iron deficiency anaemia, therefore consider hypophosphataemia as a potential reason for a patients' symptoms continuing after use of ferric carboxymaltose.
In pregnancy the maximum cumulative dose is restricted to 1000 mg for patients with Hb ≥90 g/L, or 1500 mg in patients with Hb <90 g/L. No more than 1000 mg iron should be administered in one week.
The TGA adverse event database has 15 reports of hypophosphataemia with ferric carboxymaltose (including 14 where it was the sole suspected medicine). There were six reports of hypophosphataemia relating to iron polymaltose, and no reports involving other parenteral iron products. For ferric carboxymaltose, serum phosphate was reported in six cases, with severe hypophosphataemia (<0.3mmol/L) reported in four cases. Five cases reported systemic symptoms of hypophosphataemia (fatigue, malaise, lethargy) and skeletal manifestations of hypophosphataemia were reported in three cases. Most patients recovered with oral phosphate, calcitriol or with IV phosphate supplementation, but the outcome was reported as 'not recovered' in two cases. Time to onset, where reported, was generally from a few days up to two weeks after starting ferric carboxymaltose.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/ferric-carboxymaltose-and-low-blood-phosphorous
In Hong Kong, Ferinject Solution For Injection/Infusion 100mg/2ml (HK-64137) and Ferinject Solution For Injection/Infusion 500mg/10ml (HK-64138) are pharmaceutical products registered by Zuellig Pharma Ltd, and are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to ferric carboxymaltose. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Feb 28, 2020
Issued at HKT 16:00
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