Oleh Admin Kalbe Medical pada July 11, 2013 06:15

Rekomendasi Peringatan Baru dari European Medicine’s Agency terhadap Terapi Suplementasi Zat Besi Intravena

Regulator obat Uni Eropa, European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) mengeluarkan rekomendasi penambahan peringatan pada package insert terapi suplementasi zat besi intravena, yang digunakan untuk terapi anemia defisiensi besi. Adapun rekomendasi peringatan yang dimaksud adalah risiko reaksi alergi yang berpotensi fatal.1 Rekomendasi tersebut dikeluarkan pada tanggal 28 Juni 2013.1,2 Ada tiga jenis preparat suplemen zat besi intravena antara lain iron dextran injection, iron sucrose injection, dan sodium ferric gluconate complex in sucrose injection.

Pertimbangan ulang terhadap efek samping reaksi alergi yang berpotensi fatal ini berdasarkan pada fakta bahwa kejadian reaksi alergi serius, termasuk reaksi anafilaktik, mengalami peningkatan pada subjek di wilayah Eropa dan Amerika Utara antara periode 2003-2009. Kenaikan kejadian efek samping tertinggi ditemukan dari produk iron dextran injection.1 Terjadi peningkatan yang signifikan pada laporan kejadian efek samping keseluruhan dari semua preparat zat besi intravena pada periode 2008-2009, jika dibandingkan dengan periode 2003-2009 secara keseluruhan.1,3 Jumlah kejadian efek samping yang dilaporkan pada penggunaan iron dextran injection adalah sekitar 93-100 kasus per 1 juta dosis ekuivalen, iron sucrose sekitar 8-23 kasus per 1 juta dosis ekuivalen, dan sodium ferric gluconate sekitar 10-28 kasus per 1 juta dosis ekuivalen.

Tidak ada perbedaan bermakna dalam hal frekuensi efek samping reaksi alergi pada ketiga sediaan yang disebutkan sebelumnya.

Poin penting dikeluarkannya rekomendasi peringatan ini menyangkut beberapa hal. Pertama karena kekhawatiran terhadap kejadian efek samping reaksi alergi serius yang mungkin dapat timbul, terlepas dari apapun hasil pemeriksaan reaksi terhadap dosis uji (test dose). Dan yang kedua karena kekhawatiran terhadap terapi suplementasi zat besi pada ibu hamil. Di lain pihak, terapi suplementasi zat besi intravena ini sangat bermanfaat dan EMA menilai bahwa manfaat terapi ini melebihi potensi risiko efek sampingnya.2

Terapi suplementasi zat besi intravena biasanya diberikan kepada pasien yang mengalami gangguan absorbsi zat besi per oral, ataupun kepada pasien yang tidak dapat mentoleransi terapi suplementasi zat besi per oral.2

Bersama dengan rekomendasi ini, EMA juga menginformasikan kepada para praktisi kesehatan, bahwa sehubungan dengan produk suplemen zat besi intravena:2
1. Semua jenis produk suplemen zat besi intravena dapat mengakibatkan reaksi hipersensitivitas serius yang berpotensi fatal.
2. Pemeriksaan reaksi terhadap dosis uji (test dose) tidak lagi dianjurkan karena tidak bernilai prediktif bagi reaksi alergi tersebut.
3. Terapi suplementasi zat besi intravena hanya boleh diberikan oleh tenaga kesehatan terlatih.
4. Sewaktu memberikan suplementasi zat besi secara intravena, dokter wajib memantau pasien terhadap kemungkinan timbulnya gejala-gejala alergi, sampai minimal 30 menit setelah pemberian zat besi.
5. Apabila timbul gejala alergi, segera hentikan terapi dan pertimbangkan memulai terapi terhadap reaksi hipersensitivitas.
6. Risiko reaksi hipersensitivitas meningkat pada pasien dengan riwayat penyakit atau gangguan pada sistem imunitas, riwayat alergi, dan pasien dengan riwayat penyakit terkait alergi yang berat (misalnya asma, dermatitis atopik).
7. Pemberian suplementasi zat besi secara intravena kepada ibu hamil hanya boleh dilakukan seperlunya, hanya pada trimester kedua dan ketiga, serta harus memperhatikan imbang antara efektivitas dan risiko terapi. (HLM)



Image: Ilustrasi
Referensi
1.Lowes R. New precautions recommended for IV iron supplements. Medscape [Internet]. 2013 [cited 2013 Jul 4]. Available from:
http://www.medscape.com/viewarticle/807081_print
2.European Medicines Agency. EMA/377372/2013: New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines [Internet]. 2013 [cited 2013 Jul 4]. Available from:
 
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/06/WC500144874.pdf
3.Keller DM. Iron dextran has highest adverse effects rate of all IV iron products. Medscape [Internet]. 2010 [cited 2013 Jul 4]. Available from:
http://www.medscape.com/viewarticle/724539_print

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