Adverse Effects Interactions and Pharmacokinetics

Dosages of up to 30 mg rhDNase I per day were well tolerated in healthy volunteers and CF patients 69,87 . Severe bronchospasms or anaphylactic reactions, as seen after inhalation of bovine DNase I, have never been observed with rhDNase I. The most common adverse effects reported after daily inhalation of 2.5 mg rhDNase I were voice alterations hoarseness , pharyngitis, rash, laryngitis, and conjunctivitis 74,76,78 . All these events are generally mild and transient. In patients with severe...

References

Kreuder, V., et al., Isolation, characterization and crystallization of deoxyribonuclease-I from bovine and rat parotid-gland and its interaction with rabbit skeletal-muscle actin, Eur. J. Biochem., 139, 389-400, 1984. 2. Shiokawa, D. and Tanuma, S., Characterization of human DNase I family endonucleases and activation of DNase gamma during apoptosis, Biochemistry, 40, 143-152, 2001. 3. Evans, C.J. and Aguilera, R.J., DNase II Genes, enzymes and function, Gene, 322, 1-15, 2003. 4. Nadano,...

Development of Ceredase

With the proof of concept demonstrated, significant effort was required to scale up the extraction and purification of placental glucocerebrosidase to make it clinically and commercially viable. The magnitude of this challenge can be appreciated by the fact that it took 20,000 placentas to extract enough p-glucocerebrosidase to treat 1 patient for 1 year. Genzyme Corporation adapted the purification and carbohydrate remodeling schemes developed by Brady, et al., to improve both the purification...