The most serious and common adverse drug reactions reported with agalsidase beta are infusion-related, consisting primarily of fever and chills or rigors, as well as tachycardia, hypertension, tightness of the throat, chest pain or tightness, dyspnea, abdominal pain, pruritus, urticaria, nausea and vomiting, lip or ear edema, and rash. These reactions occurred during the infusion [...]
Continue reading " Agalsidase beta: SAFETY AND CONTRAINDICATIONS "
Eng et al.,2001 Eng et al. evaluated agalsidase beta in a phase 1/2, single-center, open-label, dose-ranging study involving 15 patients with Fabry disease. The patients received one infusion of agalsidase beta at different dosage regimens for a total of five infusions. Results demonstrated a mean decrease in the GL-3 content of the liver by 84%, [...]
BACKGROUND Fabry disease is a rare X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A. This deficiency results in progressive accumulation of glyco-sphingolipids, especially globotriaosylceramide (GL-3), in numerous tissues, particularly in the vascular endothelium throughout the body. Clinical manifestations of GL-3 accumulation include skin lesions; hypohidrosis; neuropathy; gastrointestinal problems, including diarrhea and [...]
Rosenberg and colleagues conducted a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of a one-time dose of eszopi-clone using the “first-night effect” model of transient insomnia. The first-night effect refers to the insomnia that commonly occurs when someone is assessed in a sleep laboratory.
Continue reading " Eszopiclone (Lunesta): Rosenberg et al. "
Eszopiclone, a non-benzodiazepine hypnotic agent, is a pyrrolopyrazine derivative of the cyclopyrrolone class. It is the (S)-configuration isomer of zopi-clone (Imovane™, Aventis), a hypnotic agent that has been available in Europe since 1987. Eszopiclone is a white to light-yellow crystalline solid. According to the manufacturer, it is very slightly soluble in water, slightly soluble in [...]
Continue reading " Eszopiclone (Lunesta): CHEMICAL AND PHYSICAL PROPERTIES "
Because eszopiclone is metabolized via CYP3A4 and CYP2E1, caution is recommended when a potent CYP3A4 inhibitor (e.g., ketoconazole, itracon-azole, clarithromycin, troleandomycin, nefazodone, ritonavir, nelfinavir) is co-administered. A lower dose, such as 1 mg, should be prescribed when es-zopiclone is used with any of these drugs.
Continue reading " Eszopiclone (Lunesta): DRUG INTERACTIONS "
On the basis of two published clinical trials (see “Clinical Efficacy” on page 389), the most commonly reported adverse drug event (ADE) was an unpleasant taste, with an incidence of 17% to 26%, with no dose-dependent relationship. Somnolence was reported equally at all doses, with an incidence of 4% to 9%. However, headache was reported [...]
Continue reading " Eszopiclone (Lunesta): ADVERSE DRUG EFFECTS "
