Efficacy and Safety of RAZADYNE® ER

RAZADYNE® ER has been proven to help patients with mild to moderate dementia of the AD type maintain cognition and function. In clinical trials, RAZADYNE® ER was well tolerated by most patients. Generally, adverse events were mild and temporary.4

RAZADYNE® ER can help many patients stay engaged by:

  • Maintaining cognitive and functional abilities3
  • Helping patients help themselves
  • Offering convenient, once-daily dosing

Click the links to learn more about the clinical experience with RAZADYNE® ER.

RAZADYNE® ER: Helped many patients maintain cognition and function at home and in the community.

In a 6-month randomized, double-blind, placebo-controlled clinical trial, patients with mild to moderate dementia of the Alzheimer's type treated with RAZADYNE® ER showed significant improvement in cognition compared with those treated with placebo. They also maintained their level of interaction, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Patients treated with placebo generally declined in these areas.3

*"Activities of daily living" include eating, walking, using the restroom, bathing, grooming, dressing, physical performance, using common household appliances, conversation, tending to the home, managing personal belongings, travel, shopping, knowledge of current events, reading, and writing.

Primary outcome measures were ADAS-cog/11 and the Clinician's Interview-Based Impression of Change—plus caregiver input. Observed case analysis shown at months 2, 3, and 6. At each of these observations, there was no statistically significant difference between the RAZADYNE® and RAZADYNE® ER formulations. Last observation carried forward (LOCF) shown at endpoint.3

† Results shown are from a 6-month, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study comparing the safety, tolerability, and efficacy of RAZADYNE® ER with that of placebo in patients with mild to moderate Alzheimer's disease (AD). In the study, 965 patients were randomized and received at least 1 dose of placebo, RAZADYNE®, or RAZADYNE® ER. Results for patients treated with RAZADYNE® are not shown.

The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) inventory was used as a secondary outcome measure. Observed case analysis shown at months 2, 3,and 6. At each of these observations, there was no statistically significant difference between the RAZADYNE® and RAZADYNE® ER formulations. LOCF shown at endpoint.3

"Activities of daily living" include eating, walking, using the restroom, bathing, grooming, dressing, physical performance, using common household appliances, conversation, tending to the home, managing personal belongings, travel, shopping, knowledge of current events, reading, and writing.

When they know something is wrong... Let them know about the safety profile of RAZADYNE® ER.

Listed below are some of the adverse events experienced by patients during RAZADYNE® ER therapy from a pivotal study. The most frequent adverse events in the placebo-controlled trial with dose escalation every 4 weeks occurring in at least 5% of patients receiving RAZADYNE® ER and at least twice the rate of placebo.4

Most frequent adverse events

In clinical trials, the most frequent adverse events with RAZADYNE® ER were similar to those seen with RAZADYNE®.

The most frequent adverse events that occurred with RAZADYNE® were nausea, vomiting, diarrhea, anorexia, and weight loss.

IMPORTANT SAFETY INFORMATION

Anesthesia—Cholinesterase inhibitors, such as galantamine hydrobromide, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular events—Because of their pharmacologic action, cholinesterase inhibitors have vagotonic effects on the sinoatrial and atrioventricular (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with supraventricular cardiac conduction disorders or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine hydrobromide was associated with more frequent reports of bradycardia and syncope vs placebo.

Gastrointestinal—Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.

Genitourinary—Cholinesterase inhibitors may cause bladder outflow obstruction.

Neurological conditions—Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. In clinical trials, there was no increase in the incidence of convulsions with galantamine hydrobromide compared with placebo.

Pulmonary conditions—Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Deaths in subjects with mild cognitive impairment (MCI)—In controlled trials in elderly subjects with MCI, 13 subjects on RAZADYNE® (n=1026) and 1 subject on placebo (n=1022) died of various causes. About half of the RAZADYNE® deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE® and RAZADYNE® ER are not indicated for the treatment of MCI.

Hepatic or renal impairment—In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE® or RAZADYNE® ER in patients with severe hepatic impairment or severely impaired renal function (CLcr <9 mL/min) is not recommended.

  • Samochocki M, Zerlin M, Jostock R, et al. Galantamine is an allosterically potentiating ligand of the human α4/β2 nAChR. Acta Neurol Scand. 2000;176(suppl):68-73.
  • Brodaty H, Corey-Bloom J, Potocnik FCV, et al. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer's disease. Dement Geriatr Cogn Disord. 2005;20:120-132.
  • RAZADYNE ER [Prescribing Information]. Titusville, NJ:Janssen Pharmaceuticals, Inc.;2006.