Label Changes for:
Vimpat (lacosamide) tablets Vimpat (lacosamide) Injection Vimpat (lacosamide) oral solution
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.3 Cardiac Rhythm and Conduction Abnormalities
PR interval prolongation
- Dose-dependent prolongations in PR interval with VIMPAT have been observed in clinical studies in patients and in healthy volunteers. [see Clinical Pharmacology (12.2)] In clinical trials in patients with partial-onset epilepsy, asymptomatic firstdegree atrioventricular (AV) block was observed as an adverse reaction in 0.4% (4/944) of patients randomized to receive VIMPAT and 0% (0/364) of patients randomized to receive placebo. In clinical trials patients with diabetic neuropathy, asymptomatic first-degree AV block was observed as an adverse reaction in 0.5% (5/1023) of patients receiving Vimpat and 0% of patients receiving placebo. In the uncontrolled extension phases of pain studies, two subjects/[sponsor to fill in denominator of trial patients] experienced AV block type 2. Neither of these subjects had 2nd degree block at baseline although both had either PR prolongation or 1st degree AV block at baseline. In one of these cases, the block was found as result of monitoring performed after an episode of syncope. When Vimpat is given with other drugs that prolong the PR interval, further prolongation is possible. Vimpat should be used with caution in patients with known conduction problems (e.g. marked first-degree AVB, second-degree or higher AVB and sick sinus syndrome without pacemaker, with sodium channelopathies, (e.g. Brugada Syndrome), on concomitant medications that prolong PR interval, or with severe cardiac disease such as myocardial ischemia or heart failure. In such patients, obtaining an ECG before beginning Vimpat, and after Vimpat is titrated to steady state, is recommended.
6 ADVERSE REACTIONS
6.2 Post marketing experience:
- The following adverse events have been reported during post-approval use of Vimpat. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Due to the need to balance the benefit of adding potentially serious medical events to the label and the risk that doing so will discourage future reporting of such events, health care providers and consumers are encouraged to continue reporting such events regardless of whether the event is already in this section.
- added .... Cardiac disorders: 3rd degree AVB in epileptic patients
7 DRUG INTERACTIONS
- added ... Patients with renal or hepatic impairment that are on strong inhibitors of CYP3A4 and CYP2C9, may have significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients.
- Cardiac disorders: Bradycardia
- Psychiatric disorders: hallucination
- Skin and subcutaneous tissue disorders: Rash