Sorry, you need to enable JavaScript to visit this website.

LYRICA

How should I explain LYRICA-associated dizziness and somnolence to a patient?

Dizziness and somnolence in LYRICA-treated patients were the most commonly reported adverse reactions in controlled epilepsy and neuropathic pain studies

LYRICA Total Daily Dosage

Placebo
N=1151

150 mg/day
N=699

300 mg/day
N=723

600 mg/day
N=918

All LYRICA doses*
N=2589

Dizziness

(% patients)

6.8

13.2

24.5

30.4

21.9

Somnolence

(% patients)

4.6

8.2

13.1

19.5

13.2

*Includes subtherapeutic doses (50 mg and 75 mg daily)

Adapted from the LYRICA Product Information

 

In the controlled studies, dizziness and somnolence typically occurred more frequently at higher doses and emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. However, dizziness and somnolence were also the most common adverse reactions resulting in discontinuation of LYRICA.

Careful dose titration to the highest tolerable dose of LYRICA is the most appropriate approach in clinical practice.

To reduce the likelihood of dizziness and somnolence, patients should, whenever possible, take their first dose of LYRICA or any change in dose at night.

Patients should be informed that LYRICA-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery.

The exact causal mechanisms of LYRICA-associated dizziness and somnolence are not known.

 

For additional information, please search for response documents on the HOME page

 

References:

  1. LYRICA® (pregabalin) Product Information. Pfizer Australia Pty Ltd.
  2. Freynhagen R, et al. Pain Pract. 2015; 15(1):47-57.

Is treatment with LYRICA associated with weight gain?

In controlled epilepsy and neuropathic pain studies, weight gain (> 7% gain over baseline weight) occurred more frequently in patients treated with LYRICA than in patients treated with placebo.

LYRICA associated weight gain was related to dose and length of exposure, but did not appear to be associated with baseline BMI, gender or age.

LYRICA Total Daily Dosage

Placebo
N=1151

150 mg/day
N=699

300 mg/day
N=723

600 mg/day
N=918

All LYRICA doses*
N=2589

Weight gain

(% patients)

0.5

3.0

3.9

9.3

5.3

*Includes subtherapeutic doses (50 mg and 75 mg daily)

Adapted from the LYRICA Product Information

 

The time to onset of weight gain in pre-marketing clinical trials ranged from 0-29.5 days.

Among diabetic patients, LYRICA-treated patients gained an average of 1.6 kg (range: -16 to 16 kg), compared to an average 0.3 kg (range: -10 to 9 kg) weight gain in placebo patients.

In a cohort of diabetic patients who received LYRICA for at least 2 years, the average weight gain was 5.2 kg.

It has been theorised that LYRICA may lead to reduced levels of corticotrophin-releasing hormone (CRH) (via inhibition of glutamate release) which results in an increase in food intake and consequent weight gain.

 

For additional information, please search for response documents on the HOME page

 

References:

  1. LYRICA® (pregabalin) Product Information. Pfizer Australia Pty Ltd
  2. LYRICA® (pregabalin) US Package Insert. Pfizer Inc.
  3. Data on file (117,152,172). Pfizer Inc.
  4. Cabrera J, Emir B, Dills D, et al. Characterizing and understanding body weight patterns in patients treated with pregabalin. Curr Med Res Opin. 2012; 28(6):1027-1037.

What is the therapeutic dose of LYRICA in the management of neuropathic pain?

The dose range is 75 to 300 mg twice daily.

Careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.

Treatment should be initiated at a dose of 75 mg BD.

Based on individual patient response and tolerability, the dosage may be increased to
150 mg BD after 3 to 7 days, and if needed, to a maximum dose of 300 mg BD after an additional 7-days.

Dosage modification is required in patients with renal impairment (see table below).

Creatinine Clearance
(CLcr)
(mL/min)
Total Pregabalin Daily dose*Dose Regimen
Starting dose
(mg/day)
Maximum dose
(mg/day)
> 60150600Two divided doses
30 - 6075300Single daily dose or two divided doses
15 - 3025-50150Single daily dose or two divided doses
<152575Single daily dose
Supplementary dosage following haemodialysis (mg)
 25100Single dose+

*Total daily (mg/day) should be divided as indicated by dose regimen to provide mg/dose
+Supplementary dose is a single additional dose

Adapted from the LYRICA Product Information

LYRICA may be taken with or without food.

 

For additional information, please search for response documents on the HOME page

 

References:

  1. LYRICA® (pregabalin) Product Information. Pfizer Australia Pty Ltd.
  2. Freynhagen R, et al. Pain Pract. 2015; 15(1):47-57.

Tips and Tricks

Searching Tips
For more accurate search results, please ensure you enter at least two specific keywords
Haven't found what you are looking for?
Try entering additional or different clinical terms to refine your search. Or you can submit an enquiry online via the Send Medical Enquiry tab or contact Pfizer’s Medical Information Service on 1800 675 229.
Product Information
For a full list of Product Information documents, click on the Product Information tab.
Want to provide some feedback?
Complete the Pfizer Medical Information Website Survey to answer a few questions about your experience and satisfaction with the site.

Contact Pfizer Medical Information

Speak live with a Pfizer Medical Information professional
1800 675 229
Monday to Friday 8am – 5pm EST