360° view of FM.MGMT Fibromyalgia Management

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Case Study
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"Mrs C is a hypothetical FM patient. Read about her experiences to see how you may put the 4 core pillars of the FM management framework into practice."

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Case Study

Why apply Multimodal therapy?

Several pharmacological classes of medication have published data or ongoing studies in FM.
However, there are 3 FDA-approved medications indicated for the management of FM.

STRATEGY

EXAMPLES

Why apply Multimodal therapy?

FDA-Approved Pharmacotherapy1

Non-FDA-Approved Pharmacotherapy5

  • Tricyclic antidepressants
    (eg, amitriptyline, cyclobenzaprine)
  • Analgesics (eg, tramadol)
  • Other CNS-active drugs
    (eg, gabapentin, sodium oxybate)
  • Selective serotonin reuptake inhibitors
    (SSRIs) (eg, fluoxetine, paroxetine)
  • Serotinin-norepinephrine reuptake
    inhibitors (SNRIs) (eg, venlafaxine)
Why apply Multimodal therapy?

NONPharmacological Management of FM

There is strong evidence that multidisciplinary therapy, including significant nonpharmacologic and patient self-management components, is effective in FM management. It is best to integrate nonpharmacological approaches early in the treatment plan, which helps reinforce the importance of the patient's role in his or her own care.6

STRATEGY

EXAMPLES

Why apply Multimodal therapy?

Nonpharmacological Therapy

  • Cognitive behavioral therapy (CBT)1
  • Physical activity
    (eg, gentle aerobic activity)1
  • Patient education1
  • Acupuncture1
  • Tai chi7

Patient Self-Management6,8

  • Daily activity pacing
  • Stress management
  • Support groups
  • Sleep hygiene

Support From Extended Health Care Team9

  • Specialists
  • Midlevel professionals
  • Allied health professionals
Why apply Multimodal therapy?

As with any chronic medical condition, effective management requires patients to develop self-help and problem-solving skills, and may involve other sources of support beyond you and your office staff.

References:

1. Arnold LM. Biology and therapy of fibromyalgia. New therapies in fibromyalgia. Arthritis Res Ther. 2006;8(4):212.

2. LYRICA® (pregabalin) capsules Cv [package insert]. New York, NY: Pfizer Inc; 2011.

3. Cymbalta prescribing information. Indianapolis, IN: Eli Lilly and Company; 2011. Accessed October 10, 2011.

4. Savella prescribing information. New York, NY: Forest Pharmaceuticals; 2010. Accessed October 10, 2011.

5. Mease P. Fibromyalgia syndrome: review of clinical presentation, pathogenesis, outcome measures, and treatment. J Rheumatol. 2005;32(suppl 75):6-21.

6. Burckhardt CS. Educating patients: self-management approaches. Disabil Rehabil. 2005;27(12):703-709.

7. Wang C, Schmid CH, Rones R, et al. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010;363(8):743-754.

8. McCarberg BH. Clinical overview of fibromyalgia. Am J Ther. 2011 Feb 15. [E-pub ahead of print]

9. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004;292(19):2388-2395.

Pfizer

LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,683 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

The most common adverse reactions across all LYRICA clinical trials are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention).

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

Please see Full Prescribing Information and Medication Guide.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

Pfizer logo

Copyright © 2013 Pfizer Inc. All rights reserved.

PBP526913-01

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LYRICA® (pregabalin) capsules CV is indicated for the management of Fibromyalgia.

Important Safety Information

LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.

There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with these symptoms.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA immediately in patients with these symptoms.

Antiepileptic drugs (AEDs) including LYRICA increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal behavior or ideation among 27,683 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one patient for every 530 patients treated with an AED.

The most common adverse reactions across all LYRICA clinical trials are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention).

Inform patients taking LYRICA that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.

In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.

Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs. Patients who are taking other drugs associated with angioedema such as angiotensin-converting enzyme inhibitors (ACE inhibitors) may be at increased risk of developing angioedema. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.

LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.

Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.

Withdraw LYRICA gradually over a minimum of 1 week. Discontinue LYRICA immediately in patients with symptoms of hypersensitivity or angioedema.

Patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment.

In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting tumors were reported in 57 patients.

Please see Full Prescribing Information and Medication Guide.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

Pfizer logo

Copyright © 2013 Pfizer Inc. All rights reserved.

PBP526913-01