FROM MAY 2018

Fully funded for all neuropathic pain from 1 May 20181

The Special Interest Group on Neuropathic Pain (NeuPSIG) of the International Association for the Study of Pain (IASP) 20152

– PREGABALIN is recommended as a fi rst-line treatment option for the managementof neuropathic pain

The American Academy of Neurology (AAN) 20113

– PREGABALIN is recommended as the only management option with Level A evidence for painful diabetic neuropathy

The National Institute of Clinical Care and Excellence (NICE) Guidelines for England and Wales 20134

– PREGABALIN is recommended as a fi rst-line treatment for the management of neuropathic pain (except trigeminal neuralgia)

The Royal Australian College of General Practitioners (RACGP) 20135

– PREGABALIN is recommended as a fi rst-line option for the treatment of neuropathic pain

www.pregabalin.co.nz

Many International guidelines and recommendations support PREGABALIN for the management of neuropathic pain2-5

Minimum Data SheetPREGABALIN PFIZERTM(pregabalin) 25 mg, 75 mg, 150 mg & 300 mg capsules

Therapeutic Indications: Neuropathic pain in adults; adjunctive therapy in adults with partial seizures with or without secondary generalization. Contraindications: Hypersensitivity to pregabalin or excipients. Special Warnings and Precautions for Use: Pregnancy; lactation; dizziness; somnolence; history of substance abuse; congestive heart failure; galactose intolerance; withdrawal symptoms; renal impairment; peripheral oedema; creatine kinase elevation; weight gain; blurred vision; hypersensitivity reactions; increased risk of suicidal thoughts or behavior. See Data Sheet for details. Interactions: CNS depressants; alcohol; lorazepam; oxycodone; medications causing constipation. See Data Sheet for details. Undesirable Effects: Most common: dizziness, somnolence. Others include; blurred vision, fatigue, weight gain, dry mouth, headache, ataxia, peripheral oedema, impaired balance, diplopia, sedation. Post-marketing, serious: angioedema, allergic reaction, loss of consciousness, mental impairment, congestive heart failure, keratitis, pulmonary oedema. See Data Sheet for details. Dosage and Method of Administration: 150 to 600 mg orally/day given as 2 divided doses. Neuropathic pain: Start at 150 mg/day, increase to 300 mg/day after 3 to 7 days. If needed increase to a maximum of 600 mg/day after a further 7 days. Epilepsy: Start at 150 mg/day increase to 300 mg/day after 7 days. Maximum dose of 600 mg/day may be given after a further week. Renal impairment: reduce dose. See Data Sheet for details. Medicines Classifi cation: Prescription medicine Pregabalin Pfi zer is a funded prescription medicine. Before prescribing, please review full Data Sheet available from Medsafe (www.medsafe.govt.nz) or Pfi zer New Zealand Limited (www.pfi zer.co.nz) or call 0800 736 363. TM Trademark V11217

References: 1 Pregabalin Pfi zer Data Sheet. 2. Torrance N, et al. Pain 2013;154:690-699.

Pfi zer New Zealand, Level 1, Building B, 8 Nugent St, Grafton 1023 Auckland. Pfi zer© TAPS NA9940. PP-LYR-NZL-0003. 02/18. SPITFIRE J001130.

It is generally recommended neuropathic pain treatments are tried for at least 3 months or until adverse events prevent adequate dosage and continued treatment2

Flexible dosing based on individual response and tolerability1

Starting dose (150mg/day) is within the therapeutic range1

PREGABALIN Pfi zer is a suitable option for patients taking other medications Low potential for pharmacokinetic interactions1 †

Remind patients: It is important to remain on therapy to ensure adequate pain relief1

Adjustment may be needed to ensure they continue to receive the optimal dose for pain relief1

PREGABALIN withdrawal can be safely managed by slowly tapering the dose over a period of time to reduce the intensity of withdrawal symptoms.1

† Pregabalin may potentiate the effect of lorazepam or ethanol and be additive in theimpairment of cognitive and gross motor function caused by oxycodone.1

PREGABALIN Pfi zer offers fl exible dosing1

*Dose range 150 – 600/mg day in two divided dosesDosage reduction necessary in patients with renal impairment

Effective starting dose*1

Starting Dose

150milligram/day

75 milligram BDBased on individual

response and tolera-bility the dose may

be increased to 300mg/day after an

interval of 3 to 7 days*1

300milligram/day

150 milligram BD

If need to a maximum dose of 600 mg/day after an additional 7

day interval*1

600milligram/day

300 milligram BD

3-7 DAYS

7 DAYS

Dose may be adjusted according to patient response and tolerability

References: 1. Pharmac, Pharmaceutical Schedule - May 2018. 2. Finnerup NB, et al. Pharmacotherapy for Neuropathic Pain in Adults: A systematic Review and Meta-Analysis. Lancet Nuerol. 2015;14(2):162-73. 3. Bril V, et al Evidence-Based Guideline: Treatment of Painful Diabetic Neuropathy: Report of the American Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76:1758-276. 4.NICE Clinical Guidelines 173; 2010. Neuropathic pain – pharmacological management. 5.Votrubec M, et al. Neuropathic Pain. A Management Update. Aust Fam Physician. 2013;173,42(3):92-7.

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PREGABALIN Pfi zer demonstrated greater neuropathic pain reduction in people previously treated with gabapentin*1

PREGABALIN Pfi zer provided signifi cant pain relief for patients who were gabapentin responders (P≤0.025) and those who were gabapentin non-responders (P≤0.025)1

Pain symptoms by patient cohort as measured by the VAS

References: 1.Toth C. Substitution of Gabapentin Therapy with Pregabalin Therapy in Neuropathic Pain Due to Peripheral Neuropathy. Pain Med. 2010;11(3):456-65.

* Based on an open–label, prospective cohort study. Patients with very good clinical responses to gabapentin may experience less benefi t from Pregabalin Pfi zer substitution.†† P-values not reported in paper.

References: 1. Pregabalin Data Sheet 2. Gabapentin Data Sheet 3. Bockbrader HN et al, A Comparison of the Pharmacokinetics and Pharmacodynamics of Pregabalin and Gabapentin. Clin Pharmacokinetics. 2010; 49(10):661-9. 4.Toth C. Substitution of Gabapentin Therapy with Pregabalin Therapy in Neuropathic Pain Due to Peripheral Neuropathy. Pain Med. 2010;11(3):456-65. 5. Freynhagen R et al. Effi cacy of Pregabalin in Neuropathic Pain Evaluated in a 12 week, Randomised Double-Blind Multicentre Placebo-Controlled Trial of Flexible–and-Fixed Dose Regimens Pain 2005;116(3):254-63

PREGABALIN Pfi zer can be used effectively across a range of neuropathic pain aetiologies

PHN or DPN DPN

52.3% of PREGABALIN Pfi zer patients experienced ≥ 50% reduction in the pain score reduction (P<0.001 versus placebo)1

40% of PREGABALIN Pfi zer patients experienced ≥ 50% reduction in Pain Scores (p=0.001 versus placebo)2

Primary effi cacy measure was endpoint mean pain score. Fixed-dose group randomised to pregabalin 300mg/day for one week followed with 600 mg/day for remaining 11 weeks of double-blind treatment (n=132)

Primary effi cacy measure was endpoint mean pain score. Results for patients randomised to pregabalin 300 mg/day (n=761)

A 30% reduction in pain score is considered clinically signifi cant.

PREGABALIN Pfi zer versus gabapentin

PREGABALIN Pfi zer1 gabapentin2,3

Pharmacokinetic profi le Linear Non LinearPlasma concentration increases disproportionally to dose

Oral bioavailability Independent of dose ≥ 90% of all doses

Decreases with increasing dose

Therapeutic dose range Dose range from 150mg/dto 600 mg/d

Doses range from 900mg/dto 3600mg/d

Dosing BD TDS

Peak plasma concentration

1 hour 3 – 4 hours

References: 1.Freyhagen R, et al. Effi cacy of Pregabalin in Neuropathic Pain Evalusated in a 12 week, Randomised, Double-Blind, Multicentre, Placebo-Controlled Trial of Flexible-and Fixed-Dose Regimens. Pain 2005;115(3):254-63. 2. RosenstockJ et al. Pain. 2004;110:628-638.

aError bars represent SD. bSignifi cant difference between groups after GBP therapy (p<0.025). cSignifi cance within that category. Analysis between cohorts by ANOVA: *signifi cant vs pre-GBP time point; †signifi cant vs. GBP non-responder cohorts; ‡signifi cant vs. GBP continuers. P-values for ANOVA not reported in paper. Abbreviations: VAS - visual analogue scale; GBP - gabapentin.

Study Design: Results from a 12-month follow up, open label study in 146 patients diagnosed with painful peripheral neuropathy receiving gabapentin monotherapy. The enrolled populated included gabapentin responders and non-responders. Patients were either switched to Pregabalin Pfi zer or maintained on gabapentin treatment Primary effi cacy outcome: pain severity (mean change in VAS scores)

Quality of life measures (secondary endpoints)Patients who switched to PREGABALIN Pfi zer (after responding to gabapentin), showed greater QoL improvements (EQ-5D utility scores) vs gabapentin continuers at 6 and 12 months. ††

While gabapentin non-responders who switched to PREGABALIN Pfizer did not significantly differ from gabapentin continuers at the 6 month evaluation, they did demonstrate superior EQ-5D scores at the 12 month evaluation. ††

10

0“No pain”

Baseline After GBP therapy

p<0.025C p<0.025C

6 months afterswitching to PREGABALIN Pfizer

12 months afterswitching to PREGABALIN Pfizer

“Worst possible pain”

VAS

scor

ea

9

8

7

6

5

4

3

2

1

GBP responders switched to PREGABALIN Pfizer (n=32)GBP non-responders switched to PREGABALIN Pfizer (n=29)GBP continuers (n=40)

Pain reductions in gabapentin responders and non-responders after switching to PREGABALIN Pfi zer or receiving gabapentin continuously.1

Adapted from Toth 2010.

Patients switching from gabapentin to PREGABALIN Pfi zer demonstrated fewer adverse effects*4

Adverse events associated with PREGABALIN Pfi zer were usually mild to moderate5 and patients had low discontinuation rates due to adverse events (14% versus 5% for placebo)1

PREGABALIN Pfi zer adverse events appeared to be mostly transient.5

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