Shared Care Protocol –remains open to review in light of any new evidence

Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary care.

Shared Care Guideline for Olanzapine (Zyprexa®)

Development Process

This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER classification status of Olanzapine by the Barnsley Area Prescribing Committee. This guideline has been subject to consultation and endorsement by the Area Prescribing Committee on 10th December 2014 and the LMC on 10th March 2015

Introduction

Indication/Licensing information
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to severe manic episode.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder
Dosage and administration
Adults
Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.
Paediatric population
Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short-term studies of adolescent patients than in studies of adult patients
Elderly
A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant

Responsibilities of the specialist initiating treatment

Responsibilities of other prescribers

Acceptance of Responsibility by the Primary Care Clinician

It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on shared care only if they are willing and able.

Clinical Particulars

BNF therapeutic class / 4.2.1 Antipsychotic drugs; Atypical antipsychotic drugs
Cautions and Contraindications / Contraindications
Hypersensitivity to the active substance or to any of the excipients. Patients with known risk of narrow-angle glaucoma
Cautions
Ø  Dementia-related psychosis and/or behavioural disturbances
Ø  Parkinson's disease
Ø  Neuroleptic Malignant Syndrome (NMS).
Ø  Hyperglycaemia and diabetes
Ø  Lipid alterations
Ø  Anticholinergic activity
Ø  Hepatic function
Ø  Neutropenia
Ø  QT interval
Ø  Thromboembolism
Adverse Drug Reactions / The most commonly reported Adverse Drug Reactions (ADRs) with olanzapine are mild, transient antimuscarinic effects (very rarely precipitation of angle-closure glaucoma); drowsiness, speech difficulty, exacerbation of Parkinson’s disease, abnormal gait, hallucinations, akathisia, asthenia, fatigue, increased appetite, increased body temperature, raised triglyceride concentration, oedema, hyperprolactinaemia (but clinical manifestations uncommon); eosinophilia; less commonly hypotension, bradycardia, QT-interval prolongation, urinary incontinence, and photosensitivity; rarely seizures, leucopenia, and rash; very rarely hepatitis, pancreatitis, thromboembolism, hypercholesterolaemia, hypothermia, urinary retention, priapism, thrombocytopenia, neutropenia, rhabdomyolysis, and alopecia;
As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with olanzapine
Pregnancy and Lactation
Pregnancy - use only if potential benefit outweighs risk; neonatal lethargy, tremor, and hypertonia reported when used in third trimester
Breast feeding - avoid—present in milk
Monitoring / Baseline
Prolactin
Urea & electrolytes (U&Es)
Weight
Fasting Plasma Glucose (FPG)/HbA1c or Oral Glucose Tolerance Test (OGTT)
Blood Lipids
Continuation
Prolactin
U&Es – 6 monthly
Weight – as needed
Creatine Phosphokinase (CPK) – if NMS suspected
Blood Lipids – after 3 months then yearly
Fasting Plasma Glucose FPG/HbA1c - annually
Interactions / Include clinically important interactions and their management.
Benzodiazepines / Increased risk of hypotension, bradycarida and respiratory depression when intramuscular olanzapine given with parenteral benzodiazepines
Carbamazepine / Metabolism of olanazpine accelerated by carbamazepine (reduced plasma concentration)
Ciprofloxacin / Plasma concentration of olanazpine possibly increased by ciprofloxacin
Fluvoxamine / Plasma concentration of olanzapine increased by fluvoxamine
Ritonavir / Plasma concentration of olanzapine reduced by ritonavir- consider increasing dose of olanzapine

Communication

References

BNF 64 http://bnf.org

NICE Guidance www.NICE.org.uk .


Appendix A – Shared Care request form (Amber)

·  Specialist to complete when requesting GP to enter a shared care arrangement.

·  GP to return signed copy of form.

·  Both parties should retain a signed copy of the form in the patient’s record.

From (Specialist): To (GP):

Patient details

Amber Drug details

Telephone number(s) for contact:

Consultant: Date:

Monitoring

Communication

Confirmation of acceptance of shared care

Page 1 of 6

Olanzapine Shared care Guideline

Date Prepared: December 14 Review Date: December 2016