AMCo AGREEMENT SIGN UP PROCESS FORLUTRATE VIA
ST. THOMAS COURT GROUP
POSTAL ADDRESS:
Anita Hawkins (Dispensing Agreements)
Capital House
AMCo
85 King William Street
London, EC4N7BL
Prescribing information is available on the last page
Lutrate®GP Practice Discount Agreement with St. Thomas Court Group
Practice Name:______
Address:______
______
Post Code:______
Alliance Account Number: ______
With effect from ______ AMCo is able to provide Lutrate® to<Insert practice name here> at the following prices:
Lutrate® 1: net price of £47.32 (excluding VAT) 26% discount off NHS list price
Lutrate® 3: net price of £141.98 (excluding VAT) 26% discount off NHS list price
Purchases of Lutrate® must be made directly with Alliance Healthcare at NHS list price and the agreed net payments will be achieved via a retrospective discount scheme. The discount will be paid by Alliance Healthcare monthly in arrears. Both AMCo and ______do not intend to make and/or receive this payment in any promotional capacity or as an inducement to prescribe any product.
This Agreement is made in compliance with the UK Bribery Act 2010.
This Agreement is subject to the Agreement between AMCo and St Thomas Court Group dated XXXXXXX (the St Thomas Court Group Agreement), is effective once it has been signed by both parties and will continue in force until the closing date of the St Thomas Court Group Agreement (being either one year from the date of that Agreement or such other date on which that Agreement terminates).
The construction, validity and performance of this Agreement shall be governed by English law and the Parties irrevocably submit to the exclusive jurisdiction of the English courts.
Name: …………………………………….. Name:……………………………………….
Position:…………………………………… Position:…………………………………….
Signed on behalf of AMCo Signed on behalf of …………………….
DATE:DATE:
PRESCRIBING INFORMATION
Lutrate 1 month Depot 3.75 mg powder and solvent for prolonged-release suspension for injection AND
Lutrate 3 month Depot 22.5 mg powder and solvent for prolonged-release suspension for injection
(leuprorelin acetate)
Presentation: Each vial contains 3.75 mg (equivalent to 3.57 mg leuprorelin) or 22.5 mg (equivalent to 21.42 mg leuprorelin)leuprorelin acetate.
Indication: 3.75 mg: For palliative treatment of locally advanced or metastatic prostate cancer.
22.5 mg: For palliative treatment of hormone dependent advanced prostate cancer.
Dosage and administration: For intramuscular use only.Adults and elderly: 3.75 mg -The usual recommended dose is 3.75 mg every month. 22.5 mg - The usual recommended dose is 22.5 mg every three months. Therapy should not be discontinued when remission or improvement occurs.Do not administer by any other route.Paediatrics:Not recommended.
Contraindications: Hypersensitivity to any of the components or any other LHRH analogues, previous orchiectomy, spinal cord compression, spinal metastases and use in women.
Precautions and warnings: Transient rise in levels of testosterone may occur associated with or without a ‘flare’ or exacerbation. Discontinue immediately if any signs or symptoms suggestive of anaphylaxis (dyspnoea, asthma, rhinitis, angioneurotic oedema of glottis, hypotension, urticaria, rash, pruritus or interstitial pneumonitis) develop. Patients at risk of urethral obstruction (with or without haematuria), spinal cord compression, metastatic vertebral lesions, osteoporosis,impaired liver functionshould be considered carefully. Incident depression, decreased bone density, hepatic dysfunction, jaundice with elevated liver enzyme levels and increased prothrombin time have been reported in some patients. Metabolic changes, hypertension, weight changes, development or aggravation of diabetes may occur. Use with caution in the presence of cardiovascular disease (including congestive heart failure), thromboembolism, oedema, depression, pituitary apoplexy and known bleeding disorders, thrombocytopaenia, treatment with anticoagulants or medications known to cause seizures (e.g. bupropion or SSRIs).
Interactions: Medicinal products known to prolong the QT interval or able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol) antiarrhythmics, methadone, moxifloxacin, and antipsychotics.
Pregnancy and lactation: Not recommended.
Undesirable effects: Verycommon: Hot flushes. Common: Changes in appetite, insomnia, decreased libido, mood changes, depression, headache, dizziness, nausea, vomiting, hyperhidrosis, pruritus, cold sweats, night sweats, back pain, bone pain, arthralgia, pollakiuria, nocturia, urinary tract pain, decreased urine flow, erectile dysfunction, fatigue, asthenia, pain, pyrexia, local site reactions (injection site pain, erythema and induration), increased liver enzymes and increase in blood triglycerides/creatinine/glucose. Uncommon:Hypercholesterolaemia, hyperlipidaemia, vertigo, weakness, musculoskeletal pain, neck pain, feeling hot and cold, feeling jittery, QT prolongation, blood calcium and creatine increased, peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, chills, peripheral vertigo, rash, amnesia, visual disturbances, alteration in the skin sensation and infarction of pre-existing pituitary apoplexy may occur. Changes in bone density, thrombocytopaenia, leukopaenia, exacerbations of signs and symptoms of the disease have been reported.
(Please refer to the Summary of Product Characteristics for detailed information)
Overdose: No clinical experience with the effects of an acute overdose of leuprorelin acetate.In cases of overdosage, the patient should be monitored closely and management should besymptomatic and supportive.
Legal category: POM
Basic NHS costs: Lutrate 3.75 mg injection - £ 63.95; Lutrate 22.5 mg injection - £ 191.86
Marketing Authorisation Numbers: Lutrate 3.75 mg - PL 12762/0509; Lutrate 22.5 mg - PL 12762/0510.
Marketing Authorisation Holder: Amdipharm Mercury Company Ltd, 1st floor, Capital House, 85 King William Street, London, EC4N 7BL.
Adverse events should be reported to the local regulatory authority.Reporting forms and information can be found at Adverse events should also be reported to AmdipharmMercury Medical Information via telephone on 08700 70 3033 or via e-mail at .Date of preparation: September 2015.
Date of revision: November 2015.
Job bag code: AMCo/LUT/0616/0085
Date of preparation: June 2016