CLINICAL INFORMATION. Veracyte shall provide all clinical information accompanying any specimens and a manifest of shipment contests.
CLINICAL INFORMATION i. Prescribed indications Riluzole is licensed to extend life for individuals with the amyotrophic lateral sclerosis (ALS) form of motor neurone disease (MND) ii. Therapeutic summary Motor neurone disease is the term used to describe progressive muscular atrophy (PMA) and amyotrophic lateral sclerosis (ALS) which includes Progressive Bulbar Palsy. ALS, which is characterised by both upper and lower motor neurone signs, is the most common form of MND, accounting for 65% to 85% of all cases. Adult-onset MND is characterised by progressive degeneration of the motor neurones of the brain, brain stem or spinal cord, starting insidiously with symptoms and signs including stumbling, foot drop, weakened grip, slurred speech, cramp, muscle wasting, twitching and tiredness. Other symptoms of MND include muscle stiffness, paralysis, incoordination and impaired speech, swallowing and breathing. Most individuals die from ventilatory failure, resulting from progressive weakness and wasting of limb, respiratory and bulbarmuscles within approximately 3 years of the onset of symptoms. iii. Dose & Route of administration 50mg every 12 hours; Use tablets 1st line Administration - swallowing difficulties: The tablets can be crushed and mixed with soft food e.g. yoghurt or puree to aid swallowing. Tablets crushed onto food should be eaten within 15 minutes as there is no stability data available for this method of administration. Use crushed tablets with care as they may have a local anaesthetic effect in the mouth. Administration – enteral tubes: The tablets can be crushed and dispersed in water for enteral tube administration. Give immediately. Riluzole may block enteral feeding tubes, so ensure that the tube is flushed well after each dose. A licensed oral suspension is available however this is significantly more expensive. The MND specialists may recommend suspension in exceptional circumstances in patients with severe dysphagia causing coughing and aspiration, or in patients using enteral feeding where there is a risk of crushed riluzole tablets blocking feeding tubes.
CLINICAL INFORMATION i. Prescribed indications • Treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment) • Treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumours.
CLINICAL INFORMATION i. Prescribed indications Acamprosate is licenced for the maintenance of abstinence in alcohol dependence combined with counselling ii. Therapeutic summary Acamprosate is a synthetic taurine analogue, which acts as a functional glutamatergic NDMA antagonist and also increases GABAergic function. iii. Dose & Route of administration Adults Weighting: < 60 kg 666mg (2 tablets) at breakfast, 333mg (1 tablet) at midday and 333mg (1 tablet) at night with meals > 60 kg 666mg (2 tablets) three times a day with meals Initiate as soon as possible after abstinence. Acamprosate should not be administered to children or the elderly iv. Duration of treatment Recommended treatment period is 12 months and continued longer only following liaison with community alcohol teams. v. Adverse effects Diarrhoea, nausea, vomiting, abdominal pain, flatulence, pruritus, rashes and fluctuating libido are possible. Should not impair ability to drive or operate machinery. For full information consult SPC vi.
CLINICAL INFORMATION i. Prescribed indications Treatment of severe heart rhythm disorder not responding to other therapies or when other treatments cannot be used. • Prior and post cardioversion • In patients who also have heart failure or left ventricular impairment Licensed indications • Tachyarrhythmias associated with Xxxxx-Xxxxxxxxx-White syndrome. • Atrial flutter and fibrillation when other drugs cannot be used. • Tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias. Ventricular fibrillation; when other drugs cannot be used. Patients should NOT be on amiodarone for palpitation unless there is a clearly defined electrophysiological diagnosis.
CLINICAL INFORMATION i. Prescribed indications For the treatment of osteoporosis in men and postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer. Not relevant to this section Alendronic acid remains the first line treatment for osteoporosis in accordance with NICE guidance. Approximately 25% of patients cannot be treated with alendronic acid because of side effects, inability to comply with dosing instructions or malabsorption leading to inefficacy. Risedronate should also be tried if appropriate before Denosumab is considered. Denosumab provides another option for those patients also unable to take risedronate and has been recommended by NICE in this context. The guidance is available at xxxx://xxxxxxxx.xxxx.xxx.xx/TA204.
CLINICAL INFORMATION i. Prescribed indications Cinacalcet is indicated for : 1. The treatment of acute hypercalcaemia symptomatic with calcium between 2.85-3.00mmol/ L or biochemically severe hypercalcaemia calcium >3.0mmol/l due to Primary Hyperparathyroidism, when parathyroidectomy is contraindicated or not clinically appropriate , and will avoid the need for further admission to hospital. (NHSE commissioning policy) 2. The treatment of hypercalcaemia (Ca >3.0mm/l) in patients who are significantly symptomatic and awaiting surgery.
CLINICAL INFORMATION. Indication(s) Acetylcholinesterase inhibitors (donepezil, galantamine and rivastigmine) are licensed for the treatment of mild to moderate Alzheimer’s disease. Additionally, rivastigmine is licensed for the treatment of mild to moderate dementia in Xxxxxxxxx’x disease. Memantine is licensed for the treatment of moderate to severe Alzheimer's disease. Place in therapy Acetylcholinesterase inhibitors are recommended as 1st line treatment (donepezil being the preferred formulary choice) for mild to moderate Alzheimer’s disease (and rivastigmine for the treatment of mild to moderate dementia in Xxxxxxxxx’x disease). Memantine may be used 2nd line for moderate severity Alzheimer’s dementia where acetylcholinesterase inhibitors are ineffective or not tolerated. It may also be used in the treatment of severe Alzheimer’s disease. Combination treatment with memantine and an acetylcholinesterase inhibitor is not recommended. Therapeutic summary Donepezil, galantamine & rivastigmine: acetylcholinesterase inhibition Memantine: moderate affinity and uncompetitive n-methyl- D-aspartate receptor antagonism Dose and route of administration Medicine Frequency Titration week & dose (mg) Donepezil Daily (oral) 5 10 Galantamine (modified release) Daily (oral) 8 16 24 Galantamine Twice daily (oral) 4 8 12 Rivastigmine* Twice daily (oral) 1.5 3 4.5 6 Rivastigmine patch* Daily (clean dry skin) 4.6 9.5 Memantine Daily (oral) 5 10 15 20 *Manufacturer advises that treatment with rivasitgmine should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve (gastrointestinal disturbances less likely with patches, refer to BNF for guidance on switching between capsules and patches). Treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise treatment should be re- titrated from 1.5mg twice daily or the 4.6 mg/24 h patch. Dose of rivastigmine patch may be increased to 13.3mg/24hrs after 6 months if required Duration of treatment The Psychiatrist will decide when treatment should be stopped. This is considered if: Poor concordance Major adverse effects Patient asks to stop Medication not effective (global, functional & behavioural condition is below a level where the drug is considered to have a worthwhile effect e.g. which may be an SMMSE <10) Summary of adverse effects Adverse effect Frequency Management
CLINICAL INFORMATION i. Prescribed indications Naltrexone is licensed for use as part of a comprehensive programme of treatment, including psychosocial guidance, for detoxified patients who have been alcohol-dependent or opiate-dependent to support abstinence
CLINICAL INFORMATION. Indication(s): Excessive sleepiness in adults associated with narcolepsy with or without cataplexy Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations Contra-indicated in pregnancy & breast feeding, in children, moderate to severe uncontrolled hypertension, history of left ventricular hypertrophy, chest pain, arrhythmia or other manifestations of mitral valve prolapse in association with CNS stimulant use (including ischaemic ECG changes, chest pain and arrythmias) Patients with major anxiety should receive treatment in a specialist unit Sexually active women of child bearing potential should be established on a contraceptive programme before taking modafinil. Modafinil should be used with caution in patients with a history of: Psychosis, depression, or mania Abuse of alcohol, drugs or illicit substances. Place in Therapy: Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline. Such an evaluation usually consists, in addition to the patient's history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia. Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis. Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks). Therapeutic summary: Modafinil promotes wakefulness in patients with narcolepsy. The precise mechanism is unknown Dose & route of administration: Adults over 18 years: initially 200mg daily either in two divided doses or as a single dose in the morning. Dose adjusted according to response to 200-400mg daily in 2 divided doses or as a single dose. Elderly: Initiate at 100mg daily Doses should be halved in patients with severe hepatic failure (100-200mg daily). Inadequate information to determine safety and efficacy of dosing in patients with renal impairment Not licensed for use in children. Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns Duration of treatment: Long-term Summary of adverse effects: (See summary of product characteristics (SPC) ...
