CLINICAL INFORMATION. Veracyte shall provide all clinical information accompanying any specimens and a manifest of shipment contests.
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.
ii. Dose & Route of administration Lanreotide should be used as the 1st line treatment. Octreotide is reserved for use if Lanreotide has been stopped due to adverse effects or lack of efficacy. Administration Lanreotide should be injected via the deep sub-cutaneous route in the superior external quadrant of the buttock. The skin should not be folded. The needle should be inserted rapidly to its full length, perpendicularly to the skin. Octreotide is administered by either subcutaneous injection or depot (deep intragluteal) IM injection.
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 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.
ii. Therapeutic summary Amiodarone is a class III antiarrhythmic drug (Xxxxxxx-Xxxxxxxx classification) that reduces the incidence of arrhythmias by increasing the duration and refractory period of the cardiac action potential prolonging the QT interval. It also slows heart rate and cardiac action potential conduction through inhibition of beta receptors and ion channels in a similar manner to antiarrhythmic drugs from classes IA, II and IV
iii. Dose & Route of administration Oral loading* (by consultant/ specialist) 200mg 3 times daily for 1 week, reduced to 200mg twice daily for a further week. Maintenance Usually 200mg daily or the minimum dose required to control the arrhythmia. The minimum effective maintenance dose should be given because undesirable effects are usually dose related. Do not take with grapefruit juice.
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. 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 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)
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.
ii. Dose & route of administration The usual dose of cinacalcet is between 30-60mg twice daily. The calcium lowering effect is substantially present within two to three weeks (85-90%) after initiating therapy with 30mg twice daily. In patients whose serum calcium is not adequately controlled, the dose may be increased to 90mg FOUR times daily. Cinacalcet should be taken with or after food, preferably at the same time each day.
iii. Adverse effects The most frequently reported adverse events are nausea and vomiting, rash, hypersensitivity, dizziness and myalgia. Isolated cases of hypotension, worsening heart failure and arrhythmia also reported.
iv. Monitoring Requirements Baseline biochemical monitoring will be undertaken by the specialist in addition to all ongoing routine blood monitoring as described as part of the diagnosis and management of the condition (unless specifically agreed with the GP) Serum calcium 1 week after initiation or dose adjustment. After maintenance dose has been established, levels should be measured every 6 months The aim of treatment is to maintain adj Ca at between 2.50 and 2.80 mmol/l. See section 4v for advice on action to be taken if calcium levels become abnormal
CLINICAL INFORMATION i. Prescribed indications Degarelix is a gonadotrophin releasing hormone (GnRH) antagonist indicated for the treatment of adult male patients with advanced hormone-dependant prostate cancer. Degarelix will be prescribed for patients requiring a rapid lowering of testosterone presenting with symptoms such as: Impending spinal cord compression (as per NICE CG 75) Treating advanced hormone dependent prostate cancer in people with spinal metastases (as per NICE TA 404) Renal failure due to ureteric obstruction
ii. Therapeutic summary Degarelix is a selective gonadotrophin releasing-hormone (GnRH) antagonist that competitively and reversibly binds to the pituitary GnRH receptors, thereby rapidly reducing the release of the gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), and thereby reducing the secretion of testosterone (T) by the testes. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that removes the source of androgen. Unlike GnRH agonists, GnRH antagonists do not induce a LH surge with subsequent testosterone surge/tumour stimulation and potential symptomatic flare after the initiation of treatment. Patients do not require a course of anti-androgens as no tumour flare is caused by degarelix
iii. Dose & Route of administration Starting dose (to be prescribed & administered by secondary care) 240mg administered as two subcutaneous injections of 120mg each Maintenance dose (to be prescribed & administered in primary care) 80mg monthly administered as one subcutaneous injection starting one month after the starting dose & continued monthly MUST BE GIVEN SUBCUTANEOUSLY; INJECTION BY OTHER ROUTES MAY BE HARMFUL
iv. Duration of treatment Indefinite
v. Adverse effects Very common (≥1/10): Hot flush*, injection site adverse events Common (≥1/100 to <1/10): anaemia*, weight increase*, insomnia, dizziness, headache, diarrhoea, nausea, liver transaminases increased, hyperhidrosis (inc. night sweats)*, rash, musculoskeletal pain & discomfort, gynaecomastia*, testicular atrophy*, erectile dysfunction*, chills, pyrexia, fatigue*, influenza-like illness *known physiological consequence of testosterone suppression
vi. Monitoring Requirements Baseline - Specialist Serum PSA IP (U+Es, bone profile, liver function test) Full blood count Every 6 months – GP PSA Missed dose (by more than 2 weeks) PSA
vii. Action to be taken Patients should be referred back to secondary care if they have any of t...
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.
ii. Therapeutic summary Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.
iii. Dose & Route of administration 60mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or back of arm. Patients must be calcium and vitamin D replete and in most cases advice will be given to provide supplementation with calcium and vitamin D (daily dosage: calcium 1g and colecalciferol 800 units). No dosage adjustment is required in patients with renal impairment.
iv. Duration of treatment Contact specialist after 5 years of treatment to determine if treatment should continue. There is a risk of rebound fractures, especially vertebral fractures, with the cessation of treatment. Bone mineral density is also likely to return back to prior to commencing denosumab.
v. Adverse effects Common (≥ 1/100 to < 1/10): urinary tract infection, upper respiratory tract infection, sciatica, abdominal discomfort, constipation, rash and pain in extremity. Uncommon (≥ 1/1000 to < 1/100): diverticulitis, cellulitis, ear infection. Skin infections requiring hospitalisations Rare (≥ 1/10,000 to < 1/1,000): atypical femur fracture, osteonecrosis of the jaw (ONJ), hypocalcaemia (< 1.88 mmols/l), The above details are not a complete list and the current BNF and the SPC should be consulted.
vi. Monitoring Requirements Prior to initiation of ther...
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
ii. Cautions • Naltrexone is extensively metabolised by the liver and excreted predominantly in the urine. Therefore, caution should be observed in administering the medicinal product to patients with impaired hepatic or renal function. Liver function tests should be carried out both before and during treatment. • During treatment with naltrexone, painful conditions should be treated with non-opioid analgesia only. If opioids cannot be avoided i.e. opioid analgesia or anaesthesia in emergency situations, the dose needed may be higher than normal. In these cases, the respiratory depression and circulatory effects will be more profound and longer lasting. The patient requires monitoring carefully in these situations for signs of opioid toxicity. High dose opioid intake, concomitant with Naltrexone treatment, can lead to life-threatening opioid poisoning from respiratory and circulatory impairment. • Patients must be warned against the concomitant use of opioids (e.g. opioids in cough medication, opioids in symptomatic medication for the treatment of common colds, or opioids contained in anti- diarrhoeal agents, etc.) during naltrexone treatment
iii. Dose and route of administration In accordance to national guidance the therapy should be initiated and supervised by a specialist prescriber experienced in treatment of alcohol- dependent patients. NICE guidance recommends starting at a dose of 25mg daily and aim for a maintenance dose of 50mg daily. Unlicensed for use in children under 18 years of age. Safe use in children has not been established. Not recommended in elderly patients due to insufficient data on the safety and efficacy of naltrexone for this indication
iv. Duration of treatment Up to six months, or longer if service user is benefitting from the drug and wants to continue with it
v. Adverse effect Common or Very common: Joint and muscle pain, abdominal pain, anxiety, chest pain, chills, constipation, decreased potency, delayed ejaculation, diarrhoea, dizziness, headache, increased energy, increased lacrimation, increased sweating, increased thirst, irritability, mood swings, nausea, rash, reduced appetite, sleep disorders, urinary retention, vomiting.
