Indications And Dose
Prophylaxis of graft rejection in adults undergoing renal transplantation who are seropositive for the Epstein- Barr virus ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature)
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Drug reference
Prophylaxis of graft rejection in adults undergoing renal transplantation who are seropositive for the Epstein- Barr virus ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature)
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Increased risk of acute graft rejection—with tapering of corticosteroid, particularly in patients with high immunologic risk. increased risk of infection. latent and active tuberculosis. risk factors for post-transplant lymphoproliferative disorder
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Patients should be evaluated for latent and active tuberculosis before starting treatment.
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NICE decisions ▶Immunosuppressive therapy for kidney transplant in adults (October 2017) NICE TA481 Belatacept is not recommended as an initial treatment to prevent organ rejection in adults having a kidney transplant. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA481
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→Appendix 1: belatacept
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▶Common or very common Acidosis. alopecia. anaemia. angina pectoris. arrhythmias. arterial fibrosis. cataract. chest pain. constipation. cough. Cushing’s syndrome. decreased leucocytes. diabetes mellitus. diarrhoea. dizziness. dyslipidaemia. dyspnoea. ear pain. electrolyte imbalance. embolism and thrombosis. eye erythema. fatigue. fever. fluid imbalance. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headaches. healing impaired. heart failure. hepatic disorders. hypercapnia. hyperglycaemia. hypertension. hypoproteinaemia. hypotension. increased risk of infection. intervertebral disc disorder. joint disorders. lethargy. leucocytosis. lymphocele. malaise. muscle complaints. muscle weakness. nausea. neoplasms. nerve disorders. neutropenia. oral disorders. oropharyngeal complaints. osteoarthritis. pain. paraesthesia. peripheral oedema. polyomavirus infections. pulmonary oedema. red blood cell abnormalities. renal disorders. renal tubular necrosis. respiratory disorders. scrotal disorders. sepsis. shock. skin reactions. stroke. sweat changes. syncope. thrombocytopenia. tinnitus. transplant rejection. tremor . urinary disorders. urine abnormalities. vascular disorders. ventricular hypertrophy. vertigo. vesicoureteric reflux. vision disorders. vomiting. weight changes ▶Uncommon Acute coronary syndrome. adrenal insufficiency. agranulocytosis. alkalosis. anxiety. aortic valve disease. appetite decreased. arterial stenosis. atrioventricular block. attention deficit/hyperactivity disorder. bone disorders. bone fracture. breast mass. broken nails. cervical dysplasia. cholelithiasis. cognitive disorder. demyelination. depression. diabetic foot. diabetic ketoacidosis. disease recurrence. dysphonia. encephalopathy. endocarditis. eye inflammation. facial paralysis. facial swelling. feeling hot. fibrosis. flushing. haemolysis. hair changes. hearing impairment. hemiparesis. hypercoagulation. hypogammaglobulinaemia. infertility. inflammation. infusion related reaction. intermittent claudication. intracranial pressure increased. lymphangitis. memory loss. mood altered. nephritis. nephrosclerosis. pancreatitis. penile ulceration. post procedural haematoma. procedural complications. progressive multifocal leukoencephalopathy (PML). pulmonary hypertension. renal tubular atrophy. restless legs. seasonal allergy. seizure. sexual dysfunction. sleep apnoea. sleep disorders. taste altered. tendon rupture. testicular pain. ulcer. vitamin D deficiency. vulvovaginal disorders. wound dehiscence SIDE-EFFECTS, FURTHER INFORMATION Side effects are reported when used in combination with basiliximab, mycophenolate mofetil and corticosteroids.
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Adequate contraception must be used during treatment and for up to 8 weeks after last dose.
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Use only if essential.
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Avoid—no information available.
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Patients should be monitored for signs and symptoms of tuberculosis during and after treatment.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Nulojix (Bristol-Myers Squibb Pharmaceuticals Ltd) Belatacept 250 mg Nulojix 250mg powder for concentrate for solution for infusion vials | 1 vial P £354.52 (Hospital only) | 2 vial P £709.04 (Hospital only) Multiple sclerosis 1.1 Multiple sclerosis Immune system and malignant disease Description of condition Multiple sclerosis is a chronic, immune-mediated, demyelinating inflammatory condition of the central nervous system, which affects the brain, optic nerves and spinal cord, and leads to progressive severe disability. Relapsing-remitting multiple sclerosis is the most common pattern of the disease. It is characterised by periods of exacerbation of symptoms (relapses) followed by unpredictable periods of stability (remission). The severity and frequency of relapses varies greatly between patients, but on average occur once or twice per year. This clinical pattern often develops into secondary-progressive multiple sclerosis, with progressive disability unrelated to relapses. Most patients develop secondary progressive disease 6–10 years after onset. Primary-progressive multiple sclerosis follows a gradual course, with the development of symptoms that worsen over time, without relapses and remissions. Progressive-relapsing multiple sclerosis follows a course of steadily worsening neurological function from onset, in addition to acute relapses. Disease activity in relapsing-remitting multiple sclerosis Active disease is defined as at least two clinically significant relapses occurring within the last 2 years. Highly active disease is characterised by an unchanged/increased relapse rate or by ongoing severe relapses compared with the previous year, despite treatment with interferon beta p. 895. Rapidly-evolving severe relapsing-remitting multiple sclerosis is defined by two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) or a significant increase in T2 lesion load compared with a previous MRI. Aims of treatment There is no cure for multiple sclerosis. The overall aims of treatment are to modify the course of the disease and manage symptoms, in order to improve quality of life. Treatment is aimed at reducing the frequency and duration of relapses and at preventing or slowing disability. Drug treatment Shared decision-making between the patient and their clinicians is particularly important in the treatment of multiple sclerosis, due to the unpredictability of the condition and the lack of evidence of long-term benefit of treatments. g A discussion about treatment options, disease activity, risk, and benefit should take place to ensure that treatment choices are right for the patient and their circumstances. h The choice of drug also depends on the patient’s disability status, individual tolerance, disease severity and disease activity (see Disease activity in relapsing- remitting multiple sclerosis above). g Treatment should be initiated as early as possible, under the supervision of a specialist. h Note: NHS England (May 2014) has provided guidance on the use of interferon beta, glatiramer acetate p. 897, fingolimod p. 899 and natalizumab p. 904 for the treatment of multiple sclerosis in England, see Useful resources below. This Clinical Commissioning Policy outlines the funding arrangements and the criteria for initiating and discontinuing these treatment options. See also National funding/access decisions, under individual monographs for teriflunomide p. 906, dimethyl fumarate p. 898 and alemtuzumab p. 903. Low levels of vitamin D are believed to be a risk factor for developing multiple sclerosis. Patients with diagnosed multiple sclerosis are usually given regular vitamin D after assessment of their serum levels of vitamin D, but there is insufficient evidence to support its use as a treatment for multiple sclerosis. g Patients should not be offered vitamin D solely for the purpose of treating multiple Immune system and malignant disease sclerosis. h Relapsing-remitting multiple sclerosis g Disease-modifying drugs are the recommended treatment for patients presenting with active relapsing- remitting multiple sclerosis. Interferon beta and glatiramer acetate may be the preferred choice for some patients, due to their established safety profile, and the long term clinical experience associated with their use. h Peginterferon beta- 1a p. 897 requires less frequent administration and is available as an alternative to the non-pegylated interferon beta therapies. Teriflunomide and dimethyl fumarate are treatment options for patients with active disease. g They may be preferred due to their oral route of administration. h There is insufficient evidence for the use of either drug to treat highly active or rapidly-evolving severe relapsing-remitting multiple sclerosis. g More active disease may be treated with natalizumab or alemtuzumab. The MHRA has released restrictions on the use of alemtuzumab due to reports of serious cardiovascular and immune-mediated reactions, see Important safety information in the alemtuzumab drug monograph. Natalizumab may be preferred due to the complex safety profile associated with alemtuzumab. Natalizumab is only recommended for the treatment of rapidly-evolving severe relapsing-remitting multiple sclerosis. Fingolimod is also taken by the oral route and is the recommended treatment for patients with highly active disease. h The NHS England Clinical Commissioning Policy (see Useful resources below) advises that fingolimod is a suitable alternative for patients receiving natalizumab who are at high risk of developing progressive multifocal leukoencephalopathy (defined as patients previously exposed to the JC virus or who are receiving immunosuppressants or who have been receiving treatment with natalizumab for more than 2 years). Secondary progressive multiple sclerosis Currently, only interferon beta 1b is licensed for use in secondary progressive multiple sclerosis. Interferon beta 1b reduces the risk of relapse and of short-term relapse-related disability, but does not prevent the development of permanent physical disability or retard progression once it is established. Therefore its role in secondary progressive disease is limited. Primary progressive multiple sclerosis Currently there are no effective disease-modifying treatments licensed for primary progressive multiple sclerosis. Interferon beta [unlicensed indication] has been used, but there is limited evidence to support its use due to the lack of a significant reduction in disability progression. Progressive-relapsing multiple sclerosis There are no specific treatment options for this type of multiple sclerosis. None of the currently licensed disease- modifying drugs are recommended in non-relapsing progressive disease. Management of symptoms Other than episodes of neurological dysfunction, chronic symptoms (such as fatigue, spasticity, visual problems, and emotional lability) produce much of the disability in multiple sclerosis. g Smoking may increase the progression of disability in multiple sclerosis, and Smoking cessation p. 520 should be encouraged. h Relapses Suspected relapses should be referred to a specialist for diagnosis and treatment. g Corticosteroids are recommended for reducing inflammation and accelerating recovery in acute relapses of relapsing-remitting multiple sclerosis. Oral methylprednisolone p. 715 is recommended as the first-line option. Intravenous methylprednisolone should be considered as an alternative if oral methylprednisolone has failed or is not tolerated or if hospitalisation is required. h Fatigue and impaired mobility g Regular exercise may have beneficial effects on mobility and fatigue in patients with multiple sclerosis, and should be encouraged. Cognitive behavioural techniques for fatigue should also be considered in combination with exercise. Amantadine hydrochloride p. 437 [unlicensed indication] may be used to treat fatigue related to multiple sclerosis. Vitamin B12 injections are not recommended as a treatment for fatigue in patients with multiple sclerosis. h Fampridine p. 895 is licensed for the improvement of walking in patients with multiple sclerosis who have a walking disability. g NICE do not consider it to be a cost- effective treatment and do not recommend its use. h Spasticity Many factors may aggravate spasticity in multiple sclerosis, including constipation, infection, poor mobility aids, pressure ulcers, posture and pain. g These causes should be managed appropriately. The first-line options for managing spasticity in multiple sclerosis are baclofen p. 1190 or gabapentin p. 331 [unlicensed indication]. They may be used cautiously in combination if the individual drugs are ineffective or if side effects prevent an increase in the dose of either drug. Tizanidine p. 1192 or dantrolene sodium p. 1417 are second-line options; benzodiazepines may be used as third-line therapy and may also be effective in treating nocturnal spasms. A 4-week trial of cannabis extract p. 1190 can be offered as adjunctive treatment for moderate to severe spasticity in multiple sclerosis if other pharmacological treatments are not effective. Treatment with cannabis extract should be initiated and supervised by a specialist. For funding/access information, see NICE clinical guideline: Cannabis-based medicinal products (see Useful resources). h Oscillopsia g Gabapentin [unlicensed indication] is the first-line treatment for oscillopsia; memantine hydrochloride p. 320 [unlicensed indication] is the second-line option. h Emotional lability g Amitriptyline hydrochloride p. 390 [unlicensed indication] may be used to treat emotional lability in patients with multiple sclerosis. h Useful Resources Clinical Commissioning Policy: disease modifying therapies for patients with multiple sclerosis. NHS England. May 2014. www.england.nhs.uk/commissioning/spec-services/npc-crg/ group-d/d04/ Multiple sclerosis in adults: management. National Institute for Health and Care Excellence. Clinical guideline 186. October 2014. www.nice.org.uk/guidance/cg186 Cannabis-based medicinal products. National Institute for Health and Care Excellence. Clinical guideline 144. November 2019. www.nice.org.uk/guidance/ng144 Other drugs used for Multiple sclerosis Cladribine, p. 957 CHOLINERGIC RECEPTOR STIMULATING DRUGS
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Patients should be advised to avoid excessive exposure to UV light including sunlight.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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