Happy with her selfie
When the symptoms of Crohn’s disease are already harming her self-esteem, steroid-related side-effects can make things even worse.1
Budenofalk is different - it offers the efficacy of a systemic steroid, but the side-effect level is more like mesalazine.2,3
Now that’s something to smile about.
Eudragit L/S coating modified release formulation meaning the drug is released in the terminal ileum and caecum4
50x Corticosteroids, the Dr Falk way
Prescribing Information (Please refer to full SPC before prescribing) Presentation: Budenofalk®
36mg lactose monohydrate and 900mg sorbitol. Budenofalk®
9 mg gastro-resistant granules, each sachet contains 9mg budesonide, 828mg sucrose, 3mg gastro-resistant capsules, each containing 3mg
budesonide, 240mg sucrose and 12mg lactose monohydrate. Indications: (granules and capsules) Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Extraintestinal symptoms unlikely to respond. Induction of remission of active collagenous colitis. Autoimmune hepatitis (capsules only). Dosage: Adults: Granules: One sachet daily, in the morning, half an hour before food, taken with liquid without chewing or crushing granules. Capsules: For Crohn’s disease and collagenous colitis, three capsules once daily, in the morning, half an hour before food and taken with liquid. One capsule three times daily if more convenient. Both formulations: limit treatment to 8 weeks. Treatment should not be stopped abruptly but withdrawn gradually. For autoimmune hepatitis, one capsule three times daily. Combine with azathioprine in suitable cases. For maintenance of remission: one capsule twice daily (morning and evening). Revert to 3 capsules daily in the event of elevated transaminases ALAT and/or ASAT. Continue treatment for maintenance of remission of autoimmune hepatitis for 24 months. Children: Not recommended in children younger than 12 years. Safety and efficacy in adolescents aged 12 -18 years has not been established. See SmPC sections 4.8 and 5.1 for data. No specific dose recommendations in renal/hepatic impairment. Contraindications: hypersensitivity to budesonide or any of the ingredients. Hepatic cirrhosis. Warnings/ Precautions: Transfer of patients from other steroid therapy may result in symptoms relating to the lowering of systemic steroid levels. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes, or any other condition in which glucocorticoids may have undesirable effects. Not appropriate for use in upper GI Crohn’s disease or for extraintestinal symptoms e.g., of the eyes, skin, joints. Long term, high dose use may result in systemic effects of corticosteroids such as Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and rarely, psychiatric/behavioural effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity, with risk of deterioration of bacterial, fungal, amoebic and viral infections. The clinical presentation of infections may be atypical and the presentation of serious infections e.g. septicaemia and tuberculosis, may be masked. Chickenpox can be fatal in immunosuppressed patients. Those without definite medical history of this infection should avoid close personal contact with chickenpox or herpes zoster and seek medical attention if exposed. Passive immunisation is needed by exposed non-immune patients receiving (or who have received within the previous 3 months) systemic corticosteroids, within 10 days of exposure to chickenpox. Urgent specialist care is required if chickenpox is confirmed; corticosteroids should not be stopped and dosage may need to be increased. Measles: Immunosuppressed patients who come into contact with measles should receive normal immunoglobulin as soon as possible after exposure. Live vaccines should not be given to patients with chronic corticosteroid use/impaired immune responsiveness. Antibody response to other vaccines may be diminished. Patients with liver function disorders: increased systemic bioavailability of budesonide expected where there is severe impairment. Other: Corticosteroids may suppress the HPA axis and reduce the stress response. Supplementary systemic glucocorticoid treatment is recommended in patients subject to surgery or other stress. Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided. Do not use in patients with rare hereditary problems of galactose or fructose intolerance, glucose – galactose malabsorption, sucrase – isomaltase insufficiency or Lapp lactase deficiency or congenital lactase deficiency. In autoimmune hepatitis evaluate transaminase levels every 2 weeks for the first month and then every 3 months. Can lead to positive results in doping tests. Interactions: Concomitant administration of cardiac glycosides may
potentiate the activity of the glycoside (due to increased excretion of potassium); simultaneous treatment with saluretics may exacerbate the hypokalaemia. Avoid concomitant administration with ketoconazole, grapefruit juice or other CYP3A4 inhibitors (e.g. ritonavir, itraconazole and clarithromycin) because they may markedly increase the plasma concentrations of budesonide. CYP3A4 inducers (e.g. carbamazepine and rifampicin) may reduce systemic and local (gut mucosa) exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates may compete with budesonide leading to possible increases in plasma concentrations of either budesonide or substrate, depending on their relative affinities for this enzyme. Elevated plasma concentrations and enhanced effects of corticosteroids have been reported with oestrogens or oral contraceptives, although not with oral low dose contraceptives. Cimetidine has a small (non-significant) effect on the kinetic effects of budesonide. Omeprazole has no effect on the pharmacokinetics of budesonide. Steroid-binding compounds (e.g. cholestyramine) and antacids may reduce the efficacy of budesonide, therefore they should be given at least 2 hours apart. Use in pregnancy and lactation: Budenofalk should be avoided during pregnancy unless essential. Avoid breastfeeding during Budenofalk treatment. Undesirable effects: Cushing’s syndrome e.g., moon-face, truncal obesity, reduced glucose tolerance, diabetes mellitus, hypertension, sodium retention with oedema, increased excretion of potassium, inactivity or atrophy of the adrenal cortex, red striae, steroid acne, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence). Growth retardation in children, glaucoma, cataracts, stomach complaints, constipation, gastroduodenal ulcers, pancreatitis, increase in risk of infections, muscle and joint pain and weakness and twitching, osteoporosis, aseptic necrosis of bone, headache, pseudotumor cerebri (including papilloedema) in adolescents, depression, irritability and euphoria, a range of psychiatric/behavioural effects, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing, increased risk of thrombosis, vasculitis (after withdrawal from long-term treatment), tiredness and malaise, dizziness, nausea, vomiting, hyperacusis. Occasionally side effects characteristic of systemic corticosteroid therapy may occur although clinical studies have shown that the frequency of these side effects is lower with Budenofalk (approximately half) than with oral equivalent doses of prednisolone. Other adverse effects include exacerbation or reappearance of extraintestinal manifestations when switching treatment from systemically acting glucocorticosteroids. Legal category: POM. UK NHS Cost: (granules) packs of 60 sachets £135; (capsules) packs of 100 capsules £75.05. Ireland cost (PtW): (granules) packs of 60 sachets: €165.80; (capsules) packs of 100 capsules: €78.96. Product licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Product licence number: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules) PL08637/0002 (UK) PA573/2/1 (IE). Date of preparation: May 2015.
Further information is available on request. Adverse events should be reported. Reporting forms and
information can be found at
www.mhra.gov.uk/yellowcard (UK residents) or at
http://www.hpra.ie/homepage/about-us/report-an-issue (residents of the Republic of Ireland). Adverse events should also be reported to Dr Falk Pharma UK Ltd.
References: 1. McDermott E et al. Inflamm Bowel Dis 2015; 21(2): 353-60. 2. De Cassan C et al. Dig Des 2012; 30(4): 368-75. 3. Bar-Meir S et al. Gastroenterol 1998; 115(4): 835-40. 4. Data on file, Dr Falk Pharma. 5. Möllman HW et al. In: Möllman HW, May B. Glucocortcoid Therapy in Chronic Inflammatory Bowel Disease. Dordrecht: Kluwer 1996. 6. He Y et al. Cell Res 2014; 24(6): 713-26.
Date of preparation: December 2015 DrF15/143
greater receptor affinity than prednisolone meaning a lower effective steroid dose is required5,6
90%
pre-systemic clearance meaning the potential risk of side-effects is limited2
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