Budenofalk - Dr Falk

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Products

Budenofalk

Budenofalk (budesonide) is a topical corticosteroid available in three formulations

  • Budenofalk 3mg gastro-resistant capsules for treatment of mild to moderate ileo-caecal Crohn’s Disease, Autoimmune Hepatitis and Microscopic Colitis
  • Budenofalk 9mg gastro-resistant granules for treatment of mild to moderate ileo-caecal Crohn’s Disease and active Collagenous Colitis
  • Budenofalk 2mg rectal foam for the treatment of active and maintenance of Ulcerative Colitis

 

Discover more about Budenofalk

Budesonide is a highly potent glucocorticoid that acts differently to systemic corticosteroids. The gastro-resistant formulation allows the targeted release of the active drug at pH6.4 in the inflamed areas of the gut. Approximately 90% of budesonide then undergoes first pass metabolism in the liver where it is converted into inactive metabolites. Only 10% of the active drug enters the systemic circulation. This pre-systemic metabolism significantly reduces the risk of systemic side effects.

Prescribing Information (Refer to full SPC before prescribing)

Presentation: Budenofalk® gastro-resistant capsules, each containing 3mg budesonide, 240mg sucrose and 12mg lactose monohydrate. Budenofalk® gastro-resistant granules, each sachet contains 9mg budesonide, 828mg sucrose, 36mg lactose monohydrate and 900mg sorbitol. Indications: Capsules: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Microscopic colitis. Autoimmune hepatitis. Granules: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission in patients with active microscopic colitis in adults aged ≥ 18 years. Dosage: All – take with a glass of water half an hour before meals. Take once-daily doses in the morning. Adults: Capsules: Crohn’s disease: 9mg once daily or 3mg three times a day. Microscopic colitis: Induction of remission: 9mg once daily. Maintenance: lowest effective dose – 6mg once daily or 6mg once daily alternating with 3mg once daily. Autoimmune hepatitis: induction of remission: 3mg three times a day. Maintenance: 3mg twice a day. Increase back to 9mg daily if ALAT &/or ASAT increase. Granules: Crohn’s disease and induction of remission in microscopic colitis: 9mg once daily in the morning. Duration of treatment: Induction: Crohn’s disease, microscopic colitis: 8 weeks. Autoimmune hepatitis – until remission is achieved then maintenance for at least 24 months. Do not stop any treatment abruptly but taper gradually. Contra-indications: hypersensitivity to any constituent. Hepatic cirrhosis. Warnings/Precautions: Change from other steroids may result in symptoms due to reduced systemic steroids. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes or any condition in which glucocorticosteroids may have undesirable effects. Not appropriate for upper GI Crohn’s or extraintestinal symptoms. Prolonged, high dose use may result in glucocorticosteroid systemic effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. Clinical presentation of infections may be atypical and presentation of serious infections may be masked. Chickenpox and herpes zoster are of particular concern. Passive immunisation needed within 10 days in exposed non-immune patients taking systemic glucocorticosteroids. Urgent specialist care required on confirmed chickenpox. Give normal immunoglobulin immediately after measles exposure. Do not give live vaccines to those with chronic glucocorticosteroid use. Antibody response to other vaccines may be diminished. With severe liver function disorders: increased systemic bioavailability expected. Central serous chorioretinopathy or other causes may result in blurred vision/visual disturbances. Consider referral to ophthalmologist. Suppression of the HPA axis and reduced stress response: supplementary systemic glucocorticoid treatment may be needed. Avoid concomitant treatment with CYP3A4 inhibitors. Do not use in patients with galactose or fructose intolerance, glucose – galactose malabsorption, sucrase – isomaltase insufficiency or total lactase deficiency or congenital lactase deficiency. In autoimmune hepatitis evaluate transaminase levels every 2 weeks for the first month and then every 3 months. Interactions: Co-treatment with CYP3A inhibitors including cobicistat containing products may increase side effects and should be avoided where possible. Beware concomitant administration of cardiac glycosides and saluretics. CYP3A4 inducers: may reduce systemic and local exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates: may compete with budesonide increasing plasma concentrations depending on relative affinities. Small, non-significant effect of cimetidine on budesonide kinetic effects. Oestrogens/oral contraceptives (not oral low dose combination contraceptives) may elevate plasma concentrations and enhance corticosteroid effects. Steroid-binding compounds and antacids may reduce budesonide efficacy; administer at least 2 hours apart. Because adrenal function may be supressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Avoid use in pregnancy unless essential. Do not breastfeed during Budenofalk treatment. Undesirable effects: Cushing’s syndrome, growth retardation in children, glaucoma, cataracts, blurred vision, dyspepsia, abdominal pain, constipation, gastric or duodenal ulcers, pancreatitis, increase in risk of infections, muscle and joint pain and weakness and twitching, osteoporosis, osteonecrosis, headache, pseudotumor cerebri (including papilloedema) in adolescents, depression, irritability and euphoria, psychomotor hyperactivity, anxiety, aggression, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing, increased risk of thrombosis, vasculitis (after withdrawal from long-term treatment), fatigue, malaise. Side effects characteristic of systemic glucocorticosteroid therapy may occur. Exacerbation or reappearance of extraintestinal manifestations when switching from systemically acting glucocorticosteroids may occur. Frequency is likely to be lower than with equivalent dosage of prednisolone. Legal category: POM. Costs: UK NHS: 60 sachets £135; 100 capsules £75.05. Ireland (PtW): 60 sachets: €145.84; 100 capsules: €77.95. Licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Licence numbers: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules) PL08637/0002 (UK) PA573/2/1 (IE). Prepared: February 2024

Further information available on request.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store (UK residents) or at email:  medsafety@hpra.ie or at http://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form   (residents in Ireland).  Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk

Prescribing Information (Refer to full SPC before prescribing)
Name of Medicinal Product: Budenofalk 2mg rectal foam Presentation: Each dose of 1.2g foam contains 2mg budesonide. Indications: Treatment of active ulcerative colitis limited to the rectum and the sigmoid colon. Dosage & Administration: Adults aged over 18 years, one dose of 2mg budesonide daily, applied either in the morning or evening. Should not be used for longer than 6–8 weeks. Children, not recommended. Contra-indications: Known hypersensitivity to budesonide or any of the ingredients, hepatic cirrhosis. Special Warnings & Precautions: Results in lower systemic steroid levels than oral therapy with systemically acting corticoids. Transfer from systemic corticoids may result in recurrence of symptoms. Systemic effects of glucocorticosteroids may occur, especially at high and/or prolonged doses. Caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma. 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. Clinical presentation of serious infections e.g. septicaemia and tuberculosis, may be masked. Chickenpox is of particular concern in immunosuppressed patients and those without a definite medical history of this infection should avoid close personal contact with chickenpox or herpes zoster. Passive immunisation is needed by exposed non-immune patients receiving (or those who have received within the previous 3 months) systemic corticosteroids, within 10 days of exposure to chickenpox. Urgent specialist care is required on confirmed chickenpox; corticosteroids should not be stopped and the dosage may need to be increased. Immunosuppressed patients in contact with measles should immediately receive normal immunoglobulin. Live vaccines should not be given to individuals with impaired immune responsiveness and antibody response to other vaccines may be diminished. Hepatic cirrhosis may increase systemic availability. Visual disturbances may require referral to ophthalmology. Corticosteroids may suppress the HPA axis and reduce the stress response. Supplementary systemic glucocorticoid treatment is recommended in patients subject to surgery or other stresses. Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided. The cetyl alcohol and cetostearyl alcohol content may cause local skin reactions (e.g. contact dermatitis). The propylene glycol may cause skin irritation. Interactions: Co-treatment with CYP3A inhibitors including cobicistat containing products may increase risk of systemic side effects. Concomitant administration of cardiac glycosides may potentiate the activity of the glycoside (due to increased excretion of potassium); simultaneous treatment with saluretics may also 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 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. Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Budenofalk should be avoided during pregnancy unless essential. It is not known if budesonide passes into breastmilk. The risks and benefits of breastfeeding for the infant and therapy for the woman need to be considered. Undesirable effects: The assessment of undesirable effects is based on the following frequencies. Common (≥1/100 to <1/10) Uncommon: (≥1/1000 to <1/100) Rare: (≥1/10,000 to <1/1000) Very rare: (<1/10,000). Common: headache, dyspepsia, burning in the rectum and pain, Cushing’s syndrome, increased risk of infection, muscle and joint pain, muscle weakness and twitching, osteoporosis, depression, irritability, euphoria, allergic exanthema, petechiae, delayed wound healing, contact dermatitis. Uncommon: duodenal or gastric ulcer, psychomotor hyperactivity, anxiety. Rare: glaucoma, cataract, blurred vision, pancreatitis, osteonecrosis, aggression, ecchymoses. Very rare: constipation, pseudotumor cerebri (including papilloedema) in adolescents, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy), fatigue and malaise, growth retardation in children. Seen in clinical studies with topical application of foam: uncommon: increased appetite, increase in erythrocyte sedimentation rate, leucocytosis, nausea, abdominal pain, flatulence, paraesthesias in the abdominal region, anal fissure, aphthous stomatitis, frequent urge to defecate, rectal bleeding, increase in transaminases (GOT, GPT), increase in parameters of cholestasis (GGT, AP), increase in amylase, change in cortisol, urinary tract infection, dizziness, disturbances of smell, insomnia, increased sweating, asthenia, increase in body weight.
Occasionally side effects characteristic of systemic corticosteroid therapy may occur, these effects depend on the dosage, period of treatment, concomitant or previous treatment with other glucocorticosteroids and the individual sensitivity. Exacerbation or reappearance of extra intestinal manifestations can occur on switching from systemically to locally acting. Due to its local action, the risk of unwanted effects with Budenofalk rectal foam is generally lower than when taking systemically acting glucocorticoids. Basic NHS Price: Packs containing 1 can of Budenofalk rectal foam sufficient for 14 doses £57.11. Ireland: € 62.40 (PtW) Legal Category: POM. Product Licence number: PL08637/0011 (UK) PA573/2/2 (IE). Product Licence Holder: Dr Falk Pharma GmbH, Leinenweberstr. 5, D-79108 Freiburg, Germany. Date of preparation: January 2023
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 https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form (residents in Ireland). Adverse events should also be reported to Dr Falk Pharma UK Ltd at PV@drfalkpharma.co.uk

Summary of Product Characteristics (SmPC)

This information on the following pages is intended only for UK and Irish residents who have been prescribed either Budenofalk, Salofalk, Ursofalk or Jorveza.