Medac GmbH supports Guideline on Intravesical Instillations of BCG/MMC

Hamburg / Wedel (11 May 2015). medac GmbH has provided the European Association of Urology Nurses (EAUN) with an unrestricted educational grant to support the creation of a booklet “Guideline on intravesical instillations of BCG/MMC”.

Over the past 30 years medac has provided urologists with their expertise and products for the treatment and management of different diseases of the urogenital tract.

With this grant, which will enable a focus on non-muscle invasive bladder cancer (NMIBC), medac is widening its support to encompass other healthcare professionals in the area of NMIBC striving to support optimal patient care Europe wide.

The new Guideline will be presented during the EAUN Annual meeting in Madrid as a part of the EAUN congress program. The “Guideline on intravesical instillations of BCG/MMC“ will also be available as pocket book.

BCG-medac, powder and solvent for suspension for intravesical use. After reconstitution, one vial contains BCG (Bacillus Calmette-Guérin) bacteria seed RIVM derived from seed 1173-P2, 2 x 10⁸ to 3 x 10⁹ viable units. Excipients: Powder: polygeline, glucose anhydrous and polysorbate 80. Solvent: sodium chloride and water for injections. Indications: Treatment of non-invasive urothelial bladder carcinoma: 1) curative treatment of carcinoma in situ; 2) prophylactic treatment of recurrence of : a) urothelial carcinoma limited to mucosa : Ta G1-G2 if multifocal and/or recurrent tumour, Ta G3, b) urothelial carcinoma in lamina propia but not the muscular of the bladder (T1), c) carcinoma in situ. Contraindications: Hypersensitivity to any of the ingredients. BCG-medac should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., positive HIV serology, leukaemia, lymphoma), cancer therapy (e.g., cytostatic drugs, radiation) or immunosuppressive therapy (e.g. corticosteroids). BCG-medac should not be administered to persons with active tuberculosis. The risk of active tuberculosis must be ruled out by appropriate anamnesis and if indicated by diagnostic tests according to local guidelines. Past history of radiotherapy of the bladder. Women during lactation. BCG-medac must not be instilled before 2 to 3 weeks after TUR, bladder biopsy or traumatic catheterisation. Perforation of the bladder. Acute urinary tract infection. Undesirable effects: Side effects of BCG-treatment are frequent but generally mild and transient. Adverse reactions usually increase with the number of BCG instillations. Low grade fever, flu-like symptoms and general discomfort may occur. These symptoms usually subside within 24-48 hours and should be managed by standard symptomatic treatment. These reactions are signs of a starting immune reaction. All patients receiving the product should be carefully monitored and advised to report all incidences of fever and other events outside the urinary tract. Systemic adverse reactions/infections are defined as: Fever > 39.5°C during at least 12 hours, fever > 38.5°C during at least 48 hours, miliary pneumonia due to BCG, granulomatous hepatitis, liver function test abnormalities, organic dysfunction (other than genito-urinary tract) with granulomatous inflammation at biopsy, Reiter’s syndrome. Severe systemic BCG reaction/infection can lead to BCG sepsis which is a life-threatening situation. Infections, infestations: Very commonly cystitis and inflammatory reactions (granulomata) of the bladder. Uncommonly urinary tract infection, orchitis, severe systemic BCG reaction/infection, BCG sepsis, miliary pneumonitis, skin abscess, Reiter’s syndrome (conjunctivitis, asymmetrical oligoarthritis and cystitis). Rarely vascular infection (e. g. infected aneurysm), renal abscess. Very rarely BCG infection of implants and surrounding tissue (e.g. aortic graft infection, cardiac defibrillator, hip or knee arthroplasty), cervical lymphadenitis, regional lymph node infection, osteomyelitis, bone marrow infection, psoas abscess, infection of the glans penis, orchitis or epididymitis resistant to antituberculous therapy. Blood and lymphatic system: Uncommonly cytopenia, anemia. Immune system: Very commonly transient systemic BCG reaction (fever < 38.5°C, flu-like symptoms including malaise, fever, chills, general discomfort). Very rarely hypersensitivity reaction (e.g. oedema of eyelids, cough). Eye: Very rarely chorioretinitis, conjunctivitis, uveitis. Vascular: Very rarely vascular fistula. Respiratory, thoracic, mediastinal: Uncommonly pulmonary granuloma. Gastrointestinal: Very commonly nausea. Very rarely vomiting, intestinal fistula, peritonitis. Hepatobiliary: Uncommonly hepatitis. Skin, subcutaneous tissue: Uncommonly skin rash. Musculoskeletal and connective tissue: Uncommonly arthritis, arthralgia. Renal, urinary: Very commonly frequent urination with discomfort and pain. Uncommonly macroscopic haematuria, bladder retraction, urinary obstruction, bladder contracture. Reproductive system, breast: Very commonly asymptomatic granulomatous prostatitis. Uncommonly epididymitis, symptomatic granulomatous prostatitis. Frequency not known: Genital disorders (e.g. vaginal pain, dyspareunia). General; administration site: Commonly fever > 38.5°C. Uncommonly hypotension. Legal classification: POM (prescription only medicine). Marketing authorisation holder: medac GmbH, Theaterstraße 6; 22880 Wedel, Germany. Date of revision of text: 08/2014

BCG-medac has been authorised in Austria, Belgium, Croatia (Medis Adria), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Kazakhstan, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Sweden, Spain, Thailand and Ukraine.

Mitomycin powder for solution for infusion / Mitomycin 1 mg/ml, powder (and solvent) for solution for intravesical use

Qualitative and quantitative composition: Powder for infusion: 1 injection vial with 50 (250) (500) (1000) mg powder contains 2 (10) (20) (40) mg mitomycin. Powder and solvent for solution for intravesical use: 1 injection vial with 500 (1000) mg powder contains 20 (40) mg mitomycin. Excipients: Powder: Sodium chloride; Solvent: Sodium chloride, water for injection. Therapeutic indications: Adenocarcinomas emanating from the bronchi, breast, stomach or pancreas. Squamous cell carcinoma emanating from the bronchi, head, neck, mouth cavity or cervix-vulva. Urothelial cancer emanating from the bladder. Mitomycin should be given intravenously in fixed combination schedules as palliative treatment for the above listed tumour forms, and in addition as part of adjuvant chemotherapy in breast cancer and cancer of the stomach. Intravesical monotherapy in superficial bladder cancer. In DK Mitomycin is only indicated in non-invasive bladder cancer and breast cancer. Posology and method of administration: Intravenous administration: 6-10 mg/m² body surface, given as a single dose, repeated every 3 to 8 weeks, depending on the treatment regime, response and side-effects. As a general rule 6 mg/m² of Mitomycin is administered every 3 weeks and 10 mg/m² is used with 4-8 week intervals. An alternative dosage is 20 mg/m² as a single dose every 6 to 8 weeks. Intravesical administration: 20-40 mg once weekly for 8 weeks. Dose reduction may become necessary if local reactions appear. In patients with low risk of tumour recurrence one immediate postoperative instillation can be used as the adjuvant treatment; most frequent dose is 40 mg. The patient should be catheterized, the bladder emptied and the solution is instilled. The solution should be kept in the bladder for 1-2 hours. Contraindications: Hypersensitivity to mitomycin or any excipient; reduced bone marrow function; breast feeding. Systemic use: Acute infections; haemorrhagic diathesis; severe liver, lung or renal disorders; poor general condition; lactation. Intravesical use: Bladder perforation, cystitis, severe reduced kidney function. Undesirable effects: Systemic administration: Very common: Cumulative bone marrow suppression, leukocytopenia, thrombocytopenia; nausea, vomiting. Common: Interstitial pneumonia, dyspnoea, cough (steroids are suitable for prophylaxis and for the treatment of existing pulmonary reactions); mucositis, stomatitis, diarrhoea, anorexia; local exanthemata, allergic skin rash, contact dermatitis, palmar-plantar erythema, alopecia; renal impairment, serum creatinine elevation, glomerulopathy. In extravasation cellulitis, tissue necrosis; local administration of dimethyl sulfoxide (99% DMSO) and the application of a dry cold compress are the recommended treatment measures. Uncommon: Fever. Rare: Life-threatening infection, sepsis, haemolytic anaemia; cardiac failure, especially after previous treatment with anthracyclines; pulmonary hypertension, pulmonary veno-occlusive disease; liver function impairment, elevated transaminases, jaundice, hepatic veno-occlusive disease; generalised exanthemata; haemolytic uraemic syndrome, microangiopathic haemolytic anaemia (MAHA syndrome). Very rare: Severe allergic reaction. Intravesical administration: Common: Local exanthemata, allergic skin rash, contact dermatitis, palmar-plantar erythema; cystitis, dysuria, nocturia, polyuria, haematuria, local bladder wall irritation. Rare: Generalised exanthemata. Very rare: Necrotising cystitis, allergic (eosinophilic) cystitis, ureteral stenosis, reduced bladder capacity. Patients should be advised to wash hands and genital area after urination following administration to avoid contact dermatitis. Legal classification: POM (prescription only medicine). Marketing authorisation holder: medac GmbH, Fehlandtstraße 3; D-20354 Hamburg. Date of revision of text: 01/2013

Mitomycin has been authorised in Denmark (20 mg only), Germany and Sweden.

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medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6
D – 22880 Wedel
www.medac.de

medac Gesellschaft für klinische Spezialpräparate mbH
medac is an independent German pharmaceutical company located in Hamburg, Wedel and Tornesch. Medicinal products from medac support doctors and patients throughout the world in overcoming their acute and persistent diseases in the indication areas of oncology & haematology, urology and autoimmune disorders. In addition, medac develops and markets special diagnostic test systems. Since 1970, medac has been committed to unifying therapeutic and diagnostic agents under one roof. You can call up further information on the company and its products on the internet under www.medac.de.