Oncotice

/ MSD

Dosage: Per instillation, the contents of one reconstituted and diluted vial of OncoTICE, are instilled into the bladder.
Induction treatment: Weekly instillation with OncoTICE during the first 6 weeks. When used as an adjuvant therapy after TUR of a superficial urothelial cell carcinoma of the bladder, treatment with OncoTICE should be started between 10 and 15 days after performing the TUR. Treatment should not be started until mucosal lesions after TUR have healed.
Maintenance treatment: Maintenance treatment is indicated for all patients and consists of weekly instillation with OncoTICE during 3 consecutive weeks at months 3, 6 and 12 after initiation of the treatment.
The need for maintenance treatment every 6 months beyond the first year of treatment should be evaluated on the basis of classification and clinical response.

Treatment of flat urothelial cell carcinoma in situ (CIS) of the bladder and as adjuvant therapy after transurethral resection (TUR) of primary or relapsing superficial papillary urothelial cell carcinoma of bladder stage Ta (grade 2 or 3) or T₁ (grade 1, 2 or 3). Only recommended for stage Ta grade 1 papillary tumors when there is judged to be a high risk of tumor recurrence. Maintenance treatment is indicated for all patients and consists of weekly instillation during 3 consecutive weeks at months 3, 6 and 12 after initiation of the treatment. The need for maintenance treatment every 6 months beyond the first year of treatment should be evaluated on the basis of classification and clinical response.

– Urinary tract infections. In these cases therapy with OncoTICE should be interrupted until the bacterial culture from urine becomes negative and the therapy with antibiotics and/or urinary antiseptics is stopped.
– Gross haematuria. In these cases OncoTICE therapy should be stopped or
postponed until the haematuria has been successfully treated or has resolved.
– Clinical evidence of existing active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with OncoTICE.
– Treatment with anti-tuberculosis drugs like streptomycin, para-amino-salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol.
– Impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.
– Positive HIV serology
– Pregnancy and lactation

* Before the first intravesical instillation, a Tuberculin test (PPD) should be performed. If the test is positive, this medical product is contraindicated only if there is supplementary medical evidence for an active tuberculous infection.
* Traumatic catheterisation or other injuries to the urethra or bladder mucosa can promote systemic BCG infection. Administration should be delayed in such patients until mucosal damage has healed.
* It is recommended that patients known to be at risk of HIV infection be adequately screened prior to commencing therapy.
* Patients should be monitored for the presence of symptoms of systemic BCG infection and signs of toxicity after each intravesical treatment.
* In order to protect the partner, the patient should be recommended to either refrain from intercourse within one week after instillation, or to use a condom.
* This medical product is an infectious agent. Infectious complications of intravesical BCG can occur during treatment. Treatment of infectious complications of BCG requires long-term antibiotic therapy, which may include multiple drugs. Special culture media for mycobacteria are required, and physicians administering intravesical BCG or those caring for these patients should have these media readily available.
* Instillation with an actively bleeding mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.
* Deaths have been reported as a result of systemic BCG infection and sepsis. Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever above 39°C, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) last for 48 to 72 hours may also suggest active infection
See prescribing information for full details.

Very common: cystitis, dysuria, pollakiuria, haematuria, influenza-like illness, pyrexia, malaise, fatigue.
Common: urinary tract infection, anaemia, pneumonitis, abdominal pain, nausea, vomiting, diarrhoea, arthralgia, arthritis, myalgia, urinary incontinence, micturition urgency, urine analysis abnormal, rigors.
See prescribing information for full details.

Tice BCG is sensitive to most antibiotics and in particular to the routinely used antituberculosis drugs like streptomycin, para-amino salicylic acid (PAS), isoniazid (INH), rifampicin and ethambutol. Therefore, the anti-tumour activity may be influenced by concomitant therapy with antibiotics. If a patient is being treated with an antibiotic it is recommended to postpone the intravesical instillation until the end of the antibiotic-treatment.
Immunosuppressants and/or bone marrow depressants and/or radiation may interfere with the development of the immune response and thus with the anti-tumour efficacy and should therefore not be used in combination.

This medical product is contraindicated during pregnancy and lactation

Overdosage occurs when more than one vial is administered per instillation. In case of overdosage, the patient should be closely monitored for signs of systemic BCG infection and if necessary treated with anti-tuberculosis drugs.