BCG vaccine interacts in the following cases:
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 with BCG vaccine.
BCG vaccine instillation for carcinoma of the bladder is contraindicated during pregnancy.
BCG vaccine instillation for carcinoma of the bladder is contraindicated during lactation.
Not relevant.
The side effects of intravesical BCG vaccine therapy are generally mild and transient. Toxicity and side-effects appear to be directly related to the cumulative CFU count of BCG administered with the various instillations. Approximately 90% of patients develop local irritative symptoms in the bladder. Pollakiuria and dysuria are reported very frequently. The cystitis and typical inflammatory reactions (granulomas) which occur in the mucosa of the bladder after instillation of BCG, and which cause these symptoms, may be an essential part of the anti-tumour activity of the BCG. In most cases, the symptoms disappear within two days after instillation and the cystitis does not require treatment. During maintenance treatment with BCG, the symptoms of cystitis may be more pronounced and prolonged. In these cases, when severe symptoms are present, isoniazid (300 mg daily) and analgesics can be given until disappearance of symptoms.
Side effects reported during post-marketing surveillance:
| Occurrence | MedDRA SOClass | Preferred terms |
|---|---|---|
| Very common (>1/10) | Renal and urinary disorders | Cystitis, dysuria, pollakiuria, haematuria |
| General disorders and administration site conditions | Influenza-like illness, pyrexia, malaise, fatigue | |
| Common (>1/100, <1/10) | Infections and infestations | Urinary tract infection |
| Blood and lymphatic system disorders | Anaemia | |
| Respiratory, thoracic and mediastinal disorders | Pneumonitis | |
| Gastrointestinal disorders | Abdominal pain, nausea, vomiting, diarrhoea | |
| Musculoskeletal and connective tissue disorders | Arthralgia, arthritis, myalgia | |
| Renal and urinary disorders | Urinary incontinence, micturition urgency, urine analysis abnormal | |
| General disorders and administration site conditions | Rigors | |
| Uncommon (>1/1,000, <1/100) | Infections and infestations | Tuberculous infections1 |
| Blood and lymphatic system disorders | Pancytopenia, thrombocytopenia | |
| Hepatobiliary disorders | Hepatitis | |
| Skin and subcutaneous tissue disorders | Rashes, eruptions and exanthems NEC1 | |
| Renal and urinary disorders | Bladder constriction, pyuria, urinary retention, ureteric obstruction | |
| Uncommon (>1/1,000, <1/100) | Investigations | Hepatic enzyme increased |
| Rare (>1/10,000, <1/1,000) | Respiratory, thoracic and mediastinal disorders | Cough |
| Reproductive system and breast disorders | Epididymitis | |
| Very rare (<1/10,000) | Infections and infestations | Pharyngitis, orchitis, Reiter’s syndrome, Lupus vulgaris |
| Blood and lymphatic system disorders | Lymphadenopathy | |
| Metabolism and nutrition disorders | Anorexia | |
| Psychiatric disorders | Confusional state | |
| Nervous system disorders | Dizziness, dysaesthesia3, hyperaesthesia3, paraesthesia, somnolence, headache, hypertonia, neuralgia3 | |
| Eye disorders | Conjunctivitis | |
| Ear and labyrinth disorders | Vertigo3 | |
| Vascular disorders | Hypotension | |
| Respiratory, thoracic and mediastinal disorders | Bronchitis, dyspnoea, rhinitis | |
| Gastrointestinal disorders | Dyspepsia3, flatulence3 | |
| Skin and subcutaneous tissue disorders | Alopecia, hyperhidrosis | |
| Musculoskeletal and connective tissue disorders | Back pain | |
| Renal and urinary disorders | Renal failure acute | |
| Reproductive system and breast disorders | Balanoposthitis, prostatitis, vulvovaginal discomfort3 | |
| General disorders and administration site conditions | Chest pain, oedema peripheral, granuloma2 | |
| Investigations | Prostatic specific antigen increased, weight decreased |
NEC = not elsewhere classified
1 High Level Term instead of Preferred Term
2 Granuloma NOS has been observed in various organs including the aorta, bladder, epididymis, gastrointestinal tract, kidney, liver, lungs, lymphnodes, peritoneum, prostate
3 Only isolated cases reported during post-marketing surveillance
Also commonly observed are malaise, a low to medium grade fever and/or influenza-like symptoms (fever, rigors, malaise and myalgia) which may accompany the localised, irritative toxicities that often reflect hypersensitivity reactions and be treated symptomatically. These symptoms usually appear within 4 hours after instillation and last for 24 to 48 hours. Fever higher than 39°C typically resolves within 24 to 48 hours when treated with antipyretics (preferably paracetamol) and fluids. However, it is frequently not possible to distinguish these uncomplicated febrile reactions from early systemic BCG infection and antituberculosis treatment may be indicated. Fever above 39oC that does not resolve within 12 hours despite antipyretic therapy must be considered as systemic BCG-infection, necessitating clinical confirmatory diagnostics and treatment.
Systemic BCG infections could be due to traumatic catheterisation, bladder perforation or premature BCG instillation after extensive TUR of a superficial carcinoma of the bladder. These systemic infections may be manifested by pneumonitis, hepatitis, cytopenia, vasculitis, infective aneurysm and/or sepsis after a period of fever and malaise during which symptoms progressively increase. Patients with symptoms of therapy-induced systemic BCG infection should be adequately treated with anti-tuberculosis drugs according to treatment schedules used for tuberculosis infections. In these cases, further treatment with Tice BCG is contraindicated.
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