Bacillus of calmette and guerin vaccine, live Intravesical

In the U.S.

• Theracys
• Tice BCG

Available Dosage Forms:

• Powder for Solution
• Powder for Suspension

Therapeutic Class: Vaccine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bacillus of calmette and guerin vaccine, live, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bacillus of calmette and guerin vaccine, live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.

Geriatric

bacillus of calmette and guerin vaccine, live has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving bacillus of calmette and guerin vaccine, live, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using bacillus of calmette and guerin vaccine, live with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Deflazacort
• Thiotepa

Using bacillus of calmette and guerin vaccine, live with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Alemtuzumab
• Antithymocyte Globulin Rabbit
• Azathioprine
• Bendamustine
• Bortezomib
• Bosutinib
• Brodalumab
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Docetaxel
• Doxorubicin
• Dupilumab
• Epirubicin
• Etanercept
• Etoposide
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Golimumab
• Guselkumab
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Immune Globulin
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Leflunomide
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Mycophenolic Acid
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Procarbazine
• Rilonacept
• Rituximab
• Sarilumab
• Secukinumab
• Sirolimus
• Temozolomide
• Teniposide
• Teriflunomide
• Tocilizumab
• Topotecan
• Tositumomab
• Trabectedin
• Ustekinumab
• Vinblastine
• Vinorelbine

Using bacillus of calmette and guerin vaccine, live with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of bacillus of calmette and guerin vaccine, live. Make sure you tell your doctor if you have any other medical problems, especially:

• Fever—Infection may be present and could cause problems

• Immunity problems—BCG treatment is less effective and there is a risk of infection

• Urinary tract infection—Infection and irritation of the bladder may occur

Commonly reported side effects of bcg include: urinary tract infection, detrusor hyperreflexia of bladder, fever, hematuria, urinary frequency, urinary urgency, vomiting, chills, and malaise. Other side effects include: arthralgia. See below for a comprehensive list of adverse effects.

Applies to bcg: intravesical powder for reconstitution, percutaneous powder for injection

Genitourinary

Very common (10% or more): Dysuria (60%), increased urgency/frequency (40%), drug induced cystitis (30%), bacterial cystitis (27%), hematuria (27%), pollakiuria
Common (1% to 10%): Urinary tract infection, urinary incontinence, micturition urgency, urine analysis abnormal, bladder cramps, hemorrhage cystitis, urinary retention
Uncommon (0.1% to 1%): Bladder constriction, pyuria, ureteric obstruction
Rare (0.01 to less than 0.1%): Epididymitis
Very rare (less than 0.01%): Orchitis, balanoposthitis, prostatitis, vulvovaginal discomfort[Ref]

Other

Very common (10% or more): Malaise/fatigue/lethargy (19%), fever without infection (13%), influenza-like illness, pyrexia, rigors
Common (1% to 10%): Chills
Very rare (less than 0.01%): Reiter's syndrome, chest pain, peripheral edema, prostate specific antigen increased, weight decreased, BCG osteomyelitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, vertigo
Very rare (less than 0.01%): Dysesthesia, hyperesthesia, paresthesia, somnolence, headache[Ref]

Hematologic

Common (1% to 10%): Anemia, leukopenia
Uncommon (0.1% to 1%): Pancytopenia, thrombocytopenia
Very rare (less than 0.01%): Lymphadenopathy
Frequency not reported: Axillary or cervical lymphadenopathy, regional suppurative lymphadenitis[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, vomiting, diarrhea
Very rare (less than 0.01%): Dyspepsia, flatulence[Ref]

Immunologic

Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Tuberculosis infections
Very rare (less than 0.01%): Disseminated BCG infection[Ref]

Dermatologic

Common (1% to 10%): Skin rash, sweats
Uncommon (0.1% to 1%): Rashes, eruptions and exanthema not otherwise classified
Very rare (less than 0.01%): Lupus vulgaris, alopecia, hyperhidrosis, granuloma[Ref]

Respiratory

Common (1% to 10%): Pneumonitis
Rare (0.01% to 0.1%): Cough
Very rare (less than 0.01%): Pharyngitis, bronchitis, dyspnea, rhinitis[Ref]

Renal

Very rare (less than 0.01%): Renal failure acute[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, arthritis, myalgia
Very rare (less than 0.01%): Back pain[Ref]

Hypersensitivity

Common (1% to 10%): Allergic symptoms[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatitis, hepatic enzyme increased[Ref]

Cardiovascular

Very rare (less than 0.01%): Hypotension[Ref]

Psychiatric

Very rare (less than 0.01%): Confusional state[Ref]

Metabolic

Very rare (less than 0.01%): Anorexia[Ref]

Ocular

Very rare (less than 0.01%): Conjunctivitis[Ref]

Local

Frequency not reported: Injection site reactions: Induration, pustule formation, ulceration, caseous lesions, purulent draining, tenderness, itching, papules[Ref]

Some side effects of bcg may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

Administration advice:
-Do not administer intravenously, subcutaneously, intramuscularly or intradermally.

Storage requirements:
-Refrigerate; protect from light

Reconstitution/preparation techniques:
-To avoid cross contamination, do not prepare parenteral drugs in areas where this drug has been in use.
-Handle this product as potentially infectious; all equipment and materials used during reconstitution and administration should be disposed of as biohazardous material.
-The manufacturer product information should be consulted.

Patient advice:
-Immunization will not protect all susceptible individuals.
-Inform patients/guardians of risks and benefits, including variable efficacy data with this vaccine, interference with diagnosis of newly acquired tuberculosis infections, and potentially serious complications in immune compromised patients.
-No dressing is required after vaccination, but recommend loosely covering the site and keeping it dry for 24 hours.
-Keep vaccination site clean until the local reaction disappears.
-This vaccine contains live organisms.
-Although the vaccine won't survive long in a dry state, it is possible to infect others.
-After vaccination, small red papules usually appear within 10 to 14 days, after which they scale and slowly subside.
-Six months after vaccination there is usually no visible sign of the vaccination, although sometimes a faint pattern may still be visible.
-Patients who tend to form keloids may have more visible evidence of vaccination.
-Flu like symptoms may occur 24 to 48 hours after vaccination; patients should call their healthcare provider if fever is 103F or higher, or if local reactions last longer than 2 to 3 days.