TheraCys

If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. Follow your doctor's instructions and be sure to tell any other doctor who treats you that you are receiving BCG.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with BCG, especially an antibiotic, or any drugs that weaken your immune system, such as:

• cancer medicine or radiation;

• medicine to prevent organ transplant rejection; or

• medicines to treat multiple sclerosis, psoriasis, rheumatoid arthritis, or other autoimmune disorders.

This list is not complete. Other drugs may interact with BCG, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

This medicine 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 this medicine, 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 this medicine 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 this medicine 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 this medicine 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 this medicine. 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

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.

• If you have an allergy to BCG or any other part of this medicine (TheraCys).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Active TB (tuberculosis), blood in the urine, urinary tract infection (UTI), any infection, an illness with a fever, a weak immune system, or a disease that may cause a weak immune system like HIV.
• If you have or have ever had a BCG reaction.
• If you are getting other treatments like radiotherapy or chemo.
• If you are taking any drugs that suppress your immune system. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you have had any of these in the past 14 days: A biopsy, a procedure called transurethral resection (TUR), or damage to the urinary tract after a catheter has been placed.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (TheraCys) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Take extra care with your urine for the first 6 hours after getting this medicine (TheraCys). Use the same toilet each time you use the bathroom at home. Sit down to urinate so your urine does not splash or spray.
• Before flushing, add an equal amount of bleach to the urine. Wait 15 minutes, then flush. Do this for the first 6 hours after BCG is given.
• It is fine to be around close contacts like household members, friends, and caregivers. However, do not allow anyone to come into contact with your urine.
• You may need a TB (tuberculosis) test before starting this medicine.
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use this medicine (TheraCys).
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (TheraCys) while you are pregnant.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given through a catheter into the bladder.
• You will need to try to keep this medicine (TheraCys) in your bladder for up to 2 hours, but no longer than 2 hours. This medicine will come out when you pass urine.
• Drink plenty of liquids that do not have caffeine for several hours after getting this medicine unless told to drink less liquids by your doctor. This helps to get rid of the drug from your bladder.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Worse pain or burning when passing urine or if these effects will not go away.
• Not able to pass urine or change in how much urine is passed.
• Blood in the urine.
• High fever over 103.1 degrees F or 39.5 degrees C for more than 12 hours.
• Mild fever over 101.3 degrees F or 38.5 degrees C for more than 48 hours.
• Very bad dizziness or passing out.
• Chest pain.
• Joint pain.
• Eye pain.
• Eye irritation.
• Eye redness.
• Cough.
• Throwing up.
• Feeling very tired or weak.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

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