trastuzumab

Generic Name: trastuzumab (tras TOO zoo mab)

Brand Names: Herceptin

What is trastuzumab?

Trastuzumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.

Trastuzumab is used to treat breast cancer that has progressed after treatment with other chemotherapy.

Trastuzumab may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about trastuzumab?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving trastuzumab, tell your doctor if you have heart disease, congestive heart failure, a history of heart attack, or any allergies or breathing problems. You may not be able to receive trastuzumab, or you may need a dosage adjustment or special tests during treatment.

Some people receiving a trastuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, weak, itchy, or short of breath during the injection.

What should I discuss with my health care provider before receiving trastuzumab?

Before using trastuzumab, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  a history of heart attack; or

  
  


• 
  

  any allergies or breathing problems.

  
  

If you have any of these conditions, you may not be able to receive trastuzumab, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. Trastuzumab can cause harm to an unborn baby. Do not use trastuzumab without telling your doctor if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

If you are pregnant, your name may need to be listed on a Cancer and Childbirth registry when you start using this medication.

It is not known whether trastuzumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is trastuzumab given?

Trastuzumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 90 minutes to complete.

Before you receive this medication, you may need to undergo a biopsy to make sure trastuzumab is the right medication to treat your cancer.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your heart function may also need to be tested. Do not miss any scheduled visits to your doctor.

Trastuzumab is usually given once every 7 days. Follow your doctor's instructions.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your trastuzumab injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a trastuzumab overdose are unknown.

What should I avoid while receiving trastuzumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with trastuzumab.

Trastuzumab side effects

Some people receiving a trastuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, weak, itchy, or short of breath during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  fast or pounding heartbeats;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  cough or wheezing;

  
  


• 
  

  white patches or sores inside your mouth or on your lips; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Less serious side effects are more likely to occur, such as:

• 
  

  nausea, vomiting, diarrhea;

  
  


• 
  

  sore throat, sinus pain;

  
  


• 
  

  joint or muscle pain, back pain;

  
  


• 
  

  headache; or

  
  


• 
  

  tired feeling.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Trastuzumab Dosing Information

Usual Adult Dose for Breast Cancer:

For use in the treatment of metastatic breast cancer:
Administer trastuzumab, alone or in combination with paclitaxel.
Initial dose: 4 mg/kg IV infusion over 90 minutes
Subsequent therapy: 2 mg/kg IV infusion over 30 minutes once weekly until disease progression

Usual Adult Dose for Breast Cancer -- Adjuvant:

Administer according to one of the following doses and schedules:

1) Initiate trastuzumab during and following paclitaxel, docetaxel, or docetaxel/carboplatin:
Initial dose: 4 mg/kg IV infusion over 90 minutes then 2 mg/kg IV infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
Subsequent therapy: one week after the last weekly dose of trastuzumab, give trastuzumab as 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 52 weeks of therapy.

or

2) Initiate trastuzumab as a single agent within 3 weeks following completion of all chemotherapy.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 17 doses (52 weeks of therapy)

Usual Adult Dose for Esophageal Carcinoma:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

Usual Adult Dose for Gastric Cancer:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

What other drugs will affect trastuzumab?

There may be other drugs that can affect trastuzumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More trastuzumab resources

• Trastuzumab Side Effects (in more detail)
• Trastuzumab Dosage
• Trastuzumab Use in Pregnancy & Breastfeeding
• Trastuzumab Drug Interactions
• Trastuzumab Support Group
• 2 Reviews for Trastuzumab - Add your own review/rating

• trastuzumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Trastuzumab Professional Patient Advice (Wolters Kluwer)


• Trastuzumab MedFacts Consumer Leaflet (Wolters Kluwer)


• Trastuzumab Monograph (AHFS DI)


• Herceptin Prescribing Information (FDA)


• Herceptin Consumer Overview

Compare trastuzumab with other medications

• Breast Cancer
• Breast Cancer, Adjuvant
• Breast Cancer, Metastatic
• Esophageal Carcinoma
• Gastric Cancer
• Salivary Gland Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about trastuzumab.

See also: trastuzumab side effects (in more detail)

Levalbuterol Solution

Pronunciation: lev-al-BYOO-ter-ol
Generic Name: Levalbuterol
Brand Name: Xopenex

Levalbuterol Solution is used for:

Treating breathing problems in patients who have asthma or certain other airway diseases. It may also be used for other conditions as determined by your doctor.

Levalbuterol Solution is a sympathomimetic (beta agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.

Do NOT use Levalbuterol Solution if:

• you are allergic to any ingredient in Levalbuterol Solution or to albuterol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levalbuterol Solution:

Some medical conditions may interact with Levalbuterol Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart problems (eg, fast or irregular heartbeat, heart failure), blood vessel problems, high blood pressure, or low blood potassium levels


• if you have a history of seizures, diabetes, an overactive thyroid, kidney problems, or an adrenal gland tumor (pheochromocytoma)


• if you have ever had an unusual reaction to another sympathomimetic medicine (eg, albuterol, pseudoephedrine)


• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Levalbuterol Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased


• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), epinephrine, MAOIs (eg, phenelzine), short-acting sympathomimetic bronchodilators (eg, metaproterenol), stimulants (eg, amphetamine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Levalbuterol Solution's side effects


• Beta-blockers (eg, propranolol) because they may decrease Levalbuterol Solution's effectiveness


• Digoxin because its effectiveness may be decreased by Levalbuterol Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levalbuterol Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levalbuterol Solution:

Use Levalbuterol Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Levalbuterol Solution. Talk to your pharmacist if you have questions about this information.


• Levalbuterol Solution is for inhalation only. Do not get it in your eyes. If you get Levalbuterol Solution in your eyes, rinse immediately with cool tap water.


• Do not open the foil pouch until you are ready to use a dose of Levalbuterol Solution. Remove a vial from the foil pouch. Use right away.


• Do not use Levalbuterol Solution if it contains particles, is cloudy or discolored, or if the bottle is cracked or damaged.


• To use Levalbuterol Solution, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.


• Add sterile saline solution as directed by your doctor. Gently swirl the nebulizer to mix the contents.


• Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.


• Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.


• Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes).


• Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, do not save medicine in an open vial for use at a later time.


• Do not stop using Levalbuterol Solution without checking with your doctor.


• Do not mix Levalbuterol Solution with other medicines in the nebulizer unless directed otherwise by your doctor.


• If you miss a dose of Levalbuterol Solution and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levalbuterol Solution.

Important safety information:

• Levalbuterol Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Levalbuterol Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Levalbuterol Solution may sometimes cause severe breathing problems right after you use a dose. If this happens, seek medical care at once.


• If your usual dose does not work well, your symptoms become worse, or you need to use it more often than normal, contact your doctor at once. This may be a sign of seriously worsening asthma. Your doctor may need to change your dose or medicine.


• Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Levalbuterol Solution.


• Levalbuterol Solution may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.


• Tell your doctor or dentist that you take Levalbuterol Solution before you receive any medical or dental care, emergency care, or surgery.


• Check with your doctor before using any other inhaled medicines while you are using Levalbuterol Solution. Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tell you to.


• Diabetes patients - Levalbuterol Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.


• Lab tests, including lung function, may be performed while you use Levalbuterol Solution. These tests may be used to monitor your condition of check for side effects. Be sure to keep all doctor and lab appointments.


• Use Levalbuterol Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Levalbuterol Solution should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• Caution is advised when using Levalbuterol Solution in CHILDREN; they may be more sensitive to its effects, especially diarrhea or fever.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levalbuterol Solution while you are pregnant. It is not known if Levalbuterol Solution is found in breast milk. If you are or will be breast-feeding while you use Levalbuterol Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Levalbuterol Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; headache; nervousness; sinus inflammation; sore throat; stomach upset; stuffy nose; tremor.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; fever; new or worsened trouble breathing; pounding in the chest; severe cough; severe headache or dizziness; unusual hoarseness; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Levalbuterol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; nausea; seizures; severe headache or dizziness; severe or persistent nervousness, trouble sleeping, or tremor; unusual fatigue.

Proper storage of Levalbuterol Solution:

Store Levalbuterol Solution between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store vials in the protective foil pouch at all times. Use Levalbuterol Solution right away after it has been removed from the foil pouch. Do not use after expiration date on the container or box. Keep Levalbuterol Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Levalbuterol Solution, please talk with your doctor, pharmacist, or other health care provider.


• Levalbuterol Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Levalbuterol Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Levalbuterol resources

• Levalbuterol Side Effects (in more detail)
• Levalbuterol Use in Pregnancy & Breastfeeding
• Levalbuterol Drug Interactions
• Levalbuterol Support Group
• 11 Reviews for Levalbuterol - Add your own review/rating

Compare Levalbuterol with other medications

• Asthma, acute
• Asthma, Maintenance
• COPD, Acute
• COPD, Maintenance

Tranxene

Tranxene is a brand name of clorazepate, approved by the FDA in the following formulation(s):

TRANXENE (clorazepate dipotassium - tablet; oral)

• 
  Manufacturer: LUNDBECK INC
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 15MG ^[RLD][AB], 3.75MG ^[AB], 7.5MG ^[AB]

Has a generic version of Tranxene been approved?

Yes. The following products are equivalent to Tranxene:

clorazepate dipotassium tablet; oral

• 
  Manufacturer: MYLAN
  
  Approval date: July 17, 1987
  
  Strength(s): 15MG ^[AB], 3.75MG ^[AB], 7.5MG ^[AB]


• 
  Manufacturer: RANBAXY
  
  Approval date: September 29, 2004
  
  Strength(s): 15MG ^[AB], 3.75MG ^[AB], 7.5MG ^[AB]


• 
  Manufacturer: TARO
  
  Approval date: April 27, 2000
  
  Strength(s): 15MG ^[AB], 3.75MG ^[AB], 7.5MG ^[AB]


• 
  Manufacturer: WATSON LABS
  
  Approval date: February 9, 1988
  
  Strength(s): 15MG ^[AB], 3.75MG ^[AB], 7.5MG ^[AB]

GEN-XENE (clorazepate dipotassium tablet; oral)

• 
  Manufacturer: ALRA
  
  Approval date: April 26, 1988
  
  Strength(s): 15MG ^[AB], 3.75MG ^[AB], 7.5MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tranxene. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Tranxene.

See also...

• Tranxene Advanced Consumer Information (Micromedex)
• Clorazepate Consumer Information (Wolters Kluwer)
• Clorazepate Sustained-Release Tablets Consumer Information (Wolters Kluwer)
• Clorazepate Consumer Information (Cerner Multum)
• Gen-Xene Advanced Consumer Information (Micromedex)
• Clorazepate Advanced Consumer Information (Micromedex)
• Clorazepate Dipotassium AHFS DI Monographs (ASHP)

Thiola

Pronunciation: tye-oh-PRO-nin
Generic Name: Tiopronin
Brand Name: Thiola

Thiola is used for:

Preventing kidney stone formation in certain patients.

Thiola is a chelating agent. It works by removing extra cystine (the cause of kidney stones) from the urine, which keeps the kidney stones from forming.

Do NOT use Thiola if:

• you are allergic to any ingredient in Thiola


• you are breast-feeding


• you have a history of anemia, low white blood cell counts, or low platelet counts resulting from the use of Thiola

Contact your doctor or health care provider right away if any of these apply to you.

Before using Thiola:

Some medical conditions may interact with Thiola. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant or planning to become pregnant


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have anemia, bleeding in the lungs, low white blood cell counts, low platelet counts, or muscle weakness

Some MEDICINES MAY INTERACT with Thiola. However, no specific interactions with Thiola are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Thiola may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Thiola:

Use Thiola as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Thiola on an empty stomach at least 1 hour before or 2 hours after eating.


• Drink at least ten 10-ounce glasses of water each day, including 2 glasses with each meal and at bedtime. You will probably wake up at night to urinate, and you should drink 2 more glasses before returning to bed. Drink extra fluids if you have excessive sweating or urination.


• When you first start taking Thiola, it may cause an increase in urine or in frequency of urination. To prevent this from affecting sleep, try not to take any dose later than 6 pm.


• If you miss a dose of Thiola, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Thiola.

Important safety information:

• Thiola may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Be sure to follow the diet and exercise program prescribed by your health care provider.


• LAB TESTS, including blood cell counts and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Thiola is not recommended for use in CHILDREN younger than 9 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Thiola may cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Thiola during pregnancy. Thiola is excreted in breast milk. Do not breast-feed while taking Thiola.

Possible side effects of Thiola:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; changes in taste; diarrhea; drying of skin; gas; loss of appetite; nausea; soft stools; stomach bloating; stomach pain; vomiting; wrinkling or crumbling of skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; joint pain; muscle weakness; red rash with fever; sore throat; unusual bleeding or bruising; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Thiola side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Thiola:

Store Thiola at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Thiola out of the reach of children and away from pets.

General information:

• If you have any questions about Thiola, please talk with your doctor, pharmacist, or other health care provider.


• Thiola is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Thiola. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Thiola resources

• Thiola Side Effects (in more detail)
• Thiola Use in Pregnancy & Breastfeeding
• Thiola Support Group
• 0 Reviews for Thiola - Add your own review/rating

• Thiola Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Thiola with other medications

• Cystinuria

Alcool Benzylique

Alcool Benzylique may be available in the countries listed below.

Ingredient matches for Alcool Benzylique

Benzyl Alcohol

Alcool Benzylique (DCF) is known as Benzyl Alcohol in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Breminal

Breminal may be available in the countries listed below.

Ingredient matches for Breminal

Tolterodine

Tolterodine tartrate (a derivative of Tolterodine) is reported as an ingredient of Breminal in the following countries:

• Argentina

International Drug Name Search

Treanda

Generic Name: bendamustine (Intravenous route)

ben-da-MUS-teen

Commonly used brand name(s)

In the U.S.

• Treanda

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Uses For Treanda

Bendamustine belongs to the group of medicines called alkylating agents. It is used to treat a type of cancer of the white blood cells called chronic lymphocytic leukemia (CLL).

Bendamustine is also used to treat indolent B-cell non-Hodgkin's lymphoma (NHL) in patients who have already been treated with rituximab.

Bendamustine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may occur after treatment with bendamustine has been stopped.

Before you begin treatment with bendamustine, you and your doctor should talk about the benefits this medicine will have as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, bendamustine is used in certain patients with the following medical conditions:

• Breast cancer, metastatic (breast cancer that has already spread).


• Multiple myeloma (a type of cancer in the bone marrow).

Before Using Treanda

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

Appropriate studies have not been performed on the relationship of age to the effects of bendamustine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bendamustine in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 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.

• Ciprofloxacin


• Fluvoxamine


• Omeprazole

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• 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:

• Infection—May decrease your body’s ability to fight an infection.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Treanda

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Treanda

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Bendamustine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (e.g., pneumonia). It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of an infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have fever or chills; cough or hoarseness; lower back or side pain; painful or difficult urination; shortness of breath; or unusual bleeding or bruising.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chills; fever; hives; hoarseness; itching; rash; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Serious skin reactions may occur during treatment with bendamustine. Tell your doctor right away if you have rashes or blisters while receiving this medicine.

Bendamustine may cause some people to feel unusually tired or weak. Do not drive, use machines, or do anything else that could be dangerous while you are using this medicine.

Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Treanda Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chest pain


• chills


• cough or hoarseness


• diarrhea


• fever


• headache


• joint pain, stiffness, or swelling


• lack or loss of strength


• lower back, side, or stomach pain


• muscle aches


• nausea


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• shortness of breath


• sore throat


• stuffy or runny nose


• swelling of the feet or lower legs


• swollen glands


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Less common

• Burning or stinging of the skin


• fast heartbeat


• hives


• itching


• irritation


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• rash


• redness of the skin


• stiffness or swelling


• swelling of the eyelids, face, lips, hands, or feet


• tightness in the chest


• troubled breathing or swallowing


• wheezing

Incidence not known

• Blistering, flaking, or peeling of the skin


• difficulty with swallowing


• dizziness


• facial swelling


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased weight

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Treanda side effects (in more detail)

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More Treanda resources

• Treanda Side Effects (in more detail)
• Treanda Use in Pregnancy & Breastfeeding
• Treanda Drug Interactions
• Treanda Support Group
• 1 Review for Treanda - Add your own review/rating

• Treanda Prescribing Information (FDA)


• Treanda MedFacts Consumer Leaflet (Wolters Kluwer)


• Treanda Consumer Overview

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