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U.S. Department of Health and Human Services

For Consumers

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Information about your Medication

Chemotherapy

Chemotherapy is the use of drugs that kill cancer cells. You can receive your chemotherapy by mouth or through a vein. Either way, the drugs enter the bloodstream and can affect cancer cells all over the body. Chemotherapy is usually given in cycles, and a cycle can last for only one day to many days. Most people have their treatment in an outpatient clinic, at the doctor's office, or at home. Some may need to stay in the hospital during chemotherapy.

Side effects depend mainly on the specific drugs and the dose. The drugs affect cancer cells and other cells that divide rapidly:

  • Blood cells: When drugs damage healthy blood cells, you are more likely to get infections, to bruise or bleed easily, and to feel very weak and tired.
  • Cells in hair roots: Chemotherapy can cause hair loss. Your hair will grow back, but it may be somewhat different in color and texture.
  • Cells that line the gastrointestinal tract: Chemotherapy can cause poor appetite, nausea and vomiting, diarrhea, or mouth and lip sores.

Some drugs can affect a woman's ability to become pregnant, and men may not be able to father a child. Although the side effects of chemotherapy can be distressing, most of them are temporary. Your doctor can usually treat or control them.

Healthcare Provider talking to couple

Biological Therapy

Biological therapy is another type of therapy. It helps the immune system (the body's natural defense system) fight cancer. Most types of biological therapy are given through a vein and will enter your bloodstream just like chemotherapies. Some people get a rash where the therapy is injected. Some have flu-like symptoms such as fever, chills, headache, muscle aches, fatigue, weakness, and nausea. Biological therapy also can cause more serious side effects, such as changes in blood pressure and breathing problems. Biological therapy is usually given at the doctor's office, clinic, or hospital.

 


 

Cancer Therapy Product Patient Information

Patient Package Inserts, Medication Guides. and Instructions for Use

 

Patient Package Inserts (PPI), Medication Guides (MG), and Instructions for Use (IFU) are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients use the medicine safe and effectively and try to avoid serious adverse events. Not all medicines have patient information and if you have questions about your medicines you should always talk with your Healthcare Provider or Pharmacist. A description of these types of patient labeling are provided below. 

Patient Labeling:
 

 

  • Medication Guides (MG)- are required for certain medications "that pose a serious and significant public health concern."  They are developed by the manufacturer, approved by the FDA, and required to be given to consumers each time the medication is dispensed (see, 21CFR 208).

 

  • Patient Package Inserts (PPI) - Patient labeling that is part of the FDA-approved prescription drug labeling.  PPIs are developed by the manufacturer, approved by the FDA, and are required to be dispensed with specific products or classes of products (i.e., oral contraceptives and estrogen-containing products) (see, 21 CFR 310.501 and 21 CFR 310.515).  Other PPIs are submitted to the FDA voluntarily by the manufacturer and approved by the FDA, but their distribution is not mandated.

 

  • Instructions for Use (IFU) - Patient labeling that is part of the FDA-approved prescription drug labeling.  IFUs are developed by the manufacturer, approved by the FDA, and are dispensed with specific products that require:
    •  complicated dosing instructions

    • a device that patients must use to self-administer the drug                                                                                                                                                                        

       

      Sample Medication Guide


 Finding Your Medicine

To find patient information about the medicines you are prescribed, you can visitDrugs@FDA. To find the currently approved patient information you will need to follow these instructions.

  1. First you will need the name of the medicine.
  2. You will need to access Drugs@FDA.
  3. You will need to type in the name of the medicine in the search box and select submit.
  4. You will need to click on the correct medicine for more information.
  5. The drug details page will come up and you will select either Patient Package Insert, Medication Guide, or Instructions for Use.

OR

You can also visit DailyMed to find medicine information that is stored by the National Library of Medicine. To find the currently approved patient information you will need to follow these instructions.

  1. First you will need the name of the medicine.
  2. You will need to access DailyMed.
  3. In the search box on the right side of the page, you will start to type the name of the medicine.
  4. You will ned to click on the correct medicine for more information.
  5. Under Drug Label Sections you will select either, Patient Package Insert, Medication Guide, or Instructions for Use.