Side Effects: What Should I Expect?

General Considerations: Chemotherapy

Side effects from chemotherapy are different depending on the type of cancer you have and the combination of drugs given. Side effects may also be different from patient to patient and from treatment to treatment. This section discusses the most frequent and/or most serious side effects that patients experienced in the clinical trial studying ALIMTA plus cisplatin for NSCLC.

Side effects from chemotherapy should be monitored both by you and your healthcare team. Signs and symptoms such as fatigue, nausea, and vomiting are a few examples. Another group of side effects, such as those that change your blood cells, are monitored through regular blood tests, but they can also be identified through signs and symptoms you might experience.

Side effects can be serious if not treated. Though a few side effects can be permanent, many are temporary and go away after treatment dose is reduced or stopped.

ALIMTA in Combination with Cisplatin

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

Most patients taking ALIMTA will have side effects. This section will discuss some of the most common and/or most important side effects associated with ALIMTA plus cisplatin for the first-line treatment of advanced nonsquamous NSCLC. Sometimes it is not always possible to tell whether ALIMTA, cisplatin, or the cancer itself is causing these side effects, but you should always tell your healthcare team if you are experiencing anything new. Call your healthcare team right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection.

Make sure that you follow your healthcare team's instructions regarding your ALIMTA pre-medications. This should help lessen the severity of the side effects you may experience.

Side effects you and your healthcare team should monitor
Additional side effects you'll want to monitor
Drug delays and discontinuation
When to call your healthcare team

Side effects you and your healthcare team should monitor
Before and during your treatment with ALIMTA plus cisplatin, you will have regular blood tests that will monitor you for the following side effects. You may also have symptoms that you must tell your healthcare team about.

Low white blood cell count (neutropenia/leukopenia)
White blood cells help you fight infection. In a clinical trial, about 29% of patients on ALIMTA plus cisplatin had a lowered white blood cell count. You most likely will have a drop in your white blood cell count beginning several days after you receive ALIMTA plus cisplatin. During this time, you are more likely to develop an infection, and you should avoid crowds and those with colds. You should call your healthcare team right away if you have any signs of infection, such as chills or a temperature over 100.4°F. There are medications to help with low white blood cell counts.

Low red blood cell count (anemia)
Red blood cells help transport oxygen from your lungs to the other parts of your body. A low red blood cell count is called anemia. If your red blood cell count is low, you may feel tired, get tired easily, appear pale, and become short of breath. Anemia was experienced by 33% of patients receiving ALIMTA plus cisplatin in the clinical trial.

Low platelet count (thrombocytopenia)
Platelets help your blood to clot. A lowered platelet count puts you at more risk for bleeding. If your healthcare team tells you that you have a low platelet count, you may be asked to take some precautions, including avoiding injury, using stool softeners, using soft-bristle toothbrushes, etc. It is important that you call your healthcare team if you see any signs of bleeding, such as bruising or blood in your stool. Among patients receiving ALIMTA plus cisplatin in the clinical trial, 10% had a low platelet count.

Back to Top

Additional side effects you'll want to monitor

• Fever
  Fever may be the first symptom of infection, but it may also be a result of the chemotherapy itself (without infection). There are medications that may reduce a fever that can be given along with chemotherapy. If you have a fever of 100.4°F or higher, you should call your healthcare team right away.
• Tiredness (fatigue)
  In the clinical trial, 43% of patients receiving ALIMTA plus cisplatin had some degree of fatigue. If you experience fatigue, some ideas to counteract it include balancing your periods of activity with rest; increasing your fluid intake; and following a well-balanced diet with several small meals, rather than 3 large meals.
• Gastrointestinal upset
  Be sure to talk with your healthcare team if you notice any of the following side effects or anything different about the way you feel.
• • Nausea and/or vomiting
    In the clinical trial, 56% of patients treated with ALIMTA plus cisplatin experienced some degree of nausea, and 40% experienced vomiting. It is important that you tell your healthcare team if you have nausea or vomiting. There are medications that can help prevent and treat nausea and vomiting.
  • Loss of appetite (anorexia)
    Loss of appetite occurred in 27% of patients receiving ALIMTA plus cisplatin. If you experience a loss of appetite, please be sure to tell your healthcare team. Also, the National Cancer Institute (NCI) has a helpful booklet titled Eating Hints, which you can obtain by calling 1-800-4CANCER (1-800-422-6237) or visiting the NCI Web site at www.cancer.gov.
  • Constipation
    Twenty-one percent of patients treated with ALIMTA plus cisplatin had constipation. Your healthcare team can help you treat your constipation. It is important that you talk with them before you take any over-the-counter laxatives or stool softeners.
  • Diarrhea
    Among patient receiving ALIMTA plus cisplatin, 12% experienced diarrhea. Tell your healthcare team if you have diarrhea. It is very important that you talk with them before you take any over-the-counter diarrhea medicines.
• Mouth, lip, or throat sores (stomatitis/pharyngitis)
  Fourteen percent of patients on ALIMTA plus cisplatin experienced redness or sores in their mouth, throat, or on their lips. These symptoms may happen a few days after ALIMTA plus cisplatin treatment. Talk with your healthcare team about proper mouth, lip, and throat care.
  
• Hair loss (alopecia)
  In the clinical trial, 12% of patients treated with ALIMTA plus cisplatin experienced some degree of alopecia, or hair loss. This was not permanent.
  
• Nerve damage (neuropathy)
  Among patients receiving ALIMTA plus cisplatin, 9% experienced some form of nerve damage. Symptoms of neuropathy may include weakness, pain, a tingling sensation, or numbness and tingling, especially in the toes and fingertips.
  
• Rash
  Among patients treated with ALIMTA plus cisplatin, 7% developed a rash. Talk to your healthcare team if you get a severe rash or itching. They will prescribe a medication (a steroid) to reduce the incidence and/or severity of this side effect.

Contact your healthcare team right away if you have fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Back to Top

Drug delays and discontinuation
You will have regular blood tests before and during your treatment with ALIMTA plus cisplatin. Your healthcare team may adjust your dose of ALIMTA or delay treatment based on the results of your blood tests or your general condition.

Side effects may or may not be caused by the drug treatment itself; some effects may be due to the disease or to other reasons. Contact your healthcare team right away if you have fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. Talk with your healthcare team if you have any side effects that bother you or don't go away.

Back to Top

When to call your healthcare team
You are probably attuned to changes in your body now more than ever. You must never take these changes for granted. As a person living with cancer, you must always be aware of infection. If you suspect an infection of any kind, call your healthcare team immediately.

According to the American Cancer Society, you should also alert your healthcare team right away if you notice any other changes in your body or experience any of the following symptoms during your chemotherapy treatment¹:

• A fever of 100.5°F or greater
  
  
• Bleeding or unexplained bruising
  
  
• A rash or allergic reaction such as swelling or severe itching or wheezing
  
  
• Intense chills
  
  
• Pain or soreness at the chemotherapy injection site or catheter site
  
  
• Unusual pain including intense headaches
  
  
• Shortness of breath
  
  
• Prolonged diarrhea or vomiting
  
  
• Bloody stool or blood in your urine

Back to Top

Reference:

1. The American Cancer Society. When Do I Call My Doctor? Available at:
   http://www.cancer.org/docroot/ETO/content/ETO_1_7X_When_Do_I_Call_My_Doctor.asp.
   Accessed January 23, 2009.