Treatment for Malignant Pleural Mesothelioma
ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.
The information presented here will tell you about how ALIMTA works, how it is given, its side effects, and how you can help with your treatment.
About Malignant Pleural Mesothelioma
What Is ALIMTA?
Managing Your Therapy: Important Things to Know
How ALIMTA Is Given
Side Effects
About Malignant Pleural Mesothelioma
About mesothelioma
Mesothelial cells line the chest cavity, abdominal cavity, and the cavity around your heart, and cover the outer surface of most of your internal organs. These cells help protect your organs by producing a special lubricating fluid that allows organs to move around. For example, this fluid makes it easier for the lungs to move inside the chest during breathing.1
The tissue formed by these cells is called mesothelium. A malignant tumor of the mesothelium is called a malignant mesothelioma, or simply mesothelioma. About 75% of mesotheliomas start in the chest cavity. They are known as pleural mesotheliomas.1
The main risk factor for developing mesothelioma is exposure to asbestos.2 Mesothelioma is fairly rare, with an estimated 2,000 to 3,000 new cases each year in the United States. Three-fourths of people with the disease are over 65 years old, and men are five times more affected than women.3
Mesothelioma is a serious disease. By the time the symptoms appear and cancer is diagnosed, the disease is often advanced.3
Signs and symptoms of MPM4
More than half of patients with pleural mesothelioma have pain at the side of the chest or in the lower back. Many report shortness of breath, while fewer have fever, cough, weight loss, sweating, fatigue and trouble swallowing. Other symptoms include coughing up blood, hoarseness, swelling of the face and arms, sensory loss, and muscle weakness.
Most people with mesothelioma have symptoms for only 2 to 3 months before they are diagnosed. About one-fourth of people have symptoms for at least 6 months before they are diagnosed.
If you have been exposed to asbestos and have any of these symptoms, you should see a healthcare team right away.
What Is ALIMTA?
The scientific (or generic) name for ALIMTA is pemetrexed (for injection). ALIMTA is a chemotherapy drug used to treat a certain kind of cancer known as malignant pleural mesothelioma. Chemotherapy consists of treatment with one or more anticancer drugs that kill cancer cells. ALIMTA works by interfering with a crucial process that allows cancer cells to reproduce and spread. Specifically, ALIMTA works by interfering with activity of 3 enzymes that are required to help the cancer grow.
ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.
A clinical trial demonstrated that, when compared to cisplatin alone, ALIMTA plus cisplatin showed results in improving the median survival for patients with MPM.5
Managing Your Therapy: Important Things to Know
Before you begin your treatment with ALIMTA, it is important for you to do some things to help manage your treatment. If you are unsure about any of the following safety information, be sure to ask your healthcare team — working with your team is very important to you throughout your course of therapy.
- If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.
- For at least 5 of the 7 days before you start taking ALIMTA, you will need to take a folic acid pill (a type of B vitamin) once per day. Your healthcare team will tell you exactly what to take, but make sure that you are taking between 350 and 1,000 micrograms each day. This is the amount that usually is found in a standard multivitamin tablet, which is available over the counter. Ask your healthcare team or pharmacist for help in choosing a folic acid product. You will continue to take a folic acid pill every day until 21 days after your last cycle of ALIMTA.
- Your healthcare team will give you a shot (into a muscle) of vitamin B12 during the week before you start ALIMTA. Your healthcare team will then give you a shot approximately every 9 weeks, most likely on the same day as you receive your ALIMTA chemotherapy, for the rest of your cycles.
- To help your healthcare team effectively manage your treatment, make sure you tell them about all of your medical conditions.
- If you have liver or kidney problems, be sure to tell this to your healthcare team. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.
- Tell your healthcare team if you are taking other medicines, including prescription or nonprescription medicines, vitamins, and herbal supplements.
- If you are taking a nonsteroidal anti-inflammatory drug (an NSAID, like ibuprofen, or other drugs used to treat pain and arthritis conditions), you should make sure to tell your healthcare team. Depending on your situation, you may be asked to stop taking these for a period of time.
- You will be given an oral steroid medication called a corticosteroid to minimize the risk of a skin rash or certain other side effects that can occur with the use of this treatment. Be sure to take this drug twice daily on the day before, the day of, and the day after treatment unless your healthcare team gives you different instructions.
- Please use a therapy calendar to help keep track of your treatment plan. Use the calendar to mark when you have taken your daily folic acid pill. You may also want to use it to keep track of your appointments, side effects, or information you want to communicate to your healthcare team.
There is additional important information on the safety profile and side effects of ALIMTA therapy that you must be aware of. Please see the Important Safety Information for ALIMTA.
How ALIMTA Is Given
ALIMTA should be administered only by a qualified healthcare professional. Your healthcare team will give you ALIMTA by mixing it into a solution and giving it through a needle into a vein — this is called intravenous infusion (IV). Cisplatin will also be administered through an IV.
For the treatment of MPM, ALIMTA is given — in combination with cisplatin (another type of chemotherapy) — once every 21 days (3-week treatment cycles). The infusion of ALIMTA will be given on the first day of the treatment cycle and will take about 10 minutes. Cisplatin is then infused over 2 hours beginning approximately 30 minutes after the end of the ALIMTA administration. After these 2 infusions, you will receive no more chemotherapy during this 21-day cycle. These "rest days" are a normal part of your treatment with ALIMTA.
As a part of your treatment, you will also receive additional medications, including vitamin B12, folic acid, and corticosteroids.
You will have regular blood tests before and during your treatment with ALIMTA. You and your healthcare team will usually decide before each treatment whether you should continue treatment or change dose according to what benefits you have received from previous treatment and what side effects you may have experienced. Your healthcare team may ask you to return for follow-up visits after you receive ALIMTA therapy, so they can monitor how you are doing.
If you have questions about how ALIMTA is given, please be sure to discuss them with your healthcare team.
Side Effects
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 or most serious side effects that patients experienced in the clinical trial studying ALIMTA plus cisplatin for MPM.
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 a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.
Most patients taking ALIMTA plus cisplatin will have side effects. This section will discuss some of the most frequesnt and/or most serious side effects associated with ALIMTA plus cisplatin for the treatment of patients with MPM who are not candidates for surgery. 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.
For more information about all of the side effects noted in the clinical trial of ALIMTA plus cisplatin for MPM, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-
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 the clinical trial, about 56% 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. 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 26% of patients receiving ALIMTA plus cisplatin in the clinical trial. Your healthcare team may prescribe medications available to help with anemia.
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 will 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. Of the patients who received ALIMTA plus cisplatin, 23% had a lowered platelet count.
Additional side effects you'll want to monitor
- Nausea and/or vomiting: Slightly more than 8 out of 10 patients receiving ALIMTA plus cisplatin experienced nausea. About 6 out of 10 patients experienced vomiting. It is important that you tell your healthcare team if you have nausea and/or vomiting. There are now many medications that can help prevent and/or treat nausea and/or vomiting.
- Loss of appetite (anorexia): Among patients receiving ALIMTA plus cisplatin, 20% experienced a loss of appetite. 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.
- Diarrhea: Of the patients receiving ALIMTA plus cisplatin, 17% experienced diarrhea. Again, it is important that you tell your healthcare team if you have diarrhea. And it is very important that you talk with them before you take any over-the-counter diarrhea medicines.
- Constipation: Of the patients treated with ALIMTA plus cisplatin, 12% 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.
Tiredness (fatigue)
Of the patients receiving ALIMTA plus cisplatin in the clinical trial, 48% experienced 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.
Mouth, lip, or throat sores (stomatitis, pharyngitis)
Among patients receiving ALIMTA plus cisplatin, 23% experienced redness or sores in their mouth, throat, or on their lips. These symptoms may happen a few days after treatment with ALIMTA plus cisplatin. Talk with your healthcare team about proper mouth, lip, and throat care.
Rash
Of the patients receiving ALIMTA plus cisplatin, 16% developed a rash. Talk to your healthcare team if you get a severe rash or itching. They may prescribe a medication (a steroid) to reduce the incidence and/or severity of this side effect.
Hair loss (alopecia)
In the clinical trial, 11% of patients experienced some degree of alopecia, or hair loss. This was not permanent.
Nerve damage (neuropathy)
Among patients receiving ALIMTA plus cisplatin, 10% 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.
Contact your healthcare tearm 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.
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.
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.
Talk with your healthcare team
As mentioned many times in this website, it is important for you to talk with your healthcare team about any questions or concerns you have as you move through your cancer experience.
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 treatment6:
- 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
Important Safety Information for ALIMTA (pemetrexed for injection)
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.
ALIMTA as a single agent (used alone) is approved for maintaining the initial treatment effect of chemotherapy in patients with advanced nonsquamous non-small cell lung cancer whose disease has not worsened after initial therapy. ALIMTA is not indicated for patients who have another type of non-small cell lung cancer called squamous cell.
ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.
ALIMTA is a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.
ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.
If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.
Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements.
The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.
Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional.
You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.
For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-800-545-5979.
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.
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References:
- American Cancer Society. What Is Malignant Mesothelioma? Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_is_malignant_mesothelioma_29.asp?sitearea.
Accessed September 17, 2008. - American Cancer Society. What Are the Risk Factors for Malignant Mesothelioma? Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_What_are_the_risk_factors_for_malignant_mesothelioma_29.asp?rnav=cri.
Accessed September 22, 2008. - American Cancer Society. What Are the Key Statistics About Malignant Mesothelioma? Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_malignant_mesothelioma_29.asp?rnav=cri.
Accessed September 22, 2008. - American Cancer Society. How Is Malignant Mesothelioma Diagnosed? Available at:
http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_How_is_malignant_mesothelioma_diagnosed_29.asp?sitearea.
Accessed September 17, 2008. - J Clin Oncol. 2003;21(14):2640.
- 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.
