What Is ALIMTA?
The scientific (or generic) name for ALIMTA is pemetrexed for injection. ALIMTA® (pemetrexed for injection) is a chemotherapy drug used to treat certain kinds of non-small cell lung cancer (NSCLC) called advanced nonsquamous NSCLC. When discussing NSCLC, "nonsquamous" includes adenocarcinoma, large cell carcinoma, and all other cell types except squamous cell. 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 inhibiting the action of 3 enzymes that are required to help the cancer grow.
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 can suppress bone marrow function, which may cause low blood cell counts.
In a clinical trial, important differences in overall survival were observed based on histology when ALIMTA plus cisplatin was compared with GEMZAR plus cisplatin.1-3 Therefore, ALIMTA plus cisplatin is not appropriate for patients with squamous cell non-small cell lung cancer.
Only you and your healthcare team can determine whether or not ALIMTA is right for you.
Indications and Important Safety Information for ALIMTA® (pemetrexed for injection)
Indications
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 is approved by the FDA for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC 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.
Important Safety Information
What is the most important information that I should know about ALIMTA?
ALIMTA can suppress bone marrow function, which may cause low blood cell counts.
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 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.
Your doctor will prescribe a medicine called a “corticosteroid” to take for 3 days during each treatment with ALIMTA. Corticosteroids lower your chances for getting skin reactions with ALIMTA.
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.
- You must take folic acid every day for at least 5 days out of the 7 days before your first dose of ALIMTA. You must keep taking folic acid every day during the time you are getting treatment with ALIMTA, and for 21 days after your last treatment.
- Your doctor will give you vitamin B12 injections while you are getting treatment with ALIMTA. You will get your first vitamin B12 injection during the week before your first dose of ALIMTA, and then about every 9 weeks during treatment.
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.
What should I tell my doctor before receiving ALIMTA?
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.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other medicines may affect each other, causing serious side effects. Especially, tell your doctor if you are taking medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs) for pain or swelling.
What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is not always possible to tell whether ALIMTA, another medicine, or the cancer itself is causing these side effects.
Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection, which may be severe and could lead to death.
The most common side effects of ALIMTA when given alone or in combination with cisplatin are:
- Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can obtain medicines to help control some of these symptoms. Call your doctor if you get any of these symptoms.
- Low blood cell counts:
- Low red blood cells. Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
- Low white blood cells. Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 100.4°F) or other signs of infection, call your doctor right away.
- Low platelets. Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with ALIMTA.
- Tiredness. You may feel tired or weak for a few days after your ALIMTA treatments. If you have severe weakness or tiredness, call your doctor.
- Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after ALIMTA treatment. Talk with your doctor about proper mouth and throat care.
- Loss of appetite. You may lose your appetite and lose weight during your treatment. Talk to your doctor if this is a problem for you.
- Rash. You may get a rash or itching during treatment. These reactions usually appear between treatments with ALIMTA and usually go away before the next treatment. Skin reactions or rashes that include blistering or peeling may be severe and could lead to death. Call your doctor if you have any of these symptoms.
Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away.
These are not all the side effects of ALIMTA. For more information, ask your doctor, nurse, or pharmacist.
How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).
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 , or call 1-800-FDA-1088.
PM_CON_ISI_All_30NOV2011
Important Safety Information for GEMZAR® (gemcitabine for injection)
What is the most important information that I should know about GEMZAR?
GEMZAR can suppress bone marrow function, which may cause low blood cell counts.
GEMZAR may not be appropriate for some patients.
GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.
You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia (for example, feeling tired), contact your healthcare team, as these can be symptoms of low blood cell counts.
Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems as you may need to stop GEMZAR therapy.
There have been reports of serious and sometimes fatal kidney or liver damage, including kidney or liver failure, with GEMZAR treatment. If you now have or have had in the past kidney or liver problems, please tell your healthcare team. GEMZAR may not be right for you.
You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood tests and on your general condition.
Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.
The safety and effectiveness of GEMZAR in children has not been established.
Who should not receive GEMZAR?
If you are allergic to GEMZAR, tell your doctor because you should not receive it.
What should I tell my doctor before receiving GEMZAR?
If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. You and your healthcare team will decide whether you should continue to breastfeed or stop GEMZAR treatment.
Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.
What are the possible side effects of GEMZAR?
There is a risk of side effects associated with GEMZAR therapy.
Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.
The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea; vomiting; constipation; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. Lab work may identify additional side effects.
These are not all the side effects of GEMZAR. Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn’t go away.
How is GEMZAR given?
GEMZAR is given (injected) into a vein. The injection will last about 30 minutes.
You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.
For more safety information about GEMZAR, please talk with your doctor, nurse, or pharmacist, see the full Prescribing Information, visit www.GEMZAR.com, or call 1-800-545-5979.
GC_Con_ISI_all_09Dec2011
References:
- ALIMTA (pemetrexed for injection) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011.
- J Clin Oncol. 2008;26(21):3543-3551.
- Oncologist. 2009;14(3):253-263.