Alimta Side Effects

Alimta Side Effects and Warnings
zhion@zhion.com November 7, 2005

FDA Approves First Drug for Rare Type of Cancer

The Food and Drug Administration (FDA) approved Alimta (pemetrexed
disodium) for use in combination with cisplatin for the treatment of patients with
malignant pleural mesothelioma-a rare type of cancer. Alimta received a priority
review and is designated as an orphan drug. It is the first drug approved for this
condition.

Cancer of the mesothelium, a membrane that covers and protects most of the
internal organs of the body is rare; about 2,000 new cases are diagnosed in the
United States each year. This form of cancer is usually associated with a history
of asbestos exposure. Asbestos fibers lodged in the lung attach to the outer lung
lining and chest wall, causing tumors to grow. By the time symptoms appear, the
disease is usually advanced, and patients live, on average, nine to thirteen
months following diagnosis.

"Up to now there has been no effective treatment for treating mesothelioma.
Alimta offers new promise in treating this fatal cancer," said FDA Commissioner
Mark B. McClellan M.D., Ph.D, "and its quick approval demonstrates FDA's
commitment to making safe and effective products available as soon as
possible."

The effectiveness of Alimta was established in one randomized clinical trial
comparing the effects of treatment with Alimta given with cisplatin to treatment
with cisplatin alone. Patients receiving Alimta and cisplatin lived three months
longer after randomization than patients given cisplatin alone (12 months vs.
nine months). Alimta must be administered with vitamin B-12 and folic acid
supplementation to decrease the incidence and severity of adverse effects.

The most common adverse reactions observed with use of Alimta are low white
blood count, nausea, vomiting, fatigue, rash, and diarrhea. Patients and
caregivers should be encouraged to report the onset of fever, chills, diarrhea, and
mouth ulcers immediately, since these symptoms could be a sign of infection,
resulting from bone marrow suppression by the drug. Orphan drugs are
developed to treat rare diseases, that is, conditions that affect fewer than 200,000
people in the U.S. The Orphan Drug Act provides a seven-year period of exclusive
marketing for the drug to the first sponsor who obtains marketing approval for a
designated orphan drug.

Alimta will be distributed by Eli Lilly and Company, Indianapolis, Ind.

1. What is Alimta (pemetrexed for injection)?

Alimta is a new cancer drug used to treat malignant pleural mesothelioma.
Alimta is given with cisplatin, another anti-cancer medicine.

2. What is malignant pleural mesothelioma?

Malignant pleural mesothelioma is a type of cancer that affects the inside lining
of the chest cavity. It is usually associated with asbestos exposure.

3. What is asbestos and who is at risk for asbestos exposure?

Asbestos is a material made of mineral fibers that has been used by the
construction and building industry for many years. Since asbestos is not affected
by heat or chemicals and does not conduct electricity it was often used as
insulation.

Nearly everyone is exposed to asbestos at some time during his or her life.
However, most people do not become ill from their exposure. People who
become ill from asbestos are usually those who are exposed to it on a regular
basis, most often in a job where they work directly with the material and who
inhale fibers that are in the air. The risk of developing asbestos-related diseases
varies with the type of industry in which the exposure occurred, the kind and size
of fibers, and with the amount of exposure. For more information on asbestos
visit: http://cis.nci.nih.gov/fact/3_21.htm

4. How does Alimta work?

Alimta works by blocking specific enzymes thought to play a role in the rapid
growth of these lung tumors.

5. Is Alimta a cure for malignant pleural mesothelioma?

No, but in clinical trials patients who were treated with Alimta and cisplatin had a
median survival of 12.1 months compared to 9.3 months for patients treated with
cisplatin alone.

6. How is Alimta given?

Alimta is given intravenously (into a vein), about every 21 days. Cisplatin is then
infused about 30 minutes after Alimta treatment. To lower the chances of side
effects with Alimta, it is necessary to take folic acid and vitamin B12 before,
during, and after treatment.

7. What should I tell my doctor before being treated with Alimta?

To help your doctor decide if Alimta is right for you, tell your doctor if you: [1] plan
to become pregnant, or if you are pregnant, might be pregnant, or do not use
effective birth control, because Alimta may harm your unborn baby. [2] have
kidney problems. [3] are taking other medicines, including prescription and
non-prescription medicines, vitamins, and herbal supplements. Tell your doctor
or health care provider if you are taking NSAIDs (nonsteroidal anti-inflammatory
drugs). Ask your doctor or pharmacist if you are not sure, because there are
many NSAID medicines.

8. What are the possible side effects of Alimta?

Most patients treated with Alimta will experience some side effects. The most
common side effects of Alimta are: stomach upset, including nausea and
vomiting, and diarrhea, a drop in white blood cells, increasing the risk of
infection, a drop in red blood cells (anemia), causing tiredness or shortness of
breath, a drop in platelets that results in bruising or bleeding tiredness, mouth,
throat, or lip sores
loss of appetite, rash. You should contact your doctor if you have signs of
infection such as fever (temperature above 100.4F) chills, diarrhea, or mouth
sores.

9. What should I avoid while being treated with Alimta?

Women should avoid becoming pregnant while being treated with Alimta
because Alimta may cause harm to an unborn baby.
Avoid taking nonsteroidal anti-inflammatory drugs (NSAIDs) for at least 5 days
before Alimta treatment, during the day of treatment, and for two days after
treatment. If you are not sure if a drug you take is a NSAID, ask your doctor or
pharmacist. There are many NSAID medicines that are prescription and
over-the-counter.

10. What else should I know about Alimta treatment?

Your doctor will prescribe a medicine called a corticosteroid to take the day
before, day of, and day after Alimta treatment to lower your chances of getting a
skin reaction. You will have regular blood tests before and during Alimta
treatment so your doctor can monitor your treatment.

11. Where can I find more information on Alimta?

Go to FDA's Alimta web page at:
http://www.fda.gov/cder/drug/infopage/alimta/default.htm
National Cancer Institute's web page:
http://www.cancer.gov/cancerinfo/types/malignantmesothelioma

Call the manufacturer at 1-800-Lilly-Rx (1-800-545-5979).

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.