Alimta Side Effects and Warnings
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.

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.

What are the 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. It is
because these side effects could be resulting from bone marrow suppression by
the drug.

How does Alimta work?
Alimta works by blocking specific enzymes thought to play a role in the rapid growth
of these lung tumors. However, Alimta is not a cure for malignant pleural
mesothelioma. 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.

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.

What should I tell my doctor before being treated with Alimta?
You must discuss with 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, NSAIDs, vitamins, and herbal supplements.

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.

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.

Alimta is distributed by Eli Lilly and Company, Indianapolis, Ind.

SOURCE FDA Website
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.
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