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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