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Alimta (Pemetrexed Disodium) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Chemotherapeutic Agents --Cisplatin does not affect the pharmacokinetics of pemetrexed and the pharmacokinetics of total platinum are unaltered by pemetrexed.

Vitamins --Coadministration of oral folic acid or intramuscular vitamin B12 does not affect the pharmacokinetics of pemetrexed.

Drugs Metabolized by Cytochrome P450 Enzymes --Results from in vitro studies with human liver microsomes predict that pemetrexed would not cause clinically significant inhibition of metabolic clearance of drugs metabolized by CYP3A, CYP2D6, CYP2C9, and CYP1A2. No studies were conducted to determine the cytochrome P450 isozyme induction potential of pemetrexed, because ALIMTA used as recommended (once every 21 days) would not be expected to cause any significant enzyme induction.

Aspirin --Aspirin, administered in low to moderate doses (325 mg every 6 hours), does not affect the pharmacokinetics of pemetrexed. The effect of greater doses of aspirin on pemetrexed pharmacokinetics is unknown.

Ibuprofen --Daily ibuprofen doses of 400 mg qid reduce pemetrexed's clearance by about 20% (and increase AUC by 20%) in patients with normal renal function. The effect of greater doses of ibuprofen on pemetrexed pharmacokinetics is unknown (see Drug Interactions under PRECAUTIONS).

OVERDOSAGE

There have been few cases of ALIMTA overdose. Reported toxicities included neutropenia, anemia, thrombocytopenia, mucositis, and rash. Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anemia. In addition, infection with or without fever, diarrhea, and mucositis may be seen. If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician.

In clinical trials, leucovorin was permitted for CTC Grade 4 leukopenia lasting >/=3 days, CTC Grade 4 neutropenia lasting >/=3 days, and immediately for CTC Grade 4 thrombocytopenia, bleeding associated with Grade 3 thrombocytopenia, or Grade 3 or 4 mucositis. The following intravenous doses and schedules of leucovorin were recommended for intravenous use: 100 mg/m2, intravenously once, followed by leucovorin, 50 mg/m2, intravenously every 6 hours for 8 days.

The ability of ALIMTA to be dialyzed is unknown.

CONTRAINDICATIONS

ALIMTA is contraindicated in patients who have a history of severe hypersensitivity reaction to pemetrexed or to any other ingredient used in the formulation.

REFERENCES

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
  2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621.
  3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985;253:1590-1591.
  4. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
  5. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983;1:426-428.
  6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA -- A Cancer J for Clin. 1983;33:258-263.
  7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990;47:1033-1049.
  8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996;53:1669-1685.

Literature issued August 19, 2004

Manufactured by Lilly France S.A.S.

F-67640 Fegersheim, France

for Eli Lilly and Company

Indianapolis, IN 46285, USA

www.ALIMTA.com

PA 9310 FSAMP

Copyright © 2004, Eli Lilly and Company. All rights reserved.

INFORMATION FOR PATIENTS AND CAREGIVERS

ALIMTA® (uh-LIM-tuh)

(pemetrexed for injection)

Read the Patient Information that comes with ALIMTA before you start treatment and each time you get treated with ALIMTA. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about ALIMTA.

What is ALIMTA?

ALIMTA is a treatment for:

  • Malignant pleural mesothelioma. This cancer affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anti-cancer medicine (chemotherapy).
  • Non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

To lower your chances of side effects of ALIMTA, you must also take folic acid and vitamin B12 prior to and during your treatment with ALIMTA. Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during your treatment with ALIMTA. Corticosteroid medicines lower your chances of getting skin reactions with ALIMTA.

ALIMTA has not been studied in children.

What should I tell my doctor before taking ALIMTA?

Tell your doctor about all of your medical conditions, including if you:

  • are pregnant or planning to become pregnant. ALIMTA may harm your unborn baby.
  • are breastfeeding. It is not known if ALIMTA passes into breast milk. You should stop breastfeeding once you start treatment with ALIMTA.
  • 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. There are many NSAID medicines. If you are not sure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

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).
  • If you are being treated for malignant pleural mesothelioma, ALIMTA is given in combination with cisplatin (another anti-cancer drug).Cisplatin is infused in your vein for about 2 hours starting about 30 minutes after your treatment with ALIMTA.
  • Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 days during your treatment with ALIMTA. Corticosteroid medicines lower your chances for getting skin reactions with ALIMTA.
  • It is very important to take folic acid and vitamin B12 during your treatment with ALIMTA to lower your chances of harmful side effects. You must start taking 350-1000 micrograms of 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. You can get folic acid vitamins over-the-counter. Folic acid is also found in many multivitamin pills. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product. 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 treatment based on the results of your blood tests and on your general condition.

What should I avoid while taking ALIMTA?

  • Women who can become pregnant should not become pregnant during treatment with ALIMTA. ALIMTA may harm the unborn baby.
  • Ask your doctor before taking medicines called NSAIDs. There are many NSAID medicines. If you are not sure, ask your doctor or pharmacist if any of your medicines are NSAIDs.

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.

The most common side effects of ALIMTA when given alone or in combination with cisplatin are:

  • Stomach upset, including nausea, vomiting, and diarrhea. 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 usually appear between treatments with ALIMTA and usually go away before the next treatment. Call your doctor if you get a severe rash or itching.

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.

General information about ALIMTA

Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. ALIMTA was prescribed for your medical condition.

This leaflet summarizes the most important information about ALIMTA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ALIMTA that is written for health professionals. You can also call 1-800-LILLY-RX (1-800-545-5979) or visit www.ALIMTA.com.

Literature issued August 19, 2004

Manufactured by Lilly France S.A.S.

F-67640 Fegersheim, France

for Eli Lilly and Company

Indianapolis, IN 46285, USA

www.ALIMTA.com

PA 9310 FSAMP

Copyright © 2004, Eli Lilly and Company. All rights reserved.

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