Pemetrexed disodium

What is Pemetrexed disodium?

• Pemetrexed disodium (Alimta) is a folate analog metabolic inhibitor used in the treatment of non-small cell lung cancer and malignant mesothelioma.

Pemetrexed

Pemetrexed ball-and-stick

What are the uses of this medicine?

Pemetrexed disodium (Alimta) is a prescription medicine used to treat:

• a kind of lung cancer called non-squamous non-small cell lung cancer (NSCLC). ALIMTA is used:
• as the first treatment in combination with pembrolizumab and platinum chemotherapy when your lung cancer with no abnormal EGFR or ALK gene has spread (advanced NSCLC).
• as the first treatment in combination with cisplatin when your lung cancer has spread (advanced NSCLC).
• alone as maintenance treatment after you have received 4 cycles of chemotherapy that contains platinum for first treatment of your advanced NSCLC and your cancer has not progressed.
• alone when your lung cancer has returned or spread after prior chemotherapy.
• a kind of cancer called malignant pleural mesothelioma. This cancer affects the lining of the lungs and chest wall. ALIMTA is used in combination with cisplatin as the first treatment for malignant pleural mesothelioma that cannot be removed by surgery or you are not able to have surgery.

How does this medicine work?

• Pemetrexed (pem" e trex' ed) is a folic acid analog which acts as an antagonist to the enzymes involved in folate dependent synthetic pathways such as thymidine synthase, dihydrofolate reductase and glycinamide ribonucleotide formyltransferase.
• Inhibition of these enzymes leads to decrease in intracellular thymidine and purine which interferes with DNA synthesis and leads to apoptotic cell death in rapidly dividing cells.
• In vitro and in vivo studies have shown that pemetrexed inhibits growth of mesothelioma and non-small cell lung cancer cell lines, and clinical trials in advanced forms of these cancers have shown improvements in overall survival times in pemetrexed treated subjects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a severe allergic reaction to any medicine that contains pemetrexed.

What drug interactions can this medicine cause?

• You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with ALIMTA.
• Monitor patients more frequently for myelosuppression, renal, and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.

Is this medicine FDA approved?

• Pemetrexed was approved for use in the United States in 2004.
• Current indications are for locally advanced or metastatic nonsquamous, non-small cell lung cancer (NSCLC) and for malignant pleural mesothelioma, usually in combination with other antineoplastic agents (such as cisplatin) and with folic acid and vitamin B12 supplementation.

How should this medicine be used?

• Initiate folic acid 400 mcg to 1000 mcg orally, once daily, beginning 7 days prior to the first dose of ALIMTA and continue until 21 days after the last dose of ALIMTA.
• Administer vitamin B12, 1 mg intramuscularly, 1 week prior to the first dose of ALIMTA and every 3 cycles.
• Administer dexamethasone 4 mg orally, twice daily the day before, the day of, and the day after ALIMTA administration.

Recommended dosage:

Recommended Dosage for Non-Squamous NSCLC:

• The recommended dose of ALIMTA administered with pembrolizumab and platinum chemotherapy in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes, administered after pembrolizumab and prior to platinum chemotherapy, on Day 1 of each 21-day cycle.
• The recommended dose of ALIMTA, administered as a single agent or with cisplatin, in patients with creatinine clearance of 45 mL/minute or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.

Recommended Dosage for Mesothelioma:

• The recommended dose of ALIMTA when administered with cisplatin in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Administration:

• ALIMTA is given to you by intravenous (IV) infusion into your vein. The infusion is given over 10 minutes.
• ALIMTA is usually given once every 21 days (3 weeks).
• It is very important to take folic acid and vitamin B12 during your treatment with ALIMTA to lower your risk of harmful side effects.
• Take folic acid exactly as prescribed by your healthcare provider 1 time a day, beginning 7 days (1 week) before your first dose of ALIMTA and continue taking folic acid until 21 days (3 weeks) after your last dose of ALIMTA.
• Your healthcare provider will give you vitamin B12 injections during treatment with ALIMTA. You will get your first vitamin B12 injection 7 days (1 week) before your first dose of ALIMTA, and then every 3 cycles.
• Your healthcare provider will prescribe a medicine called corticosteroid for you to take 2 times a day for 3 days, beginning the day before each treatment with ALIMTA.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg or 500 mg lyophilized powder in single-dose vial.

This medicine is available in fallowing brand namesː

• ALIMTA

What side effects can this medication cause?

The most common side effects of ALIMTA when given alone are:

• tiredness
• nausea
• loss of appetite

The most common side effects of ALIMTA when given with cisplatin are:

• vomiting
• swelling or sores in your mouth or sore throat
• constipation
• low white blood cell counts (neutropenia)
• low platelet counts (thrombocytopenia)
• low red blood cell counts (anemia)

The most common side effects of ALIMTA when given with pembrolizumab and platinum chemotherapy are:

• tiredness/weakness
• constipation
• loss of appetite
• vomiting
• shortness of breath
• nausea
• diarrhea
• rash
• cough
• fever

ALIMTA can cause serious side effects, including:

• Low blood cell counts
• Kidney problems, including kidney failure
• Severe skin reactions
• pneumonitis
• Radiation recall

What special precautions should I follow?

• ALIMTA can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection. Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer ALIMTA when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of ALIMTA.
• ALIMTA can cause severe, and sometimes fatal, renal toxicity. Do not administer when creatinine clearance is less than 45 mL/min.
• Serious and sometimes fatal, bullous, blistering and exfoliative skin toxicity, including cases suggestive of Stevens-Johnson Syndrome/Toxic epidermal necrolysis can occur with ALIMTA. Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity.
• Serious interstitial pneumonitis, including fatal cases, can occur with ALIMTA treatment. Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed.
• Radiation recall can occur with ALIMTA in patients who have received radiation weeks to years previously. Monitor patients for inflammation or blistering in areas of previous radiation treatment. Permanently discontinue ALIMTA for signs of radiation recall.
• Based on findings from animal studies and its mechanism of action, ALIMTA can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Treatment of overdosage:

• No drugs are approved for the treatment of ALIMTA overdose.
• It is not known whether pemetrexed is dialyzable.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, ALIMTA can cause fetal harm when administered to a pregnant woman.
• There are no available data on ALIMTA use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of ALIMTA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: pemetrexed
• Inactive ingredients: mannitol, hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.

Who manufactures and distributes this medicine?

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
• ALIMTA is a cytotoxic drug. Follow applicable special handling and disposal procedures.

• Dailymed label info on Pemetrexed disodium
• FDA Pemetrexed disodium

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