Product Description:

• ALIMTA 500 mg Each vial contains 500 mg of pemetrexed used for:

Malignant pleural mesothelioma:

• ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Nonsmall cell lung cancer:

• ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology.


• ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinumbased chemotherapy.


• ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology.


• ALIMTA is indicated in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

How to use:

• ALIMTA must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.


• The recommended dose of ALIMTA when administered with pembrolizumab and platinum chemotherapy for the initial treatment of metastatic nonsquamous NSCLC in patients with a creatinine clearance (calculated by CockcroftGault equation) of 45 mL/min or greater is 500 mg/m2 as an intravenous infusion over 10 minutes administered after pembrolizumab and prior to carboplatin or cisplatin on Day 1 of each 21day cycle for 4 cycles. Following completion of platinumbased therapy, treatment with ALIMTA with or without pembrolizumab is administered until disease progression or unacceptable toxicity.

ALIMTA in combination with cisplatin

• The recommended dose of ALIMTA is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21day cycle.


• The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21day cycle.


• Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin.

ALIMTA as single agent:

• In patients treated for nonsmall cell lung cancer after prior chemotherapy, the recommended dose of ALIMTA is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21day cycle.

Premedication regimen:

• To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.


• The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day .


• To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation. Patients must take oral folic acid or a multivitamin containing folic acid (350 to


• 1000 micrograms) on a daily basis. At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.


• Patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter. Subsequent vitamin B12 injections may be given on the same day as pemetrexed.

Caution & Warnings:

• Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia or pancytopenia. Myelosuppression is usually the doselimiting toxicity.


• Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to > 1500 cells/mm3 and platelet count returns to > 100,000 cells/mm3.


• Dose reductions for subsequent cycles are based on ANC, platelet count and maximum nonhaematologic toxicity seen from the previous cycle.

Neutropenia:

• Febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pretreatment with folic acid and vitamin B12 was administered. Therefore,


• All patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatmentrelated toxicity.

Skin reactions:

• Have been reported in patients not pretreated with a corticosteroid. Pretreatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions.


• The use of pemetrexed in patients with creatinine clearance of < 45 ml/min is not recommended


• Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration.


• Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.


• Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving treatment.


• Immunodepressed status is common in cancer patients. As a result, concomitant use of live attenuated vaccines is not recommended.


• Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy


• ALIMTA 500 mg powder for concentrate for solution for infusion


• This medicinal product contains 54 mg sodium per vial, equivalent to 2,7 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.


• Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration. Concomitant administration of nephrotoxic drugs (e.g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed. This combination should be used with caution. If necessary, creatinine clearance should be closely monitored.


• High doses of nonsteroidal antiinflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse reactions, administration of pemetrexed with NSAIDs (e.g. ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration.

Pregnancy:

• There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy,so should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus.

Breastfeeding:

• It is unknown whether pemetrexed is excreted in human milk and adverse reactions on the breast feeding child cannot be excluded.


• Breastfeeding must be discontinued during pemetrexed therapy.

Fertility:

• Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.

Ingredients:

• A Each vial contains 500 mg of pemetrexed

Other ingredients:

• Mannitol,Nitrogen, Hydrochloric acid, Sodium hydroxide.