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ALIMTA* (PEMETREXED DISODIUM) ABBREVIATED PRESCRIBING doses of NSAIDs (such as ibuprofen >1600mg/day) and aspirin at higher
INFORMATION Presentation Type I glass vials with rubber stoppers dosage (≥1.3g daily) may decrease pemetrexed elimination and increase the
containing pemetrexed disodium equivalent to 100 and 500mg of pemetrexed, occurrence of adverse events. Patients with mild to moderate renal as a sterile white to either light yellow or green-yellow lyophilised powder. insufficiency (creatinine clearance from 49 to 79ml/min) should avoid taking Uses Alimta in combination with cisplatin is indicated for the treatment of NSAIDs (eg, ibuprofen) or aspirin at higher dosage, for 2 days before, on the
chemotherapy naive patients with unresectable malignant pleural day of, and 2 days following pemetrexed administration. In patients with mild mesothelioma. Alimta in combination with cisplatin is indicated for first-line to moderate renal insufficiency eligible for pemetrexed therapy, NSAIDs with treatment of patients with locally advanced or metastatic non-small cell lung long elimination half-lives should be interrupted for at least 5 days prior to, on cancer other than predominantly squamous cell histology. Alimta is indicated the day of, and at least 2 days following pemetrexed administration. There is as monotherapy for the maintenance treatment of locally advanced or a possible interaction between oral anticoagulants and pemetrexed; therefore, metastatic non-small cell lung cancer, other than predominantly squamous increase the frequency of International Normalised Ratio (INR) monitoring if cell histology, in patients whose disease has not progressed immediately treating with oral anticoagulants. Fertility, Pregnancy and Lactation
following platinum-based chemotherapy. Alimta is indicated as monotherapy Contraception in males and females: Women of childbearing potential must for the second-line treatment of patients with locally advanced or metastatic use effective contraception during treatment with pemetrexed. Pemetrexed non small cell lung cancer, other than predominantly squamous cell histology. can have genetically damaging effects. Sexually mature males are advised Dosage and Administration Posology: The drug is to be administered not to father a child during the treatment and up to 6 months thereafter.
intravenously, under the supervision of a physician qualified in the use of Contraceptive measures or abstinence are recommended. Pregnancy: There cytotoxic anti cancer therapy. Alimta in combination with cisplatin: The are no data from the use of pemetrexed in pregnant women but pemetrexed, recommended dose of pemetrexed is 500mg/m² of body surface area (BSA), like other anti metabolites, is suspected to cause serious birth defects when given by ten-minute infusion, on day 1 of each 21-day cycle. The administered during pregnancy. Animal studies have shown reproductive recommended dose of cisplatin is 75mg/m² BSA, given by two-hour infusion, toxicity. Pemetrexed should not be used during pregnancy unless clearly approximately 30 minutes after completion of the pemetrexed infusion on day necessary, after a careful consideration of the needs of the mother and the 1 of each cycle. Adequate anti-emetic treatment and hydration for cisplatin risk for the foetus. Breastfeeding: It is not known whether pemetrexed is treatment must be given. Alimta as single agent: The recommended dose of excreted in human milk and adverse reactions on the suckling child cannot pemetrexed is 500mg/m² BSA, given by ten-minute infusion, on day 1 of each be excluded. Breast-feeding must be discontinued during pemetrexed 21-day cycle. Pre-medication: Supplement with 1000 micrograms therapy. Fertility: Owing to the possibility of pemetrexed treatment causing intramuscular vitamin B12 and oral folic acid (350 to 1000 micrograms) to irreversible infertility, men are advised to seek counselling on sperm storage reduce toxicity (for full details see Summary of Product Characteristics before starting treatment. Driving, etc It has been reported that pemetrexed
[SPC]). To reduce the incidence and severity of skin reactions, a corticosteroid may cause fatigue. Patients should be cautioned against driving or operating should be given the day prior to, on the day of, and the day after pemetrexed machinery. Undesirable Effects Summary of the safety profile: The most
administration - this should be equivalent to 4mg of dexamethasone commonly reported undesirable effects related to pemetrexed, whether used administered orally twice a day. Monitoring: Monitor prior to each dose for as monotherapy or in combination, are bone marrow suppression, manifested complete blood cell count, including a differential white cell count and platelet as anaemia, neutropenia, leucopenia, and thrombocytopenia; and gastro- count. Absolute neutrophil count should be ≥1,500 cells/mm3 and platelets intestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, ≥100,000 cells/mm3. Prior to each dose, collect blood chemistry tests to constipation, pharyngitis, mucositis, and stomatitis. Other undesirable evaluate renal and hepatic function. Dose adjustments to pemetrexed and/ effects include renal toxicities, increased aminotransferases, alopecia, or cisplatin at the start of a subsequent cycle should be based on nadir fatigue, dehydration, rash, infection/sepsis, and neuropathy. Rarely seen haematological counts or maximum non haematological toxicity. If necessary, events include Stevens-Johnson syndrome and toxic epidermal necrolysis. delay or withhold treatment in the presence of haematological toxicity, Rare cases of anaphylactic shock have been reported. Infections and neurotoxicity, and/or impaired hepatic/renal function. (For full information on infestations: Common: Infection. Haematological: Very common: Anaemia, dose modification see SPC.) Paediatric population: There is no relevant use leucopenia, thrombocytopenia, neutropenia. Common: Febrile neutropenia of Alimta in the paediatric population in malignant pleural mesothelioma and and infection without neutropenia. Uncommon: Pancytopenia. Rarely, non-small cell lung cancer. Renal impairment: Patients with creatinine haemolytic anaemia has been reported in patients treated with pemetrexed. clearance ≥45ml/min require no dose adjustment other than those Gastro-intestinal: Very common: Nausea, vomiting, stomatitis/pharyngitis, recommended for all patients. Use in patients with creatinine clearance anorexia, diarrhoea, constipation. Common: Dyspepsia, abdominal pain, below 45ml/min is not recommended. See also ‘Warnings and Special heartburn. Uncommon: Colitis (including bleeding, sometimes fatal, intestinal Precautions’. Hepatic impairment: Patients with hepatic impairment, such as perforation, intestinal necrosis, and typhlitis). Oesophagitis/radiation bilirubin >1.5-times the upper limit of normal and/or aminotransferase >3.0- oesophagitis has been reported during trials. General: Very common: Fatigue. times the upper limit of normal (hepatic metastases absent) or >5.0-times the Common: Fever, conjunctivitis, pain, oedema. Metabolism and nutrition: upper limit of normal (hepatic metastases present), have not been specifically Common: Dehydration. Nervous system: Very common: Neuropathy - studied. Method of administration: Precautions should be taken before sensory. Common: Neuropathy - motor, dizziness, taste disturbance. Renal handling or administering Alimta. Alimta should be administered as an and urinary: Very common: Creatinine elevation, creatinine clearance intravenous infusion over 10 minutes on the first day of each 21-day cycle. decreased. Common: Renal failure, renal disorders. Hepatobiliary: Common: For instructions on reconstitution and dilution of Alimta before administration, SGPT (ALT) elevation and SGOT (AST) elevation, increased GGT. Rare: Cases see SPC. Contra-indications Hypersensitivity to pemetrexed or to any of the
of hepatitis, potentially serious, have been reported during trials. Skin and excipients. Concomitant yellow fever vaccine. Breast-feeding. Warnings
subcutaneous tissue: Very common: Rash/desquamation, alopecia. Common: and Special Precautions Myelosuppression is usually the dose-limiting Urticaria, allergic reaction/hypersensitivity, erythema multiforme, pruritus.
toxicity. All patients must be instructed to take folic acid and vitamin B12 as Rare: Radiation recall; bullous conditions have been reported, including a prophylactic measure. Pre-treatment with dexamethasone (or equivalent) Stevens-Johnson syndrome and toxic epidermal necrolysis, which in some can reduce the incidence and severity of skin reactions. Serious renal events, cases were fatal. Uncommon: Cases of peripheral ischaemia, leading including acute renal failure, have been reported with pemetrexed alone or in sometimes to extremity necrosis, have been reported. Cardiovascular and combination with other chemotherapeutic agents. Many of the patients in cerebrovascular: Uncommon: Myocardial infarction, angina pectoris, whom these occurred had underlying risk factors, including dehydration or cerebrovascular accident, supraventricular arrhythmias, transient ischaemic pre-existing hypertension or diabetes. The effect of third space fluid, such as attack, pulmonary embolism. (Usually when given in combination with other pleural effusion or ascites, on pemetrexed is not fully defined. A Phase 2 cytotoxic agents and with pre-existing cardiovascular risk.) Common: Chest study of pemetrexed in 31 solid tumour patients with stable third space fluid pain. Respiratory: Uncommon: Interstitial pneumonitis with respiratory demonstrated no difference in pemetrexed dose normalised plasma insufficiency (sometimes fatal), radiation pneumonitis. For full details of these concentrations or clearance compared to patients without third space fluid and other side-effects, please see the Summary of Product Characteristics, collections. Thus, drainage of third space fluid collection prior to pemetrexed which is available at http://emc.medicines.org.uk/. Legal Category POM
treatment should be considered, but may not be necessary. Serious Marketing Authorisation Numbers EU/1/04/290/001, EU/1/04/290/002
cardiovascular events, including myocardial infarction and cerebrovascular Basic NHS Cost 100mg vial: £160.00 per pack of 1 vial, 500mg vial: £800.00
events, have been uncommonly reported when pemetrexed is given in per pack of 1 vial Date of Preparation or Last Review November 2012 Full
combination with other cytotoxic agents; most of these patients had pre- Prescribing Information is Available From Eli Lilly and Company Limited,
existing cardiovascular risk. Concomitant use of live attenuated vaccines is Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL Telephone: not recommended. Radiation pneumonitis has been reported in patients Basingstoke (01256) 315 000 E-mail: [email protected] Website: www.
treated with radiation either prior, during, or subsequent to pemetrexed lillypro.co.uk *ALIMTA (pemetrexed disodium) is a trademark of Eli Lilly and therapy. Pay particular attention to these patients and exercise caution with use of other radiosensitising agents. Radiation recall has been reported in patients who received radiotherapy weeks or years previously. Interactions
Concomitant administration of nephrotoxic drugs and substances that are also tubularly secreted could potentially result in delayed clearance of pemetrexed. If necessary, creatinine clearance should be closely monitored. Adverse events should be reported. Reporting forms
Patients must avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) with long elimination half-lives for at least 5 days prior to, on the day, and at and further information can be found at:
least 2 days following pemetrexed administration. If concomitant www.mhra.gov.uk/yellowcard.
administration of NSAIDs is necessary, patients should be monitored closely Adverse events and product complaints should also
for toxicity, especially myelosuppression and gastro-intestinal toxicity. In be reported to Lilly: please call Lilly UK on 01256 315 000.
patients with normal renal function (creatinine clearance ≥80ml/min), high

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