Alimta 500mg Infusion

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

ALIMTA is indicated in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

ALIMTA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic adenocarcinoma of the lung after prior chemotherapy.

ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic adenocarcinoma of the lung in patients whose disease has not progressed immediately following standard chemotherapy.

ALIMTA should only be administered under the supervision of a medical practitioner qualified in the use of anti-cancer chemotherapy.

The recommended dose of ALIMTA is 500 mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.

Patients treated for malignant pleural mesothelioma should receive cisplatin at a dose of 75 mg/m2 infused over 2 hours approximately 30 minutes after completion of ALIMTA infusion on the first day of each 21-day cycle.

Patients treated for adenocarcinoma of the lung should receive ALIMTA as a single agent at a dose of 500 mg/m2 administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.

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 ALIMTA administration.

Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 mcg) on a daily basis. At least 5 daily doses of folic acid must be taken during the 7 days preceding the first dose of ALIMTA, and dosing should continue during the full course of therapy and for 21 days after the last dose of ALIMTA.

Patients must also receive an intramuscular injection of vitamin B12 (1000 mcg) in the week preceding the first dose of ALIMTA and every 3 cycles thereafter.

ALIMTA is contraindicated in patients with known hypersensitivity to pemetrexed or to any of the excipients.

ALIMTA can suppress bone marrow function as manifested by neutropenia, thrombocytopenia, anaemia or pancytopenia. Myelosuppression is usually the dose-limiting toxicity. Patients should be monitored for myelosuppression during therapy and ALIMTA should not be given to patients until absolute neutrophil count (ANC) returns to u2265 1500 cells/mm3 and platelet count returns to u2265 100 000 cells/mm3.

In the Phase 3 mesothelioma EMPHACIS trial, less overall toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered. Therefore patients treated with ALIMTA must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity.

Skin reactions have been reported in patients not pre-treated with a corticosteroid. Pre-treatment with dexamethasone or equivalent can reduce the incidence and severity of skin reactions.

An insufficient number of patients has been studied with creatinine clearance of <45 ml/min. Therefore the use of ALIMTA in patients with creatinine clearance of <45 ml/min is not recommended.

Patients with mild to moderate renal insufficiency (creatinine clearance from 45 u2013 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) with short-elimination half-lives for at least 2 days prior to, on the day of, and at least 2 days after administration of ALIMTA.

ALIMTA is primarily eliminated unchanged renally as a result of glomerular filtration and tubular secretion. In vitro studies indicate that ALIMTA is actively secreted by OAT3 (organic anion transporter 3). Concomitant administration of nephrotoxic medicines could result in delayed clearance of ALIMTA.

Although NSAIDs in moderate doses can be administered with ALIMTA in patients with normal renal function (creatinine clearance u2265 80 ml/min), caution should be used when administering NSAIDs concurrently with ALIMTA to patients with renal insufficiency (creatinine clearance 45 u2013 79 ml/min).

Pregnancy: There is no data on the use of ALIMTA in pregnant women. Animal studies have shown reproductive toxicity such as birth defects and other defects on the development of the fetus, the course of gestation and peri- and post-development. The potential risk for humans is unknown. Therefore the use of ALIMTA should be avoided during pregnancy due to the potential hazard to the fetus. Women should also be advised to avoid becoming pregnant while being treated with ALIMTA.

Lactation: It is not known whether ALIMTA is excreted in human milk. Therefore it is not recommended that breast feeding be continued during ALIMTA therapy.

No studies on the effects on the ability to drive and use machines have been performed. However, it has been reported that ALIMTA may cause fatigue. Therefore patients should be cautioned against driving or operating machinery.

The table below provides the frequency and severity of undesirable effects that have been reported in >5 % of patients.

Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia and rash. Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia and anaemia. In addition, infection with or without fever, diarrhoea and mucositis may be seen. In the event of suspected overdose, patients should be monitored with blood counts and should receive supportive therapy as necessary. The use of leucovorin in the management of ALIMTA overdosage should be considered.