Pexate 100/Pexate 500

Pexate 100/Pexate 500 Special Precautions







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Special Precautions
Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see Adverse Reactions).
Myelosuppression is usually the dose-limiting toxicity. Patients should be monitored for myelosuppression during therapy and Pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥1,500 cells/mm3 and platelet count returns to ≥100,000 cells/mm3. Dose reductions for subsequent cycles are based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see Dosage & Administration).
Less toxicity ad 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 Pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see Dosage & Administration).
Skin reactions have been reported in patients not pre-treated with a corticosteroid. Pretreatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see Dosage & Administration).
An insufficient numbers of patients have been studied with creatinine clearance of below 45 mL/min. Therefore, the use of Pemetrexed in patients with creatinine clearance of <45 mL/min is not recommended (see Dosage & Administration).
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAID) such as ibuprofen, and acetylsalicylic acid (>1.3 g daily) for 2 days prior to, on the day of, and at least 2 days after administration of Pemetrexed (see Interactions). Patients with mild to moderate renal insufficiency eligible for Pemetrexed therapy should avoid taking NSAIDs with long elimination half-lives at least 5 days prior to, on the day of, and at least 2 days after Pemetrexed administration (see Interactions).
The effect of third space fluid, such as pleural effusion or ascites, on Pemetrexed was not fully defined. A phase 2 study of Pemetrexed in 31 solid tumor patients with stable third space fluid demonstrated no difference in Pemetrexed dose normalized plasma concentration or clearance compared to patients without third space fluid collections. Thus, drainage of third space fluid collection prior to Pemetrexed treatment should be considered, but may not be necessary.
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. Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with Pemetrexed, usually when given in combination with another cytotoxic agent. Most of the patients in whom these events have been observed had preexisting cardiovascular risk factors (see Adverse Reactions).
Immunodepressed status is common in cancer patients. As a result, concomitant use of live attenuated vaccines (except yellow fever) is not recommended (see Interactions).
Pemetrexed can have genetically damaging effects. Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
Contraceptive measures or abstinence are recommended. Owing to the possibility of Pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment. Women of childbearing potential must use effective contraception during treatment with Pemetrexed (see Use in Pregnancy & Lactation).
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed. However, it has been reported that Pemetrexed may cause fatigue. Therefore, patients should be cautioned against driving or operating machinery if this event occurs.
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