Pemetrexed Kabi

Pemetrexed Kabi

pemetrexed

Manufacturer:

Fresenius Kabi Oncology

Distributor:

Zuellig Pharma

Marketer:

Fresenius Kabi
Concise Prescribing Info
Contents
Pemetrexed diNa
Indications/Uses
In combination w/ cisplatin for chemotherapy naïve patients w/ unresectable malignant pleural mesothelioma; 1st line treatment of patient w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology. Monotherapy for maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy; 2nd line treatment of patients w/ locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
Dosage/Direction for Use
IV Administer over 10 min infusion on 1st day of each 21-day cycle. Premed: Dexamethasone 4 mg orally bid prior to, on the day of & day after pemetrexed infusion. At least 5 doses of oral folic acid or multivit containing folic acid (350-1,000 mcg) daily during 7 days preceding 1st dose of pemetrexed, & continue during full course of therapy & for 21 days after last dose of pemetrexed. Vit B12 1,000 mcg IM in the wk preceding 1st dose of pemetrexed & once every 3 cycles thereafter. Subsequently, vit B12 inj on same day as pemetrexed. In combination w/ cisplatin 500 mg/m2 + cisplatin 75 mg/m2 infused over 2 hr approx 30 min after pemetrexed completion on 1st day of each 21-day cycle. Monotherapy for patients w/ NSCLC 500 mg/m2.
Contraindications
Hypersensitivity. Concomitant yellow fever vaccine. Breastfeeding.
Special Precautions
Discontinue therapy if patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed. Withhold treatment if patients develop non-haematologic toxicities ≥ Grade 3 until resolution to less than or equal to pre-therapy values. Not recommended to use in patients w/ CrCl <45 mL/min. Not to be given to patients until ANC returns to ≥1,500 cells/mm3 & platelet count returns to ≥100,000 cells/mm3. Serious renal events, including acute renal failure. May suppress bone marrow function. Myelosuppression. Skin reactions in patients not pre-treated w/ corticosteroid. Patients w/ dehydration, pre-existing HTN or diabetes. Monitor patients for myelosuppression during therapy; CBC including differential white cell & platelet count before each dose. Instruct patients to take folic acid & vit B12 as prophylaxis. Give adequate anti-emetic & appropriate hydration prior to &/or after receiving treatment. Reduce dose for subsequent cycles based on nadir ANC, platelet count & max non-haematologic toxicity. Not recommended to use concomitantly w/ attenuated vaccines. Serious CV events including MI & cerebrovascular events in patients w/ pre-existing CV risk factors when concomitantly used w/ another cytotoxic agent. Severe dehydration w/ cisplatin. Cases of radiation pneumonitis in patients treated w/ radiation either prior, during or subsequent to therapy; radiation recall in patients who received RT wk or yr previously. Concomitant use w/ other radiosensitising agents. May affect ability to drive & use machines. Avoid NSAIDs eg, ibuprofen & aspirin (>1.3 g daily) in patients w/ mild to moderate renal insufficiency (CrCl 45-79 mL/min) 2 days before, on the day of, & 2 days following administration. Interrupt NSAIDs in patients w/ mild to moderate renal insufficiency eligible for therapy at least 5 days prior to, on the day, & at least 2 days following administration. Sexually mature males should not father a child during treatment & up to 6 mth thereafter. Women of childbearing potential must use effective contraception during treatment. Pregnancy. Discontinue breastfeeding during therapy. Not recommended for use in childn & adolescent <18 yr.
Adverse Reactions
Decreased neutrophils/granulocytes, leukocytes, Hb & platelets; nausea, vomiting, stomatitis/pharyngitis, anorexia, diarrhoea (including diarrhoea w/o colostomy), constipation; fatigue; sensory neuropathy; creatinine elevation, decreased CrCl; rash/desquamation, alopecia. Conjunctivitis; dyspepsia/heartburn; mucositis; dehydration; taste disturbance; fever; SGPT & SGOT elevation; pruritus; pain.
Drug Interactions
Delayed clearance w/ nephrotoxic drugs (eg, aminoglycoside, loop diuretics, platinum compd, cyclosporin); tubularly secreted substances (eg, probenecid, penicillin). Decreased elimination w/ high doses of NSAIDs (eg, ibuprofen >1,600 mg daily & aspirin ≥1.3 g daily). Concomitant use w/ oral anticoagulants. Risk of fatal generalised vaccinate disease w/ yellow fever vaccine; possibly fatal systemic disease w/ live attenuated vaccines in immunosuppressed patients.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BA04 - pemetrexed ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Pemetrexed Kabi powd for conc for soln for infusion 100 mg
Packing/Price
1's
Form
Pemetrexed Kabi powd for conc for soln for infusion 500 mg
Packing/Price
1's
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