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MACLIMTA

PEMETREXED · by MACTER

ANTINEOPLASTICS Antimetabolite MACTER

Composition

Inj 500 mg/100 mg: Pemetrexed 500 mg/100 mg (as disodium) powder for reconstitution.

Indications & Dosage

Treatment of unresectable malignant pleural Mesothelioma (in combination with cisplatin): BY IV INF: Adults: 500 mg/m2 over 10 min on day 1 of each 21-day cycle with cisplatin 75 mg/m2 infused over 2 hr beginning 30 min after pemetrexed. Treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (in combination with cisplatin or monotherapy): BY IV INF: Adult: (consult literature or local protocol).

Administration

Administered over 10 min. Pemetrexed is compatible with standard polyvinyl chloride(PVC) administration sets and IV solution bags. Reconstitute each 100 mg vial with 4.2 ml of 0.9% NaCL (preservative free). Reconstitute 500 mg vials with 20 ml of 0.9% NaCL (preservative free). Reconstitution of either size vial gives a solution containing Pemetrexed 25 mg/ml. Gently swirl each vial until the powder is completely dissolved. Pemetrexed solution must be further diluted into a solution of 0.9% NaCL (preservative free), so that the total volume of solution is 100 ml.

Compatibility

Stable in NS. Incompatible with diluents containing calcium, including Ringers lactate injection and Ringers injection.

Stability

Store at 25 C (77 F); excursions are permitted between 15 C-30 C (59 F-86 F). Reconstituted and infusion solutions are stable for up to 24 hours following initial reconstitution when stored refrigerated between 2 C-8 C (36 F-46 F) or at 25 C (77 F); excursions are permitted to 15 C- 30 C (59 F-86 F). Discard unused portion.

Contraindications

severe renal insufficiency.

Precautions

Renal Insufficiency, diabetes, history of cardiovascular disease, prophylactic folic acid and vitamin B12 supplementation required, cardiovascular risk factors, pleural effusion, ascites, monitor for myelosuppression.

Interactions

Yellow fever and live attenuated vaccine,NSAIDs, aminoglycosides, loop diuretics, cyclosporin,Probenecid, penicillin, anticoagulants, platinum compounds.

Pregnancy

Positive evidence of risk: Avoid

Lactation

Contraindicated. Discontinue breast-feeding

Side Effects

Conjunctivitis, dehydration, GI disturbances, increased lacrimation, neuropathy, oedema, skin disorders, arrhythmias, colitis, interstitial pneumonitis, alopecia, bone-marrow suppression, extravasation, hyperuricaemia, nausea, oral mucositis, Stevens-Johnson syndrome, thromboembolism, toxicepidermal necrolysis, tumourlysis syndrome, vomiting Rare: Acute renal failure, hepatitis, peripheral ischaemia