๐ Indications & Clinical 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).
๐ Mode of 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.
โ Contraindications
severe renal insufficiency.
โ ๏ธ Precautions & Warnings
Renal Insufficiency, diabetes, history of cardiovascular disease, prophylactic folic acid and vitamin B12 supplementation required, cardiovascular risk factors, pleural effusion, ascites, monitor for myelosuppression.
๐ Drug Interactions
Yellow fever and live attenuated vaccine,NSAIDs, aminoglycosides, loop diuretics, cyclosporin,Probenecid, penicillin, anticoagulants, platinum compounds.
โ ๏ธ Adverse Reactions / 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
๐คฐ Pregnancy & Lactation Safety
Pregnancy Risk:
Positive evidence of risk: Avoid
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding
๐งช Compatibility & Storage Stability
Compatibility: Stable in NS. Incompatible with diluents containing calcium, including Ringers lactate injection and Ringers injection.
Stability & Storage: 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.
๐ Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.