DBL Cisplatin

DBL Cisplatin

cisplatin

Manufacturer:

Hospira

Distributor:

Zuellig Pharma

Marketer:

Pfizer
Concise Prescribing Info
Contents
Cisplatin
Indications/Uses
Palliative treatment of metastatic non-seminomatous germ cell carcinoma, advanced-stage refractory ovarian & bladder carcinoma, & refractory squamous cell carcinoma of the head & neck, as monotherapy or in combination w/ other chemotherapeutic agents. May be employed in addition to other modalities eg, radiotherapy or surgery.
Dosage/Direction for Use
Adult & childn Monotherapy: 50-100 mg/m2 as a single IV infusion every 3-4 wk; or 15-20 mg/m2 IV infusion daily for 5 days every 3-4 wk. Administer infusion over 1-2 hr, longer infusion time of 6-8 hr may decrease GI & renal toxicities.
Contraindications
History of hypersensitivity to cisplatin or other platinum-containing compd. Not to be used in patients w/ hearing impairment or myelosuppression. Renal impairment. Pregnancy & lactation.
Special Precautions
Carefully observe for possible anaphylactic-like reactions. For antineoplastic-experienced individuals only. Measure BUN, serum creatinine & CrCl prior to initiating therapy, & prior to subsequent doses. Hydrate to minimize nephrotoxicity. Perform audiometric testing prior to initiation of therapy & at regular intervals thereafter, particularly if clinical symptoms of tinnitus or hearing impairment occur; may enhance ototoxicity w/ radiotherapy. Do not institute subsequent courses of therapy until platelets are present at levels >100,000/mm3 & white cells >4,000/mm3. Risk of severe anaemia requiring packed red cells transfusion. Perform peripheral blood counts at regular intervals for the duration of treatment. Patients may experience clinically heterogeneous venous thromboembolic events, MI, CVA, thrombotic microangiopathy & cerebral arteritis; pulmonary embolism. Hypomagnesaemia & hypocalcaemia; monitor electrolytes. Peripheral neuropathy, postural hypotension & seizures. May increase incidence of microbial infection, delayed healing & gingival bleeding; avoid dental work during therapy. Periodically monitor liver function. Regularly perform neurological exam. Increased risk of bleeding, bruising & infection; perform necessary invasive procedures w/ extreme care. Avoid alcohol & aspirin. Patients who have recently been exposed to infections particularly chicken pox & herpes zoster. Do not use live virus vaccines. Impaired liver & renal functions. Women of childbearing potential should use effective contraception during treatment & for at least 26 wk following the last dose. Men w/ female partners of childbearing potential should be advised to use effective contraception during treatment & for at least 14 wk after the last dose. Not to breastfeed during treatment.
Adverse Reactions
Renal toxicity; tinnitus &/or high frequency hearing loss, ototoxicity; blurred vision, acquired color blindness, cortical blindness, optic neuritis, papilloedema, retinal pigmentation; infection, sepsis; secondary malignancies & acute leukemia; thrombotic microangiopathy, bone marrow failure, neutropenia, thrombocytopenia, leukopenia, anemia, Coombs positive hemolytic anemia; anaphylactic-like reactions; inappropriate antidiuretic hormone secretion; hyponatremia, hypomagnesemia, dehydration, hypokalaemia, hypophosphataemia, hyperuricemia, hypocalcemia, tetany; convulsion, peripheral neuropathy, leukoencephalopathy, reversible posterior leukoencephalopathy syndrome, CVA, hemorrhagic stroke, ischemic stroke, ageusia, cerebral arteritis, Lhermitte's sign, myelopathy, autonomic neuropathy; arrhythmia, bradycardia, tachycardia, MI, cardiac arrest, cardiac disorder; Raynaud's phenomenon, venous thromboembolism; pulmonary embolism; stomatitis, vomiting, nausea, anorexia, hiccups, diarrhea; rash, alopecia; muscle spasms; acute renal failure, renal failure & tubular disorder; abnormal spermatogenesis; pyrexia, asthenia, malaise, inj site extravasation.
Drug Interactions
Risk of GI bleeding w/ alcohol & aspirin. Nephrotoxic & ototoxic effects may be potentiated by potentially nephrotoxic- or ototoxic-drugs eg, aminoglycosides & loop diuretics. Reduced lithium blood levels. Plasma levels of anticonvulsants may become subtherapeutic. Check INR during simultaneous use w/ oral anticoagulants eg, coumarins/warfarin. Clearance of paclitaxel may be reduced, potentially intensifying neurotoxicity. May form black precipitate w/ Al; not to be used w/ Al-containing needles, syringes, catheters or IV administration sets. Stability may be adversely affected by the presence of bisulphite, metabisulphite, Na bicarbonate & fluorouracil.
ATC Classification
L01XA01 - cisplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
DBL Cisplatin inj 1 mg/mL
Packing/Price
100 mL x 1's;50 mL x 1's
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