Medicine guide

Cisplatin

1 mg/mL · Injection, Solution

Prescription only
Platinum-based Drug

Active substance: Cisplatin
Made by: Sagent Pharmaceuticals
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-01-20

What it is

Platinum-based Drug

Used for

Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or…

The label’s usual adult dose

Metastatic Testicular Tumors The usual cisplatin dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m 2 IV daily for 5 days per cycle.

Full directions ↓

Serious warning

Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

12other products contain Cisplatin — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Cisplatin Injection is indicated as therapy to be employed as follows:

Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radio therapeutic procedures.
Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures.
An established combination consists of cisplatin and cyclophosphamide.
Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy.
Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.

From the official label · 2024-01-20 · DailyMed

How it works

From this product’s own US prescribing label.

Plasma concentrations of the parent compound, cisplatin, decay monoexponentially with a half-life of about 20 to 30 minutes following bolus administrations of 50 or 100 mg/m 2 doses.
Monoexponential decay and plasma half-lives of about 0.5 hour are also seen following 2 hour or 7 hour infusions of 100 mg/m 2.

Half-life20–30 min

Mostly cleared after≈ 2.1 hfive half-lives — our arithmetic

How it leaves the body

Over a dose range of 40 to 140 mg cisplatin/m 2 given as a bolus injection or as infusions varying in length from 1 hour to 24 hours, from 10% to about 40% of the administered platinum is excreted in the urine in 24 hours.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-01-20

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Cumulative renal toxicity associated with cisplatin is severe.
Other major dose-related toxicities are myelosuppression, nausea, and vomiting.
Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant.
Anaphylactic-like reactions to cisplatin have been reported.
Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration.
Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS ).
Exercise caution to prevent inadvertent cisplatin overdose .
Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used.
Care must be taken to
avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Cisplatin is contraindicated in patients with pre-existing renal impairment.
Cisplatin should not be employed in myelosuppressed patients, or in patients with hearing impairment.
Cisplatin is contraindicated in patients with a history of allergic reactions to cisplatin or other platinum containing compounds.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Cisplatin is administered by slow intravenous infusion.
CISPLATIN SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Note:
Needles or intravenous sets containing aluminum parts that may come in contact with cisplatin should not be used for preparation or administration.
Aluminum reacts with cisplatin, causing precipitate formation and a loss of potency.
Metastatic Testicular Tumors The usual cisplatin dose for the treatment of testicular cancer in combination with other approved chemotherapeutic agents is 20 mg/m 2 IV daily for 5 days per cycle.
Metastatic Ovarian Tumors The usual cisplatin dose for the treatment of metastatic ovarian tumors in combination with cyclophosphamide is 75 to 100 mg/m 2 IV per cycle once every 4 weeks (DAY 1).
The dose of cyclophosphamide when used in combination with cisplatin is 600 mg/m 2 IV once every 4 weeks (DAY 1).
For directions for the administration of cyclophosphamide, refer to the cyclophosphamide package insert.
In combination therapy, cisplatin and cyclophosphamide are administered sequentially.
As a single agent, cisplatin should be administered at a dose of 100 mg/m 2 IV per cycle once every 4 weeks.
Advanced Bladder Cancer Cisplatin should be administered as a single agent at a dose of 50 to 70 mg/m 2 IV per cycle once every 3 to 4 weeks depending on the extent of prior exposure to radiation therapy and/or prior chemotherapy.
For heavily pretreated patients an initial dose of 50 mg/m 2 per cycle repeated every 4 weeks is recommended.
All Patients Pretreatment hydration with 1 to 2 liters of fluid infused for 8 to 12 hours prior to a cisplatin dose is recommended.
The drug is then diluted in 2 liters of 5% Dextrose in 1/2 or 1/3 normal saline containing 37.5 g of mannitol, and infused over a 6 hour to 8 hour period.
If diluted solution is not to be used within 6 hours, protect solution from light.
Do not dilute cisplatin in just 5% Dextrose Injection.
Adequate hydration and urinary output must be maintained during the following 24 hours.
A repeat course of cisplatin should not be given until the serum creatinine is below 1.5 mg/100 mL, and/or the BUN is below 25 mg/100 mL.
A repeat course should not be given until circulating blood elements are at an acceptable level (platelets ≥ 100,000/mm 3 , WBC ≥ 4,000/mm 3 ).
Subsequent doses of cisplatin should not be given until an audiometric analysis indicates that auditory acuity is within normal limits.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Cisplatin produces cumulative nephrotoxicity which is potentiated by aminoglycoside antibiotics.
The serum creatinine, blood urea nitrogen (BUN), creatinine clearance, and magnesium, sodium, potassium, and calcium levels should be measured prior to initiating therapy, and prior to each subsequent course.
At the recommended dosage, cisplatin should not be given more frequently than once every 3 to 4 weeks (see ADVERSE REACTIONS ).
There are reports of severe neuropathies in patients in whom regimens are employed using higher doses of cisplatin or greater dose frequencies than those recommended.
These neuropathies may be irreversible and are seen as paresthesias in a stocking-glove distribution, areflexia, and loss of proprioception and vibratory sensation.
Elderly patients may be more susceptible to peripheral neuropathy (see PRECAUTIONS, Geriatric Use ).
Loss of motor function has also been reported.
These reactions have occurred within minutes of administration to patients with prior exposure to cisplatin, and have been alleviated by administration of epinephrine, corticosteroids, and antihistamines.
Cisplatin can commonly cause ototoxicity which is cumulative and may be severe.
Audiometric testing should be performed prior to initiating therapy and prior to each subsequent dose of drug (see ADVERSE REACTIONS ).
All pediatric patients receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose of drug and for several years post therapy.
Cisplatin can cause fetal harm when administered to a pregnant woman.
Cisplatin is mutagenic in bacteria and produces chromosome aberrations in animal cells in tissue culture.
In mice cisplatin is teratogenic and embryotoxic.
If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Patients should be advised to avoid becoming pregnant.
The carcinogenic effect of cisplatin was studied in BD IX rats.
Cisplatin was administered intraperitoneally (i.p.) to 50 BD IX rats for 3 weeks, 3 x 1 mg/kg body weight per week.
Four hundred and fifty-five days after the first application, 33 animals died, 13 of them related to malignancies:
12 leukemias and 1 renal fibrosarcoma.
Injection site reactions may occur during the administration of cisplatin (see ADVERSE REACTIONS ).
Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
A specific treatment for extravasation reactions is unknown at this time.
Peripheral blood counts should be monitored weekly.
Liver function should be monitored periodically.
Neurologic examination should also be performed regularly (see ADVERSE REACTIONS ).
Drug Interactions Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility (See WARNINGS ).
Pregnancy Pregnancy Category D (See WARNINGS ).
Nursing Mothers Cisplatin has been reported to be found in human milk; patients receiving cisplatin should not breast-feed.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use Insufficient data are available from clinical trials of cisplatin in the treatment of metastatic testicular tumors or advanced bladder cancer to determine whether elderly patients respond differently than younger patients.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Pregnancy Category D (See WARNINGS ).
Cisplatin has been reported to be found in human milk; patients receiving cisplatin should not breast-feed.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy.
In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Caution should be exercised to prevent inadvertent overdosage with cisplatin.
Acute overdosage with this drug may result in kidney failure, liver failure, deafness, ocular toxicity (including detachment of the retina), significant myelosuppression, intractable nausea and vomiting and/or neuritis.
In addition, death can occur following overdosage.
No proven antidotes have been established for cisplatin overdosage.
Hemodialysis, even when initiated four hours after the overdosage, appears to have little effect on removing platinum from the body because of cisplatin's rapid and high degree of protein binding.
Management of overdosage should include general supportive measures to sustain the patient through any period of toxicity that may occur.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.
All children should have audiometric monitoring performed prior to initiation of therapy, prior to each subsequent dose, and for several years post therapy.
Advanced testing methods may allow for earlier detection of hearing loss in an attempt to facilitate the rapid initiation of interventions that can limit the potential adverse impact of hearing impairment on a child's cognitive and social development.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Insufficient data are available from clinical trials of cisplatin in the treatment of metastatic testicular tumors or advanced bladder cancer to determine whether elderly patients respond differently than younger patients.
In four clinical trials of combination chemotherapy for advanced ovarian carcinoma, 1,484 patients received cisplatin either in combination with cyclophosphamide or paclitaxel.
Of these, 426 (29%) were older than 65 years.
In these trials, age was not found to be a prognostic factor for survival.
However, in a later secondary analysis for one of these trials, elderly patients were found to have shorter survival compared with younger patients.
In all four trials, elderly patients experienced more severe neutropenia than younger patients.
Higher incidences of severe thrombocytopenia and leukopenia were also seen in elderly compared with younger patients, although not in all cisplatin-containing treatment arms.
In the two trials where nonhematologic toxicity was evaluated according to age, elderly patients had a numerically higher incidence of peripheral neuropathy than younger patients.
Other reported clinical experience suggests that elderly patients may be more susceptible to myelosuppression, infectious complications, and nephrotoxicity than younger patients.
Cisplatin is known to be substantially excreted by the kidney and is contraindicated in patients with pre-existing renal impairment.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Quoted from the official label, section “Geriatric Use”.

Side effects

Nephrotoxicity Dose-related and cumulative renal insufficiency, including acute renal failure, is the major dose-limiting toxicity of cisplatin.
Renal toxicity has been noted in 28% to 36% of patients treated with a single dose of 50 mg/m 2 .
It is first noted during the second week after a dose and is manifested by elevations in BUN and creatinine, serum uric acid and/or a decrease in creatinine clearance.
Renal toxicity becomes more prolonged and severe with repeated courses of the drug.
Renal function must return to normal before another dose of cisplatin can be given.
Elderly patients may be more susceptible to nephrotoxicity (see PRECAUTIONS, Geriatric Use ).
Impairment of renal function has been associated with renal tubular damage.
The administration of cisplatin using a 6 hour to 8 hour infusion with intravenous hydration, and mannitol has been used to reduce nephrotoxicity.
However, renal toxicity still can occur after utilization of these procedures.
Ototoxicity Ototoxicity has been observed in up to 31% of patients treated with a single dose of cisplatin 50 mg/m 2 , and is manifested by tinnitus and/or hearing loss in the high frequency range (4,000 to 8,000 Hz).
The prevalence of hearing loss in children is particularly high and is estimated to be 40 to 60%.
Decreased ability to hear normal conversational tones may occur.
Deafness after the initial dose of cisplatin has been reported.
Ototoxic effects may be more severe in children receiving cisplatin.
Hearing loss can be unilateral or bilateral and tends to become more frequent and severe with repeated cisplatin doses.
It is unclear whether cisplatin-induced ototoxicity is reversible.
Vestibular toxicity has also been reported.
Ototoxic effects may be related to the peak plasma concentration of cisplatin.
Ototoxicity can occur during treatment or be delayed.
Audiometric monitoring should be performed prior to initiation of therapy, prior to each subsequent dose, and for several years post therapy.
The risk of ototoxicity may be increased by prior or simultaneous cranial irradiation, and may be more severe in patients less than 5 years of age, patients being treated with other ototoxic drugs (e.g., aminoglycosides and vancomycin), and in patients with renal impairment.
Genetic factors (e.g., variants in the thiopurine S-methyltransferase [TPMT] gene) may contribute to cisplatin-induced ototoxicity; although this association has not been consistent across populations and study designs.
Hematologic Myelosuppression occurs in 25% to 30% of patients treated with cisplatin.
The nadirs in circulating platelets and leukocytes occur between days 18 to 23 (range 7.5 to 45) with most patients recovering by day 39 (range 13 to 62).
Leukopenia and thrombocytopenia are more pronounced at higher doses (>50 mg/m 2 ).
Anemia (decrease of 2 g hemoglobin/100 mL) occurs at approximately the same frequency and with the same timing as leukopenia and thrombocytopenia.
Fever and infection have also been reported in patients with neutropenia.
Potential fatalities due to infection (secondary to myelosuppression) have been reported.
Elderly patients may be more susceptible to myelosuppression (see PRECAUTIONS, Geriatric Use ).
In addition to anemia secondary to myelosuppression, a Coombs' positive hemolytic anemia has been reported.
In the presence of cisplatin hemolytic anemia, a further course of treatment may be accompanied by increased hemolysis and this risk should be weighed by the treating physician.
The development of acute leukemia coincident with the use of cisplatin has been reported.
In these reports, cisplatin was generally given in combination with other leukemogenic agents.
Gastrointestinal Marked nausea and vomiting occur in almost all patients treated with cisplatin, and may be so severe that the drug must be discontinued.
Nausea and vomiting may begin within 1 hour to 4 hours after treatment and last up to 24 hours.
Various degrees of vomiting, nausea and/or anorexia may persist for up to 1 week after treatment.
Delayed nausea and vomiting (begins or persists 24 hours or more after chemotherapy) has occurred in patients attaining complete emetic control on the day of cisplatin therapy.
Diarrhea has also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

CISplatin Injection (1 mg per mL) is supplied as follows:
NDC CISplatin Injection (1 mg per mL) Package Factor 25021-253-50 50 mg per 50 mL Multi-Dose Vial 1 vial per carton 25021-253-51 100 mg per 100 mL Multi-Dose Vial 1 vial per carton The above products are multiple dose vials packaged individually.
Storage Conditions
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate.
Protect from light.
Sterile, Nonpyrogenic, Preservative-free.
This container closure is not made with natural rubber latex.

Quoted from the official label, section “How Supplied”.

How to store it

Conditions
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate. Protect from light. Sterile, Nonpyrogenic, Preservative-free. This container closure is not made with natural rubber latex.

Quoted from the official label, section “Storage and Handling”.

What is in it

Cisplatin Injection is a clear, colorless to pale yellow solution.
Each 100 mL amber vial of Cisplatin Injection contains:
1 mg per mL cisplatin USP, 9 mg per mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection USP to a final volume of 50 mL and 100 mL respectively.
The pH range of Cisplatin Injection is 3.8 to 5.9.
Cisplatin Injection must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients ).
The active ingredient, cisplatin USP, is a yellow to orange crystalline powder.
Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position.
It is soluble in water or saline at 1 mg per mL and in dimethylformamide at 24 mg per mL.
It has a melting point of 207°C.
PtCl 2 H 6 N 2 M.W.
Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (10)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 10 of 10

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (7)

Details

Made by	Sagent Pharmaceuticals
Active substance	Cisplatin
Strength	1 mg/mL
Form	Injection, Solution
Route	Intravenous
Packs	1 VIAL in 1 CARTON / 50 mL in 1 VIAL · 1 VIAL in 1 CARTON / 100 mL in 1 VIAL
NDC	25021-253

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

13 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection, Solution9 products
- 1 mg/mL7
  1 mg/mL · 7 companies
  - Apotex Corp.
  - BluePoint Laboratories
  - FOSUN PHARMA USA INC
  - Fresenius Kabi USA, LLC
  - Gland Pharma Limited
  - Sagent Pharmaceuticals · this page
  - WG Critical Care, LLC
- 50 mg/50mL
- 100 mg/100mL
Injection3 products
- 1 mg/mL3
  1 mg/mL · 3 companies
Injection, Powder, Lyophilized, for Solution1 products
- 50 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Cisplatin1 mg/mLPrescription onlyInjection Hikma Pharmaceuticals USA Inc. · Cisplatin Cisplatin50 mg/50mLPrescription onlyInjection, Solution Teva Parenteral Medicines, Inc. · Cisplatin Cisplatin100 mg/100mLPrescription onlyInjection, Solution Teva Parenteral Medicines, Inc. · Cisplatin Cisplatin1 mg/mLPrescription onlyInjection Accord Healthcare Inc. · Cisplatin Cisplatin1 mg/mLPrescription onlyInjection, Solution WG Critical Care, LLC · Cisplatin Cisplatin50 mgPrescription onlyInjection, Powder, Lyophilized, for Solution WG Critical Care, LLC · Cisplatin

See every product with Cisplatin