What Is Cisplatin? FDA Approval, Licensing in Turkey, and Reimbursement
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Cisplatin: A Cornerstone of Cancer Treatment
A foundation of oncology protocols across cancers ranging from breast cancer to testicular and lung cancers, cisplatinis one of the most potent and widely used chemotherapy agents in oncology. It stops tumor cell division by creating cross-links in cellular DNA.
Drug Profile
- Brand Names: Platinol, Platinol-AQ, or generic Cisplatin
- Active Ingredient: Cisplatin
- Class: Alkylating agent (platinum compound)
- Category: Chemotherapeutic / antineoplastic agent
- Route of Administration: Intravenous injection (into a vein)
- Manufacturers: Bristol-Myers Squibb (original manufacturer), with many generic manufacturers
- FDA Approval: Yes (Initial Approval Date: December 19, 1978)
🇹🇷 Status in Turkey (Licensing, Price, and SGK):
- Licensing and Distribution: Licensed by the Turkish Ministry of Health and distributed by generic manufacturers such as Koçak Farma, Eczacıbaşı, and Onko & Koçsel.
- Reimbursement Status: Covered by the Social Security Institution (SGK) in Turkey.
- Reimbursement Conditions: It is included in the list of medicines without indication restrictions for a cancer diagnosis and is reimbursed by SGK for all cancer diagnoses.
🇹🇷 Status in Turkey (Licensing, Price, and SGK):
- Licensing and Distribution: Various generic cisplatin preparations are available in Turkey. Prices vary by brand, manufacturer, and package volume.
- Reimbursement Note: Cisplatin is a cornerstone chemotherapy agent widely used in oncology. However, reimbursement and public payment details should be checked separately according to brand, equivalent group, hospital supply, and current SUT conditions.
- Editorial Note: The prices below were compiled from Turkish retail/public price data available in May 2026. Prices may change periodically and should be checked against an updated list before publication.
- Turkey Price Table (May 2026):
🇹🇷 Status in Turkey (Licensing, Price, and SGK):
- Licensing and Distribution: Various generic cisplatin preparations are available in Turkey. Prices vary by brand, manufacturer, and package volume.
- Reimbursement Note: Cisplatin is a cornerstone chemotherapy agent widely used in oncology. However, reimbursement and public payment details should be checked separately according to brand, equivalent group, and current SUT conditions.
- Editorial Note: The prices below were compiled from available Turkish medicine price data for May 2026. As prices may change periodically, they should be checked again before publication.
- Current Turkey Price Table (May 2026):
Product Name Active Ingredient Dose / Form Manufacturer Approximate Price Cipintu Cisplatin 25 mg / 25 ml vial Koçsel 468.32 TL Cisplatin-Koçak Cisplatin 25 mg / 50 ml vial Koçak Farma 695.41 TL Cisplatin DBL Cisplatin 50 mg / 50 ml vial Orna 396.99 TL Cipintu Cisplatin 50 mg / 50 ml vial Koçsel 737.50 TL Cisplatin-Koçak Cisplatin 50 mg / 100 ml vial Koçak Farma 1,013.69 TL Cisplatin DBL Cisplatin 100 mg / 100 ml vial Orna 670.13 TL Cipintu Cisplatin 100 mg / 100 ml vial Koçsel 1,221.27 TL
Approved Indications (Therapeutic Indications)
Cisplatin is indicated for numerous solid tumors in both its FDA approval history and Turkish Ministry of Health licensing:
- Testicular Cancer: Treatment of metastatic nonseminomatous germ cell carcinomas.
- Ovarian Cancer: Treatment of primary or advanced and refractory ovarian cancers.
- Bladder Cancer: Treatment of advanced and refractory bladder cancers.
- Head and Neck Cancers: Squamous cell cancers of the head and neck.
- Lung Cancer: Small cell lung cancer and non-small cell lung carcinoma (NSCLC).
- Cervical Cancer: Treatment of cervical cancer.
- Hodgkin and Non-Hodgkin Lymphoma: Treatment of these lymphoma types.
- Neuroblastoma & Sarcomas: Treatment of childhood tumors and soft tissue/bone sarcomas.
- Gastric and Esophageal Cancer: Treatment of gastrointestinal tumors.
- Prostate Cancer, Melanoma, and Osteosarcoma: Included among combination agents in treatment protocols.
- Multiple Myeloma: Used in certain combination regimens for hematological malignancies.
FDA Approval History
📅 December 19, 1978: Initial Approvals (The Combination Era)
The FDA first approved cisplatin simultaneously for advanced ovarian cancer, advanced testicular cancer, and advanced bladder cancer.
📅 November 7, 2000, and September 2, 2010: Formulation and Prescribing Information Updates
Additional approvals for the injection formulation were obtained in 2000. In September 2010, the earliest official prescribing information for metastatic testicular tumors, metastatic ovarian tumors, and transitional cell bladder cancer was entered into the FDA system.
📅 March 6, 2024: A New Combination in Advanced Urothelial Carcinoma
Nivolumab combined with cisplatin and gemcitabine was FDA-approved for first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
What Is Cisplatin? Its Molecular Mechanism
Cisplatin is a cytotoxic chemotherapy medicine containing platinum. Its activity is not cell-cycle-specific.
🔬 Molecular Mechanism
After entering the cell, cisplatin reacts with water molecules to form active derivatives. Its intracellular antitumor action proceeds through these steps:
- 1. Covalent Bond Formation:
Active platinum molecules form strong covalent bonds with purine bases in DNA, namely guanine and adenine. - 2. DNA Cross-Linking:
This binding creates cross-links both between DNA strands (interstrand) and within the same strand (intrastrand), disrupting the DNA helix and causing strand breaks. - 3. Inhibition of Replication and Apoptosis:
Cross-links prevent DNA repair, replication, and RNA synthesis. When damage exceeds the capacity of repair mechanisms, the cell is destroyed through apoptosis (programmed cell death) or nonapoptotic pathways. - 4. Targeting Rapidly Dividing Cells:
Cisplatin has high selectivity/effectiveness in targeting the genetic material of rapidly and uncontrollably dividing cells, as seen particularly in malignant tumors.
Dosing and Administration Regimens
Cisplatin doses are adjusted in 3-4-week cycles according to cancer type, body surface area (m²), and combination protocols:
- Metastatic Testicular Tumors: 20 mg/m² by IV infusion daily for 5 days, generally combined with bleomycin and etoposide every 3 weeks.
- Advanced Ovarian Cancer: 75 to 100 mg/m² by IV infusion every 3 to 4 weeks, generally combined with cyclophosphamide (600 mg/m² IV).
- Advanced Bladder Cancer: 50 to 70 mg/m² by IV infusion every 3 to 4 weeks. An initial dose of 50 mg/m² is recommended in heavily pretreated patients.
- Head and Neck, NSCLC, and Cervical Cancers: Generally 75 to 100 mg/m² by IV infusion in 3- to 4-week cycles, acting synergistically with other agents.
Mechanisms of Resistance
Tumor cells develop resistance to cisplatin through several mechanisms:
| Mechanism | Cellular Action |
|---|---|
| Reduced Drug Uptake | Reduced activity of transport proteins prevents the drug from entering the cell and reaching DNA. |
| Drug Efflux | Increased efflux proteins, such as ATP-dependent pumps, lower intracellular drug concentrations. |
| Drug Inactivation | Increased intracellular glutathione and metal-binding proteins inactivate cisplatin before it can bind DNA. |
| Enhanced DNA Repair | Cellular repair systems such as nucleotide excision repair (NER) are activated, rapidly removing cross-links. |
| Apoptosis Evasion and Antioxidants | Cell-death signals are suppressed, while strengthened antioxidant systems counteract cisplatin-induced oxidative stress. |
Pharmacokinetic Properties
- Absorption: Because oral absorption is inadequate, it is administered only intravenously (IV), entering the circulation directly during infusion.
- Distribution: It binds extensively to plasma proteins such as albumin; the bound form is inactive. Free drug distributes into tissues, accumulating in the kidneys, liver, testes, ovaries, and tumors. Blood-brain barrier penetration is limited.
- Metabolism: It is not metabolized by hepatic cytochrome (CYP) enzymes in the conventional sense. In the intracellular aqueous environment, nonenzymatic chemical aquation produces active derivatives.
- Elimination: It is removed primarily through the kidneys in urine.
Drug Interactions
- Renal and Auditory (Nephrotoxic/Ototoxic) Interactions: Concomitant renally eliminated aminoglycoside antibiotics, such as gentamicin and amikacin, or loop diuretics such as furosemide compound the risk of kidney injury and hearing loss.
- Neurotoxic Agents: Combinations with medicines affecting the nervous system, such as paclitaxel or vincristine, may worsen numbness in the hands and feet and peripheral neuropathy.
- Myelosuppressive Combinations: Concomitant cytotoxic agents such as ifosfamide, cyclophosphamide, 5-FU, or doxorubicin synergistically increase bone marrow suppression and systemic adverse effects such as nausea and vomiting.
- Vaccines and Anticonvulsants: Live-virus vaccines are contraindicated because of immune suppression. Cisplatin may reduce plasma levels and effectiveness of antiepileptics such as phenytoin, making seizure control more difficult.
- Anticoagulants: Because coagulation parameters may change when combined with anticoagulants such as warfarin, bleeding/coagulation monitoring (INR) should be more frequent.
Precautions and Toxicity Management
⚠️ Critical Clinical Management:
- Renal Monitoring and Hydration: Cisplatin is renally eliminated. Creatinine and BUN monitoring are essential. Intensive intravenous hydration should be provided before and after treatment to prevent nephrotoxicity.
- Hearing and Nervous System: Regular audiometry should be performed because of tinnitus and hearing loss (ototoxicity) risk. Monitor peripheral neuropathy symptoms closely.
- Highly Emetogenic Profile: Because it causes very severe nausea and vomiting, it should be given with guideline-appropriate, highly effective antiemetic regimens.
- Pregnancy and Breastfeeding: It has established teratogenic effects on the fetus. Pregnancy must be avoided during and after treatment, and breastfeeding should be stopped.
Adverse Effects and Frequencies
Cumulative toxicity rates reported in clinical studies of cisplatin are as follows:
- Very Common Adverse Effects (More Than 10%):
• Nausea and Vomiting: Prominent in 76-100% of patients.
• Kidney Injury (Nephrotoxicity): Reflected in laboratory values in 28-36% of patients.
• Hearing Loss (Ototoxicity): May reach 31%, particularly in pediatric patients.
• Bone Marrow Suppression (Myelosuppression): Causes anemia, leukopenia, and thrombocytopenia in 25-30% of patients. - Common Adverse Effects (Between 1% and 10%):
• Allergic Reactions: Rash and hypotension may occur in 1-20% of patients.
• Hair Loss (Alopecia): Partial or complete loss occurs in 1-10% of patients. - Uncommon Adverse Effects:
• Dose-dependent peripheral neuropathy, gastrointestinal diarrhea, electrolyte imbalances such as hypomagnesemia, elevated liver function tests (AST/ALT), and local injection-site irritation.
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