Carboplatin

Carboplatin injection is a platinum-based chemotherapy approved for adults with advanced ovarian cancer. The supported uses across available products include:

• Initial treatment of advanced ovarian carcinoma — given in combination with cyclophosphamide and other approved chemotherapy agents (supported by Carboplatin injection and Kyxata intravenous injection)
• Recurrent advanced ovarian carcinoma — used as a single agent when ovarian cancer returns after prior chemotherapy (supported by Carboplatin injection and Kyxata intravenous injection)

Carboplatin belongs to a class of drugs called platinum-based compounds. Once administered, it binds directly to DNA — the genetic blueprint inside cancer cells — and forms chemical bridges called cross-links between strands of DNA. These cross-links prevent cancer cells from replicating or reading their DNA correctly, which sets off a chain of events that kills the cell. Importantly, this mechanism does not depend on where a cancer cell is in its growth cycle, meaning it can affect cells at any stage.

The chemical process that activates carboplatin (called aquation) happens more slowly than with the related drug cisplatin, but both drugs ultimately produce similar numbers of DNA cross-links and similar effects on cancer cells. The body clears carboplatin mainly through the kidneys, which is why kidney function plays a central role in how the dose is determined and adjusted.

Carboplatin is given as an intravenous (IV) infusion — into a vein — in a hospital or clinical oncology setting. Infusions typically run for at least 15 minutes. It is most commonly given once every 4 weeks (Day 1 of each cycle). Your care team calculates the dose based on your kidney function and body size, and adjusts it depending on how your blood counts respond between cycles.

• Anti-nausea medication is given before and after each infusion
• Blood counts must be checked and meet minimum thresholds before each new cycle can begin
• For Kyxata specifically, older adults' doses should be calculated using a kidney-function-based formula (AUC dosing) to reduce the risk of serious side effects
• Follow your oncology team's instructions exactly — do not miss blood count checks between cycles

Carboplatin commonly causes a range of side effects, most related to its effect on rapidly dividing cells throughout the body:

• Low platelet counts (thrombocytopenia) — risk of bleeding
• Low white blood cell counts (neutropenia, leukopenia) — increased infection risk
• Anemia — low red blood cells, which can worsen with repeated courses
• Nausea and vomiting — very common; anti-nausea drugs help significantly
• Fatigue and weakness
• Numbness or tingling in hands or feet (peripheral neuropathy)
• Low levels of magnesium, sodium, potassium, and calcium in the blood
• Mild abnormalities in kidney or liver function tests

Serious reactions to watch for and act on immediately include: signs of severe infection (fever with very low white counts), unusual heavy bleeding, a sudden allergic reaction during or right after infusion (hives, breathing difficulty, drop in blood pressure), rapid worsening of numbness or weakness, and any sudden changes in vision.

• Bone marrow suppression is the most serious and dose-limiting risk. It can be severe enough to cause fatal infections or bleeding. Blood counts must be monitored closely before and between every cycle.
• Severe allergic reactions (anaphylaxis) can occur within minutes of the infusion — even in people who tolerated previous doses. Risk is higher after 6 or more cycles or in people previously treated with platinum-based drugs. Emergency equipment and medications must be on hand during every infusion.
• Embryo-fetal harm: carboplatin can cause serious harm or death to a developing baby. Effective contraception is essential during and after treatment (6 months for females, 3 months for males).
• Hemolytic-uremic syndrome: a rare but potentially fatal blood disorder — stop carboplatin immediately if signs appear (rapidly dropping hemoglobin with low platelets, rising creatinine or bilirubin).
• Kidney function: carboplatin is cleared by the kidneys, and patients with reduced kidney function face higher risk of severe bone marrow suppression and need dose adjustments.
• Peripheral neuropathy: nerve damage (numbness, tingling) can worsen with cumulative doses, prior cisplatin use, or combination with other nerve-toxic drugs — especially in older adults.
• Hearing loss: a risk in pediatric patients at higher than recommended doses or in combination with other ear-toxic agents. Long-term hearing follow-up is recommended in children.

Carboplatin can interact with several other medications — always tell your oncology team about everything you take:

• Aminoglycoside antibiotics (e.g., gentamicin, tobramycin) — combining these with carboplatin increases the risk of kidney damage and hearing loss
• Phenytoin or fosphenytoin (seizure medications) — carboplatin can lower blood levels of these drugs, potentially causing seizures to break through
• Other bone marrow-suppressing drugs or radiation therapy — used together with carboplatin, these can cause additive and more severe drops in blood counts
• Other ototoxic drugs (drugs that damage hearing) — particularly important in children; risk of significant or delayed hearing loss increases
• Other nephrotoxic drugs (drugs that stress the kidneys) — carboplatin may make their kidney effects worse

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not use carboplatin if you have had a severe allergic reaction to cisplatin, any other platinum-containing drug, or mannitol
• Do not use if you currently have severe bone marrow suppression or significant active bleeding
• Tell your doctor about any kidney problems — carboplatin clearance depends almost entirely on kidney function, and dosing must be carefully tailored
• Older adults: at higher risk of severe low platelet counts and peripheral neuropathy; kidney function must guide dosing decisions
• Pregnancy: carboplatin causes fetal harm — females of reproductive potential must use effective contraception during treatment and for 6 months after the last dose; males must use contraception during treatment and for 3 months after
• Breastfeeding: do not breastfeed during treatment or for 1 week after the last dose
• Children: safety and effectiveness have not been established; pediatric patients face particular risk of hearing loss at higher or combined doses
• Tell your care team about all medications, including seizure drugs, antibiotics, and any other chemotherapy or radiation therapy

There is no antidote for a carboplatin overdose. Too much carboplatin can cause severe bone marrow suppression (very low blood counts) and serious liver toxicity, with very abnormal liver function tests. At doses higher than recommended, vision loss — which can be complete for light and color — has been reported, though it often recovers substantially after the drug is stopped. Clinically significant hearing loss has also been reported in children given higher-than-recommended doses alongside other ear-toxic agents. Anyone suspected of receiving an overdose should be closely monitored and given appropriate supportive care; carboplatin can be removed by dialysis.

Carboplatin's exposure-response relationships — meaning the precise link between the amount of drug in the body and its effects on tumors or side effects — have not been fully characterized. What is well established is that its bone marrow effects (lowering blood counts) are dose-dependent: higher exposure leads to more significant drops in platelets, white cells, and red cells. The lowest point of blood counts (the nadir) typically occurs around Day 21 after a dose, with most patients recovering by Day 28.

After an intravenous infusion, carboplatin levels in the blood decline in two phases: an early phase with a half-life of about 1 to 2 hours, followed by a longer phase of about 2.6 to 5.9 hours. Carboplatin is not significantly bound to plasma proteins in its active form, though platinum from carboplatin eventually binds irreversibly to proteins and is cleared very slowly — with a half-life of at least 5 days. The drug is eliminated almost entirely through the kidneys: roughly 65–71% is excreted in urine within 24 hours in patients with normal kidney function. Because kidney function directly controls how fast carboplatin is cleared from the body, patients with reduced kidney function retain higher drug levels and face greater risk of toxicity — making creatinine clearance (a measure of kidney filtering ability) the key factor in calculating a safe and effective dose.

Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 20° to 25°C (68° to 77°F) . PROTECT FROM LIGHT.