Paraplatin (carboplatin) belongs to a class of medications known as platinum-containing compounds. Carboplatin is a cancer medication that interferes with with the division of rapidly multiplying cells, particularly cancer cells, and slows their growth and spread in the body.

Paraplatin is used in adults in combination with other cancer treatments to treat ovarian cancer.

Paraplatin is also used in adults who have advanced ovarian carcinoma, where ovarian cancer has returned following prior chemotherapy, and are receiving palliative care (treatment to relieve suffering and improve quality of life during a serious illness).

Before and after Paraplatin treatment, your doctor may give you medication to lessen the nausea and vomiting associated with this cancer treatment.

You may have a severe allergic reaction within minutes of receiving a Paraplatin injection. Your caregivers will quickly treat you if you if this occurs. You may be given medicine to help prevent an allergic reaction.

You should not receive Paraplatin if you have severe bleeding or bone marrow suppression.

Paraplatin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before you receive this medicine, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

You may get infections or bleed more easily. Call your doctor if you have unusual bleeding or signs of infection (fever, cough, skin sores, painful urination).

Before taking this medicine

You should not be treated with Paraplatin if you are allergic to carboplatin, or if you have:

• severe bleeding;

• severe bone marrow suppression; or

• if you have had a severe allergic reaction to similar cancer drugs such as oxaliplatin or cisplatin.

To make sure Paraplatin is safe for you, tell your doctor if you have ever had:

• if you have recently been exposed to varicella (chickenpox), or have varicella (chickenpox);

• shingles (herpes zoster);

• hearing problems;

• weak immune system (caused by disease or by using certain medicines);

• if you have received carboplatin in the past;

• liver disease; or

• kidney disease.

Carboplatin may harm an unborn baby. Use birth control and tell your doctor if you become pregnant.

Do not breastfeed while receiving Paraplatin.

Paraplatin is injected slowly into a vein by a healthcare provider over 15 minutes or longer. This medicine is usually given once every 4 weeks.

Paraplatin doses are based on body surface area (height and weight) and kidney function. Your dose may change if you gain or lose weight or if your kidney function changes.

Tell your medical caregivers if you feel any burning or pain when Paraplatin is injected.

You may be given other medications to help prevent serious side effects or an allergic reaction.

You may get infections or bleed more easily. You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Your kidney and liver function may also need to be tested.

You may need blood transfusions while you are being treated with Paraplatin.

Usual Adult Dose of Paraplatin for Ovarian Cancer:

SINGLE AGENT THERAPY for use in the treatment of recurrent ovarian cancer:
360 mg/m2 by IV on day 1 every 4 weeks (alternatively, the Paraplatin dose may be calculated by the Calvert formula below). Usually, single intermittent courses should not be repeated until the neutrophil count is at least 2000 and the platelet count is at least 100,000.

COMBINATION THERAPY (with cyclophosphamide) for use in the treatment of advanced ovarian cancer (an effective combination for previously untreated patients):
-Paraplatin: 300 mg/m2 by IV on day 1 every 4 weeks for 6 cycles (alternatively, the Paraplatin dose may be calculated by the Calvert formula below)
-Cyclophosphamide 600 mg/m2 IV on day 1 every 4 weeks for 6 cycles
-Intermittent courses of Paraplatinin combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2000 and the platelet count is at least 100,000.

FORMULA DOSING: Another way to determine the initial dose is the use of a mathematical formula based on a patient's preexisting renal function or renal function and desired platelet nadir (renal excretion is the major route of elimination for this drug). The use of this formula allows compensation for patient variations in pretreatment renal function that might otherwise result in either under dosing (in patients with above average renal function) or overdosing (in patients with impaired renal function).
CALVERT FORMULA: Total Dose (mg) = (target AUC) x (GFR + 25); Note: With the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m2

Comments:
-This drug is usually administered by an infusion lasting 15 minutes or longer.
-No pre- or post-treatment hydration or forced diuresis is required.
-The target AUC of 4 to 6 mg/mL/min using single agent Paraplatin appears to provide the most appropriate dose range in previously treated patients.
-To avoid potential toxicity due to overdosing, if a patient's GFR is estimated based on serum creatinine measured by the standardized Isotope Dilution Mass Spectrometry (IDMS) method rather than using an actual GFR measurement, a capping of the dose of Paraplatin for the desired exposure (AUC) has been recommended.

Uses:
-For the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide.
-For the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.

You should not be treated with Paraplatin if you are allergic to carboplatin, or if you have:

• severe bleeding;

• severe bone marrow suppression; or

• if you have had a severe allergic reaction to similar cancer drugs such as oxaliplatin or cisplatin.

To make sure Paraplatin is safe for you, tell your doctor if you have ever had:

• if you have recently been exposed to varicella (chickenpox), or have varicella (chickenpox);

• shingles (herpes zoster);

• hearing problems;

• weak immune system (caused by disease or by using certain medicines);

• if you have received carboplatin in the past;

• liver disease; or

• kidney disease.

Carboplatin may harm an unborn baby. Use birth control and tell your doctor if you become pregnant.

Do not breastfeed while receiving Paraplatin.

Call your doctor for instructions if you miss an appointment for your Paraplatin injection.

In a medical setting an overdose would be treated quickly.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Ask your doctor before getting any vaccine while you are being treated with Paraplatin or after you stop treatment. Also avoid coming into contact with anyone who recently received an oral polio vaccine. In the US, polio vaccine is available only as an injection, but the oral form may still be in use in other countries.

Get emergency medical help if you have signs of an allergic reaction to Paraplatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Paraplatin may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing nausea and vomiting;

• numbness or tingly feeling in your hands or feet;

• vision problems;

• hearing problems, ringing in your ears;

• pain, burning, irritation, or skin changes where the injection was given;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of an electrolyte imbalance - increased thirst or urination, constipation, muscle weakness, leg cramps, numbness or tingling, feeling jittery, fluttering in your chest.

Common Paraplatin side effects may include:

• low blood cell counts;

• loss of appetite;

• nausea, vomiting, diarrhea;

• numbness, burning pain, or tingly feeling;

• temporary hair loss; or

• pain in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Paraplatin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your current medicines.

This list is not complete and many Other drugs may interact with carboplatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.