Cisplatin Injection

IMPORTANT WARNING:

Cisplatin injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Cisplatin may cause serious kidney problems. Kidney problems may occur more often in older people. Your doctor will order laboratory tests before and during your treatment to see if your kidneys are affected by this medication. Tell your doctor if you have or have ever had kidney disease. Tell your doctor and pharmacist if you are taking aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), or tobramycin (Tobi, Nebcin). If you experience any of the following symptoms, call your doctor immediately: decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.

Cisplatin may cause serious hearing problems, especially in children. Hearing loss may be permanent in some cases. Your doctor will order tests to monitor your hearing before and during your treatment. Tell your doctor and pharmacist if you have ever had radiation therapy to your head. Tell your doctor and pharmacist if you are taking aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), or tobramycin (Tobi, Nebcin). If you experience any of the following symptoms, call your doctor immediately: hearing loss, ringing in the ears, or dizziness.

Cisplatin may cause severe allergic reactions, especially if you have received more than one dose of cisplatin injection. If you experience an allergic reaction to cisplatin injection, it may begin within a few minutes after your infusion starts, and you may experience the following symptoms: hives; skin rash; itching; reddening of the skin; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips; dizziness; faintness; or fast heartbeat. Tell your doctor immediately if you experience any of these symptoms.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after your treatment to check your body's response to cisplatin. Your doctor may need to stop or delay your treatment if you experience certain side effects.

WHY is this medicine prescribed?

Cisplatin is used combination with other medications to treat cancer of the testicles that has not improved or that has worsened after treatment with other medications or radiation therapy. Cisplatin is used alone or in combination with other medications to treat cancer of the ovaries (cancer that begins in the female reproductive organs where eggs are formed) that has not improved or that has worsened after treatment with other medications or radiation therapy. Cisplatin is also used alone or in combination with other medications to treat bladder cancer that can not be treated with surgery or radiation therapy alone. Cisplatin is in a class of medications known as platinum-containing compounds. It works by stopping or slowing the growth of cancer cells.

Are there OTHER USES for this medicine?

Cisplatin is also sometimes used to treat head and neck cancer (including cancer of the mouth, lip, cheek, tongue, palate, throat, tonsils, and sinuses), lung cancer, cancer of the cervix and esophagus, brain tumors, malignant pleural mesothlioma (cancer in the lining of the chest or abdomen), and neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cisplatin injection comes as a solution (liquid) to be injected over 6 to 8 hours intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given once every 3 to 4 weeks.

What SPECIAL PRECAUTIONS should I follow?

Before taking cisplatin,

• tell your doctor and pharmacist if you are allergic to cisplatin, carboplatin (Paraplatin), any other medications, or any of the ingredients in cisplatin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amphotericin B (Abelcet; AmBisome; Amphotec, Fungizone Intravenous), anticonvulsants such as phenytoin (Dilantin), bumetanide (Bumex), ethacrynic acid (Edecrin), furosemide (Lasix), pyridoxine (Vitamin B-6). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with cisplatin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have kidney disease or hearing problems. Your doctor may not want you to receive cisplatin injection.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breast-feed while you are receiving cisplatin. If you become pregnant while receiving cisplatin, call your doctor. Cisplatin may harm the fetus.

What SIDE EFFECTS can this medicine cause?

Cisplatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• hair loss
• loss in ability to taste food
• hiccups
• dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• swelling, pain, redness, or burning at the injection site
• pain, burning, or tingling in the hands or feet
• muscle cramps
• difficulty walking
• feeling of an electric-like shock when you bend your neck forward
• seizures
• sudden changes in vision, including color vision
• loss of vision
• eye pain
• chest pain or pressure
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit
• vomited material that looks like coffee grounds

Cisplatin may increase the risk that you will develop other cancers. Talk to your doctor about the risks of taking this medication.

Cisplatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual tiredness or weakness
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• nausea
• vomiting
• unusual bleeding or bruising
• hearing problems
• sudden changes in vision
• fever, sore throat, chills, or other signs of infection
• pain, burning, numbness, or tingling in the hands or feet

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.