Platinol-AQ (Intravenous)

Cisplatin injection is used to treat advanced cancer of the bladder, ovaries, or testicles.

Cisplatin is an antineoplastic agent (cancer medicine). It disrupts the growth of cancer cells, which are then ultimately destroyed by the body.

This medicine is to be given only by or under the direct supervision of a doctor.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 14 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 11 months after the last dose. If you think you may be pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, diarrhea, a fever or chills, hives, hoarseness, itching, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

Cisplatin may cause serious kidney problems. Tell your doctor right away if you have blood in your urine, a change in frequency of urination or amount of urine, difficulty breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness.

Check with your doctor right away if you are experiencing burning, numbness, tingling, or painful sensations in your arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy. These symptoms may occur 3 to 8 weeks after the last dose of this medicine.

Cisplatin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in your urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have dizziness, loss of balance, loss of hearing, ringing or buzzing in your ears, or trouble hearing. These could be symptoms of hearing or ear problems.

Call your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. These could be symptoms of eye problems (e.g., optical neuritis, papilledema, cortical blindness).

This medicine may increase your risk for other cancers, including leukemia. Tell your doctor right away if you have bone or joint pain, fever, pale skin, unusual bleeding or bruising, unusual tiredness or weakness, weight loss, or swollen lymph glands in the neck, armpit, groin, or stomach.

If cisplatin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell your doctor or nurse right away if you notice redness, pain, or swelling at the injection site.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how cisplatin injection affects children. Its safety and effectiveness have not been established. This medicine may raise the risk of serious ear or hearing problems in children younger than 5 years old.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of cisplatin injection. However, older adults are more likely to have kidney issues or side effects (like nerve problems or blood/bone marrow issues) that may need caution and possible dose adjustments when receiving this medicine.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other situations, two different medicines may be used together, even if there is a risk of interaction. In such cases, your doctor may need to adjust the dose or take other precautions. When you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are notable but not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may alter your other medications.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both.

• Adenovirus Vaccine
• Aspirin
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Furosemide
• Influenza Virus Vaccine, Live
• Melphalan
• Paclitaxel
• Poliovirus Vaccine, Live
• Rituximab
• Smallpox Vaccine
• Tacrolimus
• Thioctic Acid
• Trilaciclib
• Typhoid Vaccine, Live
• Valproic Acid
• Vinorelbine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed together, your doctor may change the dose or frequency of one or both.

• Aldesleukin
• Docetaxel
• Fosphenytoin
• Lithium
• Phenytoin
• Tobramycin
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems
• Ear or hearing problems
• Kidney disease
• Nerve problems—Use with caution. May worsen these conditions.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Contact your doctor right away if any of the following side effects occur:

More common

• Black, tarry stools
• Blood in urine or stools
• Burning, numbness, tingling, or painful sensations
• Change in frequency of urination or amount of urine
• Cough or hoarseness
• Difficulty in breathing
• Dizziness
• Drowsiness
• Feeling of fullness in the ears
• Fever or chills
• Increased thirst
• Loss of appetite
• Loss of balance
• Loss of hearing
• Lower back or side pain
• Nausea or vomiting
• Painful or difficult urination
• Pinpoint red spots on skin
• Ringing or buzzing in the ears
• Swelling of the feet or lower legs
• Trouble in hearing
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Weakness in the arms, hands, legs, or feet

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Bleeding gums
• Blindness
• Blue-yellow color blindness
• Blurred vision
• Chest pain or discomfort
• Decreased vision
• Eye pain
• Fast heartbeat
• General body swelling
• Headache
• Leg pain
• Nosebleeds
• Pain or discomfort in the arms, jaw, back, or neck
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Sweating
• Unusual tiredness or weakness
• Weight loss
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to inform you about ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

Incidence not known

• Bloating
• Constipation
• Diarrhea
• Hair loss or thinning
• Indigestion
• Loss of appetite
• Muscle cramps
• Rash
• Swelling or inflammation of the mouth

Other side effects not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Platinol-AQ

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Platinum Coordination Complex

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive this medicine while you are in a medical facility. A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for 6 to 8 hours.

If any of this medicine gets on your skin or in your eyes, nose, or mouth, tell your doctor or nurse right away.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. Other medicines may be given to you to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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