Carboplatin (Page 6 of 6)

Storage

Unopened vials of Carboplatin Injection are stable to the date indicated on the package when stored at 25°C (77°F); [excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Carboplatin Injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.

Handling and Disposal

Caution should be exercised in handling and preparing carboplatin injection. Several guidelines on this subject have been published. 1-4

To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing carboplatin injection. If carboplatin injection contacts the skin, immediately wash the skin thoroughly with soap and water. If carboplatin injection contacts mucous membranes, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.

REFERENCES:

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov I dts/osta/otm/otm _vi/otm _vi_ 2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63: 1172-1193.

4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.

Patient Information

Read this entire leaflet carefully.

Keep it for future reference.

CARBOplatin

Injection

Rx only

This information will help you learn more about Carboplatin Injection. It cannot, however, cover all the possible warnings or side effects relating to Carboplatin Injection, and it does not list all of the benefits and risks of Carboplatin Injection. Your doctor should always be your first choice for detailed information about your medical condition and your treatment. Be sure to ask your doctor about any questions you may have.

What is cancer?

Under normal conditions, the cells in your body divide and grow in an orderly, controlled fashion. Cell division and growth are necessary for the human body to perform its functions and to repair itself. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood.

A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original location to other parts of the body.

What is Carboplatin Injection?

Carboplatin Injection is a medicine that is used to treat cancer of the ovaries. It acts by interfering with the division of rapidly multiplying cells, particularly cancer cells.

Who should not take Carboplatin Injection?

Treatment with Carboplatin Injection is not recommended if you:

• are allergic to carboplatin or other platinum-containing products;

• have a weakened blood-forming system (bone marrow depression) or significant bleeding;

• are pregnant, intend to become pregnant, or are breast feeding a baby.

How is Carboplatin Injection used?

Only a professional experienced in the use of cancer drugs should give you this medication. Carboplatin Injection is given by dripping the medicine slowly and directly into a vein (intravenous infusion) for 15 minutes or longer. Your doctor will determine the dose of Carboplatin Injection for you based on your weight, height, and kidney function. Carboplatin Injection may be given alone or with other drugs. Treatment is usually repeated every four weeks for a number of cycles.

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

What should you tell your doctor before starting treatment with Carboplatin Injection?

Discuss the benefits and risks of Carboplatin Injection with your doctor before beginning treatment. Be sure to inform your doctor:

• If you are allergic to carboplatin or other platinum-containing products;

• If you are or intend to become pregnant, since carboplatin may harm the developing fetus. It is important to use effective birth control while you are being treated with Carboplatin Injection;

• If you are breast-feeding, since nursing infants may be exposed to carboplatin in this way;

• If you are taking other medicines, including all prescription and non-prescription (over-the-counter) drugs, since carboplatin may affect the action of other medicines;

• If you have any other medical problems, especially chicken pox (including recent exposure to adults or children with chicken pox), shingles, hearing problems, infection, or kidney disease, since treatment with Carboplatin Injection increases the risk and severity of these conditions.

What should I avoid while taking Carboplatin Injection?

If you are pregnant or think you might be pregnant, or if you are breast feeding, let your doctor know right away. Carboplatin Injection may harm your developing fetus or breast-feeding baby. If you are a woman of childbearing age, you should use birth control to avoid getting pregnant while you are taking Carboplatin Injection.

You should avoid contact with adults and children who have infections, and tell your doctor right away if you show signs of infection such as cough, fever, and/or chills. Also, while you are being treated with Carboplatin Injection or after you stop treatment, first check with your doctor before getting any immunizations (vaccinations). Avoid contact with adults or children who have received oral polio vaccine since they can pass the polio virus to you.

What are the possible side effects of Carboplatin Injection?

Carboplatin Injection may cause unwanted effects, particularly because Carboplatin Injection interferes with the growth of normal cells as well as cancer cells. For example, the occurrence of another cancer (secondary malignancy) has been reported in patients receiving cancer chemotherapy with multiple drugs. It is not always possible to tell whether such effects are caused by carboplatin, another drug you may be taking, or your illness. Because some of these effects may be serious, you will need close medical supervision during treatment with Carboplatin Injection.

The most serious side effects of Carboplatin Injection are:

bleeding and reduced blood cells, including reduced red blood cells (anemia) and platelets (needed for proper blood clotting), which may be severe enough to require blood transfusion. You should tell your doctor right away if you notice any unusual bruising or bleeding, including black tarry stools or blood in the urine.

infection – Carboplatin Injection can temporarily lower the number of white blood cells in your blood, increasing the risk of infection;

life-threatening allergic reaction during and after treatment the doctor or nurse will observe you carefully for signs of allergic reaction;

kidney and liver problems ;

loss of hearing or ringing in the ears ;

Contact your doctor right away if you experience any of these effects, or notice effects that
worry you or are troublesome.

Of the less serious side effects associated with Carboplatin Injection treatment, the most common are nausea, vomiting, diarrhea, loss of appetite, hair loss and numbness, tingling, burning, or pain in the hands or feet.

This medicine was prescribed for your particular condition. It must be given under close medical supervision by a doctor trained in the use of drugs for the treatment of cancer.

This summary does not include everything there is to know about Carboplatin Injection. Medicines are sometimes prescribed for purposes other than those listed in patient leaflets. If you have questions or concerns, or want more information about Carboplatin Injection, your physician and pharmacist have the complete prescribing information upon which this information is based. You may want to read it and discuss it with your doctor. Remember, no written summary can replace careful discussion with your doctor.

This Patient Information Leaflet has been approved by the U.S. Food and Drug Administration.

address

www.fresenius-kabi.us

451023C

Revised: March 2017

PACKAGE LABEL — PRINCIPAL DISPLAY — Carboplatin 600 mg per 60 mL Multiple Dose Vial Label

CARBOplatin Injection

600 mg per 60 mL
(10 mg per mL)

For intravenous use.
Preservative free.
Cytotoxic agent.
60 mL

Multiple Dose Vial Rx only

vial

PACKAGE LABEL — PRINCIPAL DISPLAY — Carboplatin 600 mg per 60 mL Multiple Dose Vial Carton Panel

CARBOplatin Injection

600 mg per 60 mL
(10 mg per mL)

For intravenous use.
Preservative free.
Cytotoxic agent.
Rx only 60 mL

Multiple Dose Vial

pboxvialpbox
CARBOPLATIN carboplatin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-172
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBOPLATIN (CARBOPLATIN) CARBOPLATIN 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-172-60 1 VIAL in 1 BOX contains a VIAL
1 60 mL in 1 VIAL This package is contained within the BOX (63323-172-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077266 12/11/2009
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 manufacture (63323-172)

Revised: 12/2019 Fresenius Kabi USA, LLC

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