Ovarian Cancer Treatment - Gemzar.com (gemcitabine HCl for injection)

About Ovarian Cancer

GEMZAR is approved by the FDA in combination with carboplatin (another type of chemotherapy) for the patient with advanced ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

The Ovaries
Ovarian Cancer
Types of Ovarian Cancer
Risk Factors for Ovarian Cancer
Signs and Symptoms of Ovarian Cancer

The Ovaries
The ovaries are small, almond-shaped female reproductive organs. There are two ovaries and they are located deep in the pelvis, one on each side of the uterus. The ovaries produce female hormones and store all of the egg cells, which are released once a month during ovulation.

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Ovarian Cancer
Unusual growth of ovarian cells can result in a cancerous ("malignant") or non-cancerous ("benign") tumor. Many ovarian tumors are benign; women with benign tumors can be cured by surgically removing part or all of the affected ovary or ovaries.¹ Cancerous ovarian tumors, however, may be typically advanced at the time they are diagnosed, which means they have spread to other areas of the abdomen or to distant sites in the body.¹

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Types of Ovarian Cancer
The three main types of ovarian cancers are described by the cells within the ovary where the cancer started.¹

Epithelial ovarian cancers
The majority of ovarian cancers develop from the cells that cover the outer surface of the ovary, called "epithelial" cells.¹ Epithelial ovarian cancers account for 85 to 90 percent of all ovarian cancers.

Epithelial ovarian cancers come in several forms, which differ only in thier appearance when viewed under a microscope.

The other two major types of ovarian cancer — germ cell tumors and stromal tumors — are much less common than epithelial ovarian cancer.

Germ cell tumors
Approximately five percent of ovarian cancers begin in the cells that form the eggs, called "germ" cells. Germ cell tumors can occur in women of any age, but they tend to be found most often in women in their early 20s.
Stromal tumors
Ovarian stromal tumors develop in the tissue that hold the ovary together and the cells that produce the female hormones estrogen and progesterone.¹ Unlike epithelial ovarian cancers, 70% of the cases of stromal tumors are diagnosed early.

Since germ cell tumors and stromal tumors are rare and treated differently than the epithelial type, the term "ovarian cancer" refers only to epithelial ovarian cancers throughout this website.² Please note that GEMZAR is indicated in combination with carboplatin (another type of chemotherapy) for the patient with ovarian cancer that has returned at least 6 months after the patient had finished platinum-based therapy.

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A risk factor is something that can affect a person's chance of getting a disease such as ovarian cancer.²

Risk Factors for Ovarian Cancer
The exact cause of ovarian cancer remains unknown, although several "risk factors" have been linked to the disease. Some risk factors, such as smoking, can be controlled. Others, like a person's age or race, can't be changed. Having one or more risk factors does not mean that a person will get the disease.² Risk Factors of Ovarian Cancer

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Signs and Symptoms of Ovarian Cancer³
Women with ovarian cancer are more likely to have symptoms if the disease is in a later stage, but even early stage ovarian cancer can cause them. The most common symptoms of ovarian cancer include:

Feeling full quickly or difficulty eating
Pain in the abdomen or pelvis
Bloating
Urinary symptoms such as frequency (having to go often) or urgency (always feeling like you have to go)

Benign (non-cancerous) diseases and cancers of other organs can also cause these symptoms. If symptoms occur almost daily for more than a few weeks, you should contact your healthcare team.

Others symptoms of ovarian cancer can include:

Stomach upset
Changes in the menstrual cycle
Constipation
Extreme tiredness (fatigue)
Back pain
Pain during intercourse

Keep in mind, however, that these symptoms occur just about as often in women who do not have ovarian cancer. They are more likely to be caused by other conditions.

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Now let's discuss the diagnosis and staging of ovarian cancer.

Indications and Important Safety Information for GEMZAR

GEMZAR is approved by the FDA in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients (for whom surgery is not possible) with locally advanced (stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread) non-small cell lung cancer.

GEMZAR is approved by the FDA in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after they have received another type of chemotherapy called an anthracycline, unless their medical condition did not allow them to receive an anthracycline.

GEMZAR is approved by the FDA as a single agent (given alone) as the first-line treatment for patients with locally advanced (stage II or stage III when surgery is not an option) or metastatic (stage IV) adenocarcinoma of the pancreas. GEMZAR is also indicated for patients previously treated with 5-FU (another type of chemotherapy).

GEMZAR can suppress bone marrow function, which may cause low blood cell counts.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor because you should not receive it.

GEMZAR given for longer than 60 minutes or more than once a week has caused increased side effects.

You should call your doctor right away if you have any symptoms of infection, such as a fever or chills. If you notice bleeding, unexplained bruising, or symptoms of anemia, contact your healthcare team, as these can be symptoms of low blood cell counts.

Serious lung problems, sometimes fatal, have been reported with GEMZAR. Tell your healthcare team if you develop breathing problems.

There have been reports of serious kidney or liver damage including failure with GEMZAR treatment, sometimes fatal. If you have had kidney or liver problems or impairment, please tell your healthcare team. GEMZAR may not be right for you.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood tests and on your general condition.

If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team.

Patients who receive radiation therapy before, during, or after receiving GEMZAR may sometimes experience more side effects, especially at the site of the radiation.

Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea; vomiting; constipation; diarrhea; rash; shortness of breath; muscle aches; blood in urine; hearing changes and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. Lab work may identify additional side effects. If you have any side effect that bothers you or that does not go away, be sure to talk with your doctor. Call your healthcare team right away if you have fever or chills. These symptoms could mean you have an infection.

If you are pregnant, GEMZAR may cause fetal harm to your unborn baby. It is not known if GEMZAR passes into breast milk; because of the potential for serious side effects in nursing infants, discuss breast feeding and GEMZAR with your doctor. The safety and effectiveness of GEMZAR in children has not been established.

For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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