GEMZAR 200 mg?injection ( Gemcitabine ) IV vial

What is Gemzar and how is it used?

Gemzar is a prescription medicine used to treat the symptoms of cancer such as Pancreatic Cancer, Non-Small Cell Lung Cancer, Breast Cancer and Ovarian Cancer. Gemzar may be used alone or with other medications.

Gemzar belongs to a class of drugs called Antineoplastics, Antimetabolite.

It is not known if Gemzar is safe and effective in children.

What are the possible side effects of Gemzar?

Gemzar may cause serious side effects including:

unusual weakness,

urinating less than usual or not at all,

itching,

loss of appetite,

dark urine,

clay-colored stools,

yellowing of the skin or eyes (jaundice),

chest pain or heavy feeling,

pain spreading to the arm or shoulder,

sweating,

general ill feeling,

sudden numbness or weakness (especially on one side of the body),

sudden severe headache,

confusion,

problems with vision/speech/balance,

fever,

chills,

body aches,

flu symptoms,

white patches or sores inside your mouth or on your lips,

pain/swelling/skin changes where the needle was placed,

hearing problems,

blood in your urine, or

breathing problems

Get medical help right away if you have any of the symptoms listed above.

The most common side effects of Gemzar include:

pale skin,

easy bruising or bleeding,

numbness or tingly feeling,

weakness,

nausea,

vomiting,

upset stomach,

diarrhea,

constipation,

headache,

swelling in your hands/ankles/feet,

skin rash,

drowsiness, or

hair loss

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Gemzar. For more information, ask your doctor or pharmacist.

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

DESCRIPTION

Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2?-deoxy-2?,2?-difluorocytidine monohydrochloride (?-isomer).

The structural formula is as follows:

GEMZAR (gemcitabine) Structural Formula – Illustration

The empirical formula for gemcitabine HCl is C9H11F2N3O4 ? HCl. It has a molecular weight of 299.66.

Gemcitabine HCl is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.

Gemzar is supplied in a sterile form for intravenous use only. Vials of Gemzar contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Indications

INDICATIONS

Ovarian Cancer

Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

Breast Cancer

Gemzar in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

Non-Small Cell Lung Cancer

Gemzar is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.

Pancreatic Cancer

Gemzar is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemzar is indicated for patients previously treated with 5-FU.