gemcitabine

High Alert

Pancreatic cancer (locally advanced or metastatic).
Inoperable locally advanced/metastatic non-small cell lung cancer (with cisplatin).
Metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (unless anthracycline therapy contraindicated) (with paclitaxel).
Advanced ovarian cancer that has relapsed 6 mo after completion of platinum-based therapy (with carboplatin).

Contraindicated in:

Hypersensitivity;
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

Use Cautiously in:

History of cardiovascular disease;
Renal impairment;
Hepatic impairment;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: edema, ARRHYTHMIAS, CAPILLARY LEAK SYNDROME, CEREBROVASCULAR ACCIDENT, hypertension, MI

Derm: alopecia, ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), rash, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

GI: ↑liver enzymes, diarrhea, nausea, stomatitis, vomiting, HEPATOTOXICITY

GU: hematuria, proteinuria, ↓fertility (men), HEMOLYTIC UREMIC SYNDROME, renal failure, thrombotic microangiopathy

Hemat: anemia, leukopenia, thrombocytopenia, thrombotic microangiopathy

Local: injection site reactions

Neuro: paresthesias, POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES)

Resp: dyspnea, ADULT RESPIRATORY DISTRESS SYNDROME, bronchospasm, pulmonary edema, PULMONARY FIBROSIS

Misc: flu-like symptoms, anaphylactoid reactions, fever

Drug-drug:

↑bone marrow depression with other antineoplastics or radiation therapy.
May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.

(Generic available)

Powder for injection: 200 mg/vial; 1 g/vial; 2 g/vial
Solution for injection: 200 mg/5.26 mL; 1 g/26.3 mL; 2 g/52.6 mL; 100 mg/mL

Pancreatic Cancer

IV (Adults ): 1000 mg/m² once weekly for 7 wk, followed by a week of rest, and then 1000 mg/m² on Days 1, 8, and 15 of each 28-day cycle.

Non-Small Cell Lung Cancer

IV (Adults ): 1000 mg/m² on Days 1, 8, and 15 of each 28-day cycle (cisplatin is also given on day 1) or 1250 mg/m² on Days 1 and 8 of each 21-day cycle (cisplatin is also given on Day 1).

Breast Cancer

IV (Adults ): 1250 mg/m² on Days 1 and 8 of each 21-day cycle (paclitaxel is also given on Day 1).

Ovarian Cancer

IV (Adults ): 1000 mg/m² on Days 1 and 8 of each 21-day cycle (carboplatin is also given on Day 1).

Avgemsi, ~~Gemzar~~

Interferes with DNA synthesis (cell-cycle phase-specific).

Therapeutic effects:

Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites, nucleoside analogues

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Converted in cells to active diphosphate and triphosphate metabolites; these are excreted primarily by the kidneys.

Half-Life: 32–94 min.

( effect on blood counts)

ROUTE		ONSET		PEAK		DURATION
IV		unknown		unknown		unknown

Explain purpose and side effects of gemcitabine to patient. Do not stop receiving drug without consulting health care provider. If an appointment is missed, contact health care provider as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Emphasize the need for periodic lab tests to monitor for side effects.
Instruct patient to notify health care provider if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patient should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
Instruct patient to inspect oral mucosa for erythema and ulceration. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Stomatitis pain may require management with opioid analgesics.
Instruct patient to notify health care provider if flulike symptoms (fever, anorexia, headache, cough, chills, myalgia), swelling of feet or legs, signs and symptoms of pulmonary toxicity (shortness of breath, wheezing, cough), hemolytic-uremic syndrome (changes in color or volume of urine output, ↑ bruising or bleeding), or hepatotoxicity (jaundice, pain/tenderness in right upper abdominal quadrant) occur.
Instruct patient to notify health care provider if any rash (particularly with fever, flu-like symptoms, swollen lymph nodes) develops within 1–2 wk of starting therapy.
Discuss with patient the possibility of hair loss. Explore methods of coping.
Instruct patient not to receive any vaccinations without advice of health care provider.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during therapy and for 6 mo after final dose and to avoid breastfeeding during therapy and for ≥1 wk after last dose. Advise men with female partners of reproductive potential to use effective contraception during therapy and for 3 mo after last dose. May cause male infertility.

jem-SITE-a-been

NDC Code

0409- Hospira, Inc.
- 0409-0181- Gemcitabine
  - 0409-0181-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0181-01) / 26.3 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0181- Gemcitabine
  - 0409-0181-25- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0181-25) / 26.3 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0182- Gemcitabine
  - 0409-0182-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-01) / 52.6 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0182- Gemcitabine
  - 0409-0182-25- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0182-25) / 52.6 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0183- Gemcitabine
  - 0409-0183-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-01) / 5.26 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0183- Gemcitabine
  - 0409-0183-25- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0183-25) / 5.26 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0185- Gemcitabine
  - 0409-0185-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0185-01) / 5 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0186- Gemcitabine
  - 0409-0186-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) / 25 mL in 1 VIAL, SINGLE-DOSE

0409- Hospira, Inc.
- 0409-0187- GEMCITABINE
  - 0409-0187-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0187-01) / 50 mL in 1 VIAL, SINGLE-DOSE

14593- Emcure Pharmaceuticals Limited
- 14593-892-
  - 14593-892-01- 5 kg in 1 JAR (14593-892-01)

14593- Emcure Pharmaceuticals Limited
- 14593-892-
  - 14593-892-02- 15 kg in 1 DRUM (14593-892-02)

14593- Emcure Pharmaceuticals Limited
- 14593-892-
  - 14593-892-03- 50 kg in 1 DRUM (14593-892-03)

14593- Emcure Pharmaceuticals Limited
- 14593-892-
  14593-892-04- 1 kg in 1 POUCH (14593-892-04)

14593- Emcure Pharmaceuticals Limited
- 14593-892-
  14593-892-05- 6 kg in 1 DRUM (14593-892-05)

16714- NorthStar Rx LLC
- 16714-909- GEMCITABINE
  16714-909-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-909-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

16714- NorthStar Rx LLC
- 16714-930- GEMCITABINE
  - 16714-930-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

16729- Accord Healthcare Inc.
- 16729-391- GEMCITABINE
  - 16729-391-30- 2 mL in 1 VIAL, MULTI-DOSE (16729-391-30)

16729- Accord Healthcare Inc.
- 16729-419- GEMCITABINE
  - 16729-419-03- 10 mL in 1 VIAL, MULTI-DOSE (16729-419-03)

16729- Accord Healthcare Inc.
- 16729-423- GEMCITABINE
  - 16729-423-33- 15 mL in 1 VIAL, MULTI-DOSE (16729-423-33)

16729- Accord Healthcare Inc.
- 16729-426- GEMCITABINE
  - 16729-426-05- 20 mL in 1 VIAL, MULTI-DOSE (16729-426-05)

17404- Farmhispania S.A.
- 17404-1033-
  - 17404-1033-1- 1 BAG in 1 DRUM (17404-1033-1) / 25 kg in 1 BAG

25021- Sagent Pharmaceuticals
- 25021-234- gemcitabine
  25021-234-10- 1 VIAL in 1 CARTON (25021-234-10) / 5 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-235- gemcitabine
  - 25021-235-50- 1 VIAL in 1 CARTON (25021-235-50) / 25 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-235- gemcitabine
  - 25021-235-51- 10 VIAL in 1 CARTON (25021-235-51) / 25 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-239- Gemcitabine
  - 25021-239-05- 1 VIAL in 1 CARTON (25021-239-05) / 5.26 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-239- Gemcitabine
  - 25021-239-26- 1 VIAL in 1 CARTON (25021-239-26) / 26.3 mL in 1 VIAL

25021- Sagent Pharmaceuticals
- 25021-239- Gemcitabine
  - 25021-239-52- 1 VIAL in 1 CARTON (25021-239-52) / 52.6 mL in 1 VIAL

42385- Laurus Labs Limited
- 42385-748-
  - 42385-748-01- 2.5 kg in 1 DRUM (42385-748-01)

42385- Laurus Labs Limited
- 42385-748-
  42385-748-15- 15 kg in 1 DRUM (42385-748-15)

43265- Corden Pharma GmbH
- 43265-7749-
  43265-7749-1- 3 BAG in 1 DRUM (43265-7749-1) / 1 BAG in 1 BAG / 6000 TABLET in 1 BAG

50742- Ingenus Pharmaceuticals, LLC
- 50742-496- GEMCITABINE
  50742-496-26- 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) / 26.3 mL in 1 VIAL, SINGLE-DOSE

50742- Ingenus Pharmaceuticals, LLC
- 50742-497- GEMCITABINE
  - 50742-497-53- 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-497-53) / 52.6 mL in 1 VIAL, SINGLE-DOSE

50742- Ingenus Pharmaceuticals, LLC
- 50742-498- GEMCITABINE
  - 50742-498-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-498-05) / 5.26 mL in 1 VIAL, SINGLE-DOSE

54245- SciAnda (Changshu) Pharmaceuticals, Ltd.
- 54245-1091-
  - 54245-1091-0- 70 kg in 1 BAG (54245-1091-0)

54893- MSN Laboratories Private Limited
- 54893-0006-
  54893-0006-1- 50 kg in 1 DRUM (54893-0006-1)

55111- Dr. Reddy's Laboratories Limited
- 55111-686- gemcitabine
  55111-686-07- 1 VIAL, SINGLE-USE in 1 CARTON (55111-686-07) / 5 mL in 1 VIAL, SINGLE-USE

55111- Dr. Reddy's Laboratories Limited
- 55111-687- gemcitabine
  - 55111-687-25- 1 VIAL, SINGLE-USE in 1 CARTON (55111-687-25) / 25 mL in 1 VIAL, SINGLE-USE

55111- Dr.Reddys Laboratories Limited
- 55111-807-
  - 55111-807-00- 1 kg in 1 DRUM (55111-807-00)

58623- Zhejiang Hisun Pharmaceutical Co., Ltd.
- 58623-0019-
  58623-0019-1- 1 kg in 1 DRUM (58623-0019-1)

58623- Zhejiang Hisun Pharmaceutical Co., Ltd.
- 58623-0019-
  58623-0019-5- 5 kg in 1 DRUM (58623-0019-5)

62128- Evonik Corporation
- 62128-0383-
  62128-0383-1- 3 PAIL in 1 DRUM (62128-0383-1) / 15 kg in 1 PAIL

62128- Evonik Corporation
- 62128-0383-
  62128-0383-6- 9 PAIL in 1 BOX (62128-0383-6) / 9 kg in 1 PAIL

62756- SUN PHARMACEUTICAL INDUSTRIES, INC.
- 62756-807-
  62756-807-11- 25 kg in 1 DRUM (62756-807-11)

63323- Fresenius Kabi USA, LLC
- 63323-102- GEMCITABINE
  63323-102-13- 1 VIAL, SINGLE-DOSE in 1 BOX (63323-102-13) / 5 mL in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-102- GEMCITABINE
  - 63323-102-94- 1 VIAL, SINGLE-DOSE in 1 BOX (63323-102-94) / 5 mL in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-125- GEMCITABINE
  - 63323-125-53- 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 mL in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-125- GEMCITABINE
  - 63323-125-94- 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) / 25 mL in 1 VIAL, SINGLE-DOSE

63323- Fresenius Kabi USA, LLC
- 63323-126- GEMCITABINE
  - 63323-126-00- 1 VIAL in 1 CARTON (63323-126-00) / 50 mL in 1 VIAL

63323- Fresenius Kabi USA, LLC
- 63323-126- GEMCITABINE
  - 63323-126-03- 1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03) / 50 mL in 1 VIAL, SINGLE-DOSE

63592- Sicor de Mexico S.A. de C.V
- 63592-4075-
  - 63592-4075-2- 1 kg in 1 CARTON (63592-4075-2)

65129- ScinoPharm Taiwan Ltd.
- 65129-1091-
  65129-1091-0- 70 kg in 1 BAG (65129-1091-0)

65129- ScinoPharm Taiwan Ltd.
- 65129-1235-
  65129-1235-0- 2 kg in 1 BAG (65129-1235-0)

66529- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
- 66529-0004-
  66529-0004-1- 50 kg in 1 DRUM (66529-0004-1)

66529- Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
- 66529-0011-
  66529-0011-1- 50 kg in 1 BAG (66529-0011-1)

67457- Mylan Institutional LLC
- 67457-616- Gemcitabine
  67457-616-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-616-10) / 5.26 mL in 1 VIAL, SINGLE-DOSE

67457- Mylan Institutional LLC
- 67457-617- Gemcitabine
  - 67457-617-30- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-617-30) / 26.3 mL in 1 VIAL, SINGLE-DOSE

67457- Mylan Institutional LLC
- 67457-618- Gemcitabine
  - 67457-618-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-618-10) / 52.6 mL in 1 VIAL, SINGLE-DOSE

68001- BluePoint Laboratories
- 68001-342- GEMCITABINE
  - 68001-342-34- 1 VIAL, MULTI-DOSE in 1 CARTON (68001-342-34) / 2 mL in 1 VIAL, MULTI-DOSE

68001- BluePoint Laboratories
- 68001-348- GEMCITABINE
  - 68001-348-36- 1 VIAL, MULTI-DOSE in 1 CARTON (68001-348-36) / 10 mL in 1 VIAL, MULTI-DOSE

68001- BluePoint Laboratories
- 68001-359- GEMCITABINE
  - 68001-359-37- 1 VIAL, MULTI-DOSE in 1 CARTON (68001-359-37) / 20 mL in 1 VIAL, MULTI-DOSE

68083- Gland Pharma Limited
- 68083-148- gemcitabine hydrochloride
  - 68083-148-01- 1 VIAL in 1 CARTON (68083-148-01) / 5 mL in 1 VIAL

68083- Gland Pharma Limited
- 68083-149- gemcitabine hydrochloride
  - 68083-149-01- 1 VIAL in 1 CARTON (68083-149-01) / 25 mL in 1 VIAL

68554- Hetero Labs Limited
- 68554-0028-
  - 68554-0028-1- 10 kg in 1 DRUM (68554-0028-1)

71288- Meitheal Pharmaceuticals Inc.
- 71288-113- GEMCITABINE
  71288-113-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-114- GEMCITABINE
  - 71288-114-50- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-114-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-06- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-28- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28) / 26.3 mL in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-54- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-91- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-92- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE

71288- Meitheal Pharmaceuticals Inc.
- 71288-117- Gemcitabine
  - 71288-117-93- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE

72485- Armas Pharmaceuticals Inc.
- 72485-221- Gemcitabine
  - 72485-221-02- 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-221-02) / 5.26 mL in 1 VIAL, SINGLE-DOSE

72485- Armas Pharmaceuticals Inc.
- 72485-222- Gemcitabine
  - 72485-222-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-222-10) / 26.3 mL in 1 VIAL, SINGLE-DOSE

72485- Armas Pharmaceuticals Inc.
- 72485-223- Gemcitabine
  - 72485-223-20- 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-223-20) / 52.6 mL in 1 VIAL, SINGLE-DOSE

81955- VALARY LAB PRIVATE LIMITED
- 81955-0006-
  - 81955-0006-1- 10 kg in 1 DRUM (81955-0006-1)

82511- Teyro Labs Private Limited
- 82511-008- Gemcitabine hydrochloride
  82511-008-20- 1 VIAL, SINGLE-USE in 1 CARTON (82511-008-20) / 5 mL in 1 VIAL, SINGLE-USE

82511- Teyro Labs Private Limited
- 82511-009- Gemcitabine hydrochloride
  - 82511-009-10- 1 VIAL, SINGLE-USE in 1 CARTON (82511-009-10) / 25 mL in 1 VIAL, SINGLE-USE

82920- SHILPA PHARMA LIFESCIENCES LIMITED
- 82920-701-
  - 82920-701-00- 20 kg in 1 DRUM (82920-701-00)

83831- Avyxa Pharma, LLC
- 83831-123- AVGEMSI
  83831-123-01- 1 VIAL, MULTI-DOSE in 1 CARTON (83831-123-01) / 26.3 mL in 1 VIAL, MULTI-DOSE

83831- Avyxa Pharma, LLC
- 83831-124- AVGEMSI
  - 83831-124-01- 1 VIAL, MULTI-DOSE in 1 CARTON (83831-124-01) / 52.6 mL in 1 VIAL, MULTI-DOSE

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆