Gemcitabine

Gemcitabine is a prescription medicine used for the treatment of pancreatic cancer, non-small cell lung cancer, breast cancer, and ovarian cancer.

• Gemcitabine is available under the following different brand names: Gemzar, Infugem

Adult dosage

Injection, lyophilized powder for reconstitution

• 200mg/single-use vial (Gemzar, generics)
• 1g/single-use vial (Gemzar, generics)

Solution for injection (generics)

• 200mg/2mL (100mg/mL)
• 200mg/5.26mL (38mg/mL)
• 1g/10mL (100mg/mL)
• 1g/26.3mL (38mg/mL)
• 1.5g/15mL (100mg/mL)
• 2g/20mL (100mg/mL)
• 2g/52.6mL (38mg/mL)

Injection, single-dose premixed infusion bag (Infugem)

• 10mg/mL (contains gemcitabine in 0.9% NaCl) concentration in following sizes:
• 1200mg/120mL
• 1300mg/130mL
• 1400mg/140mL
• 1500mg/150mL
• 1600mg/160mL
• 1700mg/170mL
• 1800mg/180mL
• 1900mg/190mL
• 2000mg/200mL
• 2200mg/220mL

Pancreatic Cancer

Adult dosage

• 1000 mg/m² IV infusion over 30 min once weekly for 7 weeks; rest 1 week, THEN
• 1000 mg/m² IV once weekly for 3 weeks of each 28-day cycle

Non-small Cell Lung Cancer

Adult dosage

• 1000 mg/m² IV infusion over 30 minutes on days 1, 8, and 15 of each 28-day cycle, OR 
• 1250 mg/m² IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle
• Administer cisplatin 100 mg/m² IV after gemcitabine on day 1

Breast Cancer

Adult dosage

• 1250 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle
• With paclitaxel 175 mg/m² on Day 1 as a 3-hour infusion before gemcitabine

Ovarian Cancer

Adult dosage

• 1000 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle
• With carboplatin AUC 4 on Day 1 after gemcitabine

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Gemcitabine include:

• pale skin,
• easy bruising or bleeding,
• numbness or tingly feeling,
• weakness,
• nausea,
• vomiting,
• upset stomach,
• diarrhea,
• constipation,
• headache,
• swelling in the hands/ankles/feet,
• skin rash,
• drowsiness, and
• hair loss

Serious side effects of Gemcitabine include:

• 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 the mouth or on the lips,
• pain/swelling/skin changes at the injection site,
• hearing problems,
• blood in urine, and
• breathing problems

Rare side effects of Gemcitabine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gemcitabine has severe interactions with no other drugs.
• Gemcitabine has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • cedazuridine
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • palifermin
  • tofacitinib
• Gemcitabine has moderate interactions with at least 25 other drugs.
• Gemcitabine has minor interactions with the following drugs:
  • maitake
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gemcitabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gemcitabine?”

Cautions

• Serious cases of thrombotic microangiopathy reported
• In combination with carboplatin or paclitaxel: patients should have ANC more than 1.5 x 10^6/mL and platelet count more than 10^8/mL before each cycle
• Capillary leak syndrome reported with severe consequences; discontinue if symptoms occur
• Pulmonary toxicity, including interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, and ARDS reported; onset of pulmonary symptoms may occur up to 2 weeks after the last dose; discontinue treatment in patients who develop unexplained dyspnea, with or without bronchospasm, or have any evidence of pulmonary toxicity
• Assess renal function before initiation of therapy and periodically during treatment; hemolytic uremic syndrome reported, including fatalities; permanently discontinue therapy in patients with HUS or severe renal impairment; renal failure may not be reversible even with discontinuation of therapy
• Drug-induced liver injury reported, including liver failure and death; assess hepatic function before initiation of therapy and periodically during treatment; discontinue the drug in patients that develop severe liver injury
• Not indicated for use with radiation therapy; known to exacerbate radiation toxicity, including life-threatening mucositis, especially esophagitis and pneumonitis; excessive toxicity not observed when treatment is administered more than 7 days before or after radiation; radiation recall has been reported in patients who received drug after prior radiation
• Infusions longer than 60 minutes or more frequently than every week increase the incidence of clinically significant hypotension, severe flu-like symptoms, myelosuppression, and asthenia; gemcitabine half-life is influenced by the length of the infusion
• Posterior reversible encephalopathy syndrome (PRES) reported; PRES can present with headache, seizure, lethargy, hypertension, confusion, blindness, and other visual and neurologic disturbances; discontinue if PRES develops
• Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final dose; advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following the final dose
• Myelosuppression
  • In patients who received single-agent therapy, Grade 3-4 neutropenia, anemia, and thrombocytopenia were reported in 25%, 8%, and 5%, respectively
  • In patients receiving gemcitabine in combination with another drug Grade 3-4 neutropenia, anemia, and thrombocytopenia varied from 48% to 71%, 8% to 28%, and 5% to 55%, respectively
  • Obtain a complete blood count (CBC) with a differential and a platelet count before each dose of Gemcitabine Injection; modify dosage as recommended

Pregnancy and Lactation

• Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; therapy is expected to result in adverse reproductive effects; drug was teratogenic, embryotoxic, and fetotoxic in mice and rabbits; advise pregnant women of potential risk to a fetus
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the final dose
  • Advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following the final dose
• Pregnancy Testing
  • Verify pregnancy status in females of reproductive potential before initiating therapy
• Contraception
  • Therapy can cause fetal harm when administered to a pregnant woman
• Females
  • Because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment and for 6 months after the final dose
• Males
  • Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the final dose
• Lactation
  • There are no data on the presence of the drug in human milk, or effects of gemcitabine on the breastfed infant or milk production; because of the potential for serious adverse reactions in nursing infants from therapy, advise a lactating woman not to breastfeed during treatment and for one week after the final dose.