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gemcitabine

Trade Name: 

Gemzar®

Appearance: 

Clear, colourless solution

mixed into larger bags of fluids

Monograph Name: 

gemcitabine

Monograph Body: 
A - Drug Name

gemcitabine

COMMON TRADE NAME(S):   Gemzar®

 
B - Mechanism of Action and Pharmacokinetics

Gemcitabine is a deoxycytidine analogue that is cell phase specific, primarily killing cells undergoing DNA synthesis (S-phase) and also blocking the progression of cells through the G1/S-phase boundary. Gemcitabine is a pro-drug and is metabolized intracellularly to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic effects of gemcitabine are exerted through dFdCDP inhibition of ribonucleotide reductase and incorporation of dFdCTP into DNA, resulting in inhibition of DNA synthesis and induction of apoptosis.



Distribution

Gemcitabine pharmacokinetics are linear.  After infusions < 70 minutes, gemcitabine is not extensively distributed into tissues. 

Cross blood brain barrier? Unknown
PPB Negligible
Metabolism

Gemcitabine undergoes intracellular metabolism to the active moieties and is rapidly deaminated in the blood, liver, kidneys and other tissues. In the plasma, it is metabolized to its inactive metabolite.

Active metabolites

Yes

Inactive metabolites

Yes

Elimination
Urine 92-98% (< 10% unchanged)
Half-life

32 to 94 min (< 70 minute infusion)
245 to 638 min (> 70 minute infusion)

 
C - Indications and Status
Health Canada Approvals:

  • Locally advanced (unresectable) or metastatic adenocarcinoma of the pancreas
  • Locally advanced or metastatic non-small cell lung cancer (NSCLC) as a single agent or in combination with cisplatin
  • In combination with cisplatin for locally advanced or metastatic transitional cell carcinoma (TCC) of the bladder
  • In combination with paclitaxel for unresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy

 



Other Uses:

  • Breast cancer
  • Gastrointestinal cancer (advanced biliary tract cancer, adjuvant treatment of pancreatic cancer)
  • Genitourinary cancers (adrenal, testicular cancer, renal cell)
  • Gynecological cancers (ovarian, cervical)
  • Germ cell cancers
  • Sarcoma (leiomyosarcoma of the uterus, soft tissue sarcoma)
  • Head and neck cancer
  • Mesothelioma
  • Non-Hodgkin’s and Hodgkin’s lymphoma
  • Unknown primary cancer 
 
D - Adverse Effects

Emetogenic Potential:  

Low

Extravasation Potential:   None

The following table contains adverse effects with ≥ 5% frequency, in patients treated with gemcitabine 800-1250 mg/m2 as a single agent 30 minute weekly infusion, for various malignancies. Severe adverse events from other studies or post-marketing, may also be included.

ORGAN SITE SIDE EFFECT* (%) ONSET**
Cardiovascular Arrhythmia (rare) E
Arterial thromboembolism (rare) E
Heart failure (rare) E
Dermatological Alopecia (14%) ( ≤ grade 2) E
Rash (25%) (rarely severe eg. toxic epidermal necrolysis (TEN), stevens Johnson syndrome (SJS)) E
Gastrointestinal Constipation (8%) E
Diarrhea (12%) E
Mucositis (8%) E
Nausea, vomiting (64%) (18% severe) I  E
General Edema (20%) E
Flu-like symptoms (37%) I
Other - radiosensitizer (may be severe) E  D
Hematological Hemolytic uremic syndrome (<1%) E
Myelosuppression ± infection, bleeding (68%) (may be severe) E
Hepatobiliary Hepatotoxicity including liver failure (rare) E
↑ LFTs (68%) (10% severe) E
Hypersensitivity Hypersensitivity (rare) I
Injection site Injection site reaction (4%) I
Musculoskeletal Musculoskeletal pain (16%) I
Nervous System Peripheral neuropathy (3%) E
RPLS / PRES (rare) E  D
Somnolence (9%) E
Renal Creatinine increased (7%) E
Proteinuria (36%) E
Respiratory Adult respiratory distress syndrome (ARDS) (rare) E
Dyspnea (8%) I
Interstitial lung disease (rare) E
Vascular Capillary leak syndrome (rare) E  D
Vasculitis (rare) E


* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days)     E = early (days to weeks)
D = delayed (weeks to months)      L = late (months to years)

The most common side effects for gemcitabine include ↑ LFTs, myelosuppression ± infection, bleeding, nausea, vomiting, flu-like symptoms, proteinuria, rash, edema, musculoskeletal pain, alopecia and diarrhea.

Myelosuppression, usually of short duration, reversible and not cumulative over time, is the main dose-limiting toxicity with gemcitabine. Grade 3 or 4 hematologic toxicity has been reported and is increased when used in combination with other chemotherapy. Blood counts may continue to deteriorate even after gemcitabine administration has stopped. Patients should receive supportive therapy as necessary.

Typically mild to moderate in severity, transient rashes of macular, erythematous, and pruritic types involving the trunk and the extremities were reported. They are not dose-limiting and usually respond to topical corticosteroids.

Acute shortness of breath has been associated with gemcitabine. Bronchodilators, corticosteroids and/or oxygen may be administered to produce symptomatic relief.

Edema was frequently reported but was usually mild to moderate, reversible after stopping gemcitabine treatment and rarely resulted in discontinuation. The mechanism of edema is unknown but was not associated with any evidence of cardiac, hepatic or renal failure.

Flu-like symptoms are common and consist of low-grade fever, headache, fatigue, malaise, myalgia, arthralgia, cough and rhinitis. Fever was usually mild and clinically manageable.

Capillary leak syndrome with serious consequences has been reported rarely in single agent or combination therapy.

Posterior reversible encephalopathy syndrome (PRES) has been reported rarely in single agent or combination therapy and may be severe. Acute hypertension and seizure activity were reported in most patients. The onset of PRES signs and symptoms occurred from a few days to 6 months after initiation of gemcitabline. PRES was typically reversible.

Rare occurrences of hemolytic uremic syndrome, including fatal cases, were reported. Renal failure associated with this syndrome may not be reversible even with discontinuation of therapy and dialysis may be required. Patients with pre-existing renal dysfunction should be followed closely while being treated with gemcitabine.

Patients receiving concurrent radiation while receiving full dose gemcitabine should be closely monitored for reactions. Potentially life-threatening esophagitis and pneumonitis, particularly in patients receiving large volumes of radiotherapy, have been observed. The optimum regimen for safe administration of gemcitabine with therapeutic doses of radiation has not yet been determined. Radiation injury has been observed on targeted tissues (e.g. esophagitis, colitis, and pneumonitis) with both concurrent and non-concurrent gemcitabine use. In addition, radiation recall has been seen when gemcitabine and radiation therapy are given >7 days apart.

 
E - Dosing

Refer to protocol by which patient is being treated. Numerous dosing schedules exist depending on disease, response and concomitant therapy. 



Adults:

Pancreatic cancer:   
Cycle 1:         1000 mg/m2 weekly for 7 weeks with 1 week rest    
Cycle 2 +:    1000 mg/m2 weekly for 3 weeks with 1 week rest (Q4W)

NSCLC:       
Q 4 W:  1000 mg/m2 weekly for 3 weeks ± cisplatin 100 mg/m2 after infusion Day 1 ONLY
Q 3 W:  1250 mg/m2 weekly for 2 weeks ± cisplatin 100 mg/m2 after infusion Day 1 ONLY

TCC of the Bladder:
Q 4 W:    1000 mg/m2 weekly for 3 weeks, with cisplatin 70mg/m2 day 1 ONLY    

Breast cancer:
Q 3 W:  1250 mg/m2 weekly for 2 weeks, with paclitaxel 175mg/m2 on day 1 ONLY    

 

 


Dosage with Toxicity:

The dose modifications described here relate to gemcitabine use only.

Doses should not be re-escalated if they are reduced for non-hematological toxicities, febrile neutropenia or thrombocytopenic bleeding.

Table 1 - Day 1 of Cycle

Worst Toxicity in Previous Cycle % Full Dose
Non-hematologic Grade 3** 75%*
Non-hematologic Grade 4 Consider discontinuing, or 50-75%*
Febrile neutropenia, thrombocytopenic bleeding 75%*
> 1 Occurrence of Day 8/15 holds 75%*
  • Pneumonitis
  • Hemolytic Uremic Syndrome (HUS)
  • Stevens-Johnson syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Capillary Leak Syndrome (CLS)
  • Posterior reversible encephalopathy syndrome (PRES)
Discontinue

* Do not start new cycle until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and non-hematologic toxicity ≤ grade 2.  Discontinue if non-hematological toxicities require more than a 50% dose reduction from the starting dose.

** except nausea/vomiting or alopecia

 

Other treatment days within cycle:
 

Table 2 - Non-hematologic toxicities

Toxicity Action (% Full dose)
Grade 3** HOLD; restart at 50-75%*
Grade 4 Discontinue

* Treat only if non-hematologic toxicities recover to ≤ grade 2 and hematologic parameters are met on treatment day (Table 3). Discontinue if non-hematological toxicities require more than a 50% dose reduction from the starting dose.

**except nausea/vomiting, alopecia

 

 


Table 3 - Hematologic Toxicities:

Platelets on treatment day (x 109/L)   ANC on treatment day (x 109/L) Action (% Full Dose)
>100 And > 1 100% *
50 to 100 And/or 0.5 to 1 75% or consider omit*
<50 And/or <0.5 Omit

* Treat only if above parameters are met on treatment day and non-hematologic toxicities ≤ grade 2.



Dosage with Hepatic Impairment:

Gemcitabine should be used with caution in patients with hepatic impairment (cirrhosis, hepatitis, alcoholism, metastases, etc.); initial dose reduction should be considered if the patient is treated, especially in hyperbilirubinemia.

Suggested:

Bilirubin (micromol/L) Starting dose
> 1.2 x ULN 800 mg/m2; escalate if tolerated


Dosage with Renal Impairment:

Gemcitabine should be used with caution in patients with renal insufficiency. There is insufficient information from clinical studies to allow clear dose recommendations for this patient population. Clinical trials with cisplatin mandated CrCl ≥ 60mL/min. For patients with pre-existing renal insufficiency, the close monitoring for occurrence of hemolytic uremic syndrome is required.



Dosage in the elderly:

Decreased clearance and increased half-life occurs with increasing age; however, no dose adjustment is necessary.



Dosage based on gender:

Decreased volume of distribution and clearance are seen in women; however, no dose adjustment is necessary.



Children:

Safety and effectiveness in children have not been established.



 
F - Administration Guidelines
  • May dilute reconstituted drug in normal saline for IV infusion, resulting in a minimum final concentration of at least 0.1 mg/mL.

  • Gemcitabine is for IV administration only and should be infused over 30 minutes.

  • To prevent increased toxicity, avoid an infusion time of > 60 minutes (exception: over 90 minutes when in combination with docetaxel for soft tissue sarcomas) or dosing more frequently than once weekly

 
G - Special Precautions
Contraindications:

  • Patients who have a hypersensitivity to this drug or any of its components.

Other Warnings/Precautions:

  • Use with extreme caution in patients with compromised bone marrow reserve.

  • Use with caution in patients with hepatic impairment (including concurrent liver metastases or a previous history of hepatitis, alcoholism or liver cirrhosis) and patients with renal impairment.

  • Acute shortness of breath with a temporal relationship to gemcitabine injection administration may occur.

  • Patients receiving concurrent radiation while receiving the full dose gemcitabine should be closely monitored for reactions. Exacerbation of radiation therapy toxicity including potentially life-threatening esophagitis and pneumonitis, particularly in patients receiving large volumes of radiotherapy have been observed.

Pregnancy and Lactation:
  • Clastogenicity: Yes
  • Mutagenicity: Yes
  • Embryotoxicity: Yes
  • Fetotoxicity: Yes

    Gemcitabine is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 6 months (general recommendation) after the last dose.

  • Excretion into breast milk: Unknown
    Breastfeeding is not recommended.
  • Fertility effects: Documented in animals

    Decreased spermatogenesis and fertility in male mice.

 
H - Interactions

No specific drug interaction studies have been conducted.

AGENT EFFECT MECHANISM MANAGEMENT
warfarin possible ↑ in INR and risk of bleeding possible ↓ in metabolism and synthesis of clotting factors Monitor INR closely and adjust warfarin dose as needed
 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

Monitor Type Monitor Frequency

CBC

Baseline and before each dose

Renal function tests

Baseline, before each cycle and as clinically indicated

Liver function tests

Baseline, before each cycle and as clinically indicated
Clinical assessment of bleeding, infection, rash, diarrhea, nausea/vomiting, edema, injection site reactions, flu-like symptoms, hemolysis, signs/symptoms of capillary leak syndrome, cardiovascular, CNS and respiratory effects At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version



Suggested Clinical Monitoring

Monitor Type Monitor Frequency

Urinalysis

Baseline and as clinically indicated

INR for patient receiving warfarin

Baseline and as clinically indicated
 
K - References

Gemcitabine Product Monograph. Teva Pfizer Canada LimitedInc., June 9, 2014October 25, 2018.

Aapro MS, Martin C, Hatty S. Review paper: gemcitabine - a safety review. Anti-Cancer Drugs 1998;9:191-201.

Colucci G, Labianca R, Di Costanzo F, et al. Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51.

Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25.

Floyd J, Mirza I, Sachs B, et al. Hepatotoxicity of chemotherapy. Semin Oncol 2006;33(1):50-67.

Loehrer PJ Sr, Feng Y, Cardenes H, et al. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12.

Maki RG, Wathen JK, Patel SR, et al. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002. J Clin Oncol. 2007 Jul 1;25(19):2755-63.

Noble S, Goa K. Gemcitabine: a review of its pharmacology and clinical potential in non-small cell lung cancer and pancreatic cancer. Drugs 1997;54(3):447-72.

Oettle H, Post S, Neuhaus P, et al. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77.

Saif MW. Interaction between Gemcitabine and Warfarin Causing Gastrointestinal Bleeding in a Patient with Pancreatic Cancer. J Appl Res 2005;5(3):434-37.

Suzuki Y, Tokuda Y, Fujiwara Y, et al. Phase II study of gemcitabine monotherapy as a salvage treatment for Japanese metastatic breast cancer patients after anthracycline and taxane treatment. Jpn J Clin Oncol. 2009 Nov;39(11):699-706.

Venook AP, Egorin MJ, Rosner GL, et al. Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. JOCP 2000;18(14):2780-7.

Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703.


June 2021 removed NDFP funding info

 
L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.

The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.

Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.

While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.

CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.


Info Sheet Name: 

gemcitabine (patient)

Info Sheet Introduction: 
  • For treating certain types of cancers such as bladder, pancreas, lung, breast and other types of cancer.
Info Sheet Date:  Wednesday, March 3, 2021 Info Sheet body: 
Medication Information Sheet
gemcitabine (jem-SITE-a-been)
This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Gemzar®

Appearance:
Clear, colourless solution

mixed into larger bags of fluids

What is this medication for?
  • For treating certain types of cancers such as bladder, pancreas, lung, breast and other types of cancer.
What should I do before I have this medication?
  • Tell your health care team if you have or had significant medical condition(s), especially if you have or had:
    • liver, lung, kidney or heart problems
    • Issues with your bone marrow or
    • any allergies.
       
  • Tell your health care team if you have had or will be getting radiation therapy.

 

Remember to:

  • Tell your health care team about all of the other medications you are taking.

  • Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

 

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

  • How this medication may affect your sexual health.

  • How this medication may affect your ability to have a baby, if this applies to you.
     

This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

  • If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until 6 months after your last dose. Talk to your health care team about which birth control options are best for you.

  • Do not use hormonal birth control (such as birth control pills), unless your health care team told you that they are safe. Talk to your health care team about the safest birth control for you.

  • Do not breastfeed while on this medication.

How is this medication given?
  • This drug is given through an IV (injected into a vein) . Talk to your health care team about your treatment schedule.

  • If you missed your treatment appointment, talk to your health care team to find out what to do.

 

To Prevent or Treat Nausea and Vomiting

You may be given medications to help prevent nausea (feeling like throwing up) and vomiting (throwing up) before they start.

  • These are called anti-nausea medications and include medications such as dexamethasone or others.

     
What else do I need to know while on this medication?
  • Will this medication interact with other medications or natural health products?

    • Although this medication is unlikely to interact with other medications, vitamins, foods and natural health products, tell your health care team about all of your:

      • prescription and over-the-counter (non-prescription) medications and all other drugs, such as marijuana (medical or recreational)

      • natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements

    • Check with your health care team before starting or stopping any of them.

  • If you are taking a blood thinner (such as warfarin), your health care team may need extra blood tests and may change your dose.

  • What should I do if I feel unwell, have pain, a headache or a fever?

    • Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).

      • Fever can be a sign of infection that may need treatment right away.

      • If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
         

    How to check for fever:

    Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

    • You have a fever if your temperature taken in your mouth (oral temperature) is:
       
      • 38.3°C (100.9°F) or higher at any time

        OR
         
      • 38.0°C (100.4°F) or higher for at least one hour.


    If you do have a fever:

    • Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
    • Ask your health care team for the Fever pamphlet for more information. 
       

    If you do not have a fever but have mild symptoms such as headache or mild pain:

    • Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.

    • Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.

    • Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.
       

  • What to DO while on this medication:

  • DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

  • DO consider asking someone to drive you to and from the hospital on your treatment days. You may feel weak or dizzy after your treatment.
  • What NOT to DO while on this medication:

  • DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

NOTE:

  • Gemcitabine makes your body more sensitive to radiation therapy. If you get radiation treatment at the same time as gemcitabine, you may get worse side effects from radiation.
What are the side effects of this medication?

The following table lists side effects that you may have when getting gemcitabine. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on gemcitabine.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do When to contact health care team

Low neutrophils (white blood cells) in the blood (neutropenia)

(May be severe)

When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information.
 

What to look for?

  • If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever.
  • Do not take medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen).
  • Do not eat or drink anything hot or cold right before taking your temperature.

You have a fever if your temperature taken in your mouth (oral temperature) is:

  • 38.3°C (100.9°F) or higher at any time

    OR

  • 38.0°C (100.4°F) or higher for at least one hour.

What to do?

If your health care team has told you that you have low neutrophils:

  • Wash your hands often to prevent infection.
  • Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist.
  • Keep a digital thermometer at home so you can easily check for a fever.

If you have a fever:

If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.

If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.

Low platelets in the blood

(May be severe)

When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information.
 

What to look for?

  • Watch for signs of bleeding:
    • bleeding from your gums
    • unusual or heavy nosebleeds
    • bruising easily or more than normal
    • black coloured stools (poo) or blood in your stools (poo)
    • coughing up red or brown coloured mucus
    • dizziness, constant headache or changes in your vision
    • heavy vaginal bleeding
    • red or pink coloured urine (pee)

 

What to do?

If your health care team has told you that you have low platelets:

  • Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication.
  • Check with your healthcare team before you go to the dentist.
  • Take care of your mouth and use a soft toothbrush.
  • Try to prevent cuts and bruises.
  • Ask your health care team what activities are safe for you.
  • Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion.
     

If you have signs of bleeding:

  • If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes.
     

If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.

 

Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away.

Liver problems

Your health care team may check your liver function with a blood test. The liver changes do not usually cause any symptoms.


What to look for?

  • Rarely, you may develop yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. This may be severe.


What to do?

If you have any symptoms of liver problems, get emergency medical help right away.

Get emergency medical help right away

Nausea and vomiting

(Generally mild)

What to look for?

  • Nausea is feeling like you need to throw up. You may also feel light-headed.
  • You may feel nausea within hours to days after your treatment.

What to do?

To help prevent nausea:

  • It is easier to prevent nausea than to treat it once it happens.
  • Take your anti-nausea medication(s) as prescribed, even if you do not feel like throwing up.
  • Drink clear liquids and have small meals. Get fresh air and rest.
  • Do not eat spicy, fried foods or foods with a strong smell.
  • Limit caffeine (like coffee, tea) and avoid alcohol.


If you have nausea or vomiting:

  • Take your rescue (as-needed) anti-nausea medication(s) as prescribed.
  • Ask your health care team for the Nausea & Vomiting pamphlet for more information.
  • Talk to your health care team if:
    • nausea lasts more than 48 hours
    • vomiting lasts more than 24 hours or if it is severe
Talk to your health care team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if severe

 

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do When to contact health care team

Headache, Flu-like symptoms

You may feel like you have the flu for around 2 days after your IV treatment. These flu-like symptoms may not be signs of an infection.

What to look for?

  • You may have chills, headache and muscle pain.
  • You may feel tired and have a poor appetite.
  • Symptoms may happen at any time after you receive your treatment and usually go away as your body gets used to the medication.

What to do?

  • Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?" on page 3.
  • If you do have a fever, try to speak to your health care team. If you are unable to talk to them for advice, you MUST get emergency medical help right away.
Talk to your health care team if it does not improve or if it is severe

Proteins in Urine

Your health care team may do urine tests to check for proteins in your pee.
 

What to look for?

  • Swelling in your face, legs, or belly.  
  • Recent weight gain that is not normal for you.
  • Foamy, frothy, or bubbly-looking pee.
     

What to do?

Talk to your health care team if it does not improve or if it is severe.

 

Talk to your health care team if it does not improve or if it is severe

Rash; dry, itchy skin

(Rarely severe)

What to look for?

  • You may have cracked, rough, flaking or peeling areas of the skin.
  • Your skin may look red and feel warm, like a sunburn.
  • Your skin may itch, burn, sting or feel very tender when touched.

What to do?

To prevent and treat dry skin:

  • Use fragrance-free skin moisturizer.
  • Protect your skin from the sun and the cold.
  • Use sunscreen with UVA and UVB protection and a SPF of at least 30.
  • Avoid perfumed products and lotions that contain alcohol.
  • Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less.

Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.

Talk to your health care team if it does not improve or if it is severe

 

 

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do When to contact health care team

Mild swelling

What to look for?

  • You may have mild swelling or puffiness in your arms and/or legs. Rarely, this may be severe.
     

What to do?

To help prevent swelling:

  • Eat a low-salt diet.


If you have swelling:

  • Wear loose-fitting clothing.
  • For swollen legs or feet, keep your feet up when sitting.

 

Talk to your health care team if it does not improve or if it is severe

Mild joint, muscle pain or cramps 

What to look for?

  • New pain in your muscles or joints, muscle cramps, or feeling achy.
     

What to do?

  • Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed.
  • Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" on page 3 before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding.
  • Rest often and try light exercise (such as walking) as it may help.

Ask your health care team for the Pain pamphlet for more information.

Talk to your health care team if it does not improve or if it is severe

Hair thinning or loss 

(Generally mild)

What to look for?

  • Your hair may begin to become thin or fall out during or after treatment.
  • In most cases, your hair will grow back after treatment, but the texture or colour may change.
  • In very rare cases, hair loss may be permanent.
     

What to do?

  • Use a gentle soft brush.
  • Do not use hair sprays, bleaches, dyes and perms.
Talk to your health care team if this bothers you

Diarrhea

What to look for?

  • Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment.
     

 

What to do?

If you have diarrhea:

  • Take anti-diarrhea medication if your health care team prescribed it or told you to take it.
  • Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol.
  • Eat many small meals and snacks instead of 2 or 3 large meals.
  • Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less.
  • Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy.
  • Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day.


Ask your health care team for the Diarrhea pamphlet for more information.

Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day)

 

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

  • Sudden onset of signs and symptoms of kidney failure such as leg/body swelling or passing little or no urine

  • Sudden changes to vision, speech, or the use of your limb(s)

  • Chest pain, shortness of breath or pain in chest, belly or limb

  • Increased cough or coughing up blood

  • Dizziness or passing out, unexpected weight gain, throwing up blood or throw up that looks like coffee grounds or black, tarry, or bloody stools.

  • Irregular heartbeat or chest pain

  • Severe swollen face, lip or tongue, chest or throat tightness; may occur during or shortly after the drug is given

  • Red or purple patches on the skin, rash/patches that do not turn white when pressed

  • Severe headache, loss of consciousness, seizures, confusion, vision loss

 

Who do I contact if I have questions or need help?          

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

 

Other Notes:

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

 


For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):  pdf download gemcitabine patient.pdf Info Sheet (French):  pdf download gemcitabine pour le patient.pdf Monograph:  pdf download gemcitabine.pdf Phonetic Spelling: 

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Eligibility Form:  pdf download Gemcitabine - Advanced Pancreatic Cancer pdf download Gemcitabine - Carcinoma of Bladder or Urothelium pdf download Gemcitabine - Non-Small Cell Lung Cancer (NSCLC) pdf download Gemcitabine and Nab-Paclitaxel - Advanced Pancreatic Cancer Cancer Type:  Breast Endocrine Adrenal Thyroid Gastrointestinal Hepatobiliary / Liver / Bile Duct Pancreas Genitourinary Bladder / Urothelial Renal cell / Kidney Testis Gynecologic Cervix Germ Cell Ovary Uterine Sarcoma Head and Neck Nasopharynx Hematologic Lymphoma - Hodgkin Lymphoma - Non-Hodgkin's High Grade Lymphoma - Non-Hodgkin's Intermediate Grade Lymphoma - Non-Hodgkin's Low Grade Lymphoma - T-cell Rare Diseases Lung Mesothelioma Non-Small Cell Sarcoma Soft Tissue Uterine Unknown Primary Type of Content:  Drug Monograph Status:  Null Info Sheet Status:  Null Global Date:  Wednesday, June 16, 2021 Universal Date:  2021-06-16 00:00:00 AddThis:  Title URL:  gemcitabine Drug Display Status:  Active Revision Summary: 
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