Patient Medication Information: uses, side effects, how to take - Gemcitabine for Injection Concentrate
What the medication is used for:
Gemcitabine for Injection Concentrate is an approved chemotherapy for treatment of:
- Non-small cell lung cancer (NSCLC), alone or in combination with another medication
- Pancreatic Cancer
- Bladder Cancer, in combination with another medication
- Breast Cancer, in combination with another medication
What it does:
Gemcitabine for Injection Concentrate is a chemotherapy that works through disrupting the cells ability to divide or grow. Chemotherapies are active in both healthy and cancer cells. However, cancer cells are known to divide or grow at a faster rate than most healthy cells making chemotherapies such as Gemcitabine for Injection Concentrate effective in the treatment of various cancers. While the time it takes to see if Gemcitabine for Injection Concentrate shrinks your cancer varies from person to person, your doctor will ask you if you are feeling better and will perform regularly scheduled examinations and x-rays to determine if Gemcitabine for Injection Concentrate has been effective.
When it should not be used:
Do not take Gemcitabine for Injection Concentrate if you have had an allergic or sensitivity reaction to this drug or any of its ingredients (see “What the nonmedicinal ingredients are” section of this leaflet).
What the medicinal ingredient is:
Gemcitabine hydrochloride
What the nonmedicinal ingredients are:
Macrogol 300, Propylene Glycol, Ethanol anhydrous,
Sodium Hydroxide and Hydrochloric acid, concentrated.
What dosage forms it comes in:
Gemcitabine for Injection Concentrate is available as 100 mg/mL, 2 mL, 10 mL, 15 mL and 20 mL Solution for infusion.
Serious Warnings and Precautions
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BEFORE you receive Gemcitabine for Injection Concentrate talk to your doctor if:
- You have had an allergic reaction to any chemotherapy or have been treated with any chemotherapy in the past
You are pregnant, plan on becoming pregnant, or are currently breast feeding
- You have liver or kidney problems, or a bone marrow disorder
Gemcitabine for Injection Concentrate is known to increase your body’s sensitivity to radiation therapy.
It is very important to tell your doctor about any medications you may be taking, including over-the-counter drugs, such as Aspirin (acetylsalicylic acid), vitamins, and other pain relievers. Be sure to check with your doctor before taking any medications on your own.
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
Usual dose:
Your doctor will develop a Gemcitabine for Injection Concentrate treatment plan based on your needs. You are encouraged to discuss your treatment plan with your doctor. There are many points your doctor will consider when selecting the appropriate treatment plan for you. Your doctor may recommend skipping a dose based upon your response to Gemcitabine for Injection Concentrate.
Overdose:
Gemcitabine for Injection Concentrate will be given under the supervision of a qualified physician. Any overdose should be managed by a qualified physician experienced in the use of anticancer agents.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Contact your healthcare professional immediately for further instructions.
In clinical studies of gemcitabine hydrochloride, side effects were generally manageable. Side effects significant enough to cause your treatment to be stopped occurred in about 10% of all patients. Less than 1% of patients stopped therapy due to any one side effect. Most side effects were reversible and can be managed by either a delay in your treatment, a reduction of the dose of chemotherapy or both. Therefore it is important for you to know about common side effects and for you to communicate any suspected side effects to your doctor.
You should discuss possible side effects with your doctor before beginning Gemcitabine for Injection Concentrate therapy and at any time you think you may be experiencing a side effect. For a list of possible side effects see the “Call Your Doctor or Nurse If You Experience” section and Serious Side Effects Table below.
In clinical studies of gemcitabine hydrochloride, the most common reason for dosage adjustments was low blood counts. About two thirds of patients had low blood counts. In about one fourth of patients, decreases in blood counts were severe. For more information speak with your doctor and see section below on Low Blood Counts.
Shortness of breath may develop or worsen during treatment due to disease progression or in rare cases, due to a direct effect of the drug. If this occurs, patients should inform their treating doctor immediately of the developing or worsening of shortness of breath.
Nausea and vomiting were the most common side effects in clinical studies of gemcitabine hydrochloride. About two thirds of patients experienced nausea and vomiting, which were usually mild to moderate. Other common side effects included fever, swelling, rash, and flu-like symptoms.
In rare cases, Gemcitabine for Injection Concentrate may affect your liver, especially if you have liver metastases (spreading of cancer) or a medical history of hepatitis (inflammation of the liver), alcoholism or liver cirrhosis (liver disease). Follow your doctor’s instructions on having periodic blood work to check your liver.
In rare cases, Gemcitabine for Inection Concentrate may affect your kidney, especially if your kidney function is not normal. Follow your doctor’s instructions on having periodic blood work to check your kidneys.
Low Blood Counts:
Chemotherapy drugs often affect the blood cells, which means that temporary changes in their counts may occur. These effects may be more common in patients older than 65 and in women. Blood tests will be done before each dose of Gemcitabine for Injection Concentrate to monitor your blood counts.
If your doctor notices changes in your blood counts, follow their advice, which may include:
White Blood Count:
- if your white blood count becomes low, you may have trouble fighting infections
- stay out of crowds and away from people with colds or other illnesses
- call your doctor if you develop a temperature over 38°C
- ensure regular mouth care to reduce chance of infection
Red Blood Count:
- if your red blood count becomes low, you may feel tired or weak. If it becomes too low, your doctor may recommend a red blood cell transfusion
- rest as much as you need to
- try to eat a well balanced diet
Platelet Count:
- if your platelet count becomes low, your blood may not clot as fast as usual, and bleeding or bruising may occur. Sometimes, a blood
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
- transfusion is given if platelet counts drop very low
- try to avoid getting cuts, bumps, or bruises (for example avoid contact sport and use an electric razor)
- since acetylsalicylic acid can affect your platelets, you should avoid taking acetylsalicylic acid while you are receiving chemotherapy, unless your doctor advises otherwise
Call Your Doctor or Nurse If You Experience:
- any unusual bruising or bleeding
- any pain around an infusion site
- a sore mouth or throat
- prolonged or uncomfortable swelling
- severe diarrhea, meaning three or more watery bowel movements per day, lasting more than 24 hours
- severe constipation for three days that has not been relieved by laxatives
- numbness or tingling in your hands or feet
- vomiting for more than 24 hours after your treatment
- any changes in your skin, especially rash or potential allergic skin reactions
- headache with confusion, and/or seizures (fits), and/or changes in vision
- see Also Serious Side Effects Table below
This is not a complete list of side effects. For any unexpected effects while taking Gemcitabine for Injection Concentrate, contact your doctor or nurse.
Handling and storage of Gemcitabine for Injection Concentrate is restricted to qualified healthcare professionals.
Gemcitabine for Injection Concentrate should be stored at controlled room temperature (15 °C to 25 °C).
Gemcitabine for Injection Concentrate should be inspected visually for clarity, particulate matter, precipitation, discolouration, and leakage, prior to administration, whenever solution and container permit.
Gemcitabine for Injection Concentrate should be diluted before use. Sterile isotonic saline (0.9% sodium chloride injection) without added preservatives should be used as a diluent. The diluted solution (in 0.9 % sodium chloride solution) is stable for 60 days at 25°C and 2 °C to 8 °C.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect NOTE: Should you require information related to the management of side effects, contact your health care provider. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
Gemcitabine for Injection Concentrate is manufactured by: Accord Healthcare Inc.
Last revised: 4 April 2014
| Symptom / effect | Talk with your doctor or nurse | ||
| Only if severe | In all cases | ||
| Very Common | Diarrhea | ||
| Swelling | |||
| Vomiting | |||
| Common | Body temperature over 38 C or shaking chills | ||
| Fatigue | |||
| Uncommon | Shortness of breath | ||
| Very Rare | Skin reactions including blistering | ||
| Headache with confusion, and/or seizures (fits), and/or changes in vision | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM