Gemcitabine Accord
Gemcitabine Accord is a cancer medicine that works by killing rapidly growing cells, including cancer cells.
Form
infuusiokonsentraatti, liuosta varten
Strength
100 mg/ml
Active Ingredient
Gemcitabine hydrochloride
Manufacturer
Accord Healthcare B.V.
How to Use
Dosage
Your doctor will calculate your dose, usually between 1000 mg and 1250 mg for each square meter of your body surface area.
Method
This medicine is given as a drip (infusion) into a vein, and it usually takes about 30 minutes.
Important
Your doctor will decide your maximum daily dose based on your health and blood test results.
Possible Side Effects
COMMON
- •Low white blood cell count
- •Trouble breathing (usually mild and resolves quickly after infusion)
- •Vomiting
- •Nausea
- •Hair loss
- •Abnormal liver blood tests
- •Blood in urine or protein in urine
- •Flu-like symptoms including fever
- •Swelling (e.g., ankles, fingers, feet, face)
- •Bleeding (e.g., gums, nose, mouth), red/pink urine, or unusual bruising
- •Feeling tired, dizzy, short of breath, or pale (due to low red blood cell count)
- •Mild to moderate skin rash or itching
- •Fever (38°C or higher) with sweating or other signs of infection
- •Pain, redness, swelling, or sores in the mouth (stomatitis)
- •Loss of appetite
- •Headache
- •Insomnia (trouble sleeping)
- •Drowsiness
- •Cough
- •Runny nose
- •Constipation
- •Diarrhea
- •Heavy sweating
- •Muscle pain
- •Back pain
- •Weakness
- •Chills
- •Infections
RARE
- •Scarring in the lungs (interstitial lung disease)
- •Wheezing or breathing difficulties due to narrowed airways
- •Lung damage (abnormal chest X-rays)
- •Heart failure
- •Stroke
- •Severe liver damage, including liver failure
- •Kidney failure
- •Low blood pressure
- •Skin peeling, sores, or blisters
- •Reactions at the injection site
- •Large blisters and oozing from the skin
- •Gangrene of fingers or toes
- •Fluid in the lungs
- •Severe lung inflammation leading to breathing failure (Adult Respiratory Distress Syndrome)
- •Severe sunburn-like rash, especially on areas previously treated with radiation (radiation recall)
- •Lung damage related to radiation therapy (radiation toxicity)
- •Blood vessel inflammation (peripheral vasculitis)
- •High liver enzyme levels (GGT, transaminases)
- •High platelet count
- •Inflammation of the large intestine lining due to poor blood flow (ischemic colitis)
- •Blood clots in small blood vessels (thrombotic microangiopathy)
- •Low hemoglobin (anemia), low white blood cells, and low platelets detected in blood tests
- •Sepsis (severe infection where bacteria harm organs)
- •Pseudocellulitis (redness and swelling of the skin)
- •Irregular heartbeat (arrhythmia)
- •Extreme tiredness, weakness, purple spots (purpura), bruising, sudden kidney failure (very little or no urine), and signs of infection (hemolytic uremic syndrome); this can be life-threatening
- •Severe chest pain (heart attack)
- •Severe allergic reaction with widespread rash, redness, itching, swelling of hands, feet, ankles, face, lips, mouth, throat (difficulty swallowing or breathing), wheezing, fast heartbeat, and dizziness (anaphylactic reaction)
- •General swelling, shortness of breath, or weight gain due to fluid leaking from small blood vessels (capillary leak syndrome)
- •Headache with vision problems, confusion, seizures, or fits (Posterior Reversible Encephalopathy Syndrome - PRES)
- •Severe, itchy rash, blisters, or peeling skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- •Red, scaly, widespread rash with bumps under swollen skin (including skin folds, torso, and upper limbs) and blisters, with fever (Acute Generalized Exanthematous Pustulosis - AGEP)
Important Warnings
- Do not take this medicine if you are allergic to gemcitabine or any other ingredient.
- Do not take this medicine if you are breastfeeding.
- Tell your doctor right away if you have liver, heart, or kidney problems.
- Tell your doctor if you have recently had radiation therapy or a vaccine.
- This medicine contains alcohol. Tell your doctor if you have alcoholism or epilepsy.
Show 8 more warnings
- Women who can get pregnant must use effective birth control during treatment and for 6 months after the last dose.
- Men must use effective birth control during treatment and for 3 months after the last dose, and should avoid fathering a child.
- Do not drive or operate machinery if you feel drowsy, especially if you have consumed alcohol.
- Call your doctor right away if you get severe skin rashes, peeling skin, or mouth sores.
- Call your doctor right away if you experience headache with confusion, seizures, or changes in vision.
- Call your doctor right away if you have trouble breathing, feel very weak, or look very pale.
- Call your doctor right away if you notice sudden swelling, weight gain, or very low blood pressure.
- This medicine is not recommended for children under 18 years of age.