Azacitidine Stada

This medicine is an anti-cancer drug that helps stop cancer cells from growing and corrects problems with blood cell production in the bone marrow.

Form
injektiokuiva-aine, suspensiota varten
Strength
25 mg/ml
Active Ingredient
Azacitidine
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

The recommended dose is 75 mg per square meter of body surface area; your doctor will adjust it based on your health, height, and weight.

Method

It is given as an injection under the skin (subcutaneous) into the thigh, abdomen, or upper arm, daily for one week, followed by a 3-week break; this cycle is repeated every 4 weeks for at least 6 cycles.

Important

Your doctor will determine your daily dose; if the dose is higher than 4 ml, it will be given in two separate injection sites.

Possible Side Effects

COMMON
  • Low red blood cell count (anemia), causing tiredness and paleness.
  • Low white blood cell count, possibly with fever, making you more prone to infections.
  • Low platelet count, making you more likely to bleed and bruise.
  • Constipation
  • Diarrhea
  • Nausea and vomiting
  • Lung inflammation (pneumonia)
  • Chest pain, shortness of breath
  • Fatigue
  • Redness, pain, or skin reaction at the injection site.
  • Loss of appetite
  • Joint pain
  • Bruises
  • Rash
  • Red or purple spots under the skin
  • Abdominal pain
  • Itching
  • Fever
  • Nose and throat pain
  • Dizziness
  • Headache
  • Difficulty sleeping (insomnia)
  • Nosebleeds
  • Muscle aches
  • Weakness
  • Weight loss
  • Low potassium levels in the blood.
RARE
  • Bleeding inside the head
  • Bacterial blood infection (sepsis), possibly due to low white blood cell count.
  • Bone marrow failure, leading to low red, white, and platelet counts.
  • Type of anemia with low red, white, and platelet counts.
  • Urinary tract infection
  • Viral infection causing cold sores (herpes).
  • Bleeding from gums, stomach, intestines, hemorrhoids, eyes, or under the skin (hematoma).
  • Blood in urine
  • Sores in the mouth or on the tongue.
  • Skin changes at the injection site, including swelling, hardened skin, bruising, bleeding under the skin, rash, itching, and skin discoloration.
  • Reddened skin
  • Skin infection (cellulitis)
  • Infection of the nose, throat, or sinuses (sinusitis), or sore throat.
  • High or low blood pressure.
  • Shortness of breath when active.
  • Throat and larynx pain.
  • Indigestion
  • Lethargy
  • General feeling of being unwell.
  • Anxiety
  • Confusion
  • Hair loss
  • Kidney failure.
  • Dehydration
  • White coating on the tongue, inside of cheeks, palate, gums, and tonsils (oral fungal infection).
  • Fainting
  • Dizziness when standing up due to a drop in blood pressure.
  • Drowsiness
  • Bleeding from a catheter.
  • Bowel disease that can cause fever, vomiting, and abdominal pain (diverticulitis).
  • Fluid around the lungs (pleural effusion).
  • Chills
  • Muscle cramps
  • Hives (itchy rash, urticaria).
  • Fluid around the heart (pericardial effusion).
  • Allergic reaction (hypersensitivity).
  • Tremors
  • Liver failure.
  • Large, raised, painful purple skin patches with fever.
  • Painful skin ulcers (pyoderma gangrenosum).
  • Inflammation of the sac around the heart (pericarditis).
  • Dry cough
  • Painless swelling of fingertips (clubbing).
  • Tumor lysis syndrome (metabolic complications due to dying cancer cells, causing changes in blood chemistry, kidney problems, heart rhythm changes, seizures, and sometimes death).
  • Fast-spreading, life-threatening infection of the deep skin layers (necrotizing fasciitis).
  • Severe immune reaction (differentiation syndrome) that can cause fever, cough, breathing difficulties, rash, reduced urination, low blood pressure, swollen arms or legs, and rapid weight gain.
  • Inflammation of blood vessels in the skin, which can cause a rash (cutaneous vasculitis).

Important Warnings

  • Do not use if you are allergic to azacitidine or any other ingredient in this medicine.
  • Do not use if you have advanced liver cancer.
  • Do not breastfeed while using this medicine.
  • Tell your doctor if you have low blood cell counts (platelets, red, or white blood cells), kidney problems, liver problems, or have had heart or lung disease.
  • This medicine can harm an unborn baby; women who can get pregnant must use effective birth control during treatment and for 6 months after, and men must use effective birth control during treatment and for 3 months after.
Show 2 more warnings
  • This medicine is not recommended for children and adolescents under 18 years of age.
  • Do not drive or use machines if you feel tired or experience other side effects that affect your ability.