Azacitidine Hikma

Azacitidine Hikma is a cancer medicine containing azacitidine, which belongs to a group of drugs called "antimetabolites" that helps slow down cancer cell growth.

Form
injektiokuiva-aine, suspensiota varten
Strength
25 mg/ml
Active Ingredient
Azacitidine
Manufacturer
Hikma Farmacêutica (Portugal) S.A.

How to Use

Dosage

The recommended dose is 75 mg per square meter of body surface area.

Method

This medicine is given as an injection under the skin by a doctor or nurse. It can be injected into the thigh, abdomen, or upper arm.

Important

The recommended maximum daily dose is 75 mg/m² of body surface area, given daily for one week as part of a treatment cycle.

Possible Side Effects

COMMON
  • Drowsiness, tremors, yellow skin (jaundice), abdominal swelling, and easy bruising. These can be signs of life-threatening liver failure.
  • Swelling of legs and feet, back pain, reduced urination, increased thirst, fast pulse, dizziness, nausea, vomiting, decreased appetite, and feelings of confusion, restlessness, or tiredness. These can be signs of life-threatening kidney failure.
  • Fever, which could be due to a life-threatening infection caused by a low white blood cell count.
  • Chest pain or shortness of breath, possibly with fever. This could be a life-threatening lung infection (pneumonia).
  • Bleeding, such as blood in stool from stomach or intestinal bleeding, or bleeding inside the head. These can be signs of low platelet counts.
  • Difficulty breathing, swollen lips, itching, or rash. These could be signs of a severe allergic reaction.
  • Low red blood cell count (anemia), causing tiredness and paleness.
  • Low white blood cell count, potentially leading to fever and increased risk of infections.
  • Low platelet count (thrombocytopenia), making you more prone to bleeding and bruising.
  • Constipation.
  • Diarrhea.
  • Nausea (feeling sick).
  • Vomiting.
  • Pneumonia (lung infection).
  • Chest pain.
  • Shortness of breath.
  • Tiredness.
  • Injection site reaction, including redness, pain, or skin reaction.
  • Loss of appetite.
  • Joint pain.
  • Bruising.
  • Rash.
  • Red or purple spots under the skin.
  • Abdominal pain.
  • Itching.
  • Fever.
  • Nose and throat pain.
  • Dizziness.
  • Headache.
  • Trouble sleeping.
  • Nosebleeds.
  • Muscle pain.
  • Weakness.
  • Weight loss.
  • Low potassium levels in the blood.
  • Bleeding inside the head.
  • Blood infection (sepsis) due to low white blood cell count.
  • Bone marrow failure, leading to low red blood cells, white blood cells, and platelets.
  • A type of anemia with reduced red blood cells, white blood cells, and platelets.
  • Urinary tract infection.
  • Herpes virus infection (cold sores).
  • Bleeding, such as gum bleeding, stomach or intestinal bleeding, anal bleeding from hemorrhoids, eye bleeding, or bleeding under the skin.
  • Blood in urine.
  • Sores in the mouth or on the tongue.
  • Skin changes at the injection site, including swelling, hardness, bruising, bleeding under the skin, rash, itching, and discoloration.
  • Skin redness.
  • Skin infection (cellulitis).
  • Nasal and throat infection or sore throat.
  • Sore or runny nose or sinus pain (sinusitis).
  • High or low blood pressure.
  • Shortness of breath when moving.
  • Sore throat and larynx.
  • Indigestion.
  • Lethargy.
  • General feeling of unwellness.
  • Anxiety.
  • Confusion.
  • Hair loss.
  • Kidney failure.
  • Dehydration.
  • White coating on the tongue, inside of the cheeks, sometimes on the palate, gums, and tonsils (oral thrush).
  • Fainting.
  • Drop in blood pressure when standing (orthostatic hypotension), causing dizziness when standing or sitting up.
  • Sleepiness or drowsiness.
  • Bleeding from a catheter.
  • Bowel disease causing fever, vomiting, and abdominal pain (diverticulitis).
  • Fluid around the lungs (pleural effusion).
  • Chills.
  • Muscle spasms.
  • Hives (itchy raised rash).
  • Fluid around the heart (pericardial effusion).
RARE
  • Allergic (hypersensitivity) reaction.
  • Tremors.
  • Liver failure.
  • Large painful skin patches with fever, which are bone-colored and raised.
  • Painful skin ulcers (pyoderma gangrenosum).
  • Inflammation of the sac around the heart (pericarditis).
  • Dry cough.
  • Painless swelling of the fingertips.
  • Tumor lysis syndrome - metabolic complications that can occur during cancer treatment or sometimes without it. This happens when dying cancer cells release substances that cause problems, including changes in blood chemistry, high potassium, phosphorus, and uric acid levels, low calcium levels, which can lead to kidney and heart rhythm problems, seizures, and sometimes death.

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 use if you are breastfeeding.
  • Tell your doctor if you have low blood cell counts (platelets, red or white blood cells).
  • Tell your doctor if you have kidney disease.
Show 6 more warnings
  • Tell your doctor if you have liver disease.
  • Tell your doctor if you have ever had heart disease, a heart attack, or lung disease.
  • Azacitidine Hikma can cause a serious immune reaction called 'differentiation syndrome'.
  • Do not use if pregnant. If you are a woman who can become pregnant, use effective birth control during treatment and for 6 months after. Tell your doctor immediately if you become pregnant.
  • Men should not father children during Azacitidine Hikma treatment. Men must use effective birth control during treatment and for 3 months after stopping the medicine.
  • Do not drive or use tools or machines if you experience side effects like tiredness.