Oribamide
Oribamide is a medicine that helps treat certain blood diseases by stopping cancer cells from growing.
Form
kapseli, kova
Strength
500 mg
Active Ingredient
Hydroxyurea
Manufacturer
Orifarm Generics A/S
How to Use
Dosage
Your doctor will tell you exactly how much to take. The dose depends on your weight and blood cell counts. Older patients may need a lower dose.
Method
Swallow the capsules whole with water. Do not crush or chew them. Handle capsules carefully; wear gloves or wash your hands well after touching them. Pregnant women should not handle these capsules.
Important
Your doctor will adjust your dose based on your needs; there is no single fixed maximum daily dose for everyone.
Possible Side Effects
COMMON
- •No or very few sperm in semen.
- •Reduced blood cell counts, especially white blood cells (leukopenia, including reduced CD4 lymphocytes), red blood cells (anemia), and platelets (thrombocytopenia). This means your bone marrow isn't working as well.
- •Nausea, vomiting, loss of appetite, mouth sores (stomatitis), diarrhea, constipation, stomach pain, inflammation of mucous membranes (mucositis), indigestion (dyspepsia).
- •Black, tar-like stools or blood in stools.
- •In combination with certain HIV medicines: pancreas inflammation (pancreatitis) with stomach pain.
- •Drug-induced fever, chills, discomfort (malaise), weakness, lack of energy.
- •Skin ulcers, especially leg ulcers.
- •Skin reactions with bumps and blisters (maculopapular rash), facial redness, redness of hands and feet (hand-foot syndrome).
- •Skin changes, such as purplish rash and thinning skin; darkening and wasting of skin and nails, itching, small violet bumps, skin peeling, darkening and death of skin tissue.
- •Hair loss (alopecia).
- •Temporary kidney problems with increased blood levels of uric acid, urea, and creatinine.
- •Difficulty urinating.
- •Enlarged immature red blood cells (megaloblastosis).
- •Skin cancer.
- •Increased liver enzymes.
- •Liver inflammation (hepatitis) causing flu-like symptoms, including tiredness, loss of appetite, fever, aches, nausea/vomiting, pressure or pain under the right ribs, and possibly yellow skin or eyes.
- •Problems with bile flow (cholestasis), which can cause itching, yellow skin, very dark urine, or very pale stools.
- •Nervous system disorders, such as headache, dizziness, drowsiness, confusion (disorientation), hallucinations, and seizures.
- •Acute and chronic lung reactions with changes in lung tissue seen on X-rays, shortness of breath, fever in acute reactions, and dry cough in chronic reactions.
- •In combination with certain HIV medicines: numbness, tingling or pain in arms and legs (peripheral neuropathy), and stomach pain, nausea or vomiting, or yellow skin (hepatotoxicity).
RARE
- •Thick, scaly patches on the skin (actinic keratosis).
- •High levels of red blood cell breakdown product (bilirubin) in the blood.
- •Allergic reactions.
- •Metabolic complications due to breakdown products from cancer cells (tumor lysis syndrome).
- •Skin ulcer with severe infection.
- •Skin inflammation causing red, scaly patches on the skin, possibly with joint pain.
- •Worsening kidney function.
- •High blood potassium levels, which may cause abnormal heart rhythm.
- •Fever, cough, shortness of breath, which may be a sign of severe lung disease; allergic inflammation of lung alveoli.
- •Hemolytic anemia.
- •Dry skin.
- •Low blood sodium levels, which may cause tiredness, confusion, muscle twitching, seizures, or deep unconsciousness.
- •In long-term treatment, secondary leukemia (blood cancer) may develop.
Important Warnings
- Do not take Oribamide if you are allergic to hydroxycarbamide or any other ingredient, or if your blood cell counts are too low.
- You will need regular blood tests before and during treatment (usually weekly) to check your blood cell counts and ensure your kidneys and liver are working well.
- Tell your doctor if you have ever had gout or a folic acid deficiency.
- If you have a low red blood cell count (anemia) before or during treatment, you may need blood transfusions.
- If you develop hemolytic anemia (red blood cells are destroyed too quickly), your doctor will stop Oribamide treatment.
Show 13 more warnings
- Drink plenty of fluids during treatment.
- If you have kidney or liver problems, tell your doctor before starting treatment.
- Long-term use may increase the risk of skin cancer. Protect your skin from the sun and check it regularly. Your doctor will also check your skin.
- Leg ulcers may develop. If this happens, your doctor will decide if you should continue treatment. Ulcers usually heal slowly if treatment is stopped.
- If you use continuous glucose monitoring (CGM) for diabetes, Oribamide may cause falsely high glucose readings, potentially leading to low blood sugar if you take too much insulin. Discuss this with your doctor.
- Tell your doctor or pharmacist about all other medicines you are taking, have recently taken, or might take.
- Previous or ongoing radiation therapy may cause skin redness and irritation.
- If you are taking certain HIV medicines (like NRTI), Oribamide may increase their side effects, including a drop in white blood cells.
- Tell your doctor if you have recently had or plan to have a vaccine.
- Do not use this medicine if you are pregnant, breastfeeding, or trying to conceive, unless specifically told by your doctor. It can harm an unborn baby and passes into breast milk.
- Use effective contraception before, during, and for six months after treatment.
- This medicine may affect your ability to drive or use machines. Be careful if you need to perform tasks requiring sharp focus.
- If you have an intolerance to certain sugars, talk to your doctor before taking this medicine as it contains lactose.