Methotrexat Accord
Methotrexat Accord is a medicine that stops fast-growing cells, like cancer cells, from growing, helping to treat certain types of cancer.
Form
infuusiokonsentraatti, liuosta varten
Strength
100 mg/ml
Active Ingredient
Methotrexate
Manufacturer
Accord Healthcare B.V.
How to Use
Dosage
Your doctor will decide your dose based on your specific illness, health, age, weight, and body size.
Method
This medicine is given by a healthcare professional as an injection into a muscle, a vein, or an artery. It must not be given into your spine. Larger doses are usually given as a slow drip (infusion) over 24 hours.
Important
Your doctor will determine the maximum amount you can receive each day.
Possible Side Effects
COMMON
- •Feeling less hungry, nausea, throwing up, stomach ache, or poor digestion.
- •Sores or inflammation in your mouth and throat.
- •Higher levels of liver enzymes in blood tests.
- •Shingles, a painful rash caused by the chickenpox virus.
- •Changes in blood cells, such as low red blood cells (anemia), low white blood cells, or low platelets.
- •Loose stools.
- •Dry cough, feeling short of breath, chest pain, or fever.
- •Skin rash, redness, or itching.
- •Headache, feeling tired, or drowsy.
- •Unexplained shortness of breath, a dry cough, or wheezing (signs of lung problems).
- •Sudden itching, skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth or throat (which may make breathing and swallowing difficult). You might also feel faint (signs of a severe allergic reaction).
- •Vomiting, diarrhea, or mouth inflammation and stomach/duodenal ulcers (signs of digestive tract problems).
- •Yellow skin or eyes, dark urine (signs of liver problems).
- •Fever, chills, body aches, and sore throat (signs of an infection).
- •Unexplained bleeding (like bleeding gums, dark urine, blood in urine or vomit) or bruising, black or tar-like stool – this could be due to reduced blood clotting or stomach/intestinal bleeding.
- •Skin rashes with flaking or blistering and mouth sores, e.g., in the nose (signs of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).
- •Abnormal behavior, temporary blindness, and seizures (signs of central nervous system effects).
- •Paralysis (paresis, partial paralysis).
RARE
- •Very low levels of all blood cells (pancytopenia), very low white blood cells (agranulocytosis).
- •Inflammation of blood vessels (vasculitis).
- •Severe allergic reactions (anaphylaxis) or allergic inflammation in blood vessels.
- •Dizziness, feeling confused, or depression.
- •Seizures or brain swelling (encephalopathy).
- •Lymphoma (cancer of the lymph nodes).
- •Scarring of the lungs (lung fibrosis).
- •Bleeding or sores in the stomach or intestines.
- •Inflammation of the pancreas (pancreatitis).
- •Problems related to diabetes.
- •Low levels of albumin (a protein in the blood).
- •Darkening of the skin.
- •Hair loss, painful scaly sores due to psoriasis.
- •Increased number of rheumatic nodules (lumps under the skin).
- •Skin and mucous membrane effects, sometimes severe (like Stevens-Johnson syndrome, toxic epidermal necrolysis).
- •Sunburn-like reactions due to increased skin sensitivity to sunlight.
- •Hives (itchy rash).
- •Bone thinning (osteoporosis), joint pain, muscle pain.
- •Liver scarring (fibrosis or cirrhosis), fatty liver.
- •Bladder inflammation or sores, blood in urine, painful urination, vaginal inflammation or sores.
- •Inflammation of the sac around the heart (pericarditis), fluid around the heart (pericardial effusion), or pressure on the heart due to fluid (tamponade).
- •A type of anemia where red blood cells are larger than normal.
- •Changes in mood.
- •Partial paralysis.
- •Problems with speech, like difficulty articulating words (dysarthria) or understanding speech (aphasia).
- •Disease of the bone marrow (myelopathy).
- •Vision problems, blurred vision.
- •Blood clots in blood vessels (e.g., in the brain, deep veins, or retina).
- •Low blood pressure.
- •Diabetes.
- •Throat inflammation, temporary stopping of breathing (apnea), asthma, gum inflammation.
- •Small bowel inflammation.
- •Bloody stools.
- •Poor absorption of nutrients.
- •Acne, skin ulcers, changes in nail color (pigmentation), bruising.
- •Bone fractures.
- •Kidney failure, very little urine (oliguria), high levels of urea in blood (azotemia), or no urine production (anuria).
- •High levels of uric acid in the blood (hyperuricemia).
- •High levels of creatinine and urea in blood tests (showing poor kidney function).
- •Liver damage.
- •Abnormal development of breast glands.
- •Severe bone marrow issues, anemia from marrow not making enough red blood cells (aplastic anemia), swollen lymph nodes (lymphadenopathy), abnormal growth of white blood cells (lymphoproliferative disorders), low white blood cells (neutropenia, eosinophilia), and low gamma globulins.
- •Weakened immune system (immunosuppression).
- •Trouble sleeping (insomnia).
- •Problems with thinking, memory, and reasoning.
- •Joint and/or muscle pain, weakness.
- •Muscle weakness (myasthenia).
- •Symptoms like paralysis or vomiting, or sudden inflammation of the membranes around the brain (aseptic meningitis).
- •Abnormal sensations or changes in taste (metallic taste).
- •Eye inflammation (conjunctivitis), changes in the retina (retinopathy), vision problems, swollen eyelids.
- •Inflammation of tear ducts, increased tearing, and sensitivity to light.
- •Rapid breakdown of tumor cells (tumor lysis syndrome).
- •Allergic inflammation of blood vessel walls (vasculitis), inflammation of sweat glands (hidradenitis).
- •Lung problems, shortness of breath, pneumonia, lung infection, fluid in the lungs (pleural effusion).
- •Enlarged large intestine (toxic megacolon), bloody vomit.
- •Chronic hepatitis returning, acute liver damage, herpes simplex infection, liver inflammation, impaired liver function.
- •Painful swelling around the nails.
- •Enlarged small blood vessels in the skin (paronychia).
- •Protein in the urine (proteinuria).
- •Decreased sex drive (libido), impotence.
- •Menstrual problems, vaginal discharge.
- •Infertility.
- •Fever, poor wound healing.
- •Bleeding outside blood vessels.
- •Psychosis (severe mental disorder).
- •Fluid buildup in the brain and lungs.
- •Metabolic disorders.
- •Skin tissue death (necrosis), severe skin peeling and redness (exfoliative dermatitis).
- •Jaw bone damage (due to abnormal growth of white blood cells).
- •Skin redness and peeling.
Important Warnings
- Do not use if you are allergic to methotrexate or any other ingredient in this medicine.
- Do not use if you have severe liver or kidney disease.
- Avoid if you drink a lot of alcohol.
- Do not use if you have severe blood disorders.
- Do not use if you have a severe or active infection, like tuberculosis or HIV.
Show 12 more warnings
- Do not use if you have sores in your mouth or throat, or ulcers in your stomach or intestines.
- Do not breastfeed while using this medicine.
- Do not get live vaccines during treatment with Methotrexat Accord.
- This medicine can lower your immune system and increase your risk of infections or bleeding. Tell your doctor if you cough up blood.
- Women should avoid getting pregnant during treatment and for at least 6 months after. This medicine can cause miscarriage and birth defects.
- Men should avoid fathering a child or donating sperm during treatment and for at least 3 months after. This medicine can affect sperm production and lead to birth defects.
- This medicine can make your skin sensitive to sunlight. Avoid strong sun and sunbeds.
- Tell your doctor if you are receiving radiation therapy, as it can increase the risk of tissue and bone damage.
- This medicine must not be injected into your spinal fluid (intrathecal administration), as it can cause life-threatening brain inflammation.
- Tell your doctor if you have a condition where fluid builds up in your body, such as in the lungs or stomach.
- If you have insulin-dependent diabetes, your treatment needs careful monitoring.
- Seek medical help immediately if you notice new or worsening neurological symptoms like muscle weakness, vision changes, confusion, or personality changes, as these can be signs of a rare, serious brain infection (PML).