Brand Name Choices
What Rheumatrex is and what it is used for
Jylamvo is a medicine that:
•suppresses the growth of certain cells in the body that multiply rapidly (an anticancer medicine)
•reduces unwanted reactions by the body's own defense mechanisms (an immunosuppressive agent)
•has an anti-inflammatory effect Jylamvo is used in patients with:
•the following rheumatic and skin diseases: o active rheumatoid arthritis (RA) in adults o polyarthritic forms (when five or more joints are affected) of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate o severe, treatment-resistant, disabling psoriasis that does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, as well as in severe psoriasis that also affects the joints (psoriatic arthritis) in adult patients
•acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over You must talk to a doctor if you do not feel better or if you feel worse
How to take Rheumatrex
Jylamvo should be prescribed only by doctors who are familiar with the properties of the medicine and 5 how it works. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking Jylamvo incorrectly can result in severe side effects and even death. The duration of the treatment is determined by the treating physician. Treatment of rheumatoid arthritis, severe juvenile idiopathic arthritis, severe psoriasis and severe psoriatic arthritis with Jylamvo is a long-term treatment. Recommended dose Your doctor will decide what dose of Jylamvo you should take according to the condition you are being treated for, how severe it is and your general health. Keep to the dose exactly and follow your doctor’s instructions exactly on when to take the medicine. Dose in rheumatic and skin diseases (RA, JIA and psoriasis or psoriatic arthritis) Take Jylamvo only once a week. Decide with your doctor the most suitable day of the week to take the medicine. Dosage in adult rheumatoid arthritis: The usual initial dose is 7.5 mg (3.75 ml), once a week.. Dosage for psoriasis and psoriatic arthritis: The usual initial dose is 7.5 mg (3.75 ml), once a week. The doctor may increase the dose if the used dose is not effective but tolerated well. Your doctor may adjust the dose to suit you according to your response to treatment and side effects. Dose in acute lymphoblastic leukaemia (ALL) Your doctor will tell you what dose you should take for your condition and when you should take the dose. Keep to this dose exactly. Use in children and adolescents The doctor will calculate the dose required from the child’s body surface area (m2 ), and the dose is expressed as mg/m2 . Elderly Because of the reduced liver and kidney function and the lower folate reserves in elderly patients, a relatively low dosage should be chosen for them. How to take the medicine Your pack of Jylamvo contains a bottle of medicine with a cap, a bottle adaptor and a white dosing syringe. Always use the syringe provided to take your medicine. If you are a parent or caregiver giving the medicine, wash your hands before and after giving a dose. Wipe up spillages immediately. For protection, you should wear disposable gloves when handling Jylamvo. Women who are pregnant, planning to be or breast-feeding should not handle methotrexate. If Jylamvo comes into contact with skin, eyes or nose, you should wash the affected area with water and soap. Jylamvo is for oral use and provided ready for use. Please note that this oral solution contains 2 mg methotrexate in 1 ml solution and that the 6 scaling of the dosing syringe is in ml and not mg. Methotrexate can be taken with or without food. When you have taken your dose, drink some water and swallow it to ensure you have taken your full dose and there is no methotrexate left in your mouth. When you use the medicine follow the instructions below: 1. Put on disposable gloves before handling. 2. Shake the bottle. 3. Remove the bottle cap and push the adaptor firmly into the top of the bottle. 4. Push the tip of the dosing syringe into the hole in the adaptor. 5. Turn the bottle upside down. 6. Pull the syringe plunger back SLOWLY so that the medicine is drawn from the bottle into the syringe until the WIDEST part of the white syringe plunger is lined up to the black syringe marking of the dose required. DO NOT measure to the narrow tip of the plunger. If there are air bubbles in the syringe, repeat until bubbles are eliminated. 7. Turn the bottle back the right way up and carefully remove the syringe from the adaptor, holding the syringe by the barrel rather than the plunger. 8. Confirm that the dose in the syringe is correct. 9. Ensure that the patient is sitting up or standing before giving the medicine. 10 Gently place the tip of the syringe into the patient’s mouth and direct it to the inside of the cheek. 11. Slowly and gently push the plunger down to gently squirt the medicine into the inside of the cheek. DO NOT push down the plunger too hard or squirt the medicine to the back of the mouth or throat as this may cause choking. The plunger should be pushed back gently to the seated position until it clicks into place. 12. Remove the syringe from the patient’s mouth. 13. Ask the patient to swallow the medicine and then to drink some water, making sure no medicine is left in the mouth. 14. Put the cap back on the bottle with the adaptor left in place. Ensure that the cap is tightly closed. 15. Wash the syringe immediately after use with fresh warm, ‘soapy’ water and rinse well. The syringe should be held under water and the plunger drawn in and out several times until all traces of medicine are removed from inside the syringe including the tip. The plunger and barrel should then be separated and both washed thoroughly in the warm soapy water. They should then be rinsed thoroughly under COLD water and excess water shaken off before wiping dry with a clean paper towel. The plunger and barrel should be stored in a clean dry container with the medicine and reassembled before next use. All parts of the syringe should be completely dry before using it for the next dose. Repeat the above instructions for each dose, as instructed by your doctor or pharmacist. If you take more Jylamvo than you should Follow your doctor's dose recommendations. Never change the dose on your own. If you suspect that you (or someone else) have (has) taken too much Jylamvo, tell your doctor immediately or contact the nearest hospital casualty department. The doctor will decide whether any treatment is needed. An overdose of methotrexate can cause serious reactions. The symptoms of an overdose can include bleeding, an unusual feeling of weakness, ulcers in the mouth, feeling sick, vomiting, black or bloody stools, coughing up blood or vomiting blood with a coffee grounds appearance and a reduced urine. See also section 4 “Possible side effects”. Take the medicine pack with you when you visit your doctor or the hospital. The antidote in the event of an overdose is calcium folinate. If you forget to take Jylamvo 7 Never take a double dose to make up for a forgotten dose but continue with the prescribed dose. Ask your doctor for advice. If you stop taking Jylamvo Do not interrupt or stop the treatment with Jylamvo without first discussing this with your doctor. If you suspect you have a severe side effect, talk to your doctor immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you suddenly get wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting your whole body).
Contact your doctor immediately if you develop any of the side effects listed below:
breathing problems (these include a general feeling of illness, dry, irritating cough, shortness of
breath, difficulty in breathing, chest pain or fever)
spitting or coughing blood*
serious peeling or blistering of the skin
unusual bleeding (including vomiting blood), bruising or nose bleeds
nausea, vomiting, abdominal discomfort or severe diarrhoea
black or tarry stools
blood in the urine or stool
small red spots on the skin
fever, sore throat, flu-like symptoms
yellow colouring of the skin (jaundice) or dark urine
pain or difficulties in passing urine
thirst and/or frequent urination
blurred or restricted vision
*has been reported for methotrexate used in patients with underlying rheumatologic disease.
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people): loss of appetite, feeling sick (nausea), vomiting, abdominal pain, indigestion, inflammation and ulcers of the mouth and throat blood test showing raised liver enzymes.
Common (may affect up to 1 in 10 people): infections reduced blood cell formation with a decrease in white and/or red blood cells and/or platelets (leucocytopenia, anaemia, thrombocytopenia) headache, tiredness, lightheadedness inflammation of the lungs (pneumonia) with dry cough, shortness of breath and fever diarrhoea skin rash, skin redness and itching. 8
Uncommon (may affect up to 1 in 100 people): lymphoma (lump in neck, groin or armpits with associated backache, weight loss or night sweats) severe allergic reactions diabetes depression dizziness, confusion, seizures lung damage ulcers and bleeding in the digestive tract liver diseases, reduced content of blood proteins nettle rash, skin reaction in strong light, brown discoloration of the skin, hair loss, increased number of rheumatic nodules, shingles, painful psoriasis, slow wound healing joint or muscle pain, osteoporosis (reduction in bone strength) kidney disease, inflammation or ulcers of the bladder (possibly also with blood in the urine), painful urination inflammation and ulcers of the vagina.
Rare (may affect up to 1 in 1,000 people): a blood disorder characterised by the appearance of very large red blood cells (megaloblastic anaemia) mood swings weakness in movements, also only limited to the left or right side of the body severe visual disorders inflammation of the heart sac, accumulation of fluid in the heart sac low blood pressure, blood clots tonsillitis, stopping breathing, asthma inflammation of the pancreas, inflammation of the digestive tract, bloody stools, inflamed gums, indigestion acute hepatitis (inflammation of the liver) discoloration of the nails,acne, red or purple spots due to bleeding from blood vessels worsening of psoriasis during treatment with UV therapy skin lesions resembling sunburn or dermatitis after radiotherapy bone fractures kidney failure, reduction or lack of urine production, abnormal levels of electrolytes in blood impaired sperm formation, menstrual disorders.
Very rare (may affect up to 1 in 10,000 people): viral, fungal or bacterial systemic infections, serious disorder of bone marrow (anaemia), swollen glands lymphoproliferative disorders (excessive growth of white blood cells) insomnia pain, muscle weakness, changes in the sense of taste (metallic taste), inflammation of the membrane lining the brain resulting in paralysis or vomiting, pins and needles in arm and legs impaired movement of the muscles used for speech production, difficulty in speaking, impairment of language, feeling sleepy or tired, feeling confused, having unusual sensations in the head, brain swelling, ringing in ears red eyes, damage to the retina of the eye accumulation of fluid in the lung, lung infections vomiting blood, severe complications in the digestive tract liver failure fingernail infections, detachment of the nail from the nail bed, boils, widening of small blood vessels, damage to the blood vessels of the skin, allergic inflammation of blood vessels protein in the urine loss of sex drive, erection problems, vaginal discharge, infertility, enlargement of the breasts in 9 men (gynaecomastia) fever.
Not known (frequency cannot be estimated from the available data) pathological change of the white matter of the brain (leukoencephalopathy) haemorrhages bleeding from the lungs* bone damage in the jaw (secondary to excessive growth of white blood cells). *has been reported for methotrexate used in patients with underlying rheumatologic disease. Methotrexate can reduce the number of white blood cells and therefore weaken your immune defences. If you notice any symptoms of an infection such as fever or a marked worsening in your general state of health or fever with local signs of an infection such as sore throat/inflammation of the throat or mouth or problems passing water, see your doctor immediately. A blood test will be done to check for reduction in the white blood cells (agranulocytosis). It is important to tell your doctor about all the medicines you take. Methotrexate can cause serious (sometimes life-threatening) side effects. Your doctor will therefore do tests to check for any changes in your blood (such as a low white blood cell count, a low blood platelet count, lymphomas), kidneys or liver.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
How to Store Rheumatrex
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental
ingestion can be lethal for children.
Do not use the medicine after the expiry date which is stated on the carton and label after ‘Exp’. The expiry
date refers to the last day of that month.
Do not store above 25°C.
Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.
After first opening, throw away any unused medicine after 3 months.
Any unused medicine or waste material should be disposed of in accordance with local requirements for
•check with your pharmacist.
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