7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg, 27.5 mg, 30 mg solution for injection in pre-filled pen
methotrexate
What Metojectpen is and what it is used for
Metojectpen is intended for the treatment of
- active rheumatoid arthritis in adult patients
- polyarthritic forms of severe, active juvenile idiopathic arthritis , when treatment with non-steroidal anti-inflammatory drugs ( NSAIDs ) has given insufficient response
- moderate to severe psoriasis in adult patients and severe psoriatic arthritis in adults
- mild to moderate Crohn’s disease in adult patients when there is a lack of appropriate treatment with other drugs.
Rheumatoid arthritis (RA) is a chronic collagen disease, which is characterized by inflammation of the synovial membranes (synovial membranes). These membranes produce a fluid that acts as a lubricant for many joints. Inflammation causes the skin to thicken and the joint to swell.
Juvenile arthritis occurs in children and adolescents under 16 years of age. Polyarthritic forms are those that affect five or more joints during the first 6 months of the disease.
Psoriasis is a common, chronic skin condition characterized by red spots covered with thick, dry, silvery scaly scales.
Psoriatic arthritis is a type of arthritis ( inflammatory joint disease) with psoriatic ulcers in the skin and nails, especially at the joints of the fingers and toes.
Metojectpen relieves and slows the course of the disease.
Crohn’s disease is a type of inflammatory bowel disease that can affect all parts of the gastrointestinal tract and lead to symptoms such as abdominal pain, diarrhea, vomiting, or weight loss.
Methotrexate contained in Metojectpen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Metojectpen
Do not use Metojectpen
- if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6).
- if you have liver disease or severe kidney disease or blood disease
- if you regularly drink large amounts of alcohol
- if you have a serious infection , such as tuberculosis , HIV or other immune deficiency syndromes
- if you have sores in your mouth, stomach ulcers or sores in your intestines
- if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- if you are being vaccinated with live vaccines at the same time.
Special precautions for use with Metojectpen
Methotrexate temporarily affects sperm and egg production, an effect that in most cases decreases after the end of treatment. Methotrexate can cause miscarriage and severe congenital malformations. You must avoid becoming pregnant while using methotrexate and for at least 6 months after stopping treatment. See also section “Pregnancy, breast-feeding and fertility”
Warnings and cautions
Talk to your doctor or pharmacist before using Metojectpen if:
- you are older or if you generally feel sick and weak
- you have problems with liver function
- you are dehydrated (dehydration).
Recommended follow-up examinations and safety measures
Even when Metojectpen is given in low doses, serious side effects can occur. For them to be detected in time, your doctor must perform checks and laboratory tests.
Before treatment
Before starting treatment, you will be given blood samples so that your doctor can check that you have enough blood cells and test your liver function, the level of serum albumin (a protein in the blood), and kidney function. Your doctor will also check if you have tuberculosis (a contagious disease with small lumps in the affected tissue) and have you have a lung X-ray.
During treatment
You will undergo the following tests at least once a month for the first six months and thereafter at least every three months:
- examination of the mouth and throat to see if there have been any changes in the mucous membrane
- blood tests
- control of liver function
- control of renal function
- control of the respiratory system and, if necessary, lung function test.
Acute hemorrhage from the lungs of patients with the underlying rheumatic disease has been reported with methotrexate. If you experience symptoms such as blood in the saliva or bloody cough, contact your doctor immediately.
Methotrexate may affect your immune system and your vaccination results. It can also affect the results of immunological tests. Inactive, chronic infections (such as herpes zoster [shingles], tuberculosis, hepatitis B or C) can flare-up. You must not be vaccinated with live vaccines while being treated with Metojectpen.
Radiation-induced dermatitis and increased sun sensitivity with the risk of skin burns may recur during treatment with methotrexate (“recall” reaction). Psoriasis lesions may be exacerbated by UV radiation and concomitant administration of methotrexate.
Enlarged lymph nodes ( lymphoma ) can occur and if this happens, treatment must be stopped.
Diarrhea can be a possible side effect of Metojectpen and requires discontinuation of treatment. If you have diarrhea, you should talk to your doctor.
Certain brain diseases (encephalopathy/leukoencephalopathy) have been reported in cancer patients receiving methotrexate treatment. Such side effects can not be ruled out when methotrexate is used to treat other diseases.
If you, your partner, or your healthcare provider discover new or worsening neurological symptoms, such as general muscle weakness, visual disturbances, changes in thinking ability, memory, and orientation that lead to confusion and personality changes, you should contact your doctor immediately as these may be symptoms of a very rare, severe brain infection called progressive multifocal leukoencephalopathy (PML).
Other medicines and Metojectpen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Please note that this also applies to medicines that you will take in the future.
The effect of the treatment can be affected if Metojectpen is given at the same time as certain other medicines:
- antibiotics such as: tetracyclines , chloramphenicol and non-absorbable broad-spectrum antibiotics, penicillins , glycopeptides, sulfonamides , ciprofloxacin and cephalothin (medicines that prevent / fight certain infections )
- non-steroidal anti-inflammatory drugs or salicylates (medicines for pain and / or inflammation ) such as acetylsalicylic acid , diclofenac and ibuprofen or pyrazole)
- probenecid (anti- gout medicine )
- weak organic acids such as loop diuretics (“diuretic tablets”).
- drugs that may have adverse effects on bone marrow , such as trimethoprim-sulfamethoxazole (an antibiotic ) and pyrimethamine
- other drugs used to treat rheumatoid arthritis such as leflunomide, sulfasalazine and azathioprine
- mercaptopurine (a cytotoxic drug )
- retinoids (medicines for psoriasis and other skin diseases)
- theophylline (medicine for bronchial asthma and other lung diseases)
- certain medicines for stomach problems such as omeprazole and pantoprazole
- hypoglycaemic agents (medicines used to lower blood sugar ).
Vitamins that contain folic acid can impair the effect of the treatment and should only be taken if your doctor prescribes it.
Vaccination with live vaccines must be avoided.
Metojectpen with food, drink and alcohol
Alcohol as well as large amounts of coffee, soft drinks containing caffeine, and black tea should be avoided during treatment with Metojectpen.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Metojectpen during pregnancy or if you are trying to conceive. Methotrexate can cause congenital malformations, birth defects, and miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain arms, and legs. It is therefore very important that methotrexate is not given to pregnant patients or patients planning to become pregnant. Infertile women, pregnancy must be ruled out by appropriate measures, e.g. a pregnancy test before starting treatment. You must avoid becoming pregnant while taking methotrexate and for at least 6 months after stopping treatment, using reliable contraception during this time (see also section “Warnings and precautions”).
If you become pregnant during treatment or suspect you may be pregnant, talk to your doctor as soon as possible. You should be offered medical advice on the risk of harmful effects on the child due to the treatment.
If you wish to become pregnant, consult your doctor, who may refer you to specialist advice before the planned start of treatment.
Breast-feeding
Discontinue breastfeeding before and during treatment with Metojectpen.
Fertility in men
Available data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg/week. However, risk can not be completely ruled out. Methotrexate may be genotoxic. This means that the drug can cause gene mutation. Methotrexate can affect sperm production and can cause congenital malformations. Therefore, you should avoid getting a woman pregnant and donating sperm while taking methotrexate and for at least 6 months after stopping treatment.
Driving and using machines
Treatment with Metojectpen can cause side effects that affect the central nervous system, such as fatigue and dizziness. Therefore, in some cases, the ability to drive and/or use machines may be impaired. If you feel tired or drowsy, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Metojectpen contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Metojectpen
| Important warning regarding dosing one of Metojectpen (methotrexate): Metojectpen should only be used once a week for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, and Crohn’s disease. Using too much Metojectpen (methotrexate) can be life-threatening. Read section 3 of this leaflet very carefully. If you have any further questions, ask your doctor or pharmacist. |
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on a dose, which will be adjusted individually for you. It usually takes 4 – 8 weeks before the treatment has any effect.
Metojectpen is given subcutaneously (under the skin) by or under the supervision of a doctor or healthcare professional as an injection only once a week. Together with your doctor, you decide on a suitable day each week when you receive your injection.
Use for children and adolescents
The doctor will determine the appropriate dose for children and adolescents with polyarthritic forms of juvenile idiopathic arthritis.
Metojectpen is not recommended for use in children below 3 years of age due to insufficient experience in the treatment of this age group.
Method of administration and duration
Metojectpen is injected once a week!
The duration of treatment is determined by the attending physician. Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis Vulgaris, psoriatic arthritis, and Crohn’s disease with Metojectpen is a long-term treatment.
At the beginning of treatment, Metojectpen can be injected by healthcare professionals. However, your doctor may decide that you can learn to inject Metojectpen yourself. In that case, you will receive instructions on how to proceed. Under no circumstances should you try to inject yourself, unless you have learned how to do it.
You can also find instructions for using the Metojectpen in the “Instructions for Use” section at the end of this leaflet.
Note that all content must be used.
The medicine and the pre-filled pen must be handled and disposed of following local regulations. Pregnant healthcare professionals should not handle and/or administer Metojectpen.
Methotrexate should not come into contact with the skin or mucous membranes. If this happens, the affected area must be rinsed immediately with copious amounts of water.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects as well as their severity depends on the dose level and the frequency with which the medicine is given. As serious side effects can occur even at low doses, your doctor must check you regularly. Your doctor will perform tests to check for abnormalities in your blood (such as low white blood cell count, low platelet count, lymphoma ) and changes in your kidneys and liver.
Tell your doctor immediately if you get any of the following symptoms, as these may indicate a serious, possibly life-threatening side effect, which requires urgent specific treatment:
- persistent, dry, unproductive cough, shortness of breath and fever ; this may be a sign of pneumonia [common]
- saliva or coughing up blood : there may be signs of bleeding from the lungs [no known frequency]
- symptoms of liver damage, such as yellowing of the skin and whites of the eyes ; methotrexate can cause chronic liver damage ( liver cirrhosis ), scarring of the liver (liver fibrosis), fatty liver [all uncommon], hepatitis ( acute hepatitis ) [rare] and liver failure [very rare]
- allergic reactions such as rash including red, itchy skin, swollen hands, feet, ankles, face, lips, mouth or throat (which may make it difficult to swallow or breathe) and fainting ; this may be a sign of severe allergic reactions or an anaphylactic shock [rare]
- symptoms of kidney damage such as swollen hands, ankles or feet, altered urination frequency, decreased urine output ( oliguria ) or lack of urine ( anuria ) ; this may be a sign of kidney failure [rare]
- symptoms of infection are, e.g. fever, chills, diffuse pain, sore throat ; Methotrexate may make you more susceptible to infection . Severe infections such as a certain type of pneumonia ( Pneumocystis jirovecii – pneumonia ) and sepsis can occur [rare]
- symptoms such as weakness in one side of the body ( stroke ) or pain, swelling, redness and unusual heat in one leg (deep vein thrombosis ), this can occur when a loose blood clot clogs a blood vessel (thromboembolic event) [rare]
- fever and severe deterioration of your general condition or sudden fever along with sore throat or mouth, or urination problems ; methotrexate can cause a sharp decrease in the number of certain white blood cells ( agranulocytosis ) and severe bone marrow inhibition [very rare]
- unexpected bleeding, e.g. bleeding gums, blood in the urine, bloody vomiting or bruising ; this may be a sign of a sharp decrease in platelet count caused by severe bone marrow suppression [very rare]
- symptoms such as very severe headache often in combination with fever, stiff neck, nausea, vomiting , confusion and sensitivity to light may indicate an inflammation of the meninges ( acute aseptic meningitis ) [very rare]
- Certain brain diseases (encephalopathy / leukoencephalopathy) have been reported in cancer patients receiving methotrexate. Such side effects can not be ruled out when methotrexate is used to treat other diseases. Signs of this type of brain disease can be altered mental state, movement disorders ( ataxia ), visual disturbances or memory disorders [no known frequency]
- severe skin rash or blisters on the skin (this can also affect the mouth, eyes and genitals) ; this may be a sign of a condition called Stevens-Johnson syndrome and a burn-like condition (toxic epidermal necrolysis / Lyell’s syndrome) [very rare]
Listed below are other side effects that may occur:
Very common: may affect more than 1 in 10 people
- Inflammation of the oral mucosa, indigestion, nausea, loss of appetite, abdominal pain
- Deviating liver function values ( AST , ALT , bilirubin , alkaline phosphatase)
Common: may affect up to 1 in 10 people
- Sores in the mouth, diarrhea
- Rash, redness of the skin, itching
- Headache, fatigue, drowsiness
- Decreased blood cell formation with reduced number of white and / or red blood cells and / or platelets
Uncommon: may affect up to 1 in 100 people
- Sore throat
- Intestinal inflammation, vomiting, pancreatitis, black or tar-like stools, ulcers and bleeding in the gastrointestinal tract
- Increased photosensitivity, hair loss, increased number of rheumatic lumps, skin ulcers, shingles , inflammation of blood vessels, herpes-like rash, hives
- Debut of diabetes mellitus
- Dizziness, confusion, depression
- Decreased level of serum albumin
- Reduced number of all blood cells and platelets
- Inflammation and ulcers in the bladder or vagina, impaired kidney function, disturbed urination
- Joint pain, muscle pain, decreased bone mass
Rare: may affect up to 1 in 1,000 people
- Inflammation of the gums
- Increased skin pigmentation, acne , bruising on the skin due to vascular bleeding ( ecchymosis , petechiae ), allergic inflammation of blood vessels
- Decreased number of antibodies are in the blood
- Infection (incl. Reactivation of inactive chronic infection ), red eyes ( conjunctivitis )
- Mood swings (mood swings)
- Visual disturbances
- Inflammation of the pericardium, accumulation of fluid around the heart, obstruction of the heart’s blood filling due to fluid around the heart
- Low blood pressure
- Formation of scar tissue in the lung ( pulmonary fibrosis ), shortness of breath and bronchial asthma , accumulation of fluid in the alveoli
- Stress fracture
- Electrolyte disturbances
- Fever, impaired wound healing
Very rare: may affect up to 1 in 10,000 people
- Acute toxic enlargement of the intestine (toxic megacolon)
- Increased pigmentation of the nails, inflammation of the cuticles ( acute paronychia ), deep infection of the hair follicles ( furunculosis ), visible enlargement of small blood vessels
- Pain, loss of strength or feeling of numbness or tingling / lower sensitivity to stimulation than normal, taste changes (metallic taste), seizures, paralysis, meningism
- Impaired vision, non- inflammatory eye disease ( retinopathy )
- Loss of sexual drive, impotence , breast augmentation in men, insufficient sperm formation (oligospermia), menstrual disorders, discharge from the vagina
- Enlarged lymph nodes ( lymphoma )
- Lymphoproliferative disorders (abnormal growth of white blood cells )
Has been reported: occurs in an unknown number of users
- Increased number of certain white blood cells
- Nasal blood
- Protein in the urine
- Feeling weak
- Bone damage in the jaw (as a result of abnormal growth of white blood cells )
- Tissue destruction at the injection site
- Skin redness and scaly skin
- Swelling
Subcutaneous application of methotrexate is well tolerated locally. Only mild local skin reactions (such as burning sensation, reddening of the skin, swelling, discoloration, severe itching, pain) were observed, which subsided during treatment.
How to store Metojectpen
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store the pre-filled pens in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton and the pre-filled pen after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is methotrexate.
A pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate.One pre-filled pen of 0.2 ml solution contains 10 mg methotrexate.A pre-filled pen with 0.25 ml solution contains 12.5 mg methotrexate.One pre-filled pen with 0.3 ml solution contains 15 mg methotrexate.A pre-filled pen with 0.35 ml solution contains 17.5 mg methotrexate.A pre-filled pen with 0.4 ml solution contains 20 mg methotrexate.One pre-filled pen with 0.45 ml solution contains 22.5 mg methotrexate.A pre-filled pen with 0.5 ml solution contains 25 mg methotrexate.One pre-filled pen of 0.55 ml solution contains 27.5 mg methotrexate.One pre-filled pen of 0.6 ml solution contains 30 mg methotrexate. - The other ingredients are sodium chloride, sodium hydroxide and hydrochloric acid for pH adjustment and water for injections.
What the medicine looks like and contents of the pack
This medicine is supplied as a solution for injection in a pre-filled pen.
The solution is clear, yellow-brown.
The following pack sizes are available:
The Metojectpen is available in packs of 1, 2, 4, 5, 6, 10, 11, 12, 14, 15, and 24 pre-filled pens.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
medac
Society for Clinical Specialties MBH
Theater. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
This medicinal product is authorized under the European Economic Area under the names:
Finland, Greece, Netherlands, Romania, Slovakia, Slovenia, Spain, United Kingdom, Czech Republic, Hungary, Austria:
Metoject PEN
Iceland, Sweden:
Metojectpen
Germany:
meter PEN
Estonia, Latvia, Lithuania, Norway:
Meta
Poland, Portugal:
Metex PEN
Denmark:
Metex Pen
Belgium:
Project