METOJECT PEN 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

1. what metoject pen is and what it is used for

Metoject PEN is indicated for the treatment of

• active rheumatoid arthritis in adult patients.
• polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate.
• moderate to severe psoriasis in adult patients, and severe psoriatic arthritis in adults.
• mild to moderate Crohn’s disease in adult patients when adequate treatment with other medicines is not possible.

Rheumatoid arthritis (RA) is a chronic collagen disease, characterised by inflammation of the synovial membranes (joint membranes). These membranes produce a fluid which acts as a lubricant for many joints. The inflammation causes thickening of the membrane and swelling of the joint.

Juvenile arthritis concerns children and adolescents less than 16 years. Polyarthritic forms are indicated if 5 or more joints are affected within the first 6 months of the disease.

Psoriasis is a common chronic skin disease, characterised by red patches covered by thick, dry, silvery, adherent scales.

Psoriatic arthritis is a kind of arthritis with psoriatic lesions of the skin and nails, especially at the joints of fingers and toes.

Metoject PEN modifies and slows down the progression of the disease.

Crohn’s disease is a type of inflammatory bowel disease that may affect any part of the gastrointestinal tract causing symptoms such as abdominal pain, diarrhoea, vomiting or weight loss.

2. what you need to know before you use metoject pen

Do not use Metoject PEN:

• if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from liver or severe kidney diseases or blood diseases.
• if you regularly drink large amounts of alcohol.
• if you suffer from a severe infection, such as tuberculosis, HIV or other immunodeficiency syndromes.
• if you suffer from mouth ulcers, stomach ulcer or intestinal ulcer.
• if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
• if you receive vaccinations with live vaccines at the same time.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metoject PEN if:

• you are elderly or if you feel generally unwell and weak.
• you have problems with the way your liver works.
• you suffer from dehydration (water loss).

Special precautionary measures for treatment with Metoject PEN

Methotrexate temporarily affects sperm and egg production, which is reversible in most cases. Methotrexate can cause miscarriage and severe birth defects. You must avoid becoming pregnant when using methotrexate and for at least six months after treatment has stopped. See also section “Pregnancy, breast-feeding and fertility”.

Recommended follow-up examinations and safety measures

Even when Metoject PEN is administered in low doses, severe side effects can occur. In order to detect them in time, check-ups and laboratory tests have to be carried out by your doctor.

Before therapy

Before starting the treatment, blood samples will be taken in order to check that you have enough blood cells, tests to check your liver function, serum albumin (a protein in the blood) and kidney function. Your doctor will also check if you suffer from tuberculosis (infectious disease in combination with little nodules in the affected tissue) and a chest X-ray will be taken.

During therapy

You will have the following tests at least once a month during the first six months and at least every three months thereafter:

• Examination of the mouth and throat for changes of the mucosa.
• Blood tests.
• Check of liver function.
• Check of kidney function.
• Check of respiratory system and if necessary lung function test.

Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate. If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.

Methotrexate may affect your immune system and vaccination results. It may also affect the result of immunological tests. Inactive, chronic infections (such as herpes zoster [shingles], tuberculosis, hepatitis B or C) may flare up. During therapy with Metoject PEN you must not be vaccinated with live vaccines.

Radiation-induced dermatitis and sun-burn can reappear under methotrexate therapy (recall-reaction). Psoriatic lesions can exacerbate during UV-irradiation and simultaneous administration of methotrexate. Enlarged lymph nodes (lymphoma) may occur and if this is the case, therapy must be stopped.

Diarrhoea can be a possible side effect of Metoject PEN and requires an interruption of therapy. If you suffer from diarrhoea please speak to your doctor.

Certain brain disorders (encephalopathy/ leukoencephalo­pathy) have been reported in cancer patients receiving methotrexate. Such side effects cannot be excluded when methotrexate is used to treat other diseases.

Other medicines and Metoject PEN

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 may be affected if Metoject PEN is administered at the same time as certain other medicines:

• Antibiotics such as: tetracyclines, chloramphenicol, non-absorbable broad-spectrum antibiotics, penicillines, glycopeptides, sulphonamides, ciprofloxacin and cefalotin (medicines to prevent/fight certain infections).
• Non-steroidal anti-inflammatory drugs or salicylates (medicines against pain and/or inflammation such as acetylsalicylic acid, diclofenac and ibuprofen or pyrazole).
• Probenecid (medicine against gout).
• Weak organic acids like loop diuretics (“water tablets”).
• Medicines, which may have adverse effects on the bone marrow, such as trimethoprim-sulphamethoxazole (an antibiotic) and pyrimethamine.
• Other medicines used to treat rheumatoid arthritis such as leflunomide, sulphasalazine and azathioprine.
• Mercaptopurine (a cytostatic medicine).
• Retinoids (medicine against psoriasis and other dermatological diseases).
• Theophylline (medicine against bronchial asthma and other lung diseases).
• Some medicines against stomach trouble such as omeprazole and pantoprazole.
• Hypoglycaemics (medicines that are used to lower the blood sugar).

Vitamins containing folic acid may impair the effect of your treatment and should only be taken when advised by your doctor.

Vaccination with live vaccine must be avoided.

Metoject PEN with food, drink and alcohol

Alcohol as well as large amounts of coffee, caffeinecontaining soft drinks and black tea should be avoided during treatment with Metoject PEN.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not use Metoject PEN during pregnancy or if you are trying to become pregnant. Methotrexate can cause birth defects, harm the unborn child or cause miscarriage. It is associated with malformations of the skull, face, heart and blood vessels, brain and limbs. Therefore, it is very important that methotrexate is not given to pregnant patients or patients planning to become pregnant.

In women of child-bearing age, any possibility of pregnancy must be excluded with appropriate measures, e.g. pregnancy test before starting treatment.

You must avoid becoming pregnant whilst taking methotrexate and for at least 6 months after treatment is stopped by using reliable contraception throughout this time (see also section “Warnings and precautions”).

If you do become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible. You should be offered advice regarding the risk of harmful effects on the child through treatment.

If you wish to become pregnant you should consult your doctor, who may refer you for specialist advice before the planned start of treatment.

Breast-feeding

Stop breast-feeding prior to and during treatment with Metoject PEN.

Male fertility

The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes methotrexate less than 30 mg/week. However, a risk cannot be completely excluded. Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation. Methotrexate can affect sperm production with the potential to cause birth defects. Therefore, you should avoid fathering a child or to donate semen whilst taking methotrexate and for at least 6 months after treatment is stopped.

Driving and using machines

Treatment with Metoject PEN may cause adverse reactions affecting the central nervous system, such as tiredness and dizziness. Thus the ability to drive a vehicle and/or to operate machines may, in certain cases, be compromised. If you feel tired or drowsy do not drive or use machines.

Metoject PEN contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose; that is to say essentially “sodium-free”.

3. how to use metoject pen

Important warning about the dose of Metoject PEN (methotrexate):

Use Metoject PEN only once a week for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis, and Crohn’s disease. Using too much of Metoject PEN (methotrexate) may be fatal. Please read section 3 of this leaflet very carefully. If you have any questions, please talk to your doctor or pharmacist before you take this medicine.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor decides on the dose, which is adjusted individually to you. Usually it takes 4 – 8 weeks before there is any effect of the treatment.

Metoject PEN is administered subcutaneously (under the skin) by or under the supervision of a physician or healthcare staff as an injection once a week only. Together with your doctor you decide on a suitable weekday each week on which you receive your injection.

Use in children and adolescents

The doctor decides on the appropriate dose in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis.

Metoject PEN is not recommended in children less than 3 years of age due to insufficient experience in this age group.

Instructions for use

Recommendations

• > Carefully read the instructions below before starting your injection.

• > Always use the injection technique advised by your doctor, pharmacist or nurse.

Additional information

The manner of handling and throwing away of the medicine and pre-filled pen must be in accordance with local requirements. Pregnant healthcare personnel should not handle and/or administer Metoject PEN.

Methotrexate should not come into contact with the surface of the skin or mucosa. In the event of contamination, the affected area must be rinsed immediately with plenty of water.

What you need in order to administer your injection using the Metoject PEN pre-filled pen

You need:

• 1 Metoject PEN pre-filled pen
• 1 alcohol pad

Metoject PEN pre-filled pen components:

Injection button

Handling area

Transparent control zone

Cap

With cap before injection

After cap removal before injection

After injection

What you need to do before administering your injection

• 1. Wash your hands very carefully.

• 2. Remove the system from its packaging.

• 3. Check the Metoject PEN pre-filled pen before using it:

  
  

If the Metoject PEN pre-filled pen appears to be damaged do not use it. Use another one and contact your doctor, pharmacist or nurse.

In case a small air bubble is visible through the transparent control zone, this will not affect your dose nor will it harm you.

If you are not able to see or to check the system correctly prior to injection, ask someone around you for assistance.

• 4. Set the Metoject PEN pre-filled pen on a clean flat surface (such as a table).

Where you should administer the injection

The most appropriate zones for your injection are: upper thighs, abdomen except around the navel.

If someone around you administers the injection for you, the person may also use the top of the zone at the back of the arm, just below the shoulder.

• Change the injection area with each injection. This will minimise any reactions at the injection site.
• Never inject into areas where the skin is tender, bruised, red or hard or where you have scars or stretch marks. If you have psoriasis, you should not try to inject directly into any raised, thick, red or scaly skin patches or lesions.

How to prepare the injection

Choose an injection site and clean the area of and around the chosen injection site using the enclosed alcohol pad.

Do not remove the cap before you are ready to administer the injection.

Hold the pen with one hand in the handling area with the cap pointing upwards. Use your other hand to gently pull the cap straight off (do not bend or twist the cap). The cap has a small needle shield that should come off with the cap automatically. If the needle shield does not come off, use another pen and contact your doctor, pharmacist or nurse.

• If you are unable to remove the cap, ask someone around you for assistance.

Note: Once you have removed the cap, perform your injection without delay.

With your free hand, build a skin fold by gently squeezing the area of the cleaned skin at the injection site.

The fold must be held pinched until the Metoject PEN pre-filled pen is removed from the skin after the injection.

Position the uncapped transparent end of Metoject PEN pre-filled pen perpendicular to the fold of skin.

Without pressing the button , push the Metoject PEN pre-filled pen firmly onto your skin in order to unlock the button.

If you are unable to push the Metoject PEN pre-filled pen to the stop-point, ask someone around you for assistance.

How to administer the injection:

• 10. While holding the Metoject PEN pre-filled pen firmly against the skin, now press the button with your thumb.

• 11. You will hear a click which indicates the start of the injection. Keep holding the pen against the raised skin until all of the medicine is injected. This can take up to 5 seconds.

Note:

Do not remove the Metoject PEN pre-filled pen from the skin before the end of the injection to avoid incomplete injection.

If the injection is not triggered, release the button, make sure that the Metoject PEN pre-filled pen is pressed firmly against the skin and push hard on the button.

If you have troubles with your hearing, count 5 seconds from the moment you have pressed the button and then lift the Metoject PEN pre-filled pen from the injection site.

• 12. Remove the Metoject PEN pre -filled pen from the injection site, perpendicular to the skin (pull up).

• 13. The protective shield automatically moves into place over the needle. The protective shield is then locked and the needle is protected.

• 14. In case of a slight bleeding use a plaster.