250 micrograms / 0.5 ml injection solution in prefilled pen 
ropeginterferon alpha-2b

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Besremi is and what it is used for 
2. What you need to know before you use Besremi 
3. How to use Besremi 
4. Possible side effects 
5. How to store Besremi 
6. Contents of the packaging and other information 

1. What Besremi is and what it is used for

Besremi contains the active substance peginterferon alfa-2b which belongs to a class of medicines called interferons. Interferon is made by your immune system to inhibit the growth of cancer cells.

Besremi is the only drug used to treat polycythemia vera in adults. Polycythemia vera is a type of cancer in which the bone marrow produces too many red blood cells , white blood cells and platelets (cells that cause the blood to coagulate).

2. What you need to know before using Besremi

Do not use Besremi

  • if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6).
  • if you have thyroid disease that is not controlled by medication.
  • if you have or have had severe mental disorders (eg depression or suicidal ideation or if you have attempted suicide).
  • if you have or have had severe heart problems (eg heart attack or stroke ).
  • if you have or have had an autoimmune disease (eg rheumatoid arthritis , psoriasis or inflammatory bowel disease).
  • if you have had an organ transplant and are taking medicines that suppress your immune system.
  • if you are taking telbivudine (a medicine used to treat hepatitis B infection ).
  • if you have advanced and uncontrolled liver disease.
  • if you have severe kidney disease (your kidney function is lower than 15% of normal function)

Warnings and cautions

Talk to your doctor before using Besremi:

  • if you have thyroid disease.
  • if you have diabetes or high blood pressure – your doctor may have you have an eye examination.
  • if you have liver problems – you will have to take blood samples regularly to check how your liver is working if you receive long-term treatment with Besremi.
  • if you have kidney problems.
  • if you have psoriasis or other skin problems as they may worsen during treatment with Besremi.

Once you have started treatment with Besremi, talk to your doctor:

  • if you develop symptoms of depression (eg if you feel sad, depressed or have suicidal thoughts).
  • if you develop signs of a severe allergic reaction (eg difficulty breathing, wheezing or hives ) while using Besremi – if so, seek immediate medical attention.
  • if you develop symptoms of a cold or respiratory infection (eg difficulty breathing, cough, fever and chest pain).
  • if you experience vision changes – you need to talk to a doctor and have an eye examination immediately. Severe eye problems may occur during treatment with Besremi. Your doctor will usually check your vision before starting treatment. If you have health problems that can lead to eye problems, e.g. diabetes or high blood pressure , your doctor should also check your vision during treatment. If your vision deteriorates, your doctor may decide to discontinue your treatment.

Dental or gum diseases that can lead to tooth loss can occur with drugs containing interferon. In addition, dry mouth can damage the teeth and oral mucosa during long-term treatment with Besremi. You should brush your teeth thoroughly twice a day and undergo regular dental checkups.

It will take a while before your individual optimal dose of Besremi is reached. Your doctor will decide if it is necessary to treat you with another medicine for an early reduction in your blood levels to prevent blood clots and bleeding.

Children and young people

Do not give this medicine to children and adolescents as no information is available on the use of Besremi in this age group.

Other medicines and Besremi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use Besremi if you are taking telbivudine (to treat hepatitis B) as the combination of these medicines increases the risk of peripheral neuropathy(numbness, stinging or burning sensation in the arms and legs). Tell your doctor if you are being treated with telbivudine.

Talk to your doctor especially if you are taking any of the following medicines:

  • theophylline (a medicine used to treat lung diseases such as asthma )
  • methadone (a medicine used to treat pain or opioid dependence)
  • vortioxetine or risperidone (medicines used to treat mental disorders)
  • cancer drugs such as those that stop or slow down the growth of blood-forming cells in the bone marrow (eg hydroxycarbamide)
  • drugs that act on the central nervous system to relieve pain, help you fall asleep, or that have a calming effect (eg morphine, midazolam).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The effect of Besremi during pregnancy is unknown. The use of Besremi is not recommended during pregnancy. If you are a pregnant woman, your doctor will discuss whether effective contraception should be used during your treatment with Besremi.

Breast-feeding

It is unknown whether Besremi is excreted in human milk. Your doctor will help you decide if you need to stop breast-feeding while you are taking this medicine.

Driving and using machines

Do not drive or use machines if you feel dizzy, sleepy, or confused while using Besremi.

Besremi contains besyl alcohol

This medicine contains 5 mg of benzyl alcohol in every 0.5 ml. Benzyl alcohol can cause allergic reactions.

Talk to a doctor or pharmacist:

  • if you are pregnant or breastfeeding.
  • if you have liver or kidney disease.

Large amounts of benzyl alcohol can be stored in the body and cause side effects(metabolic acidosis ).

Besremi contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.

3. How to use Besremi

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage one is determined individually for you by your doctor for your condition. The usual starting dose of Besremi is 100 micrograms every two weeks. Your doctor will then gradually increase your dose and may adjust your dose during treatment.

Your doctor will reduce your starting dose to 50 micrograms if you have severe kidney problems.

This medicine is for subcutaneous use which means it is injected into the tissue beneath your skin. It should not be injected into an area of ​​the body where the skin is irritated, red, bruised, infected, or scarred.

If you inject the medicine yourself, you will receive clear instructions on how to prepare and inject the medicine.

To prevent transmission of infectious diseases, never share the pre-filled pen with Besremi with anyone else, even if the needle is changed.

Detailed information on how to prepare and inject Besremi can be found in the instructions for use. Read it before using Besremi.

If you use more Besremi than you should  

Talk to a doctor as soon as possible.

If you forget to use Besremi

You should inject dose one as soon as you remember. If it has been longer than two days since the missed dose, you should skip that dose and inject the next dose when it is time. Do not inject a double dose to make up for a forgotten dose. Ask your doctor or pharmacist if you are unsure.

If you stop using Besremi

Do not stop using Besremi until you have talked to a doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor immediately if you experience any of the following serious side effects during your treatment with Besremi:

Common side effects (may affect up to 1 in 10 people):

  • change of heartbeat (when the heart beats very fast and unevenly).

Uncommon side effects (may affect up to 1 in 100 people):

  • suicide attempts, suicidal thoughts
  • vision loss that can be caused by bleeding in the retina (the retina is the photosensitive layer in the eye) or the accumulation of fat in or under the retina.

Rare side effects (may affect up to 1 in 1,000 people):

  • vision loss that can be caused by damage to the retina (such as blockage of blood vessels in the eye) or optic nerve.

Very rare side effects (may affect up to 1 in 10,000 people):

  • blindness
  • respiratory problems such as shortness of breath, cough, and chest pain that can be caused by pulmonary infiltrate, pneumonia ( pneumonia ), pulmonary arterial hypertension (high blood pressure in the blood vessels that carry blood from the heart to the lungs), and lung fibrosis (a lung disease when scars form in the lung tissue).

Adverse reactions that have been reported (affects an unknown number of users):

  • retinal detachment (you may experience eye problems, including vision changes).

Other side effects are

Very common side effects (may affect more than 1 in 10 people):

  • decreased number of white blood cell types (called leukocytes ) and blood clotting cells ( platelets ) –
  • joint or muscle pain –
  • flu-like symptoms, feeling tired –
  • in blood samples: increased level of an enzyme called gamma-glutamyltransferase.

Common side effects (may affect up to 1 in 10 people):

  • respiratory tract infections, runny or stuffy nose, fungal infections
  • decreased number or size of red blood cells
  • increase or decrease in thyroid activity increased level of thyroid-stimulating hormone, inflammation of the thyroid gland
  • increased levels of triglycerides (a type of fat) in the blood, decreased appetite
  • aggressive behavior, depression, anxiety, difficulty falling asleep or sleeping, mood swings, lack of energy or motivation
  • headache, dizziness, the impaired feeling of touch or sensation, drowsiness, tingling or stinging sensation
  • dry eye
  • damage to the capillaries (very small blood vessels) in the body
  • breathing problems
  • diarrhea, nausea, abdominal pain, stomach upset, constipation, dry mouth
  • liver disease, increased levels of certain liver enzymes (shown in blood tests)
  • itching, hair loss, rash, redness of the skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating
  • a disease called Sjögren’s syndrome when the body’s immune system attacks glands that form fluid (such as lacrimal and salivary glands), arthritis, pain in the arms and legs, leg pain, painful sudden muscle contraction
  • fever, weakness, chills, general health problems, irritation or redness at the injection site
  • in blood tests: antibodies are formed by the body’s immune system, increased levels of an enzyme called lactate dehydrogenase .

Uncommon side effects (may affect up to 1 in 100 people):

  • infection and re-infection with herpes, bacterial infections
  • increased platelet count
  • autoimmune disease of the thyroid gland, sarcoidosis (areas of inflamed tissue in different parts of the body)
  • diabetes
  • panic attack, hallucination (seeing, hearing, or feeling things that do not exist), feeling stressed, feeling nervous, lack of interest in activities, nightmares, irritability, confusion
  • damage to the nervous system, migraine, mental disorders (health conditions involving changes in thought, feeling, or behavior), visual or emotional disorders, tremors in the hands
  • eye discomfort, eyelid eczema
  • hearing loss, ringing in the ears ( tinnitus ), dizzy feeling (dizziness)
  • heart diseases such as heart block (a disease that affects the electrical activity of the heart), blood clots in the blood vessels of the heart, leakage in the aortic valve
  • high blood pressure, decreased blood supply in certain parts of the body, hematoma (accumulation of blood under the skin), hot flashes
  • inflammation of lung tissue, cough, nosebleeds, sore throat
  • inflammation of the stomach, disturbance in the abdominal wall, gas in the intestine, indigestion, painful swallowing, bleeding gums
  • inflammation of the liver, damage to the liver, enlarged liver
  • sensitive to sunlight, scaly skin, nail disease
  • muscle weakness, neck pain, groin pain
  • inflammation of the bladder, painful urination, increased need to urinate, inability to urinate
  • sexual problems
  • pain or itching at the injection site, sensitivity to weather changes
  • weight loss
  • in blood tests: increased levels of uric acid, antibodies formed by the body’s immune system against red blood cells.

Rare side effects (may affect up to 1 in 1,000 people):

  • bipolar disorder (mood disorders with periods of depression and agitation), mania (extreme agitation or unfounded enthusiasm)
  • cardiomyopathy (diseases affecting the heart muscle), angina pectoris (a severe chest pain as a result of a blockage of the heart vessels )
  • liver failure.

Very rare side effects (may affect up to 1 in 10,000 people):

  • idiopathic or thrombotic thrombocytopenic purpura (increased incidence of bruising, bleeding, decreased platelet level, anemia, and extreme weakness)
  • myocardial ischemia (decreased blood flow to the heart muscle).

Adverse reactions that have been reported (affects an unknown number of users):

  • Vogt-Koyanagi-Harada disease (a rare disease that can lead to vision loss, hearing loss, and skin pigmentation), severe allergic reaction
  • discoloration of the skin
  • periodontal (affects the gums) and dental diseases, discoloration of the tongue.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Besremi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”. The expiration date is the last day of the specified month.

Store in a refrigerator (2-8 ° C).

Do not freeze.

Keep the pre-filled pen in the outer carton. Sensitive to light.

After opening, the pre-filled pen can be stored for a maximum of 30 days in a refrigerator (2–8 ° C) when stored with the cap affixed to the pen and the outer carton to protect from light.

Do not use this medicine if you find that the pre-filled pen appears to be damaged, the solution in it is cloudy, contains particles or flakes or has a color other than colorless to light yellow.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ropeginterferon alfa-2b. Each pre-filled pen of 0.5 ml solution contains 250 micrograms of ropeginterferon alfa-2b measured as protein alone corresponding to 500 micrograms / ml.
  • The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, concentrated acetic acid, and water for injections. For benzyl alcohol and sodium , see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”.

What the medicine looks like and the contents of the pack

Besremi is supplied as a solution for injection ( injection ) in a pre-filled pen. Each pre-filled pen contains 0.5 ml of solution. The medicine is available in packs containing 1 pre-filled pen and 2 syringes.

Marketing Authorization Holder and Manufacturer

AOP Orphan Pharmaceuticals AG

Wilhelminenstrasse 91 / II f

1160 Vienna

Austria

Muhammad Nadeem

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