DOPTELET 20 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Doptelet 20 mg, film-coated tablets

avatrombopag

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Doptelet and what is it used for
2. What you need to know before you take Doptelet
3. How to take Doptelet
4. Possible side effects
5. Storage of Doptelet
6. Contents of the pack and other information

1. What is Doptelet and what is it used for

Doptelet contains the active substance avatrombopag. It belongs to a group of medicines known as thrombopoietin receptor agonists.

Doptelet is used in adults with chronic liver disease to treat low platelet counts (thrombocytopenia) before undergoing a medical procedure where there is a risk of bleeding.

Doptelet is used to treat adults with low platelet counts due to primary chronic immune thrombocytopenia (ITP) when previous treatment for ITP (such as corticosteroids or immunoglobulins) has not worked well enough.

Doptelet helps increase the platelet count in the blood. Platelets are blood cells that help the blood to clot to reduce or prevent bleeding.

2. What you need to know before you take Doptelet

Do not take Doptelet:

• if you are allergic to avatrombopag or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Doptelet.

Warnings and precautions

Talk to your doctor or pharmacist before starting Doptelet if:

• you are at risk of blood clots in the veins or arteries, or your family members have had blood clots.
• you have another blood disorder known as myelodysplastic syndrome (MDS); taking Doptelet may worsen MDS.

It is possible that the risk of blood clots may increaseas you get older if:

• you have been bedridden for a long time.
• you have cancer.

• you are taking birth control pills or hormone replacement therapy.
• you have recently undergone surgery or had an injury.
• you are overweight.
• you smoke.
• you have advanced chronic liver disease.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Doptelet.

Blood tests for platelet count

If you stop taking Doptelet, your platelet count is likely to decrease to the level before treatment or even below that, with a risk of bleeding. This can happen within days. Your platelet count will be monitored and your doctor will discuss the appropriate precautions with you.

Tests to check the bone marrow

In people with bone marrow problems, medicines like Doptelet may worsen these problems. Signs of changes in the bone marrow may appear as abnormal blood test results. Your doctor may also perform tests to directly examine the bone marrow during treatment with Doptelet.

Children and adolescents

Do not give Doptelet to people under 18 years of age. The safety and efficacy of this medicine in this age group are not known.

Other medicines and Doptelet

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

If you are taking other medicines for ITP, you may need to take them in lower doses or stop them during treatment with Doptelet.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Doptelet is not recommended during pregnancy or in women of childbearing potential not using contraception.

If you are breastfeeding, ask your doctor or pharmacist for advice before taking Doptelet. This medicine may pass into breast milk. Your doctor will decide whether the benefits of breastfeeding are greater than the possible risks to the baby during this period.

Driving and using machines

Doptelet is not expected to affect your ability to drive, ride a bicycle or use tools or machines.

Doptelet contains lactose

Doptelet contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Doptelet

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

If you have chronic liver disease and a low platelet count, your medical procedure should be scheduled 5 to 8 days after the last dose of Doptelet.

If you have chronic ITP, your doctor will tell you how much Doptelet to take and how often.

How much to take

If you have chronic liver disease and are scheduled for an invasive procedure

• Doptelet is available as 20 mg tablets. The recommended dose is usually 40 mg (2 tablets) or 60 mg (3 tablets) per day for 5 consecutive days.
• The dose will depend on your platelet count.
• Your doctor or pharmacist will tell you how many tablets to take and when.

If you have chronic ITP

• The recommended initial dose is usually 20 mg (1 tablet) per day. If you are taking certain other medicines, you may need a different initial dose.
• Your doctor or pharmacist will tell you how many tablets to take and when.
• Your doctor will monitor your platelet count regularly and adjust the dose as needed.

How to take this medicine

• Swallow the tablets whole and take them with food at the same time each day you take Doptelet.

If you have chronic liver disease and a low platelet count

• Start taking Doptelet 10 to 13 days before the scheduled medical procedure.
• Your doctor or pharmacist will tell you how many tablets to take and when.

If you have chronic ITP

• Your doctor or pharmacist will tell you how many tablets to take and when.

If you take more Doptelet than you should

• Contact a doctor or pharmacist immediately.

If you forget to take Doptelet

• Take the missed dose as soon as possible and then take the next dose at the usual time.
• Do not take a double dose to make up for missed doses.

If you stop taking Doptelet

Take Doptelet for as long as your doctor has told you. Do not stop taking Doptelet unless your doctor tells you to.

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

4. Possible side effects

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

See your doctor or pharmacist if you notice any of the following side effects:

The following side effects have been reported in patients with chronic liver disease taking Doptelet:

Common(may affect up to 1 in 10 people)

• fatigue.

Uncommon(may affect up to 1 in 100 people)

• decrease in red blood cell count (anaemia).
• blood clots in the portal vein (the blood vessel that carries blood to the liver from the intestine), which can cause pain or inflammation in the upper abdomen.
• bone pain.
• muscle pain.
• fever.

Frequency not known(cannot be estimated from the available data)

• allergic reactions including swelling of the face, swelling of the tongue and skin changes such as rash and itching.

The following side effects have been reported in patients with chronic ITP taking Doptelet:

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

• fatigue.
• headache.

Common(may affect up to 1 in 10 people)

• back pain, muscle pain, joint pain, pain in the arms or legs.
• discomfort or pain in the bones, muscles, ligaments, tendons and nerves.
• nausea, diarrhea, vomiting, abdominal pain, gas.
• dizziness, headache discomfort.
• migraine.
• decreased appetite.
• weakness.
• nosebleeds.
• skin rash, itching, acne, red spots on the skin.
• tingling, pins and needles or numbness.
• enlargement of the spleen.
• shortness of breath.
• high blood pressure.
• tendency to bruising or bleeding (low platelet count).

Common side effects that may be detected in blood tests

• increase in fats (cholesterol, triglycerides).
• increase or decrease in blood sugar (glucose).
• increase in a liver enzyme (alanine aminotransferase).
• increase in lactate dehydrogenase.
• increase in gastrin.
• decrease in red blood cell count (anaemia).
• increase or decrease in platelet count.

Uncommon(may affect up to 1 in 100 people)

• redness, swelling and pain in a vein caused by a blood clot.
• pain, swelling and tenderness to the touch in one leg (usually in the calf), with the skin feeling hot in the affected area (signs of a deep vein blood clot).
• blood clots in the veins that carry blood from the brain.
• narrowing of blood vessels (vasoconstriction).
• sudden shortness of breath, especially when accompanied by sharp chest pain and/or rapid breathing, which could be signs of a blood clot in the lungs.
• blockage or narrowing of the vein that carries blood to the liver.
• stroke or transient stroke.
• heart attack.
• irregular heartbeat.
• hemorrhoids.
• enlargement of the veins in the rectum.
• inflammation (swelling) and infection of the nose, sinuses, throat, tonsils or middle ear (upper respiratory tract infection).
• scarring of the bone marrow.
• loss of body water or fluids (dehydration).
• increased appetite, hunger.
• emotional instability.
• abnormal thinking.
• changes in the senses of taste, smell, hearing and vision.
• eye problems such as irritation, discomfort, itching, swelling, watering, sensitivity to light, blurred vision, changes in vision, loss of vision.
• ear pain.
• increased sensitivity to everyday sounds.
• coughing up blood.
• nasal congestion.
• pain, discomfort or swelling in the abdomen.
• constipation.
• belching.
• acid reflux.
• burning or stinging sensation in the mouth.
• numbness of the mouth, swelling of the tongue, problems with the tongue.
• numbness.
• hair loss.
• boils.
• dry skin.
• dark purple spots on the skin (bleeding from blood vessels, bruising).
• excessive sweating.
• changes in skin color.
• itchy rash.
• skin irritation.
• joint problems.
• muscle cramps, muscle weakness.
• blood in the urine.
• heavy menstrual bleeding.
• breast pain.
• chest pain.
• pain.
• swelling in the legs or arms.

Uncommon side effects that may be detected in blood tests

• bacteria in the blood.
• increase in white blood cell count.
• decrease in iron in the blood.
• increase in a liver enzyme (aspartate aminotransferase), abnormal liver tests.

Frequency not known(cannot be estimated from the available data)

• allergic reactions including swelling of the face, swelling of the tongue and skin changes such as rash and itching.

Reporting of side effects

If you experience 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 in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doptelet

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 carton and on each blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What is in Doptelet

• The active substance is avatrombopag. Each film-coated tablet contains a amount of avatrombopag maleate equivalent to 20 mg of avatrombopag.

• The other ingredients are:

Tablet core: lactose monohydrate (see section 2 ‘Doptelet contains lactose’); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; colloidal anhydrous silica [E551]; magnesium stearate [E470b].

Tablet coating: polyvinyl alcohol [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; yellow iron oxide [E172].

Appearance of Doptelet and contents of the pack

The 20 mg film-coated tablets (tablets) of Doptelet are light yellow, rounded at the top and bottom, and have the letters «AVA» embossed on one side of the tablet and the number «20» on the other.

The tablets are supplied in cartons containing one or two aluminum blisters. Each blister contains 10 or 15 tablets.

Marketing authorisation holder

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Manufacturer

Swedish Orphan Biovitrum AB (publ)

Strandbergsgatan 49

Stockholm 112 51

Sweden

Date of last revision of this leaflet: 02/2024.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.