Doptelet 20 mg comprimidos recubiertos con pelicula

Product Information for the Patient

Doptelet 20 mg, Film-Coated Tablets

avatrombopag

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this product information. See section 4.

Doptelet contains an active substance called 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 levels (thrombocytopenia) before undergoing a medical procedure where there is a risk of bleeding.

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

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

Do not take Doptelet:

• if you are allergic to avatrombopag or any of the other components of this medication (listed in section 6). If you are unsure, consult your doctor or pharmacist before taking Doptelet.

Warnings and precautions

Consult your doctor or pharmacist before starting Doptelet if:

• there is a risk of blood clots forming in veins or arteries, or if your family members have had blood clots.
• you have another blood disorder known as myelodysplastic syndrome (MDS); taking Doptelet may worsen MDS

It may be possible thatthe risk of blood clots increasesas you get older if:

• you have had to stay in bed for a prolonged period
• 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 your case (or you are unsure), consult your doctor or pharmacist before taking Doptelet.

Blood tests for platelet count

If you interrupt treatment with Doptelet, it is likely that your platelet count will decrease to the pre-treatment level or even below this, with a risk of bleeding. This may occur within days. Your platelet count will be monitored and your doctor will discuss the necessary precautions with you.

Bone marrow tests

In people with bone marrow problems, medications like Doptelet may worsen these problems. Signs of changes in the bone marrow may be evident from abnormal blood test results. Your doctor may also perform tests to directly inspect the bone marrow during treatment with Doptelet.

Children and adolescents

Do not administer Doptelet to individuals under 18 years of age. The safety and efficacy of this medication in this age group are unknown.

Other medications and Doptelet

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking other medications for thrombocytopenia, you may need to take them at lower doses or interrupt them during treatment with Doptelet.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Doptelet is not recommended for use during pregnancy or in fertile women who do not use contraceptive methods.

If you are breastfeeding, consult your doctor or pharmacist before taking Doptelet. This medication may be transferred through breast milk. Your doctor will decide whether the benefits of breastfeeding outweigh the potential risks to the baby during this period.

Driving and operating machinery

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

Doptelet contains lactose

Doptelet contains lactose (a type of sugar). If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

If you have chronic thrombocytopenic purpura (TPI), 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 in 20 mg tablets. The usual recommended dose is 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 TPI

• The usual recommended initial dose is 20 mg (1 tablet) per day. If you are taking other certain medications, 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 periodically and adjust the dose as needed.

How to take this medication

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

If you have chronic liver disease and a low platelet count

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

If you have TPI

• 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 the missed doses.

If you interrupt treatment with Doptelet

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

The following side effects have been reported in association with Doptelet treatment in adult patients with chronic liver disease:

Common(may affect up to one in ten people)

• fatigue

Uncommon(may affect up to one in 100 people)

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

Frequency not known(cannot be estimated from available data)

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

The following side effects have been reported in association with Doptelet treatment in adult patients with chronic thrombocytopenic purpura:

Very common(may affect more than one in ten people)

• fatigue
• headache

Common(may affect up to one in ten 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, digestive gases
• dizziness, discomfort in the head, migraine
• decreased appetite
• weakness
• nasal bleeding
• 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 form bruises or bleedings (low platelet count)

Common side effects that can 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 (anemia)
• increase or decrease in platelet count

Uncommon(may affect up to one in 100 people)

• redness, swelling, and pain in a vein caused by a blood clot
• redness, swelling, and tenderness in one leg (usually in the calf), with the skin warm in the affected area (signs of a blood clot in a deep vein)
• blood clots in the veins that carry blood from the brain
• narrowing of blood vessels (vasoconstriction)
• sudden shortness of breath, especially when accompanied by stabbing chest pain and/or rapid breathing, which may be signs of a blood clot in the lungs
• obstruction or narrowing of the vein that carries blood to the liver
• stroke or transient ischemic attack
• heart attack
• irregular heartbeat
• hemorrhoids
• dilation of the rectal veins
• inflammation (swelling) and infection of the nose, paranasal sinuses, throat, tonsils, or middle ear (upper respiratory tract infection)
• formation of scar tissue in the bone marrow
• dehydration (loss of body fluids)
• increased appetite, hunger
• emotional instability
• abnormal thinking
• alterations in the senses of taste, smell, hearing, and vision
• eye problems such as irritation, discomfort, itching, swelling, tearing, sensitivity to light, blurred vision, vision changes, loss of vision
• ear pain
• increased sensitivity to everyday sounds
• coughing up blood
• nasal congestion
• abdominal pain, discomfort, or swelling
• constipation
• belching
• acid reflux
• burning or stinging sensation in the mouth
• numbness of the mouth, swelling of the tongue, tongue problems
• tingling
• hair loss
• boils
• dry skin
• dark purple spots on the skin (bleeding from blood vessels, formation of hematomas)
• excessive sweating
• skin color changes
• pruritic rash
• skin irritation
• joint anomaly
• 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 can 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 available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on each blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the medications that you no longer need. This will help protect the environment.

Composition of Doptelet

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

• The other components are:

Tablet core: monohydrate lactose (see section 2 "Doptelet contains lactose"); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; anhydrous colloidal 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 packaging

The 20 mg film-coated tablets (tablets) of Doptelet are light yellow, rounded on top and bottom, and have the letters "AVA" in relief on one side of the tablet and the count "20" on the other.

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

Marketing authorization holder

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Responsible for manufacturing:

Swedish Orphan Biovitrum AB (publ)

Strandbergsgatan 49

Stockholm 112 51

Sweden

Last review date of this leaflet: 02/2024.

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.