Doptelet

Patient Information Leaflet

Doptelet 20 mg film-coated tablets

avatrombopag
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Doptelet is and what it is used for

Doptelet contains an active substance called avatrombopag, which 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), prior to undergoing a medical procedure that carries a risk of bleeding.
Doptelet is used to treat adults with low platelet counts due to chronic primary immune thrombocytopenia (ITP), when a previous ITP treatment (such as corticosteroids or immunoglobulins) has not worked well enough.
Doptelet works by helping to increase the number of platelets in the blood. Platelets are blood cells that play a role in blood clotting, thereby reducing or preventing bleeding.

2. What you need to know before taking Doptelet

Do not take Doptelet

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Doptelet:

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

Your risk of thrombosis may be higher as you get older or if:

• you have been confined to bed for a prolonged period
• you have cancer
• you are taking oral contraceptives or hormone replacement therapy
• you recently had surgery or suffered trauma
• you are significantly overweight
• you smoke
• you have advanced chronic liver disease.

If any of the above situations apply to you (or if you have any doubts), consult your doctor or pharmacist before using Doptelet.
Blood tests for platelet count
If you stop taking Doptelet, your platelet count is likely to decrease to levels similar to or even lower than before treatment, increasing the risk of bleeding. This may occur within a few days.
Your platelet count will be monitored and your doctor will discuss appropriate precautions with you.
Tests to monitor bone marrow
In people with bone marrow disorders, medicines such as Doptelet may worsen the condition. Signs of bone marrow changes may appear as abnormal results in your blood tests. Your doctor may also perform a test to directly examine your bone marrow during treatment with Doptelet.
Children and adolescents
Doptelet must not be given to individuals under 18 years of age. In this age group, the safety and efficacy of this medicine are unknown.
Other medicines and Doptelet
Inform 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 be able to take a lower dose or stop taking them while on Doptelet.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The use of Doptelet is not recommended during pregnancy and in women of childbearing potential who are not using contraception.
If you are breastfeeding, consult your doctor or pharmacist before taking Doptelet. This medicine may pass into breast milk. Your doctor will help you decide whether the benefits of breastfeeding outweigh any potential risk to the baby while you are taking Doptelet.
Driving and using machines
Doptelet is unlikely to affect your ability to drive, ride a bicycle, or operate tools or machinery.
Doptelet contains lactose
Doptelet contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Doptelet

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
If you have chronic liver disease and a low platelet count, the medical procedure you are scheduled
to undergo should be planned 5 to 8 days after taking your last dose of Doptelet.
If you have chronic ITP, your doctor will tell you how much Doptelet to take and how often.
How much medicine to take
If you have chronic liver disease and are scheduled for an invasive procedure

• Doptelet is available as 20 mg tablets. The usual recommended dose is usually 40 mg (2 tablets) or 60 mg (3 tablets) once daily 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 usual recommended starting dose is 20 mg (1 tablet) once daily. If you are taking certain other medicines, you may require a different starting dose.
• Your doctor or pharmacist will tell you how many tablets to take and when to take them.
• Your doctor will regularly monitor your platelet count and adjust the dose as needed.

How to take this medicine

• Swallow the tablets whole. Take them with a meal at the same time each day of Doptelet treatment.

If you have chronic liver disease and a low platelet count

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

If you have chronic ITP

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

If you take more Doptelet than you should

• Contact your doctor or pharmacist immediately.

If you forget to take Doptelet

• Take the missed dose as soon as you remember, then take the next dose at the scheduled time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Doptelet
Take Doptelet for the length of time prescribed by your doctor. Stop treatment with Doptelet
only if your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact 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
adults with chronic liver disease:

Common (may occur in up to 1 in 10 people)

• Feeling of tiredness

Uncommon (may occur in up to 1 in 100 people)

• Low red blood cell count (anaemia)
• Formation of a blood clot in the portal vein (the blood vessel carrying blood from the intestine to the liver), which may cause upper abdominal pain or swelling
• Bone pain
• Muscle pain
• Fever

Not known (frequency cannot be estimated from the available data)

• Allergic reactions including facial swelling, swollen tongue, and skin reactions such as rash and itching

The following side effects have been reported in association with Doptelet treatment in
adults with chronic primary ITP:

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

• Feeling of tiredness
• Headache

Common (may occur in up to 1 in 10 people)

• Back pain, muscle pain, joint pain, pain in arms or legs
• Discomfort or pain in bones, muscles, ligaments, tendons, and nerves
• Nausea, diarrhoea, vomiting, abdominal pain, flatulence
• Dizziness, discomfort in head, migraine
• Decreased appetite
• Weakness
• Nosebleeds
• Rash, itching, acne, red spots on the skin
• Tingling, prickling, or numbness sensation, commonly known as “pins and needles”
• Enlargement of the spleen
• Shortness of breath
• High blood pressure
• Tendency to bruise or bleed (low platelets)

Common side effects that may be revealed by blood tests

• Increase in blood fats (cholesterol, triglycerides)
• Increase or decrease in blood glucose (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 occur in up to 1 in 100 people)

• Redness, swelling, and pain in a vein due to a blood clot
• Pain, swelling, and tenderness in one of the legs (usually in the calf), with warm skin in the affected area (signs of a blood clot in a deep vein)
• Blood clots in veins carrying blood from the brain
• Constriction of blood vessels (vasoconstriction)
• Sudden shortness of breath, especially when accompanied by sharp chest pain and/or rapid breathing, which may indicate a blood clot in the lungs
• Blockage or narrowing of the vein carrying blood to the liver
• Stroke or mini-stroke
• Heart attack
• Irregular heartbeat
• Haemorrhoids
• Dilatation of rectal veins
• Inflammation (swelling) and infection of nose, sinuses, throat, tonsils, or middle ear (upper respiratory tract infection)
• Bone marrow fibrosis
• Loss of body water or fluids (dehydration)
• Increased appetite, hunger
• Mood swings
• Abnormal thoughts
• Changes in senses of taste, smell, hearing, vision
• Eye problems including irritation, discomfort, itching, swelling, tearing, light sensitivity, blurred vision, vision changes, vision loss
• Ear pain
• Increased sensitivity to common sounds
• Coughing up blood
• Nasal congestion
• Pain, discomfort, or swelling in the abdomen
• Constipation
• Belching
• Acid reflux
• Burning or prickling sensation in the mouth
• Numbness of the mouth, tongue swelling, tongue problems
• Numbness
• Hair loss
• Boils
• Dry skin
• Dark purple spots on the skin (bleeding from blood vessels, bruising)
• Excessive sweating
• Changes in skin colour
• Itchy rash
• Skin irritation
• Joint abnormality
• Muscle cramps, muscle weakness
• Blood in urine
• Heavy menstrual cycle
• Nipple pain
• Chest pain
• Pain
• Swelling of arms or legs

Uncommon side effects that may be revealed by blood tests

• Bacteria in the blood
• Increase in white blood cells
• Decrease in blood iron
• Increase in a liver enzyme (aspartate aminotransferase), abnormal liver tests

Not known (frequency cannot be estimated from the available data)

• Allergic reactions including facial swelling, tongue swelling, and skin reactions such as rash and itching

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 after "Exp." and on each blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Doptelet contains

• The other components 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]. Film coating: polyvinyl alcohol [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; yellow iron oxide [E172].

Description of the appearance of Doptelet and contents of the pack
Doptelet 20 film-coated tablets (tablets) are pale yellow in colour, round in shape, rounded on both sides, and marked with the inscription “AVA” imprinted on one side and the number “20” on the other side.
The tablets are supplied in cardboard boxes containing one or two aluminium 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)
Norra Stationsgatan 93
113 64 Stockholm
Sweden

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.