20 mg film-coated tablets
avatrombopag
1. What Doptelet is and what it is used for
Doptelet contains an active substance called avatrombopag. It belongs to a group of medicines called thrombopoietin receptor agonists.
Doptelet is used in adults with chronic liver disease to treat low platelet counts ( thrombocytopenia ) before a medical procedure that carries a risk of bleeding.
Doptelet is used to treat adults with low platelet counts due to primary chronic immunological thrombocytopenia (ITP) when previous treatment with ITP (such as corticosteroids or immunoglobulins) has not worked well enough.
Doptelet works by helping to increase the number of platelets in the blood. The platelets are blood cells that help the blood to coagulate and thus reduce or prevent bleeding.
2. What you need to know before taking 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 cautions
Talk to your doctor or pharmacist before taking Doptelet if:
- you are at risk of getting blood clots in your veins or arteries, or if any family member has had blood clots.
- you have another blood disorder called myelodysplastic syndrome (MDS); treatment with Doptelet may worsen MDS.
The risk of getting blood clots can be higher as you get older if:
- you stay in bed for a long time
- you have cancer
- you are taking pills or receiving hormone replacement therapy
- you have recently had surgery or been injured
- you are severely overweight
- you are smoking
- you have advanced chronic liver disease.
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Blood tests to check the number of platelets
If you stop taking Doptelet, the platelet count will probably be as low as before or even lower, leading to a risk of bleeding. This can happen within a few days. The platelet count will be checked and your doctor will discuss appropriate precautions with you.
Tests to check the bone marrow a
In people who have problems with the bone marrow, drugs such as Doptelet can make the problems worse. Signs of changes in the bone marrow may show abnormal results in blood tests. Your doctor may also take samples to directly check your bone marrow during treatment with Doptelet.
Children and young people
Do not give Doptelet to anyone under 18 years of age. The safety and efficacy of the drug 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 lower your dose or stop taking it while you are taking 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 breast-feeding, ask your doctor or pharmacist for advice before taking Doptelet. This medicine can pass into breast milk. Your doctor will help you determine if the benefits of breastfeeding outweigh the potential risks to your baby while breastfeeding.
Driving and using machines
Doptelet is not expected to affect the ability to drive, cycle or use tools or machines.
Doptelet contains lactose
Doptelet contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Doptelet
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
If you have chronic liver disease and low platelet counts, your planned medical procedure should be performed within 5 to 8 days after the last dose of Doptelet.
If you have chronic immunological thrombocytopenia, your doctor will tell you how much Doptelet to take and when to take it.
How many doses should I take?
If you have chronic liver disease and are about to undergo an invasive procedure
- Doptelet is available as 20 mg tablets. The usual dose is either 40 mg (2 tablets) or 60 mg (3 tablets) a day, 5 days in a row.
- Dose one depends on your platelet count ( platelet count ).
- Your doctor or pharmacist will tell you how many tablets to take and when to take them.
If you have chronic immunological thrombocytopenia
- The usual starting dose is 20 mg (1 tablet) a day. If you are taking certain other medicines, you may need a different starting dose.
- Your doctor or pharmacist will tell you how many tablets to take and when to take them.
- Your doctor will check your platelet count at regular intervals and will adjust your dose as needed.
Take the medicine like this
- The tablets should be swallowed whole and Doptelet should be taken with food, at the same time each day.
If you have chronic liver disease and low platelet counts
- Start taking Doptelet 10 to 13 days before the planned medical procedure.
- Your doctor or pharmacist will tell you how many tablets to take and when to take them.
If you have chronic immunological thrombocytopenia
- Your doctor or pharmacist will tell you how many tablets to take and when to take them.
If you take more Doptelet then you should
- Talk to a doctor or pharmacist immediately.
If you forget to take Doptelet
- Take the missed dose as soon as you remember and then take the next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Doptelet
Take Doptelet for as long as your doctor tells you to. Do not stop taking Doptelet unless your doctor tells you to.
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.
Talk to your doctor or pharmacist if you get any of the following side effects.
The following side effects have been reported with Doptelet treatment in adult patients with chronic liver disease:
Common (may affect up to 1 in 10 people)
- fatigue.
Uncommon (may affect up to 1 in 100 people)
- low red blood cell count ( anemia )
- a blood clot in the portal vein (the blood vessel that carries blood from the intestines to the liver), which can lead to pain or swelling in the upper abdomen
- skeletal pain
- muscle aches
- fever.
The following adverse reactions have been reported with Doptelet treatment in adult patients with primary chronic immunological thrombocytopenia :
Very common (may affect more than 1 in 10 people)
- fatigue
- headache.
Common (may affect up to 1 in 10 people)
- back pain, muscle aches, joint pain, pain in arms or legs
- discomfort or pain in the skeleton, muscles, ligaments, tendons, and nerves
- nausea, diarrhea, vomiting, abdominal pain, flatulence
- dizziness, discomfort in the head, migraine
- decreased appetite
- weakness
- nosebleeds
- skin rash, itching, acne, red spots on the skin
- tingling or numbness
- enlarged spleen
- shortness of breath
- high blood pressure
- the tendency to bruise or bleed (low platelet count ).
Common side effects are those that can show up in blood tests
- elevated fats ( cholesterol, triglycerides )
- elevated or decreased blood sugar ( glucose )
- the elevated liver enzyme ( alanine aminotransferase )
- elevated lactate dehydrogenase
- elevated gastrin
- decreased number of red blood cells ( anemia )
- increased or decreased platelet count.
Uncommon (may affect 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 the calf) with hot skin on 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 with a sharp pain in the chest and/or rapid breathing, which may be a sign of a blood clot in the lungs
- clogging or narrowing of the vein that carries blood to the liver
- stroke or “mini-stroke”
- myocardial infarction
- irregular heartbeat
- hemorrhoids
- dilation of rectal veins
- inflammation (swelling) and infection of the nose, sinuses, throat, tonsils, or middle ear (upper respiratory tract infection)
- scarring of the bone marrow a
- reduced amount of water or body fluids (dehydration)
- increased appetite, hunger
- mood swings
- abnormal thinking
- altered sense of taste, hearing, or sight
- eye problems including irritation, discomfort, itching, swelling, tearing, photosensitivity, blurred vision, impaired vision, loss of vision
- earache
- increased sensitivity to everyday sounds
- bloody vomiting
- nasal congestion
- pain, discomfort, or swelling in the abdomen
- constipation
- belching
- acid reflux
- burning or burning sensation in the mouth
- numbness in the mouth, swollen tongue, tongue problems
- numbness
- hair loss
- varbölder
- dry skin
- dark purple spots on the skin (blood leakage from blood vessels, bruising)
- heavy sweating
- changed skin color
- itchy rash
- skin irritation
- abnormality in a joint
- muscle cramps, muscle weakness
- blood in the urine
- heavy menstruation
- pain in nipples
- chest pain
- pain
- swelling in arms or legs.
Uncommon side effects can be seen in blood tests
- bacteria in the blood
- increased white blood cell count
- decreased amount of iron in the blood
- the elevated liver enzyme ( aspartate aminotransferase ), abnormal liver values.
5. How to store the 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 each blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 avatrombopag. Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg avatrombopag.
- The other ingredients are:
Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”), microcrystalline cellulose [E460 (i)], crospovidone type B [E1202], colloidalanhydrous silica [E551], magnesium stearate [E470b].
Film coating: polyvinyl alcohol [E1203], talc [E553b], macrogol 3350 [E1521], titanium dioxide [E171], yellow iron oxide [E172].
What the medicine looks like and the contents of the pack
Doptelet 20 mg film-coated tablets are light yellow, round, with a curved top and bottom, marked with “AVA” on one side and “20” on the other.
The tablets are packed in cartons containing one or two blister cards made of aluminum. Each blister card contains 10 or 15 tablets.
Manufacturer
Cilatus Manufacturing Services Limited
Regus House
Harcourt Center
Harcourt Road
Dublin 2
D02 HW77
Ireland