Patient Medication Information: uses, side effects, how to take - Doptelet
What is DOPTELET used for?
- To treat severe low platelet counts in adults with long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure.
- To treat low platelet counts in adults with chronic immune thrombocytopenia (ITP) when another treatment has not worked.
How does DOPTELET work?
DOPTELET works by helping to increase the number of platelets in the blood. Platelets are blood cells that help the blood to clot and so reduce or prevent bleeding.
What are the ingredients in DOPTELET?
Medicinal ingredient: avatrombopag maleate
Non-medicinal ingredients: colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Tablet coating film: iron oxide yellow, macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide.
DOPTELET comes in the following dosage form:
Tablets: 20 mg avatrombopag (as maleate)
Do not use DOPTELET if:
- you are allergic to avatrombopag or any of the other ingredients of this medicine (see What are the ingredients in DOPTELET?). If you are not sure, talk to your healthcare professional before taking DOPTELET.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DOPTELET. Talk about any health conditions or problems you may have, including if you:
- have ever had a blood clot or are at risk of blood clots
- have a disorder caused by blood cells that are poorly formed or don’t work properly (Myelodysplastic syndromes)
- have severe liver problems (Child-Turcotte-Pugh Class C, model for end-stage liver disease [MELD] score > 24)
- have a rare hereditary intolerance to lactose or galactose.
Other warnings you should know about:
Driving and using machines
DOPTELET is not expected to affect your ability to drive or use machinery. However, do not drive or operate any machinery until you know how DOPTELET affects you.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before taking this medicine. DOPTELET is not recommended in pregnancy and in women who are planning to have a baby.
DOPTELET may pass into breast milk. Do not breastfeed during your treatment with DOPTELET and for at least 2 weeks after the last dose. Talk to your healthcare professional about the best way to feed your baby during this time.
Check-ups and testing
If you take DOPTELET to treat your low platelet counts due to chronic liver disease before a scheduled medical or dental procedure, your healthcare professional will check your platelet count before you receive DOPTELET and again on the day of your procedure.
If you take DOPTELET to treat your low platelet counts due to chronic immune thrombocytopenia, your healthcare professional will check your platelet count before, during and for at least 4 weeks after stopping your treatment with DOPTELET.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
This includes drugs used to increase the number of platelets in the blood such as corticosteroids, danazol, dapsone, and intravenous immunoglobulin (IVIg).
DOPTELET may be affected by other drugs and may require a dose adjustment when co-administered with other drugs. This may depend on how long you will be taking DOPTELET.
The following may interact with DOPTELET:
- Certain antifungal drugs such as itraconazole and fluconazole
- Certain drugs used to prevent and treat tuberculosis such as rifampicin
How to take DOPTELET:
Swallow tablets whole with food
- Take DOPTELET exactly as your healthcare professional tells you to take it.
- Your healthcare professional will tell you how much DOPTELET to take and when to start taking it.
- Your healthcare professional may change your dose of DOPTELET depending on your platelet counts.
Usual dose:
If you have chronic liver disease and are scheduled for a medical or dental procedure
- Treatment with DOPTELET is usually started 10 to 13 days before your planned procedure.
- Your dose will depend on your platelet count.
- The usual recommended dose is either 40 mg (2 tablets) or 60 mg (3 tablets) every day for 5 days in a row.
- Your healthcare professional will tell you how many tablets to take and when to take them.
If you have chronic immune thrombocytopenia
- The usual recommended starting dose is 20 mg (1 tablet) a day. If you are taking certain other medicines you may need a different starting dose.
- Your healthcare professional will tell you how many tablets to take and when to take them.
- Your healthcare professional will monitor your platelet count regularly and will adjust your dose as needed.
Overdose:
| If you think you, or a person you are caring for, have taken too much DOPTELET, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
Prior to a scheduled medical or dental procedure
- If you miss a dose, contact your healthcare professional for further dosing instructions.
Chronic immune thrombocytopenia
- If you miss a dose of DOPTELET, take it as soon as you remember. Do not take 2 doses at one time to make up for a missed dose. Take your next dose at your usual scheduled time.
What are possible side effects from using DOPTELET?
These are not all the possible side effects you may have when taking DOPTELET. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of DOPTELET when used to treat low platelet counts in adults with chronic liver disease (CLD) who are scheduled to have a medical or dental procedure are:
- fever
- stomach pain
- feeling sick (nausea and vomiting)
- headache
- feeling tired
- swelling of hands or feet
- chills
- urinary tract infection
- muscle spasms
- difficulty sleeping (insomnia)
- coughing
- shortness of breath
The most common side effects of DOPTELET when used to treat low platelet counts in adults with chronic immune thrombocytopenia (ITP) are:
- headache
- dizziness
- difficulty sleeping (insomnia)
- nervousness
- eye itchiness or pain
- feeling tired
- bruising
- bleeding of the gums
- diarrhea
- feeling sick (nausea and vomiting)
- constipation
- abdominal pain and discomfort
- nose bleed
- runny nose, sore throat and cough (upper respiratory tract infection)
- stiff joint
- purple or red spots on your skin
- decreased appetite
- increase in blood pressure
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Allergic reactions: difficulty breathing or swallowing, swelling of tongue, lips and face, skin rash, itching and hives | √ | ||
| Blood clots in artery or vein (including portal vein): swelling, pain or tenderness in your legs, hands or feet, fast heartbeat, shortness of breath, stomach pain or tenderness, chest pain | √ | ||
| Low sodium levels in the blood (Hyponatremia): nausea and vomiting, headache, confusion, loss of energy, drowsiness and fatigue, restlessness and irritability, muscle weakness, spasms and cramps, seizures and coma | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store DOPTELET at room temperature between 15°C to 30°C. Store DOPTELET tablets in the original package.
Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or other healthcare professional how to throw away medicines you no longer use. These measures will help to protect the environment.
Keep out of reach and sight of children.
If you want more information about DOPTELET:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://health-products.canada.ca/dpd-bdpp/; the manufacturer’s website: https://www.sobi.com/canada/en, or by calling 1-833-697-0049.
DOPTELET is a registered trademark of AkaRx, Inc. © 2024 Swedish Orphan Biovitrum AB (publ). All rights reserved.