Patient Medication Information: uses, side effects, how to take - Tavneos
What is TAVNEOS used for?
TAVNEOS is used to treat adults with conditions known as severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
- These include granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- TAVNEOS is used with other medicines to treat your condition.
How does TAVNEOS work?
TAVNEOS binds to a receptor in the body and blocks inflammation. This can be detected within hours. Your symptoms may improve within the first 4 weeks.
What are the ingredients in TAVNEOS?
Medicinal ingredient: avacopan
Non-medicinal ingredients: black iron oxide, gelatin, macrogol 4000, macrogolglycerol hydroxystearate, polysorbate 80, potassium hydroxide, red iron oxide, shellac, titanium dioxide, and yellow iron oxide.
TAVNEOS comes in the following dosage forms:
Capsules; 10 mg.
Do not use TAVNEOS if:
- You are allergic to avacopan or to any of the ingredients in TAVNEOS.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TAVNEOS. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have hepatitis B virus (HBV) infection.
are pregnant, think you might be pregnant, are planning to become pregnant or can become pregnant and are not using an effective birth control method. It is not known if TAVNEOS can harm an unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if TAVNEOS can pass into your breast milk and harm your baby. Talk to your healthcare professional about the best way to feed your baby if you take TAVNEOS.
- have an infection, a history of infections, infections that often come back or have a condition that puts you at risk for an infection.
- have been exposed to tuberculosis or have resided or travelled in areas where it is present.
- have heart problems.
- are planning to receive a vaccine. It is recommended that you receive vaccinations before starting treatment with TAVNEOS.
- are taking the medicines cyclophosphamide and azathioprine.
Other warnings you should know about:
Macrogolglycerol hydroxystearate: TAVNEOS contains macrogolglycerol hydroxystearate as a non-medicinal ingredient. This may cause stomach upset, diarrhea, vomiting and nausea.
TAVNEOS can cause serious side effects, including:
- Liver problems: Serious liver problems have happened to patients taking TAVNEOS. Some cases even lead to death. Your healthcare professional will monitor your liver function before you start TAVNEOS and while you are taking it. They might decide to stop your treatment based on your test results. Talk to your healthcare professional right away if you get any symptoms of liver problems.
- Angioedema (serious swelling under the skin)
- Infections: Serious infections can happen in people taking TAVNEOS and these infections can lead to death. The most common serious infections were pneumonia and urinary tract infections. Other infections can also happen. Your healthcare professional will monitor you for infections while you are taking TAVNEOS. They might stop and restart your treatment. It is recommended that you have treatment to prevent a lung infection called Pneumocystis jirovecii pneumonia during treatment with TAVNEOS.
- Hepatitis B virus reactivation: Before you take TAVNEOS, your healthcare professional will do blood tests to check for hepatitis B virus (HBV) infection. If you have HBV infection, TAVNEOS could cause you to have an active infection again. Your healthcare professional will monitor your HBV infection during treatment with TAVNEOS. Talk to your healthcare professional right away if you get any symptoms of HBV infection.
See the Serious side effects and what to do about them table for more information on this and other serious side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TAVNEOS:
- fentanyl, a strong opioid medicine used to relieve pain.
- bosentan, used to treat high blood pressure in the lungs.
- carbamazepine, phenobarbital and phenytoin, used to treat epilepsy and other illnesses.
- clarithromycin, used to treat bacterial infections.
- cyclosporine, sirolimus and tacrolimus, used to suppress the immune system to prevent organ transplant rejections and treat certain autoimmune diseases.
- dihydroergotamine, used to treat migraine.
- enzalutamide and mitotane, used to treat cancer.
- efavirenz, etravirine, lopinavir and ritonavir, used to treat HIV infections.
- itraconazole, ketoconazole, posaconazole and voriconazole, used to treat fungal infections.
- modafinil, used to treat an extreme tendency to fall asleep.
- St. John’s Wort, a herbal remedy.
- rifampicin, used to treat tuberculosis or certain other bacterial infections.
- simvastatin, used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood.
- midazolam, used to produce sleepiness and relieve anxiety before surgery or certain procedures.
- celecoxib, used to reduce pain and inflammation.
Grapefruit and grapefruit juice are not recommended during treatment with TAVNEOS, as they can influence the effect of the medicine.
Drinking alcohol while taking TAVNEOS can change the way your liver works. Talk to your healthcare professional about limiting your alcohol intake.
How to take TAVNEOS:
- Take TAVNEOS exactly as your healthcare professional tells you to.
- It will be prescribed to you by a healthcare professional with experience in the diagnosis and treatment of GPA and MPA.
Take TAVNEOS with food.
- Swallow the capsules whole with water. Do not crush, chew or open the capsules.
- Check with your healthcare professional if you are not sure how to take TAVNEOS.
Usual dose:
Take 3 capsules with food in the morning and 3 capsules with food in the evening.
Overdose:
| If you think you, or a person you are caring for, have taken too much TAVNEOS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you missed a dose, take the missed dose as soon as you remember. However, do not take the missed dose if it is within 3 hours to your next dose. Never take two doses at the same time.
What are possible side effects from using TAVNEOS?
These are not all the possible side effects you may have when taking TAVNEOS. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- high blood pressure, fatigue
- nausea, vomiting, diarrhea, pain in the belly
- headache
- rash
- flu, cold
- cold sore
- gastroenteritis (stomach flu)
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 | ||
| COMMON | |||
| Increased levels of a blood enzyme (creatine phosphokinase): cramps, muscle pain, tenderness and stiffness. | √ | ||
| Infection of the respiratory system, mouth, skin or ear: fever, chills, sore throat that does not go away, white patches in your mouth, pain when swallowing, cough, stuffy nose that does not go away, pain or pressure in your face, fatigue, body aches, earache, headache, red, swollen, painful or itchy areas of the skin, rash, numbness or tingling of your skin, skin blisters. | √ | ||
| Liver problems: yellow skin or eyes, tiredness or feeling sick (nausea or vomiting), loss of appetite, fever, skin rash, itching, abdominal pain, pale stool or dark coloured urine. | √ | ||
| Pneumonia (infection of the lungs): cough with or without mucus, fever, chills, shortness of breath. | √ | ||
| Urinary tract infection: pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine, fever. | √ | ||
| UNCOMMON | |||
Allergic Reaction: difficulty swallowing or breathing, wheezing, swelling of the face, lips, tongue or throat. | √ | ||
| Angioedema (serious swelling under the skin): swelling of the face, throat, arms, legs or genitals, rash or hives, pain and warmth of affected areas, throat tightness, | √ | ||
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 | ||
| difficulty breathing, trouble swallowing, abdominal pain, vomiting, feeling dizzy, chest pain. | |||
| Decreased levels of white blood cells: infections, fatigue, fever, aches, pains and flu-like symptoms. | √ | ||
| Hepatitis B virus reactivation: fever, tiredness, yellow skin or eyes, abdominal pain, diarrhea. | √ | ||
| Nausea | √ | ||
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. |
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Storage:
Store TAVNEOS at room temperature (15°C - 30°C) and in the original package.
Keep out of reach and sight of children.
If you want more information about TAVNEOS:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.otsukacanada.com), or by calling 1-877-341-9245.