Patient Medication Information: uses, side effects, how to take - Joenja
What JOENJA is used for:
JOENJA is used to treat adults and children (12 years of age or older and weigh 45 kg or more) with activated phosphoinositide 3-kinase delta syndrome (APDS). APDS is an inherited condition that causes your immune system to not work properly.
How JOENJA works:
In patients with APDS, an enzyme called phosphoinositide 3-kinase is overactive. This interferes with the normal development of B and T cells (white blood cells that help the body fight infections).
JOENJA contains the active substance leniolisib, which belongs to a group of medicines called immunostimulants. It works by blocking the action of the enzyme phosphoinositide 3-kinase. This allows B and T cells to develop normally, reducing the symptoms of this disease.
The ingredients in JOENJA are:
Medicinal ingredients: leniolisib (as leniolisib phosphate)
Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate (Type A), talc, titanium dioxide
JOENJA comes in the following dosage form:
Tablets: 70 mg
JOENJA is available in bottles containing 60 tablets.
Do not use JOENJA if:
- you are allergic to leniolisib or to any ingredient in the formulation, or component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JOENJA. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- are planning to receive any vaccines. JOENJA may affect how well a vaccine works.
Other warnings you should know about:
Female patients
Pregnancy and birth control
- Tell your healthcare professional if you are pregnant, think you might be pregnant, or are planning to become pregnant. There are specific risks you should discuss with your healthcare professional.
- You should NOT take JOENJA if you are pregnant. This is because it is possible that JOENJA can harm your unborn baby.
If you are able to become pregnant:
- Your healthcare professional will verify your pregnancy status before starting treatment with JOENJA.
- You should use highly effective methods of birth control while taking JOENJA and for at least 1 week after the last JOENJA dose. Talk to your healthcare professional about birth control options that may be right for you.
- If you become pregnant during treatment with JOENJA, tell your healthcare professional right away.
Breast-feeding
- Do NOT breast-feed while taking JOENJA. It is not known if JOENJA passes through breast milk.
- Talk to your healthcare professional about the best way to feed your baby during treatment with JOENJA.
Male patients – fertility
It is unclear if JOENJA will affect your ability to father children in the future. Talk to your healthcare professional if this is a concern for you.
Children (under 12 years of age): JOENJA should not be used in children under 12 years of age and/or who weigh less than 45 kg. This is because JOENJA has not been studied in this age group.
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 JOENJA:
- avasimibe – a medicine used to treat build-up of cholesterol plaque in the arteries
- bosentan – a medicine used to treat pulmonary artery hypertension (PAH)
- carbamazepine, phenobarbital, phenytoin – medicines used to treat seizures (epilepsy)
- cobicistat, efavirenz, elvitegravir, etravirine, indinavir, lopinavir, ritonavir, saquinavir, tipranavir – medicines used to treat human immunodeficiency virus (HIV) infection
- danoprevir, dasabuvir, ombitasvir, paritaprevir – medicines used to treat hepatitis C (HCV)
- genistein, a hormone-like substance thought mimic estrogen – medicine used for conditions related to estrogen levels in the body
- itraconazole, ketoconazole, posaconazole, voriconazole – medicines used to treat fungal infections
- magnesium-, aluminum-, calcium-based antacids, sodium bicarbonate – fast acting antacids used to treat heartburn or indigestion. Take antacids 2 hours before or 2 hours after taking JOENJA.
- mitotane – a medicine used to treat cancer
- modafinil – medicine used for the treatment of excessive daytime sleepiness (narcolepsy)
- nafcillin, rifabutin, rifampin, telithromycin, troleandomycin – medicines used for bacterial infections
- St. John’s Wort (Hypericum perforatum) – a herbal medicine for depression and sleep problems
- thioridazine – a medicine used in the treatment of schizophrenia
- alosetron – a medicine used to treat irritable bowel syndrome (IBS) in women
- caffeine – a stimulant found in some beverages and foods
- duloxetine – a medicine used to treat depression
- letermovir – a medicine to prevent cytomegalovirus (CMV) infection
- melatonin, ramelteon, tasimelteon – medicines used for insomnia
- metformin – a medicine used for high blood sugar levels caused by diabetes
- rosuvastatin, pitavastatin – medicines used for lowering cholesterol
- tizanidine – a medicine used for muscle relaxation
- certain type of vaccines
Do NOT eat or drink products or juices containing grapefruit while taking JOENJA.
Reduce or completely stop smoking while taking JOENJA.
How to take JOENJA:
- Take JOENJA exactly as your healthcare professional has told you to. Check with your healthcare professional if you’re not sure.
- Take JOENJA at the same time every day.
You can take JOENJA with or without food.
Usual dose:
Adults and children (12 years or older and weigh 45 kg or more):
- The usual dose is 70 mg (1 tablet) by mouth twice a day, approximately 12 hours apart.
- If vomiting occurs within 1 hour after taking the tablet, take another tablet right away. If you vomit more than 1 hour after taking the tablet, wait and take the next dose at your usual scheduled time.
Overdose:
If you think you, or a person you are caring for, have taken too much JOENJA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you forget to take JOENJA by:
- less than 6 hours, take it as soon as you remember. Take the next dose at your usual scheduled time.
- more than 6 hours, do NOT take another tablet. Skip the missed dose and take your next dose at your usual scheduled time.
Possible side effects from using JOENJA:
These are not all the possible side effects you may have when taking JOENJA. If you experience any side effects not listed here, tell your healthcare professional.
- Headache
- Sinusitis
- Skin inflammation with rash
- Fever
- Abdominal pain or discomfort
- Diarrhea
- Hair loss
- Back pain
- Tiredness
- Neck pain
- Increased weight
- Canker sores
- Vomiting
- Taste disorder
- Pain in a joint
JOENJA may cause abnormal urine and blood test results, such as:
- High level of liver enzymes
- High level of pancreas enzymes
- Protein in the urine
Your healthcare professional will tell you if your blood or urine test results are abnormal and if you need treatment to correct these side effects.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Anemia (low levels of red blood cells): tiredness, weakness, fatigue, pale skin | X | ||
| Lymphopenia (low levels of white blood cells: lymphocytes): fever, | X | ||
| cough, runny nose, enlarged lymph nodes, painful joints; rash; night sweats, weight loss | |||
| Neutropenia (low levels of white blood cells: neutrophils): fever, enlarged lymph nodes, gum inflammation, rash | X | ||
| Thrombocytopenia (low platelet count): spontaneous bleeding or bruising | X | ||
| Eosinophilia (high levels of white blood cells: eosinophils): abdominal pain, rash, weight loss, wheezing | X | ||
| Changes in monocyte levels (increase or decrease in a type of white blood cells): fever, chills, sore throat, cough and fatigue | X | ||
| Common | |||
| Hyperglycemia (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | X | ||
| Liver problems: yellowing of the skin or eyes, dark urine, nausea, vomiting, loss of appetite, or pain in the upper right side of the abdomen | X | ||
| Pancreas problems: severe abdominal pain, nausea, and vomiting | X | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail, or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store at room temperature (15°C to 30°C). Do NOT refrigerate.
- Keep out of reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the carton and bottle 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 how to throw away medicines you no longer use. These measures will help protect the environment.
If you want more information about JOENJA:
- 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 [https://www.pharming.com/products], or by calling 1-800-930-5221.
Date of Authorization: 2026-07-08