Patient Medication Information: uses, side effects, how to take - Truseltiq
What is TRUSELTIQ™ used for?
For the following indication TRUSELTIQ™ has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional. TRUSELTIQ™ is used to treat adult patients with a type of cancer called cholangiocarcinoma (bile duct cancer) when it:
A test will be done to find out if the cancer has an FGFR2 abnormality. This is to make sure that TRUSELTIQ is right for you. |
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
How does TRUSELTIQ™ work?
Fibroblast growth factor receptors (FGFRs) are proteins found on cells that help them grow and divide. People with bile duct cancer may have abnormalities in the FGFR2 gene. This causes their cancer cells to grow and spread. TRUSELTIQ™ works by slowing down the growth and/or spread of cancer cells caused by the FGFR2 abnormality.
What are the ingredients in TRUSELTIQ™?
Medicinal ingredients: infigratinib (as infigratinib phosphate)
Non-medicinal ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, hypromellose, lactose monohydrate, magnesium stearate (from vegetable source), microcrystalline cellulose, pharmaceutical grade printing ink, red iron oxide, titanium dioxide, and yellow iron oxide.
TRUSELTIQ™ comes in the following dosage forms:
Capsules: 25 mg and 100 mg infigratinib (as infigratinib phosphate)
Do not use TRUSELTIQ™ if:
- You are allergic to infigratinib or any of the other ingredients in TRUSELTIQ™ in any part of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRUSELTIQ™. Talk about any health conditions or problems you may have, including if you:
- have liver problems.
- have kidney problems.
Other warnings you should know about:
Treatment with TRUSELTQ can cause serious side effects, including:
Hyperphosphatemia (high phosphate levels in the blood) or Hypophosphatemia (low phosphate levels in the blood): Your healthcare professional will do blood tests to check levels of phosphate in your blood. These tests will be done 7-14 days after starting TRUSELTIQ™. They will be repeated after your first treatment cycle and then every month thereafter. If your levels are high, you may need:
- changes to your dose of TRUSELTIQ™, or
- additional medications to lower the amount of phosphate in your blood.
Eye and vision problems including:
- Dry eye. If this happens your healthcare professional may recommend that you use artificial tears or something similar.
- Retinal pigment epithelial detachment (RPED). This condition happens when fluid builds up inside the eye. It can lead to blurred vision.
Your healthcare professional will check your eyes and vision before you start taking TRUSELTIQ™, after your first month of treatment, after your first 3 months of treatment and then every 3 months thereafter. You may need to see an eye specialist (an ophthalmologist) during your treatment. This provider will help you to manage any eye or vision problems. Your healthcare professional will continue to check your eyes
- and vision every 3 weeks until the side effect goes away or you stop taking TRUSELTIQ™.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Birth control, pregnancy and breastfeeding – information for women
- If you are pregnant or are still able to get pregnant and / or breastfeed, there are specific risk you must discuss with your healthcare professional.
- You should not take TRUSELTIQ™ if you are pregnant. It may harm your unborn baby or make you lose the pregnancy.
For women who are able to get pregnant:
- Your healthcare professional will do a pregnancy test before you start treatment with TRUSELTIQ™.
- Use effective birth control during your treatment with TRUSELTIQ™ and for 1 month after your last dose. Talk to your healthcare professional about birth control methods that may be right for you.
- If, during your treatment, you become pregnant or think you are pregnant, tell your healthcare professional right away.
- It is not known if TRUSELTIQ™ passes into breastmilk. Do not breastfeed while you are taking TRUSELTIQ™ and for 1 month after your last dose. Talk to your healthcare professional about the best way to feed your baby during this time.
Birth control and pregnancy – information for men:
- Use effective birth control each time you have sex with a woman who can get pregnant. This is necessary during your treatment with TRUSELTIQ™ and for 1 month after your last dose. If your sexual partner gets pregnant during this time, tell your healthcare professional right away.
Driving and using machines: Before you do tasks which may require special attention, wait until you know how you respond to TRUSELTIQ™. If you experience vision problems, do not drive or use tools or machines until the side effect goes away.
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 TRUSELTIQ™:
Medicines used to treat bacterial, viral and fungal infections including
- rifampin, clarithromycin
- indinavir, ritonavir
- itraconazole, ketoconazole
- An herbal remedy typically used to treat depression called St. John’s wort
- Medicines used to treat heartburn and acid reflux called histamine-2 (H2)-antagonists, proton pump inhibitors or antacids such as ranitidine, lansoprazole or calcium carbonate.
- Medicines used to lower the amount of phosphate.
Do not eat or drink grapefruit juice or products containing grapefruit during your treatment with TRUSLETIQTM. These can affect the way the medicine works.
How to take TRUSELTIQ™:
- Take TRUSELTIQ™ exactly as your healthcare provider professional tells you to. Check with your doctor or pharmacist if you are not sure.
- Do not separate the blister cards from the carton during your treatment.
- Take your dose once each day, at least 1 hour before or 2 hours after eating.
- Take TRUSELTIQ at about the same time each day.
- Swallow capsules whole with a glass of water. Do not open, crush, chew or dissolve capsules.
- You will take your TRUSELTIQ™ every day for 3 weeks in a row (days 1 to 21). This is followed by 1 week (days 22 to 28) with no doses (treatment-free week). Three weeks of treatment and 1 treatment-free week make up a 28-day cycle.
- Do not change your dose or stop taking TRUSELTIQ™ unless your healthcare provider tells you to.
Avoid taking medications to treat heartburn or acid reflux while you are taking TRUSELTIQ. If you must take H2-antagonists or antacids, talk to your healthcare professional as there are specific instructions to follow.
- If you take H2-antagonists: take your TRUSELTIQ™ 2 or more hours before or 10 hours after taking these medicines.
- If you use antacids: take your TRUSELTIQ™ 2 hours before or 2 hours after taking these medicines.
- TRUSELTIQ™ is packaged in blister cards. To help track your doses, write the day you start each treatment cycle (start date) on the blister card. There is a spot for this information. For weeks 1, 2 and 3, push each cell to release the capsule. For week 4, use the peel away tabs to track the days of your treatment-free week.
Usual dose: 125 mg per day. This daily dose is made by taking one 25 mg capsule and one 100 mg capsule together each day for 3 weeks followed by a treatment free-week.
If you have kidney or liver problems, or you experience certain side effects, your healthcare professional may change your dose to one of the following:
100 mg per day: Take one 100 mg capsule each day.
75 mg per day: Take three 25 mg capsules together each day.
50 mg per day: Take two 25 mg capsules together each day.
Each of these daily doses is taken for 3 weeks followed by a treatment-free week.
Do not change your dose or stop taking TRUSELTIQ™ unless your healthcare professional tells you to.
Your healthcare professional may temporarily or permanently stop your treatment. This may happen if you develop certain side effects or if your disease gets worse.
Overdose:
| If you think you, or a person you are caring for, have taken too much TRUSELTIQ™, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If it is 4 or more hours later than when you should have taken your TRUSELTIQ™, or you vomit after taking your dose, do not make up the dose. Skip it and continue with your next dose at the usual time. Do not take an extra dose the next day to make up for the missed dose.
If it is less than 4 hours later than when you should have taken your TRUSELTIQ™, take it as soon as you remember. Continue with your next dose at the usual time.
What are possible side effects from using TRUSELTIQ™?
These are not all the possible side effects you may have when taking TRUSELTIQ™. If you experience any side effects not listed here, tell your healthcare professional.
- Feeling tired
- Fever
- Chills
- Nail changes
- Rash
- Itching
- Dry skin
- Eyelash changes
- Hair loss
- Redness, swelling, peeling or tenderness, mainly on the hands and feet (Hand-foot syndrome)
- Mouth sores
- Trouble swallowing
- Taste changes
- Constipation
- Dry mouth
- Diarrhea
- Decreased appetite
- Vomiting
- Nausea
- Heartburn or indigestion
- Mouth pain
- Joint, muscle, back or chest pain
- Pain in the extremities
- Muscle weakness
- Tingling and numbness in the hands and feet
- Pain or discomfort in stomach
- Swelling of the body parts
- Headache
- Dizziness
- Nose bleeds
- Trouble sleeping
- Cough
- Shortness of breath
TRUSELTIQ™ can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment and will interpret the results.
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 | ||
| VERY COMMON | |||
| Eye and vision problems including retinal pigment epithelial detachment: vision changes, distorted vision, blurred vision, dry eye | ✔ | ||
| Hyperphosphatemia (high blood phosphate levels): muscle cramps and tingling | ✔ | ||
| COMMON | |||
| Hypophosphatemia (low blood phosphate levels): muscle weakness and pain, confusion, seizures, tea-coloured urine, heart or breathing problems | ✔ | ||
| Infection: Fever, burning or pain with urination | ✔ | ||
| Anemia (decrease red blood cells): Fatigue, weakness | ✔ | ||
| Blood creatinine increased: feeling tired, loss of appetite, nausea, itching | ✔ | ||
| Sepsis (full-body response to infection): Fever, chills, shortness of breath and confusion | ✔ | ||
| Hypercalcemia (increase in blood calcium): Bone pain, fatigue, headaches, lethargy | ✔ | ||
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 TRUSELTIQ™ at 15°C to 25°C.
Keep out of reach and sight of children.
If you want more information about TRUSELTIQ™:
- 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.qedtx.com, or by calling 1-905-477-4553.