Patient Medication Information: uses, side effects, how to take - Jamp Tretinoin
Serious Warnings and Precautions
Female Patients: Pregnancy
- Do not take JAMP Tretinoin if you are pregnant, may become pregnant during or within one month after treatment. It may harm your unborn baby and cause birth defects.
- If you are able to get pregnant:
- Use effective birth control for at least 1 month before treatment, during treatment and for at least 1 month after your last dose. Ask your healthcare professional about methods of birth control available to you. Some types of birth control might not work as well during treatment with JAMP Tretinoin.
- Do not take JAMP Tretinoin if you are breastfeeding.
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- Your healthcare professional will do a pregnancy test within 2 weeks before you start taking JAMP Tretinoin. This test must show that you are not pregnant. More pregnancy tests might be done monthly during treatment.
- Get your blood monitored regularly and keep all of your scheduled doctor's appointments.
Differentiation Syndrome and Hyperleukocytosis:
- JAMP Tretinoin may cause hyperleukocytosis and differentiation syndrome. Symptoms include fever, shortness of breath, lung problems, low blood pressure, swelling and weight gain. This may lead to lung, liver, renal and multi-organ failure.
- Your healthcare professional will monitor you for signs and symptoms of hyperleukocytosis and differentiation syndrome. They might treat you with other medicines in addition with JAMP Tretinoin.
What is JAMP Tretinoin used for?
JAMP Tretinoin is used to treat adults and children (13 years and older) with a type of blood cancer called acute promyelocytic leukemia (APL).
JAMP Tretinoin can be used in patients with APL:
- who have never been treated for APL before, or
- where other current cancer treatments do not work, or
- where the APL has come back even after previous cancer treatment.
How does JAMP Tretinoin work?
JAMP Tretinoin helps stop the growth of abnormal blood cells which occur in APL.
What are the ingredients in JAMP Tretinoin?
Medicinal ingredients: Tretinoin (all-trans retinoic acid)
Non-medicinal ingredients: Butylated hydroxyanisole, edetate disodium, gelatin, glycerin, hydrogenated vegetable oil type I, hydrogenated vegetable oil type II, non-crystallizing sorbitol solution, medium-chain triglycerides (as Captex 355), red ferric oxide, soybean oil, titanium dioxide, yellow wax, Phosal 53 MCT and purified water.
The capsules may include traces of ascorbyl palmitate, caprylic / capric triglycerides, oleic acid, phosphatidycholine, sunflower seed oil glyceride and tocopherol. The capsule ink-printing contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.
JAMP Tretinoin comes in the following dosage forms:
Capsules, 10 mg
Do not use JAMP Tretinoin if:
- you are allergic to tretinoin or to any ingredient in this medicine or container
- you are pregnant or breastfeeding
- you are taking Vitamin A, tetracyclines or other retinoids
- you are 0 - 12 years old.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Tretinoin. Talk about any health conditions or problems you may have, including if you:
- have liver or kidney problems
- have ever had any mental health problems like depression
- have skin problems
- are pregnant, plan on getting pregnant, or are breastfeeding
- have an increased body mass index (BMI)
Other warnings you should know about:
Blood clots: JAMP Tretinoin may cause thrombosis (blood clots) during the first month of treatment.
Brain problems: JAMP Tretinoin may cause intracranial hypertension or pseudotumor cerebri (build of pressure around the brain). This is more common in children.
Heart problems: JAMP Tretinoin may cause heart problems, including myocarditis (inflammation of the heart muscle and lining around the heart). This can cause a heart attack which may lead to death. Your healthcare professional will decide the best treatment options for you.
Mental health problems: JAMP Tretinoin may cause depression, aggression, anxiety and mood changes. You may not notice these problems. It is important to tell your friends and family that JAMP Tretinoin can cause these mental problems. They could tell you if they notice these problems. Your healthcare professional will also monitor you for signs of these mental health problems.
Skin problems: JAMP Tretinoin may cause skin problems like Sweet’s syndrome, which is a type of rash.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They might do blood tests to check:
- Your calcium levels
- Blood health
- Blood fat levels
- Liver and kidney health
- Lung health
Driving and using machines: JAMP Tretinoin can cause dizziness or serious headache. Before you drive or do tasks that require special attention, wait until you know how you respond to JAMP Tretinoin.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may also interact with JAMP Tretinoin:
- Medicines used to treat bacterial infections (antibiotics), like rifampin, erythromycin
- Medicines typically used to treat epilepsy (seizures) and insomnia like phenobarbital, pentobarbital
- Medicines used to treat stomach ulcers like cimetidine
- Medicines used to treat high blood pressure like verapamil, diltiazem
- Medicines used to treat arthritis like ciclosporin
- Medicines containing progestogen, like some types of birth control pills (minipill)
Glucocorticoids (steroid hormones) used to treat inflammation and autoimmune diseases
Serious Drug Interactions
Taking the following medicines with JAMP Tretinoin cause serious problems:
- Vitamin A or vitamin A related compounds: This can cause overdose levels of vitamin A.
- Medicines to treat blood clots, such as tranexamic acid, aminocaproic acid, and aprotinin. These can cause deadly blood clot related problems.
- Medicines that can cause build-up of pressure around the brain like tetracyclines (a type of antibiotic, used to treat bacterial infections). Taking JAMP Tretinoin with these medicines might increase the risk of this problem.
- Imidazole and triazole type of medicines, like ketoconazole. These are used to treat fungal infections.
How to take JAMP Tretinoin:
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Do not change your dose or stop taking it unless your healthcare professional tells you to.
- Swallow capsules whole with water. Do not chew the tablets.
Take with a meal or shortly after a meal.
Usual dose:
- Your healthcare professional will decide on the best dosage for you based on your size and condition.
- Your healthcare professional may have you do other treatments if you respond to JAMP Tretinoin.
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.
Overdose:
Missed Dose:
If you miss a dose of JAMP Tretinoin:
- Take the missed dose as soon as possible if it has been within 6 hours of your missed dose.
- Skip the missed dose if it has been 6 hours or more since your missed dose. Take your next dose at the usual time.
- Continue taking your capsules according to your usual schedule.
What are possible side effects from using JAMP Tretinoin?
These are not all the possible side effects you may have when taking JAMP Tretinoin. If you experience any side effects not listed here, tell your healthcare professional.
- dry skin
- dry mouth and lips
- swelling of the mouth and lips
- rash
- swelling
- nausea, vomiting
- headache
- shivering
- tiredness
- back, chest, bone or stomachpain
- coughing
If you think you, or a person you are caring for, have taken too much JAMP Tretinoin, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
JAMP Tretinoin can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment.
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 | |||
Differentiation Syndrome: fever, difficulty breathing, shortness of breath, lightheadedness, dizziness or a faint feeling, unusual swelling, weight gain, difficulty in urination, yellowing of the skin or eyes | X | ||
Flushing: severe flushing may include general swelling, rash, itchiness | X | ||
Heart problems (disorders affecting your heart muscle, heart lining, valves or rhythm): Chest pain, or chest discomfort, high blood pressure, irregular heart rhythm, shortness of breath, fainting, swelling of the legs, ankles and feet, weakness, tiredness | X | ||
Hypervitaminosis A (too much vitamin A in the body): dry skin, lip and mouth dryness, lip inflammation, rash, swelling, nausea, vomiting, bone pain, headache, fever, shivering, tiredness, back pain, chest pain, shortness of breath, coughing, stomach pain, bleeding into the skin, hair loss, vision changes | X | ||
Infections (blood, fungal, respiratory): fever and chills, nausea, vomiting, diarrhea, generally feeling unwell, itching, burning, soreness, irritation, whitish-grey cottage cheese-like discharge from vagina, thick white patches in the mouth, tongue or on the throat, chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, sweating, shortness of breath, runny or stuffy nose, body aches, headache, sneezing | X | ||
Intercranial hypertension / pseudotumor cerebri (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 | ||
| around the brain): headache, nausea, ear buzzing, dizziness | X | ||
Mental health problems: depression (feelings of sadness, irritability, unusual tiredness, trouble concentrating, change in normal sleep patterns and loss of appetite with possible weight loss), agitation, anxiety, mood changes, forgetfulness, feeling of weakness | X | ||
Skin problems, including Sweet’s syndrome: rash, itchy, red skin when exposed to sunlight | X | ||
Thrombosis (clot in a blood vessel): swelling and pain in one part of the body | 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.
Storage:
- Keep out of reach and sight of children.
- Keep the bottle tightly closed, store at 20°C to 25°C.
- Store away from heat and direct light.
- Wear rubber gloves when touching and throwing away broken capsules.
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/adverse-reaction-reporting.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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
If you want more information about JAMP Tretinoin:
- 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 (http://www.jamppharma.com); or by calling 1-866-399- 9091.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Revision: July 17, 2023