Details for: ENVARSUS PA
Company: ENDO VENTURES LTD.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02485877 | ENVARSUS PA | TACROLIMUS | 0.75 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02485885 | ENVARSUS PA | TACROLIMUS | 1 MG | TABLET (EXTENDED-RELEASE) | ORAL |
| 02485893 | ENVARSUS PA | TACROLIMUS | 4 MG | TABLET (EXTENDED-RELEASE) | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- ENVARSUS PA is used to help prevent organ rejection.
- It is used in adults who have had a kidney or a liver transplant.
- It is used along with other medicines.
- It is a prolonged-release tablet and is not the same as tacrolimus extended-release capsules or tacrolimus immediate-release capsules. Your doctor should decide which medicine is right for you.
What it does
Your immune system protects your body from infections and foreign materials. When you receive a transplant, your immune system will try to reject it. ENVARSUS PA is an immunosuppressant that blocks some parts of your immune system and helps your body accept a transplanted organ.
When it should not be used
- are allergic to tacrolimus.
- are allergic to any of the other ingredients in this medication or to a component of the container.
What the medicinal ingredient is
tacrolimus
What the non-medicinal ingredients are
butylated hydroxytoluene, dimethicone, hypromellose, lactose monohydrate, magnesium stearate, poloxamer 188, polyethylene glycol, tartaric acid
What dosage form it comes in
0.75 mg, 1 mg and 4 mg tablets
Warnings and precautions
Serious Warnings and Precautions
- ENVARSUS PA may increase your chances of getting serious infections and some kinds of cancer, like skin cancer and lymphoma. These may lead to hospitalization or death.
- ENVARSUS PA should only be prescribed by doctors who have experience in the use of immunosuppressive (anti-rejection) drugs and the management of organ transplants.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ENVARSUS PA. Talk about any health conditions or problems you may have, including if you:
- have a hereditary problem of galactose intolerance, such as the Lapp lactase deficiency or glucose-galactose malabsorption;
- have or have had a heart problem, such as heart failure, arrhythmia, congenital or acquired QT prolongation;
- have or have had high blood pressure called hypertension;
- have or have had kidney or liver problems;
- have any infections;
- have swelling or edema;
- have or have had diarrhea;
- have hepatitis.
Other warnings you should know about
ENVARSUS PA may cause new onset diabetes. Your doctor may order tests to monitor your blood glucose levels.
You should limit your exposure to the sun and ultraviolet (UV) light while taking ENVARSUS PA. This is because immunosuppressants can increase the risk of skin cancer. You must wear appropriate protective clothing and use a sunscreen with a high sun protection factor (SPF 30 or higher). Your doctor might examine your skin for any changes while taking ENVARSUS PA.
Stopping your treatment may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to do so.
You should not receive any vaccine while using ENVARSUS PA. Tell your doctor if you have had or are scheduled to have any vaccination(s).
Pregnancy and breastfeeding: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, do not use this medicine unless advised by your doctor. It is not known if it will harm your unborn baby. ENVARSUS PA can pass into your breast milk and may harm your baby.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with ENVARSUS PA:
- Alcohol;
- Medicines used for irregular heart rhythm, such as amiodarone;
- Medicines used for bacterial infections, such as clarithromycin, chloramphenicol and erythromycin;
- Medicines used to control seizures and/or epilepsy, such as phenytoin, carbamazepine and phenobarbital;
- Medicines used to treat nausea and vomiting, such as metoclopramide;
- Medicines used for tuberculosis such as rifampin and rifabutin;
- Medicines used for fungal infections such as clotrimazole, fluconazole, voriconazole, posaconazole, itraconazole, ketoconazole and isavuconazole;
- Medicines used to treat inflammations or suppress the immune system (e.g. in transplant rejection), such as methylprednisolone and prednisone;
- Grapefruit and grapefruit juice;
- Medicines used to treat stomach disorders, such as cimetidine, lansoprazole, omeprazole and antacids (e.g. magnesium and aluminum hydroxide antacids);
- Medicines used to treat HIV infection, such as ritonavir, nelfinavir, saquinavir and cobicistat;
- Hormone treatments, including contraceptive pills, such as danazol and ethinyl estradiol;
- Medicines called calcium channel blockers used to treat high blood pressure, such as verapamil, diltiazem, nifedipine;
- Letermovir, a medicine used to treat cytomegalovirus (CMV) infections;
- Sirolimus, a medicine used to avoid rejection of the kidney transplant;
- Nilotinib, a medicine used to treat certain cancers;
- St John’s Wort, a herbal product used to treat depression.
Proper use of this medication
Make sure that you receive the same tacrolimus medicine every time you collect your treatment, unless your doctor changed it to a different tacrolimus medicine. Speak to your pharmacist as soon as possible to make sure that you have the right product:
- if the appearance of your medicine is not the same as usual;
- if dose instructions have changed, or;
- if the brand name is different.
- Take ENVARSUS PA exactly as your doctor tells you to.
- Swallow the tablets whole with fluid (preferably with water).
- Do not chew, divide or crush the tablets before swallowing. If you cannot swallow ENVARSUS PA tablets whole, talk to your doctor.
- Take the tablets once a day at the same time each day. It is best to take it in the morning.
- It is recommended to take your medicine at least 1 hour before or 2 hours after a meal.
- If your doctor decides to switch your current tacrolimus medicine to Envarsus PA, continue taking your medication with meals, if you were doing so.
Usual Dose
Your doctor will tell you how many tablets to take. Your doctor may change your dose if needed. Do not stop taking ENVARSUS PA or change your dose without talking to your doctor.
Overdose
If you think you have taken too much ENVARSUS PA, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
If you miss your dose of ENVARSUS PA, take it as soon as possible on the same day. Take your regular dose the next morning as usual. Never take two doses to make up for a forgotten dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking ENVARSUS PA. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects may include:
- Anxiety
- Constipation
- Edema (swelling) of the legs and arms
- Insomnia
- Tremor (shaking), especially of the hands
ENVARSUS PA can cause abnormal blood test results. Your doctor may perform blood tests and will interpret the results.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Anemia (decreased red blood cells): dizziness, fainting, fatigue, feeling unwell, lack of energy, pale skin, pale stool, rapid heartbeat, shortness of breath, weakness | ✔ | ||
| Diabetes (high blood sugar): blurred vision, confusion, drowsiness, frequent urination, fruity smell on your breath, increased thirst and hunger, loss of appetite, nausea, stomach pain or vomiting | ✔ | ||
| Hypertension (high blood pressure): usually without symptoms but can appear as altered vision, dizziness, fainting, headache, head feeling “light”, tinnitus (buzzing or hissing in the ears), vertigo | ✔ | ||
| Infections of urinary tract: frequent urination, pain or burning sensation when urinating, pain or pressure in lower back or abdomen, urine not looking or smelling normal | ✔ | ||
| Leukopenia (decreased white blood cells): aches, fatigue, fever, infections, mouth ulcers, pains and flu -like symptoms, sweating | ✔ | ||
| Liver problem: back pain, yellowing of the skin or eyes | ✔ | ||
| Kidney problem: back and abdominal pain, change in the colour of urine (pale or dark), less urine produced, pain or discomfort when urinating, swelling of the legs and ankles | ✔ | ||
| COMMON | |||
| Infections of upper respiratory tract (sinus, nose, throat): common cold symptoms, cough, facial pain or pressure, fever, headache, nasal congestion, runny or stuffy nose, sneezing, sore throat | ✔ | ||
| Electrolyte disturbance (high/low blood levels of calcium, magnesium and/or phosphate): dehydration, diarrhea, eating disorders, vomiting | ✔ | ||
| RARE / UNKNOWN | |||
| Posterior encephalopathy syndrome (a nervous system disorder): change in mental state, coma, confusion, numbness and tingling, headache, seizures, vision changes | ✔ | ||
| Heart problems: abnormal heart rhythms, chest pain, dizziness, fainting, low or no pulse, nausea, pain irradiating in the arm, neck or back, palpitations, short breath, sweating | ✔ | ||
| Gastrointestinal perforation (a hole in your stomach or bowels): chills or fever, nausea, severe abdominal pain, vomiting | ✔ | ||
| Respiratory distress: chest pain, difficulty to breathe, short breath | ✔ | ||
| Sepsis: confusion, fever, low body temperature, rapid breathing, rapid heart rate, swelling | ✔ | ||
| Cancer: new or abnormal mole on the skin, patch on the skin that doesn’t heal, or is itchy, bleeds or oozes, size or shape of an existing mole, skin ulcers (broken skin with an open wound), appearance of lumps in your breast or other areas of the body, a nagging cough or hoarseness, persistent and severe headaches, swollen lymph nodes, a change in your bladder or bowel habits | ✔ | ||
| Progressive multifocal leukoencephalopathy (PML) (rare brain infection): changes in thinking, clumsiness of limbs, confusion, disturbance of vision, progressive weakness on one side of the body, memory and orientation, personality changes | ✔ | ||
| Pure red cell aplasia (PCRA) (bone marrow stops producing red cells): dizziness, fainting, fatigue, feeling unwell, pale skin, pale stools, rapid heartbeat, shortness of breath, weakness | ✔ | ||
| Optic neuropathy (problem with the nerves in your eye): change or loss of vision | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store between 15°C-25°C, protect from light.
Keep out of reach and sight of children.
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/healthcanada/services/drugs-health-products/medeffectcanada/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.
More information
If you want more information about ENVARSUS PA:
- 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 (http://hc-sc.gc.ca/index-eng.php); the distributor’s website www.paladinlabs.com, or by calling 1-888-867-7426.
This leaflet was prepared by Endo Ventures Ltd.
Last Revised: June 16, 2020