Details for: ADVAGRAF
Company: ASTELLAS PHARMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02296462 | ADVAGRAF | TACROLIMUS | 0.5 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02296470 | ADVAGRAF | TACROLIMUS | 1 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02331667 | ADVAGRAF | TACROLIMUS | 3 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02296489 | ADVAGRAF | TACROLIMUS | 5 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
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
- Advagraf is used to help prevent organ rejection.
- It is used in adults who have received a kidney or a liver transplant.
- It is used along with other medicines.
- Advagraf is the brand name for tacrolimus extended release capsules.
What it does
Your immune system is your body’s defence system. Immunity is the way your body protects itself from infections and other foreign material. When you receive a transplant, your immune system recognizes the transplanted organ as foreign and will try to reject it. Advagraf is an anti-rejection drug that helps your body accept your 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
Ethylcellulose, ferric oxide, gelatin, hypromellose, lactose, magnesium stearate, sodium lauryl sulfate and titanium dioxide.
What dosage form it comes in
Advagraf is available in an extended release capsule. Each capsule contains 0.5 mg, 1 mg, 3 mg or 5 mg of tacrolimus.
Warnings and precautions
Serious Warnings and Precautions
- Advagraf may increase your chances of getting serious infection and some kinds of cancer. These include skin cancer and lymphoma.
- Advagraf should only be prescribed by doctors with experience in the use of immunosuppressive (anti-rejection) drugs and the management of organ transplants.
- have heart problems including congenital or acquired QT prolongation
- have or have had liver problems
- have or have had kidney problems
- have a hereditary disease of galactose intolerance, such as the Lapp lactase deficiency or glucose-galactose malabsorption, since Advagraf contains lactose
- are taking a diuretic medicine
Other warnings you should know about
Pregnancy:
Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant, or
father a child while taking Advagraf. Advagraf can cause development problems in an unborn baby. You
should not use Advagraf if you are pregnant unless advised by your doctor. It is not known if it will harm
your unborn baby.
You should consider the use of a reliable method of birth control before, during your treatment and for 6
weeks after stopping your treatment with Advagraf.
Breastfeeding:
Tell your doctor if you are breastfeeding or planning to breastfeed your baby. Advagraf can pass into your breast milk. It is not known if this can harm your baby. You should not breastfeed your baby while you are taking Advagraf.
New onset diabetes:
Advagraf may cause new onset diabetes in kidney transplant patients. Your doctor may order tests to monitor your blood glucose levels.
Vaccinations and other medicines:
While you are taking Advagraf, do not get any vaccinations without your transplant team’s approval. The vaccination may not work as well as it should or may result in serious side effects. Tell your doctor if you have had or are scheduled to have any vaccinations. Always check with your transplant team before starting any new medicine or supplement. You should avoid taking too much potassium while you are taking Advagraf. Talk to your doctor if you are not sure if your potassium intake is high.
Driving and using machines:
Advagraf may cause vision and nervous system problems. Wait until you know how Advagraf affects you before driving or using machines.
Skin protection:
Prograf may increase your chances of getting some kinds of cancer including skin cancer. You must protect your skin from sunlight and UV light. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF 30 or higher) while you are taking Advagraf.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Antacids: magnesium aluminum hydrochloride
- Medicines used to treat irregular heart rhythm such as amiodarone
- Medicines used for fungal infections such as clotrimazole, fluconazole, ketoconazole, itraconazole, voriconazole
- Medicines used to treat circulation and heart problems such as diltiazem nicardipine, nifedipine, verapamil
- Medicines used to treat stomach disorders such as cisapride*, metoclopramide, lansoprazole, omeprazole
- Medicines used for bacterial infections such as erythromycin, clarithromycin, troleandomycin
- Other drugs such as bromocriptine, cimetidine, chloramphenicol, cyclosporine, danazol, ethinyl estradiol, methylprednisolone, nefazodone
- Medicines used to treat HIV infection such as ritonavir, nelfinavir, and saquinavir
- Medicines used to treat HCV infection such as sofosbuvir, telaprevir and boceprevir
- Cytomegalovirus (CMV) antiviral medicines such as letermovir
- Anticonvulsant medicines used to control seizures such as carbamazepine, phenobarbital, phenytoin
- Anti-infective medicines used to treat tuberculosis such as rifampin, rifabutin, capsofungin
- Sirolimus, a medicine used to avoid rejection of the kidney transplant
- Potassium sparing diuretics such as amiloride, triamterene, or spironolactone
- St. John’s Wort (Hypericum perforatum), an herbal product used for depression
- Schisandra sphenanthera extracts, an herbal product with various uses
- Grapefruits or grapefruit juice
Proper use of this medication
You need to take Advagraf correctly so that it can protect your new kidney or liver. Take Advagraf exactly as your doctor and transplant team have told you to.
Your new organ needs around-the-clock protection so your body does not reject it. The success of your transplant depends a great deal upon how well you help Advagraf do its job. Here is what you need to do:
1. Take Advagraf exactly as prescribed
Your transplant team will tell you what dose to take and how to take it. It is important to take Advagraf
capsules exactly as told by your transplant team. Your transplant team may adjust your dose until they
find what works best for you. Never change your dose on your own. Never stop taking Advagraf even if
you are feeling well. If you feel poorly on Advagraf, discuss this with your transplant team.
2. Take Advagraf once-a-day, in the morning
Try to pick a time that will be easy for you. You must take Advagraf at the same time every day. If you
decide to take Advagraf at 7:00 a.m., take it at this same time every day. This will make sure you always
have enough medicine in your body to give your new organ the around-the-clock protection it needs.
3. Take Advagraf the same way each day
Whether you take Advagraf with or without food, it is important to take Advagraf the same way every day.
For example, if you take Advagraf with food, you should always take it with food. Do not change the way
you take this medicine without telling your transplant team, since this could change the amount of
protection you get from Advagraf.
4. Take your full dose of medication, every day
It is important to take your dose exactly as prescribed by your doctor. If you miss even one dose, your
new kidney could lose the protection it needs against rejection by your body.
If you travel and change time zones, be sure to ask your transplant team how to adjust your dosage schedule so your new organ does not lose its protection.
5. Take the same tacrolimus medicine every time
Make sure that you receive the same tacrolimus medicine (the brand name of the medicine should always
be the same) every time you collect your prescription. Advagraf should be taken once a day. If the
appearance is not the same as usual, or if dosage instructions have changed, or if the brand name is
different, speak to your doctor or pharmacist as soon as possible to make sure that you have the right
medicine. Serious side effects can occur if you do not take the exact tacrolimus medication that you are
supposed to take. You need to take the exact tacrolimus medicine prescribed to you by your doctor to
ensure that your organ is protected.
6. Plan ahead so that you do not run out of Advagraf
Make sure you have your prescription for Advagraf refilled and at home before you need it. Circle the
date on a calendar when you need to order your refill. Allow extra time if you receive your medicines
through the mail.
7. When having a blood test to measure Advagraf
On the days you are going to have a blood test to measure the amount of Advagraf in your body, your
transplant team will ask you not to take your dose until after the blood sample is taken.
Avoid inhalation, or direct contact with your skin or mucous membranes with the powder inside the Advagraf capsule. If such contact occurs, wash the skin and eyes.
Usual Dose
Your doctor will tell you what dose to take and how to take it. Your doctor may adjust your dose until they find what works best for you. Never change your dose on your own.
Overdose
If you think you have taken too much Advagraf, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
If you miss a dose of Advagraf you may take it up to 14 hours from the scheduled time of your dose. For example, if you miss an 8:00 am dose, you may take the missed dose by 10:00 pm. If it has been more than 14 hours since the missed dose, do not take the missed dose. Wait until the usual scheduled time the following morning and take your next regular daily dose. Never take a double dose to make up for a missed dose.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Advagraf. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects may include:
- Anxiety
- Constipation
- Diarrhea
- Edema (swelling) of the legs and arms
- Headache
- Insomnia
- Tremor (shaking), especially of the hands
Advagraf can cause abnormal blood test results. Your doctor may perform blood tests and will interpret the results.
Like other medicines, Advagraf may cause side effects in some people. If you think that you are having side effects, talk to your doctor right away.DO NOT stop taking Advagraf on your own.
It is important to regularly tell your doctor how you are feeling and if you have developed any new symptoms while taking Advagraf.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and 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 | ✔ | ||
| Infections: chills, fatigue, feeling unwell, fever, 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 (PRCA) (bone marrow stops producing red cells): dizziness, fainting, fatigue, feeling unwell, pale skin, pale stools, rapid heartbeat, shortness of breath, weakness | ✔ | ||
| Febrile Neutropenia (decrease in white blood cells): fever | ✔ | ||
| 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 at room temperature (15°C – 30°C).
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
- 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/indexeng.php); the manufacturer’s website http://www.astellas.ca/, or by calling 1-888-338-1824
This leaflet was prepared by Astellas Pharma Canada, Inc.
Last Revised December 1, 2020
Prograf® and Advagraf® are registered trademarks of Astellas Pharma Inc. All other trademarks or registered trademarks are the property of their respective owners.