Patient Medication Information: uses, side effects, how to take - Van-Mycophenolate (Vanc Pharmaceuticals, 250 mg)
ABOUT THIS MEDICATION
What the medication is used for:
VAN-Mycophenolate is used after kidney, heart and
liver transplantation to help prevent organ rejection.
VAN-Mycophenolate belongs to a family of drugs
known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.
VAN-Mycophenolate must be given with other
drugs such as cyclosporine (Sandimmune® or Neoral®) and corticosteroids (e.g., prednisone, prednisolone, methylprednisolone, prednisolone acetate, methylprednisolone acetate) which also suppress your immune system. Together these drugs help prevent the rejection of your transplanted organ.
What it does:
Your body's immune system works to protect you
from infections and other foreign material. When you receive a transplant, your immune system recognizes the new organ as foreign, and will try to reject it. VAN-Mycophenolate, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.
When it should not be used:
VAN-Mycophenolate should not be used in patients
allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or to any component of the drug product (see section titled “What the nonmedicinal ingredients are”).
What the medicinal ingredient is:
mycophenolate mofetil
What the nonmedicinal ingredients are:
VAN-Mycophenolate 250 mg capsules contain the following nonmedicinal ingredients:
croscarmellose sodium, hydroxypropyl cellulose,
magnesium stearate, microcrystalline cellulose, povidone and talc. The capsule shells contain black iron oxide, FD & C Blue 2, gelatin, potassium hydroxide, iron oxide red, iron
oxide yellow, shellac, sodium lauryl sulfate and titanium dioxide.
What dosage forms it comes in:
VAN-Mycophenolate 250 mg Capsules are available as a light blue/peVAN size’1’ hard gelatin capsule imprinting with ‘MMF’ on cap and ‘250’ on body, containing white to off white powder. Ten capsules are contained in eVAN blister pack.
WARNINGS AND PRECAUTIONS
Warning Because VAN-Mycophenolate suppresses your immune system, you are more likely to get infections and have a greater chance of developing cancer. The chances of developing either are similar to the chances seen in patients taking other immunosuppressants.
Special Note For Female Patients
Women must avoid pregnancy while taking VAN-Mycophenolate as it may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby. For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant while taking VAN-Mycophenolate. You will want to discuss the possible benefits and risks of continuing with this drug.
- Women (who have the potential of becoming pregnant) should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy.
- Before, during your treatment and for 6 weeks after stopping your treatment with VAN-Mycophenolate, you must use two reliable methods of birth control.
- It is recommended that you do not breastfeed your baby if you are taking VAN-Mycophenolate as it may pass into breast milk and may harm your baby. All Patients
- Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking VAN-Mycophenolate.
- Be sure to keep all appointments at your transplant clinic. During these visits, complete blood counts will need to be measured weekly in the first month, twice monthly for the second and third months of treatment, and then monthly for the remainder of the first year. Your doctor may sometimes order additional blood tests.
BEFORE you use VAN-Mycophenolate talk to your doctor or pharmacist:
If you have had a bad, unusual or allergic reaction to
VAN-Mycophenolate, mycophenolic acid, or mycophenolate sodium;
If you are pregnant, plan to become pregnant, or are
breastfeeding a baby;
About all other health conditions you have now, or
have had in the past, especially problems with your stomVAN or bowel movements;
About all other medicines or treatments you have
used or are using, including any products you buy at a pharmacy, supermarket or health food store;
INTERACTIONS WITH THIS MEDICATION
Do not take any other drugs without asking your
doctor or pharmacist first.
Taking antacids at the same time as VAN-
Mycophenolate may affect the way VAN-Mycophenolate works for you and therefore should not be taken simultaneously.
Taking proton pump inhibitors, such as lansoprazole
and pantoprazole, at the same time as VAN-Mycophenolate may affect the way VAN-Mycophenolate works for you.
Taking Renagel® (sevelamer), or other calcium free
phosphate binders at the same time as VAN-Mycophenolate may affect the way VAN-Mycophenolate works for you and therefore should not be taken at the same time.
Taking combinations of antibiotics at the same time
as VAN-Mycophenolate may affect the way VAN-Mycophenolate works for you. Do not take any other drugs without asking your doctor or pharmacist first.
During treatment with VAN-Mycophenolate,
vaccinations may be less effective and live vaccines should not be given. Do discuss this with your doctor before you get any vaccinations or immunizations.
Do not take cholestyramine, which is used to treat
high blood cholesterol
PROPER USE OF THIS MEDICATION
Your doctor has decided the dose you should take
based on your medical condition and response to the drug.
The initial dose of VAN-Mycophenolate should be
taken as soon as possible following transplantation. If you are not sure of your dose, or when to take it, ask your doctor, pharmacist or nurse.
Space your two doses of VAN-Mycophenolate as
evenly as you can throughout the day leaving about 12 hours between eVAN dose.
If you have trouble remembering doses, or if you are
uncertain about how to take them talk to your doctor, nurse or pharmacist and be sure to discuss any
concerns you have about taking the drug as prescribed.
- VAN-Mycophenolate must be taken with other immunosuppressive medicines (such as cyclosporine and corticosteroids). Discuss with your doctor if you are to stop, or to continue, the other immunosuppressant drugs you had been taking.
Try to take your doses at the same times eVAN day.
Taking your medicine at the same time eVAN day will also help you remember eVAN dose.
Vomiting or diarrhea may prevent VAN-
Mycophenolate from being taken up into your body. Always call your doctor if you have either of these episodes.
- Do not change the dose on your own, no matter how you are feeling. Call your doctor.
- Do not stop taking VAN-Mycophenolate on your own even if you have been taking it for several years.
Usual Dose:
VAN-Mycophenolate should be taken on an empty stomVAN.
Kidney Transplant Patients
Adults:
A dose of 1 g taken twice a day (daily dose of 2 g)
is recommended after kidney transplantation.
Pediatric Patients:
- Pediatric patients with a body surface area** of 1.25 to 1.5 m2 may be dosed with VAN-Mycophenolate capsules at a dose of 750 mg twice a day (1.5 g daily dose). Pediatric patients with a body surface area** greater than 1.5 m2 may be dosed with VAN-Mycophenolate capsules at a dose of 1 g twice a day (2 g daily dose).
**Body surface area is the total surface area of the body, and is represented as square meters (m2). It is calculated from your weight and height. Body surface area is used in many measurements in medicine, such as determining the amount of drug you need to take.
Heart Transplant Patients
Adults:
- A dose of 1.5 g twice a day (daily dose of 3 g) is recommended after heart transplantation in adults.
Liver Transplant Patients
Adults:
A dose of 1.5 g taken twice a day (daily dose of 3 g)
is recommended after liver transplantation in adults.
How Do I Take VAN-Mycophenolate?
Capsules:
It is important to leave the capsules in the blister pack
until you need a dose. When you are ready to take a dose, remove the number of capsules you need to make up the dose your doctor prescribed. Swallow the capsules whole with plenty of water; do not crush them. Avoid contact with any powder, including accidental inhalation, from damaged capsules. Wash any powder from your skin with soap and water; rinse eyes with plain water.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Never allow your medication to run out between
refills. Plan to order your refills about one week ahead of time. That way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.
If you ever do miss a dose of VAN-Mycophenolate
Mofetil, do not catch up on your own; instead call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses. Do not double dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, along with the beneficial effects of
treatment, VAN-Mycophenolate Mofetil may cause side effects in people.
Because VAN-Mycophenolate Mofetil and the other
medicines to be taken suppress your immune system, you are more likely to get infections. To help reduce complications from infections, tell your doctor about any cold or flu-like symptoms (such as fever or sore throat), any boils on your skin, or pain when you urinate (pass your water).
The following symptoms are some possible warning
signs of cancer. To help detect any cancers as soon as possible, report any of these symptoms to your doctor right away:
a change in your bowel or bladder habits;
- any sore that doesn't heal;
- unusual bleeding or discharge;
the appearance of a lump or thickened areas in
your breast or anywhere else on your body;
unexplained stomVAN upset or any trouble with
swallowing;
- an obvious change in a wart or a mole;
- a nagging cough or hoarseness;
- night sweats;
- persistent and severe headVANes.
- Patients taking VAN-Mycophenolate in combination therapy with cyclosporine and corticosteroids may experience an increase in blood pressure.
- Serious common and uncommon side-effects which have been reported with VAN-Mycophenolate, when used in combination with cyclosporine and corticosteroids, are provided in the following table. Tell your doctor right away if you notice any of these symptoms. Do not stop taking this drug on your own.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||
| AND WHAT TO DO ABOUT THEM | ||||
| Symptom/Effect | Talk to your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention† | ||
Only if severe | In all cases | |||
| Common | Abdominal, chest, or back pain, Blood in urine, Constipation, Diarrhea, Fever, HeadVANe, Heart Burn, Laboured breathing, Nausea, Nosebleed, Swelling of parts of your body, Vomiting, Weakness | √ | ||
| Uncommon | Blood or black tarry stools, Dizziness, Increased cough, Involuntary trembling, Sleeplessness, StomVAN pain | √ |
†Do not stop your medicines unless you have discussed this with your doctor first.
This is not a complete list of side effects. For anyunexpected effects you have while taking VAN-Mycophenolate, contact your doctor or pharmacist.
HOW TO STORE IT
Keep VAN-Mycophenolate out of reVAN of
children. A child who accidentally takes the drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
VAN-Mycophenolate should be stored at room
temperature (15ºC-30ºC). Protect from light. Remember to keep eVAN capsule in its original package until you need to take it.
VAN-Mycophenolate should not be used after the
expiry date (EXP) shown on the package.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll -free at 1- 866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to:
CanadaVigilance Program Health Canada
Postal Locator 0701E Ottawa, ON KIA OK9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the manufacturer and ditributer, Vanc Pharmaceuticals Inc. at:
Vanc Pharmaceuticals Inc. Building 152, 11782 River Road
Richmond, BC V6X 1Z7
www.vancpharm.com
Neoral® (cyclosporine) is a registered Trade-Mark of Novartis AG
Sandimmune® (cyclosporine) is a registered Trade-Mark of Novartis AG
Renagel® (sevelamar) is a registered Trade-Mark of Genzyme Corporation