Details for: MYCOPHENOLATE MOFETIL FOR INJECTION, USP
Company: ACCORD HEALTHCARE INC
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02444836||MYCOPHENOLATE MOFETIL FOR INJECTION, USP||MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE)||500 MG / VIAL||POWDER FOR SOLUTION||INTRAVENOUS|
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
- Mycophenolate Mofetil for Injection, USP is used after kidney, heart and liver transplantation to help prevent organ rejection.
- Mycophenolate Mofetil for Injection, USP belongs to a family of drugs known as "immunosuppressants". These drugs work to "suppress" or reduce the body's immune response.
- Mycophenolate Mofetil for Injection, USP 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. Mycophenolate Mofetil for Injection, USP, works to reduce this reaction, so that your body is more likely to accept the transplanted organ.
When it should not be used
- Mycophenolate Mofetil for Injection, USP 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 non-medicinal ingredients are”).
- Mycophenolate Mofetil for Injection, USP should not be used in patients who are allergic to Polysorbate 80 (TWEEN).
- Mycophenolate Mofetil for Injection, USP should not be used if you are pregnant or breastfeeding.
- Mycophenolate Mofetil for Injection, USP should not be used if you can become pregnant and are not using highly effective birth control.
- Mycophenolate Mofetil for Injection, USP should not be used unless you have a pregnancy test result showing that you are not pregnant.
What the medicinal ingredient is
mycophenolate mofetil (as mycophenolate mofetil hydrochloride)
What the non-medicinal ingredients are
Mycophenolate Mofetil for Injection, USP contains the following nonmedicinal ingredients: citric acid, 5 mg, hydrochloric acid concentrate, 103.4 mg, polysorbate 80, 25 mg, sodium chloride, 7.5 mg, and sodium hydroxide and/or hydrochloric acid to adjust pH.
What dosage form it comes in
Mycophenolate Mofetil for Injection, USP is available
for patients who are unable to take oral medications.
Mycophenolate Mofetil for Injection, USP is available as a 20 mL sterile vial containing 500 mg of mycophenolate mofetil (as mycophenolate mofetil hydrochloride).
Warnings and precautions
Serious Warnings and Precautions
- If you use mycophenolate mofetil in combination with other medicines used to prevent organ rejection when you are pregnant; you are likely to have early pregnancy loss and infant birth defects (see Special Note for Female Patients).
- Because Mycophenolate Mofetil for Injection, USP 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 not take Mycophenolate Mofetil for Injection, USP while they are pregnant as Mycophenolate Mofetil for Injection, USP may cause an increased risk of first trimester pregnancy loss or damage to the unborn baby (affecting development of ears, limbs, face, heart, brain for example). For this reason it is recommended that you discuss with your doctor if you are pregnant or become pregnant or plan on becoming pregnant while taking Mycophenolate Mofetil for Injection, USP. You will want to discuss the possible benefits and risks of continuing with this drug.
- If you think you may be pregnant tell your doctor straight away. However, keep taking Mycophenolate Mofetil for Injection, USP until you see him or her. Your doctor will talk to you about other medicines you can take to prevent rejection of your transplant organ.
- Women (who have the potential of becoming pregnant) should have two negative serum (blood) or urine pregnancy tests. The second test should be performed 8- 10 days later. You can only start Mycophenolate Mofetil for Injection, USP if the tests are negative. Repeat pregnancy tests should be performed during routine follow-up visits.
- Before you start taking Mycophenolate Mofetil for Injection, USP,
- During your entire treatment with Mycophenolate Mofetil for Injection, USP and
- For 6 weeks after stopping your treatment with Mycophenolate Mofetil for Injection, USP
If you take oral contraceptives (birth control pills) while using Mycophenolate Mofetil for Injection, USP you must also use another form of birth control method as Mycophenolate Mofetil for Injection, USP may adversely affect the efficacy of an oral contraceptive.
- Do not breastfeed your baby if you are taking Mycophenolate Mofetil for Injection, USP as it may pass into breast milk and may harm your baby.
- Be sure to keep all appointments at your transplant clinic. During these visits, pregnancy tests may be administered by your doctor.
- Sexually active male patients and/or their female partners are recommended to use effective birth control while taking Mycophenolate Mofetil for Injection, USP and for at least 90 days after stopping treatment. If pregnancy occurs, talk to your doctor. (See Special Note For Female Patients, above.)
- Men should not donate semen during therapy and for 90 days after taking of Mycophenolate Mofetil for Injection, USP.
- Tell all health professionals you see (doctor, dentist, nurses, pharmacists) that you are taking Mycophenolate Mofetil for Injection, USP.
- 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.
- Patients should not donate blood during therapy and for at least 6 weeks after taking Mycophenolate Mofetil for Injection, USP.
- Mycophenolate Mofetil for Injection, USP reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
- wearing protective clothing which also covers your head, neck, arms and legs.
- using a sunscreen with a high sun protection factor (SPF).
- Patients should use caution when driving or using machines.
- If you have had a bad, unusual or allergic reaction to Mycophenolate Mofetil for Injection, USP, mycophenolic acid, or mycophenolate sodium;
- If you are pregnant, plan to become pregnant, or are breastfeeding a baby or plan to breastfeed;
- About all other health conditions you have now, or have had in the past, especially problems with your stomach 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
- Tell your doctor if you are taking medicines containing telmisartan, rifampicin or azathioprine.
- Do not take any other drugs without asking your doctor or pharmacist first.
- Taking combinations of antibiotics at the same time as Mycophenolate Mofetil for Injection, USP may affect the way Mycophenolate Mofetil for Injection, USP works for you. Do not take any other drugs without asking your doctor or pharmacist first.
- During treatment with Mycophenolate Mofetil for Injection, USP, 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 Mycophenolate Mofetil for Injection, USP 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.
- 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.
- Mycophenolate Mofetil for Injection, USP 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.
- Do not change the dose on your own, no matter how you are feeling. Call your doctor.
- Do not stop taking Mycophenolate Mofetil for Injection, USP on your own even if you have been taking it for several years.
Kidney Transplant Patients
- A dose of 1 g administered intravenously (over 2 hours) twice a day (daily dose of 2 g) is recommended after kidney transplantation.
- In pediatrics (2 years and older), the recommended dose of mycophenolate mofetil oral suspension following kidney transplantation is 600 mg/m2 body surface area** twice a day (up to a maximum daily dose of 2 g).
- Pediatric patients with a body surface area** of 1.25 to 1.5 m2 may be dosed with mycophenolate mofetil 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 mycophenolate mofetil capsules or tablets 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
- A dose of 1.5 g twice daily administered intravenously (over no less than 2 hours) is recommended after heart transplantation in adults.
- A dose of 1 g twice daily administered intravenously (over no less than 2 hours) is recommended after liver transplantation in adults.
Mycophenolate Mofetil for Injection, USP comes as a powder. Your doctor or nurse will make up the medicine and give it to you.
If you miss a dose of Mycophenolate Mofetil for Injection, USP, your doctor will decide when you should receive your next dose.
Side effects and what to do about them
- Like all medicines, along with the beneficial effects of treatment, Mycophenolate Mofetil for Injection, USP may cause side effects in people.
- Because Mycophenolate Mofetil for Injection, USP 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 stomach 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 headaches.
- Patients taking Mycophenolate Mofetil for Injection, USP 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 mycophenolate mofetil, 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.
|Symptom / effect||Talk with your doctor, nurse, or pharmacist only if severe||Talk with your doctor, nurse, or pharmacist in all cases||Stop taking drug and talk with your doctor or pharmacist†|
|Abdominal, pain, Blood in urine, Constipation, Increased cough Diarrhea, Fever, Laboured breathing, Headache Hypertension Swelling of parts of your body, Vomiting, Weakness||✔|
|Chest or back pain Dizziness, Heartburn Involuntary trembling, Muscle weakness, Nausea, Nosebleed, Sleeplessness, Stomach pain||✔|
|Blood or black tarry stools||✔|
†Do not stop your medicines unless you have discussed this
with your doctor first.
This is not a complete list of side effects. For any unexpected effects you have while taking Mycophenolate Mofetil for Injection, USP, contact your doctor or pharmacist.
How to store
- Keep Mycophenolate Mofetil for Injection, USP out of reach and sight 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.
- Mycophenolate Mofetil for Injection, USP, 500 mg/vial: Store between 15ºC to 30ºC and protect from light.
- Reconstituted/Infusion solutions: Store at 15ºC to 30ºC. Commence treatment within 4 hours from reconstitution/dilution.
- Mycophenolate Mofetil for Injection, USP should not be used after the expiry date (EXP) shown on the package.
Reporting 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 three 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:
Canada Vigilance Program
Postal Locator 0701E
Ottawa ON K1A 0K9
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 side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
If you want more information about Mycophenolate Mofetil for Injection, USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the sponsor, Accord Healthcare Inc. at 1-866-296-0354.
Accord Healthcare Inc.
3535 boul. St. Charles suite 704
Kirkland, QC, H9H 5B9
Last revised: May 29, 2019
Neoral® (cyclosporine) is a registered Trade-Mark of Novartis Pharmaceuticals Canada Inc.
Sandimmune® (cyclosporine) is a registered Trade-Mark of Novartis HOW TO STORE IT Pharmaceuticals Canada Inc.