Cellcept

Mycophenolate mofetil is usually started as soon as possible following the organ transplant. The dose varies according to circumstances. The dose for children following a kidney transplant is based on body surface area, which takes into account a person's height and weight.

The medication is usually given twice daily. The 2 doses should be spaced as close to 12 hours apart as possible and at approximately the same time each day. The oral medication should be taken on an empty stomach (1 hour before or 2 hours after meals). If you vomit or have Diarrhea after taking mycophenolate mofetil, always call your doctor for further direction. Do not stop taking the medication without first talking with your doctor.

You should leave the capsules and tablets in the blister packs until it is time for your dose. The capsules and tablets should be swallowed whole, and not crushed or chewed.

If using the suspension, be sure to shake the closed bottle well for about 5 seconds before each use. Do not mix the suspension with any liquid. Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

Avoid skin contact with damaged capsules or caplets. If any powder from any of the forms of mycophenolate mofetil should get on your skin, quickly wash with soap and water. If the medication comes in contact with your eyes, rinse them thoroughly with water. Use a wet paper towel to wipe up spills.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Cellcept (Mycophenolate-mofetil-oral) be taken exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist for instructions. Do not take a double dose to make up for a missed one.

Store mycophenolate mofetil tablets, capsules, and suspension at room temperature. Protect the tablets from light. Discard any unused portion of mycophenolate mofetil suspension 60 days after mixing.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause stomach ache; it may cause sleep disturbances or insomnia; it may lower your white blood cell count, which can lead to fever, chills, sore throat or infections - if you experience any of these symptoms, contact your doctor right away; it may cause nausea and vomiting; it could cause water retention and swelling; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Capsules
Each oblong, blue/brown, two-piece hard gelatin capsule, printed in black with "CellCept 250" on the blue cap and "Roche" on the brown body, contains 250 mg of mycophenolate mofetil. Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, povidone (K-90), and pregelatinized starch; capsule shell: black iron oxide, gelatin, indigotine (FD&C Blue No. 2) Aluminum Lake, potassium hydroxide, red iron oxide, shellac, titanium dioxide, and yellow iron oxide.

Tablets
Each lavender-coloured, caplet-shaped, film-coated tablet, engraved with "CellCept 500" on one side and "Roche" on the other, contains 500 mg of mycophenolate mofetil. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, indigotine (FD&C Blue No. 2) Aluminum Lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone (K-90), and titanium dioxide.

Powder for Oral Suspension
Available as a white-to-off-white powder blend for reconstitution to a white-to-off-white fruit flavor suspension containing 200 mg per mL of mycophenolate mofetil. Each bottle of CellCept powder for oral suspension contains 35 g of mycophenolate mofetil in a 110 g powder for oral suspension. Nonmedicinal ingredients: aspartame, citric acid, colloidal silicon dioxide, fruit flavor, methylparaben, sodium citrate, sorbitol, soybean lecithin, and xanthan gum.

Injectable solution
Each vial of sterile, white-to-off-white lyophilized powder for I.V. infusion contains the equivalent of 500 mg of mycophenolate mofetil as the hydrochloride salt. Nonmedicinal ingredients: citric acid, polysorbate 80 (Tween), and sodium hydroxide and/or hydrochloric acid to adjust pH.

Do not take Cellcept (Mycophenolate-mofetil-oral) if you:

• are allergic to mycophenolate or any ingredients of the medication
• are or may become pregnant
• are breast-feeding

There may be an interaction between mycophenolate mofetil and any of the following:

• acyclovir
• antacids containing magnesium and aluminum
• Azathioprine
• BCG
• calcium carbonate
• Cholestyramine
• Colesevelam
• Colestipol
• clindamycin
• Cyclosporine
• Denosumab
• echinacea
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Fingolimod
• Ganciclovir – valganciclovir
• Leflunomide
• magnesium supplements (magnesium citrate, magnesium sulfate)
• Metronidazole
• Natalizumab
• Nivolumab
• oral contraceptives (birth control pills)
• penicillins (e.g., penicillin, amoxicillin, ampicillin)
• Pimecrolimus
• probenecid
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifabutin
• rifampin
• Roflumilast
• Rosiglitazone
• sevelamer
• Tacrolimus
• Tofacitinib
• Tolvaptan
• Trastuzumab
• vaccines
• Valacyclovir

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Cellcept (Mycophenolate-mofetil-oral). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Cellcept (Mycophenolate-mofetil-oral).

Blood donation: People taking mycophenolate should not donate blood during therapy and for at least 6 weeks after stopping Cellcept (Mycophenolate-mofetil-oral).

Bronchiectasis: When mycophenolate mofetil is used in combination with other immunosuppressants, there have been rare reports of bronchiectasis. Bronchiectasis is a condition where there is injury to the walls of the airways, resulting in a decreased ability to clear mucus and an increased risk of infection. If you develop symptoms such as coughing, shortness of breath, or recurrent respiratory infections, let your doctor know as soon as possible.

Infection: Cellcept (Mycophenolate-mofetil-oral) reduces the number of cells that fight infection in the body. Take extra measures to prevent infection, and avoid people with infections if at all possible. Report any signs of infection (e.g., fever, chills, sore throat, painful or difficult urination) to your doctor immediately.

Kidney function: If you have poor kidney function, discuss with your doctor how Cellcept (Mycophenolate-mofetil-oral) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cellcept (Mycophenolate-mofetil-oral), and whether any special monitoring is needed.

Lymphoma and other malignancies: People taking immunosuppressant medications, such as mycophenolate mofetil, are at increased risk of developing a type of cancer known as lymphoma. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than one specific medication.

Possible warning signs of cancer include a change in bowel or bladder habits, sores that don’t heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough, or persistent and severe Headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.

People with phenylketonuria: Mycophenolate mofetil oral suspension (liquid) contains aspartame (0.56 mg of phenylalanine per mL of suspension).

Pure red cell aplasia (PRCA): Cellcept (Mycophenolate-mofetil-oral) may cause PRCA, a condition where the bone marrow does not make red blood cells. If you have symptoms of PRCA, such as sudden tiredness or shortness of breath, get immediate medical attention.

Stomach and intestinal problems: Since some people receiving Cellcept (Mycophenolate-mofetil-oral) have experienced stomach bleeding, people with existing stomach and intestinal problems should be monitored closely by their doctor while taking Cellcept (Mycophenolate-mofetil-oral). If you notice symptoms of stomach bleeding (e.g., black, tarry stools; vomiting or spitting up blood or material that looks like coffee grounds; blood in the stools), seek immediate medical attention.

Pregnancy: Mycophenolate mofetil should not be used during pregnancy. Severe birth defects and pregnancy loss, including spontaneous abortion, have been reported in babies who were exposed to Cellcept (Mycophenolate-mofetil-oral) before birth. Women who may become pregnant should have a negative urine or blood pregnancy test within one week before starting Cellcept (Mycophenolate-mofetil-oral).

Two methods of effective birth control (unless abstinence is the chosen method) should be used before the start of treatment with mycophenolate mofetil, during treatment, and for 6 weeks after the medication has been stopped. Consult your doctor immediately if you become pregnant while taking Cellcept (Mycophenolate-mofetil-oral).

If you are a sexually active man, you should use condoms during and for 13 weeks after stopping treatment. Your partner should also use effective birth control during this time period.

Breast-feeding: It is not known if mycophenolate mofetil passes into breast milk. If you are a breast-feeding mother and are taking Cellcept (Mycophenolate-mofetil-oral), it may cause serious side effects for your baby. Cellcept (Mycophenolate-mofetil-oral) is not recommended during breast-feeding.

Children: The safety and effectiveness of Cellcept (Mycophenolate-mofetil-oral) for children with heart or liver transplants have not been established.

Seniors: Seniors may have a higher risk of side effects from Cellcept (Mycophenolate-mofetil-oral).

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. The capsule of this medication should not be opened, crushed or chewed. You should take this medication at approximately the same time each day. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication should not be taken with food. It is best taken on an empty stomach, one hour before or 2 hours after a meal.