What Form Does This Medication Come In
CapsulesEach 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 , and pregelatinized starch capsule shell: black iron oxide, gelatin, indigotine Aluminum Lake, potassium hydroxide, red iron oxide, shellac, titanium dioxide, and yellow iron oxide.
TabletsEach 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 Aluminum Lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone , and titanium dioxide.
Powder for Oral SuspensionAvailable 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.
How Long Does Cellcept Stay In Your System
CellCept will stay in your system for about 1 week after your last dose. To keep steady levels of the drug in your system, its important that you keep taking CellCept as your doctor prescribes.
It likely isnt safe to take CellCept during pregnancy. When used during pregnancy, CellCept may cause birth defects and miscarriage . The risk of miscarriage is highest during the first 3 months of pregnancy.
CellCept has a boxed warning for the risk of birth defects and miscarriage during pregnancy. A boxed warning is the most serious warning from the FDA.
It isnt known how often miscarriage or birth defects may have happened in clinical studies of CellCept. However, data from pregnancy registries shows that 45% to 49% of people who took CellCept while pregnant had a miscarriage in the first 3 months of their pregnancy.
In addition, 23% to 27% of women who took part in pregnancy registries reported birth defects after taking CellCept. Birth defects that were reported include facial defects, heart defects, and defects affecting the arms and legs.
Its important to note that pregnancy registry data is self-reported, meaning the results are submitted by people taking the drug. Therefore, this information was not gathered in a clinical study overseen by researchers.
Financial And Insurance Assistance
If you need financial support to pay for CellCept, or if you need help understanding your insurance coverage, help is available.
Genentech, the manufacturer of CellCept, offers the CellCept Co-pay Card. This card may help lower the cost of the drug for you. For more information and to find out if youre eligible for support, call 833-CellCept or visit the CellCept Patient Assistance page.
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Drug Forms And Strengths
CellCept is available in the following forms and strengths:
- capsules, available in one strength of 250 milligrams
- tablets, available in one strength of 500 mg
- liquid that you swallow, available in one strength of 200 mg per milliliter of liquid
- intravenous infusion* thats given into a vein over a period of time by your doctor, available in one strength of 500 mg per vial
The first oral dose of CellCept is given as soon as possible after a kidney, heart, or liver transplant. The IV infusion is given within 24 hours of a transplant.
* The CellCept IV infusion is used for people who arent able to swallow CellCept capsules, tablets, or liquid. In this situation, your doctor may give you the CellCept infusion for up to 14 days. However, as soon as youre able to swallow CellCept capsules, tablets, or liquid, your doctor will likely stop giving you the infusion form.
What Do I Need To Tell My Doctor Before I Take Cellcept
- If you have an allergy to mycophenolate or any other part of CellCept .
- If you are allergic to CellCept any part of CellCept or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have Lesch-Nyhan or Kelley-Seegmiller syndrome or a rare inherited deficiency of hypoxanthine-guanine phosphoribosyl-transferase .
- If you are taking any of these drugs: Azathioprine, cholestyramine, colesevelam, colestipol, norfloxacin with metronidazole, or sevelamer.
- If you are taking another drug that has the same drug in it.
- If you are able to get pregnant and are not using 2 kinds of birth control.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with CellCept .
Tell your doctor and pharmacist about all of your drugs and health problems. You must check to make sure that it is safe for you to take CellCept with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
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Consumer Information Use And Disclaimer
How Long Does It Take For Cellcept To Start Working
The normal dose of Cellcept is between 500 and 1500 mg twice per day. It takes 6 to 12 weeks for the Cellcept to start working. It is important for patients starting this medicine to keep taking it as prescribed. Taking Cellcept with food can help minimize possible side effects like nausea and stomach pain.
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How Do I Store And/or Throw Out Cellcept
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
How Long Does Cellcept Stay In Your System After Stopping
People break down medication at different rates. In healthy non-pregnant adults, it takes an average of one week for most of the mycophenolate to be gone from your body. If you are planning pregnancy, talk to your healthcare provide about when you should stop this medication and your treatment options.
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What Are The Possible Side Effects Of Cellceptcellcept Can Cause Serious Side Effects Including:
- See What is the most important information I should know about CellCept?
- Low blood cell counts. People taking high doses of CellCept each day may have a decrease in blood counts, including:
- white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant
- red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low
- platelets. Platelets help with blood clotting
Your doctor will do blood tests before you start taking CellCept and during treatment with CellCept to check your blood cell counts. Tell your doctor right away if you have any signs of infection , including any unexpected bruising or bleeding. Also, tell your doctor if you have unusual tiredness, lack of energy, dizziness or fainting.
The most common side effects of CellCept include:
- blood problems including low white and red blood cell counts
- swelling of the lower legs, ankles and feet
- changes in laboratory blood levels, including high levels of blood sugar
- stomach problems including diarrhea, constipation, nausea and vomiting
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Inosine Monophosphate Dehydrogenase Activity And Inosine Monophosphate Dehydrogenase Ii Protein Expression
IMPDH activity was significantly lower in patients with diabetes versus the nondiabetic group throughout the 12-hour dosing interval . Mean ± standard deviation of IMPDH activity was 17.5 ± 2.8 nmol XMP/h/gprotein in patients with diabetes versus 46.6 ± 2.5 nmol XMP/h/gprotein in nondiabetics. A comparison of IMPDH activity at predose baseline revealed that IMPDH activity was significantly different between the patients with diabetes and nondiabetic patients . The highest degree of IMPDH inhibition was observed at 2 hours after ECMPS dose and the lowest IMPDH inhibition was observed at 12 hours postdose .
A, Inosine 5-monophosphate dehydrogenase catalytic activity versus time postdose in diabetic and nondiabetic kidney transplant recipients. B, IMPDH catalytic activity in patients with diabetes and nondiabetic patients on concomitant therapy with cyclosporine or tacrolimus .
The IMPDH activity was compared between patients with diabetes and nondiabetic patients receiving concomitant cyclosporine or tacrolimus therapy . The IMPDH activity was pronouncedly lower in the patients with diabetes on cyclosporine than on tacrolimus . Pharmacokinetics parameters, MPA, fMPA, or AcMPAG concentrations were comparable between patients with diabetes and nondiabetic patients coadministered either cyclosporine or tacrolimus however, the concentration of MPAG was significantly higher in patients with diabetes on tacrolimus.
Taking Cellcept With Food
You should avoid eating at least 1 hour before and 2 hours after taking CellCept. However, if your transplant is stable, you may take CellCept with or without food. Talk with your doctor about whether or not your condition is stable enough to take this drug with food.
* Organ rejection occurs when the immune system attacks a transplanted organ.
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What Is Mycophenolate Mofetil What Is Mycophenolate Mofetil Used For
Mycophenolic acid is an immunosuppressive drug. It is indicated for the prophylaxis of organ rejection in patients receiving kidney, heart, or liver transplants. mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
Mycophenolate mofetil is a prodrug of mycophenolic acid . Following oral administration, mycophenolate mofetil is rapidly absorbed and hydrolyzed to MPA. MPA is the active metabolite which has pharmacological activity.
MPA is a strong, reversible inhibitor of inosine monophosphate dehydrogenase . IMPDH plays a critical role in the production of DNA. T and B lymphocytes are heavily dependent on the activity of IMPDH to make DNA to proliferate, whereas other cells can use alternative pathways. In patients who have received transplanted organs, the recipient’s immune system attacks the transplanted organ because the body perceives it as foreign or harmful. MPA decreases the activity of the immune system by inhibiting the proliferation of immune cells that attack the transplanted organ. Mycophenolate is used with other medications that also inhibit the rejection of transplanted organs such as cyclosporine and corticosteroids.
Mycophenolate mofetil was approved by the U.S. FDA on May 3, 1995.
What brand names are available for mycophenolate mofetil?
Is mycophenolate mofetil available as a generic drug?
Do I need a prescription for mycophenolate mofetil?
Cellcept Can Cause Serious Side Effects Including:
Increased risk of loss of a pregnancy and higher risk of birth defects. Females who take CellCept during pregnancy have a higher risk of miscarriage during the first 3 months , and a higher risk that their baby will be born with birth defects.
The purpose of this registry is to gather information about the health of you and your baby.
Increased risk of getting certain cancers. People who take CellCept have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have:
- unexplained fever, prolonged tiredness, weight loss or lymph node swelling
- a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other
- a change in the size and color of a mole
- a new skin lesion or bump
- any other changes to your health
Increased risk of getting serious infections. CellCept weakens the bodys immune system and affects your ability to fight infections. Serious infections can happen with CellCept and can lead to hospitalizations and death. These serious infections can include:
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Dosage For Preventing Organ Rejection After A Transplant
The dosage for CellCept varies depending on its use. Below are the typical doses for preventing organ rejection after a heart, kidney, or liver transplant in adults.
Dosage for adults receiving kidney transplant
The typical dosage of CellCept for preventing rejection of a kidney transplant is 1,000 mg taken twice per day. If youre taking a form of CellCept thats swallowed, in most cases you should take it on an empty stomach. This means taking your dose either 1 hour before eating or 2 hours after eating.
If youre receiving the CellCept IV infusion, the dose is given by your doctor over a period of about 2 hours, twice per day.
Dosage for adults receiving heart transplant
The typical dosage of CellCept for preventing rejection of a heart transplant is 1,500 mg taken twice per day. If youre taking a form of CellCept thats swallowed, in most cases you should take it on an empty stomach. This means taking your dose either 1 hour before eating or 2 hours after eating.
If youre receiving the CellCept IV infusion, the dose is given by your doctor over a period of about 2 hours, twice per day.
Dosage for adults receiving liver transplant
The typical dosage of CellCept for preventing rejection of a liver transplant is 1,500 mg taken twice per day. If youre taking a form of CellCept thats swallowed, in most cases you should take it on an empty stomach. This means taking your dose either 1 hour before eating or 2 hours after eating.
How Long Do You Stay On Cellcept
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. People also ask, what are the long term side effects of CellCept?
Common side effects of CellCept include: asthma, herpes simplex infection, infection, metabolic acidosis, oral candidiasis, pleural effusion, respiratory tract infection, systemic cytomegalovirus disease, urinary tract infection, viremia, abdominal pain, acne vulgaris, anemia, anxiety, asthenia, back pain,
Likewise, how long should you take mycophenolate? Mycophenolate does not work immediately it can take up to 8 – 12 weeks before you have any benefit. It is important to continue treatment during this time. Mycophenolate cannot cure the condition and you may need to take it for several years to keep your relapses under control.
Correspondingly, what happens if I stop taking CellCept?
You should consult your doctor before you stop taking this medicine or before you change the amount for any reason. You may become ill if you stop taking this medicine suddenly. Taking Mycophenolate with food may help to lessen stomach cramping and diarrhea. Food affects how the body absorbs Mycophenolate.
What happens if you stop taking mycophenolate?
Mycophenolate will lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. Do not stop taking this medicine without checking first with your doctor. Doing so may cause rejection of your transplanted organ.
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