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Cellcept

Generic name: mycophenolate mofetil (oral/injection) [MYE-koe-FEN-oh-late-MOE-fe-til]
Drug class: selective immunosuppressants

What is Cellcept?

Cellcept works by weakening your immune system to prevent it from "rejecting". When the immune system attacks the new organ, it is called "organ rejection". Cellcept prevents organ rejection for patients aged at least 3 months who have had a kidney, liver, or heart transplant. Cellcept can be used in conjunction with other immunosuppressive medicines that contain cyclosporine or corticosteroids.

Warnings

Cellcept can cause miscarriage and birth defects if used during pregnancy. Men and women alike should use effective contraception to prevent pregnancy while taking cellcept and for a short time after. Cellcept can increase your risk for cancer, serious infections, or kidney failure. If you experience any of the following symptoms, call your doctor immediately: fever; swollen or enlarged glands; loss of weight; nausea; and diarrhea. Other symptoms include painful urination or a new skin lession.

Before you take this drug

Cellcept should not be used if you have an allergy to mycophenolate, mycophenolic acid, or polysorbate acid. Cellcept may have risks and benefits. Discuss them with your doctor. This medicine can increase your risk for cancer, serious or deadly infections, or a virus that can cause kidney failure.

If you've ever:

  • A stomach ulcer, or digestive problems;
  • Cellcept may worsen or activate hepatitis B, C, or any other viral infection.
  • Phenylketonuria (the liquid form may contain phenylalanine);
  • A rare inherited deficiency of enzymes such as Lesch Nyhan syndrome or Kelley Seegmiller syndrome.

Mycophenolate mofetil may cause miscarriage or birth defects.This statement holds true during the initial three months of gestation. You must have a negative test for pregnancy before and after treatment. You must avoid pregnancy if you can get pregnant while taking cellcept and for 6 weeks following your last dose. Sexually active males and their partners must use effective contraception throughout treatment and at least 90 days after the last dosage. Cellcept can reduce the effectiveness of birth-control pills. Ask your doctor if you can use an additional barrier birth control method (condoms, diaphragms, cervical caps, or contraceptive spong). If you are using an intrauterine device, have had tubal ligation, or your partner has undergone a vasectomy, you do not need additional birth control.

The patient instructions that come with this medicine include information on the best non-hormonal birth control methods to use. Please follow the instructions carefully. If you have questions, ask your doctor. Do not stop taking cellcept if you become pregnant during treatment. Contact your doctor to get instructions. Call the Mycophenolate Pregnancy Registry at 1-800-617-8191. Cellcept can be given to women who are pregnant. If you cannot use other transplant medications, your doctor will determine if this is the best option for you. Cellcept should not be used while breastfeeding.

Similar/related drugs

Prednisone, Triamcinolone, Prednisolone, Azthioprine, Cyclosporine, and Mycophenolate Mofetil

How to take Cellcept?

Cellcept should be taken exactly as prescribed by your physician. Read all the instructions on the prescription label. Cellcept must be used under the supervision of a physician. Cellcept is administered as an intravenous infusion. Healthcare provider will administer this injection. Take oral cellcept at least an hour before or two hours after eating. Do not open, crush, chew, or break the tablet or capsule. Swallow it whole. If you are having trouble swallowing a capsule or tablet, tell your doctor.

Please read and follow all directions that accompany your medication carefully, if any are unclear please seek the advice of a pharmacist or your physician for clarification. If the instructions remain confusing for any reason contact either them directly. Before measuring a dose, shake the orally suspended liquid. Only use the dosing needle that comes with this medication.

Cellcept, abnothe, and myfortic are not absorbed in the same way by the body. Use only the form and strength prescribed by your doctor to avoid medication mistakes. Medical tests will be required frequently. Store bottles away from heat and moisture at room temperature when not being used; when not required for consumption keep tightly shut when not needed. If the liquid is older than 60 days, it should be thrown away. You can also store the liquid medicines in the fridge. Do not freeze.

Details on dosage

Adult dose for organ transplantation: rejection prophylaxis

-RENAL Transplantation: 1 g, orally, or intravenously, 2 times per day (2 g); [in clinical studies, 1.5 g, orally, or intravenously, 2 times per day (3 g) was effective, but the safety profile of 3 g was lower].
Cardiac Transplantation: 1.5g orally or 2 g IV twice a day. (3 gm/day)
-HEPATIC TRANSPLANTATION: 1.5 g orally or 1 g IV twice a day. (3 grammes orally per day, or 2 grammes intravenously per day)
Comments:
This drug should be taken in conjunction with cyclosporine and corticosteroids.
The IV formulation must be administered in no less than two hours.
Patients who are unable to swallow oral medications should receive IV administration. Oral administration should begin as soon as possible.

The usual dose for organ transplantation in geriatric patients—rejection prophylaxis:

Renal Transplantation: 1g orally or 2 g IV twice a day.
Cardiac Transplantation: 1.5g orally or 2 g IV twice a day. (3 gm/day)
-HEPATIC TRANSPLANTATION: 1.5 g orally or 1 g IV twice a day. (3 grammes per 24 hours orally and 2 grammes per 24 hours IV).
Comments:
This drug should be taken in conjunction with cyclosporine and corticosteroids.
The IV formulation must be administered in no less than two hours.
Patients who are unable to swallow oral medications should receive IV administration. Oral administration should begin as soon as possible.

The Usual Paediatric Dose for Organ Transplantation—Rejection Prevention:

-RENAL TRANSPLANTATION:
From 3 months up to 18 years:
Oral Suspension: 600 mg/m2 twice per day, up to 2 grammes.
Children with a surface area between 1.25 and 1.5 m2 can be given 750 mg of the capsules orally twice a day.
Oral capsules of 1 g can be given to paediatric patients with a surface area greater than 1.5 m2 twice a day.
Comments:
This drug should be taken in conjunction with corticosteroids and cyclosporine.
Patients who are unable to swallow oral medications should receive IV administration. Oral administration should begin as soon as possible.

What happens if I miss the dose?

If you miss a dose, take it immediately.Skip the missed dose when your next dose is in less than two hours. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 immediately if you suspect poison, or seek immediate medical care.

What should be avoided?

Do not drive or engage in risky activities until you understand how the medicine will impact you. You may be unable to react properly. Mycophenolate mofetil can cause you to sunburn more easily. Avoid tanning beds or sunlight. When you're outdoors, wear protective clothing and apply sunscreen (SPF 30) or higher. Cellcept should not be used in conjunction with a live vaccine. The vaccine might not work well or protect you fully from disease. Do not donate blood (for sperm or blood) while taking this medication.

Side effects of Cellcept

If you experience any of the following symptoms of an allergic reaction: difficulty breathing, hives, swelling of your lips, face, tongue, or throat, get emergency medical attention. Cellcept can cause a serious infection of the brain that may lead to death or disability. If you experience problems with your speech, thoughts, vision, or muscle movements, call your doctor immediately. These symptoms can start slowly and then get worse very quickly.

Mycophenolate mofetil can affect your immune system, increasing your risk of serious infections or cancer. If symptoms occur such as:

  • Headache; nausea; diarrhea. Weight gain.
  • You may experience confusion, difficulty thinking, or a loss of interest in things that you normally enjoy.
  • Dark urine, jaundice (yellowing or pain in the skin or eyes), and pain around the transplanted renal
  • A tingly or painful blistering skin rash on one side of your body; swelling, warmth, redness, or oozing from a wound
  • A new lesion or mole that has changed colour or size

Call your doctor immediately if you:

  • If you have any of the following symptoms: fever, joint pain and stiffness, bloody or tarry stool, or vomiting that looks like coffee grounds,
  • Low blood cell counts: fever, chills, and tiredness; mouth sores or skin sores; easy bruising; unusual bleeding. Pale skin, cold feet, and cold hands

Cellcept may cause the following side effects:

  • Stomach pain, nausea, vomiting, diarrhoea, constipation, swelling of your ankles and feet, rash, or pain anywhere on your body
  • If you experience any of the following symptoms: headache, dizziness, or tremors; fever; sore neck; cold symptoms or other signs or symptoms of infection
  • High blood pressure, high blood glucose, or low blood pressure cause a rapid heart rate.

There may be other side effects.Call your physician immediately if experiencing side effects; to report side effects directly with FDA please dial: 1-800-FDA-1088

Interaction with other drug

Take your cellcept oral dose at least 2 hours before taking sevelamer or an antacid.

Combining medications is not always safe; certain substances could interfere with one another and alter blood levels, potentially leading to adverse side effects or making them less effective.

Tell your doctor all the medications you are taking. Cellcept can be affected by many drugs, including:

  • Azathioprine, cholestyramine;
  • Antiviral medicines: acyclovir; valacyclovir; valganciclovir
  • An antibiotic is amoxicillin or ciprofloxacin. Metronidazole, norfloxacin, rifampin, and sulfa drugs
  • A stomach acid reducer: esomeprazole (lansoprazole), omeprazole (omeprazole), Nexium (Prevacid), Prilosec (Prilosec), Protonix, and others

Mycophenolate mofetil may interact with many other drugs. These include prescription and over-the-counter medicines, vitamins, and herbal products; this list does not encompass every possible interaction.

 

DRUG STATUS

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Prescription only

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