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CellCept (Generic Mycophenolate)

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WARNING

Birth defect risk:

Women who are pregnant or may become pregnant should not use mycophenolate. Mycophenolate carries a significant risk of miscarriage (loss of pregnancy) in the first three months of pregnancy and of birth abnormalities in the unborn child (problems that are present at birth).

If you are pregnant or think you might be pregnant, you shouldn’t take mycophenolate. Pregnancy tests must be negative before beginning mycophenolate therapy, as well as eight to ten days later and during periodic follow-up visits. Throughout your therapy and for six weeks after you finish taking mycophenolate, you must utilise an effective method of contraception. Whatever methods of birth control are appropriate for you to use will be specified by your doctor. It is very necessary to use a second method of birth control along with this type of contraception since mycophenolate may reduce the effectiveness of oral contraceptives (birth control tablets).

You should use a reliable form of birth control throughout treatment and for at least 90 days after your final dose if you are a male with a female partner who might become pregnant. Don’t give away your sperm while you’re receiving therapy and for 90 days at least following your last dose.

If you suspect you or your partner is pregnant or if you miss a period, call your doctor straight once.

Don’t donate blood while you are receiving treatment and for at least six weeks after your final dosage because it’s possible that it will end up in the hands of a woman who is or may become pregnant.

Potentially fatal infections:

The immune system is weakened by mycophenolate, which may reduce your capacity to fight infection and raise your chance of contracting a serious illness, such as a significant fungal, bacterial, or viral infection that spreads throughout the body. These infections may require medical treatment and may result in death. If you currently have an infection of any kind or suspect that you could, let your doctor know. This includes transient infections (like cold sores), minor infections (such open cuts or sores), and persistent infections. Moreover, let your doctor know if you have ever had herpes zoster, hepatitis B or C, acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or hepatitis B or C. (shingles; a rash that can occur in people who have had chickenpox in the past). Call your doctor right away if you have any of the following symptoms: fever, chills, sore throat, or cough; unusual bruising or bleeding; frequent urination; discomfort or burning when urinating; a cut or sore that is red, warm, or won’t heal; signs of the “flu” or a “cold,” general weakness, acute exhaustion, or a nauseous feeling; drainage from a skin wound; White patches in the mouth or throat, cold sores, blisters, a headache or earache, discomfort or swelling in the neck, groyne, or armpits, as well as other infection-related symptoms.

You may be more likely to experience progressive multifocal leukoencephalopathy if you use mycophenolate (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Inform your doctor if you have or have previously had PML or another immune-related disease. Call your doctor right away if you have any of the following symptoms: weakness on one side of the body or in the legs, trouble controlling your muscles, trouble thinking clearly, or a lack of enthusiasm or concern for regular tasks or things you typically care about are all symptoms of mental illness.

Mycophenolate may raise your risk of acquiring some cancers, including as skin cancer and lymphoma (a cancer that arises in the lymphatic system). If you have skin cancer or any other sort of cancer, let your doctor know. Use protective clothes, sunglasses, and sunscreen, and avoid unnecessary or prolonged exposure to natural and artificial sunshine (tanning beds, sunlamps, and light treatment) (with a SPF factor of 30 or above). By doing this, you’ll be able to lower your risk of getting skin cancer. If you suffer any of the following signs, contact your doctor right away: A new skin sore or bump, a change in the size or colour of a mole, a brown or black skin lesion (sore) with uneven edges or one part of the lesion that does not resemble the other, changes to your skin, unhealed sores, an unexplained fever, persistent fatigue, weight loss, or any other changes to your health should all be reported.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start mycophenolate treatment and at each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website at http://www.fda.gov/Drugs.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to mycophenolate, your doctor will request specific lab tests.

The dangers of using mycophenolate should be discussed with your doctor.

Why is this medication prescribed?

In adults and children 3 months of age and older who have had kidney, heart, or liver transplants, mycophenolate (CellCept) is used along with other drugs to assist avoid transplant organ rejection (attack of the transplanted organ by the immune system of the person receiving the organ). In order to assist prevent the body from rejecting kidney transplants in adults and children 5 years of age and older, mycophenolate (Myfortic) is used in combination with other drugs. Mycophenolate belongs to the group of drugs known as immunosuppressive agents. In order to prevent the body from attacking and rejecting the transplanted organ, it operates by suppressing the immune system.

How should this medicine be used?

The oral forms of mycophenolate include capsules, tablets, delayed-release tablets (which release the drug in the gut), and suspensions (liquids). Unless your doctor instructs you otherwise, it is typically given twice daily on an empty stomach, either one hour before or two hours after eating or drinking. Try to space out your doses of mycophenolate by approximately 12 hours and take them at roughly the same times each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the mycophenolate directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

The body absorbs the drug in the delayed-release tablet (Myfortic) differently from the drug in the solution, tablet, and capsule (CellCept). These goods can’t be used in place of one another. Be sure you get the appropriate medication each time your prescription is filled. Speak with your doctor and pharmacist right away if you believe you were prescribed the incorrect prescription.

Do not split, chew, or crush the tablets, delayed-release tablets, or capsules; swallow them whole. Don’t break the capsules open. If a capsule is accidently opened, keep your skin and eyes away from it, and don’t inhale the powder. If any contact occurs, thoroughly wash the area with soap and water, and then rinse your eyes.

Mycophenolate suspension shouldn’t be combined with any other medications.

Be mindful not to splash or spill the suspension on your skin. If the suspension does get on your skin, thoroughly wash the area with soap and water. Rinse your eyes with simple water if the suspension gets there. All liquid spills should be cleaned up using moist paper towels.

Only while you are taking mycophenolate will it help avoid organ transplant rejection. Mycophenolate should still be taken even if you feel OK. Without consulting your doctor, do not stop taking mycophenolate.

Other uses for this medicine

Crohn’s disease is also treated with mycophenolate (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever). Discuss the potential dangers of using this medicine for your illness with your doctor.

Inquire with your doctor or pharmacist for more details if you believe this drug may be prescribed for other purposes.

What special precautions should I follow?

Before taking mycophenolate,

  • If you have an allergy to mycophenolate, mycophenolic acid, any other medications, or any of the substances in the mycophenolate or mycophenolic acid product you are taking, let your doctor and pharmacist know right once. Tell your doctor and pharmacist if you take mycophenolate liquid if you have a sorbitol or aspartame allergy. Get a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Tell your doctor right once if you stop taking any of your prescription drugs. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Use sevelamer (Renagel, Renvela) or antacids containing aluminium or magnesium two hours after taking mycophenolate.
  • Inform your doctor if you have or have ever had ulcers, any disease affecting your stomach, intestines, or digestive system, kidney or liver disease, anaemia (a lower than normal number of red blood cells), neutropenia (less than normal number of white blood cells), or Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome (inherited diseases that cause high levels of a certain substance in the blood, joint pain, and problems with motion and behaviour).
  • If you are breastfeeding, let your doctor know.
  • You should be aware that mycophenolate may cause you to feel sleepy, disoriented, lightheaded, dizzy, or cause an uncontrollable trembling of a body part. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Without first consulting your doctor, avoid getting any shots.
  • You should be aware that mycophenolate suspension includes aspartame, a source of phenylalanine, if you suffer from phenylketonuria (PKU), an inherited disorder that necessitates following a particular diet to prevent brain damage that could result in severe intellectual incapacity.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Take the missed dosage of mycophenolate immediately after remembering if you take it as a tablet, pill, or suspension (Cellcept). Skip the missed dose and carry on with your regular dosing plan, though, if the time between doses is shorter than 2 hours. Never take two doses at once to make up for missing ones.

Take the missed dose of Mycophenolate Delayed Release Tablet (Myfortic) as soon as you remember if you are taking it. Skip the missed dose and carry on with your regular dosing plan, nevertheless, if it is almost time for the subsequent dose. Never take two doses at once to make up for missing ones.

What side effects can this medication cause?

Mycophenolate could have negative effects. If any of these symptoms are severe or do not go away, consult your doctor:

  • Constipation
  • Nausea
  • Vomiting
  • Having trouble falling or staying asleep
  • Back, muscles, or joints in particular
  • Headache
  • Gas
  • Sensation of prickling, stinging, or burning on the skin
  • Edoema of the lower legs, lower arms, feet, ankles, or hands
  • Tremor

Some adverse effects may be severe. Call your doctor right away if you see any of the symptoms below or those in the IMPORTANT CAUTION section:

  • Abrupt, excruciating stomach discomfort, persistent stomach pain, or diarrhoea
  • Having trouble breathing
  • Chest ache
  • Rash
  • Itching
  • Disorientation, fainting, pale skin, fatigue, breathlessness, or a rapid heartbeat
  • Unexplained bleeding or bruises, red or black, tarry stools, vomiting blood or brown stuff that resembles coffee grounds, or urinating blood
  • Heat, stiffness or discomfort in the muscles or joints

Other adverse effects of mycophenolate may occur. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). The mycophenolate suspension can also be kept in the fridge. No mycophenolate suspension should be frozen. After 60 days, discard any unused mycophenolate suspension.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Abdominal pain
  • Nausea
  • Vomiting
  • Heartburn
  • Diarrhea
  • Symptoms of infection such as a fever, chills, sore throat, and cough

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • CellCept®
  • Myfortic®
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