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CellCept (Generic Mycophenolate Injection)

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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.

If you are pregnant or think you could become pregnant, you should not receive mycophenolate injection. 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 utilize 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 injection, 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. Call your doctor right away if you have any of the following symptoms: discomfort or burning when urinating; fever, sore throat, chills, or cough; unusual bruising or bleeding; frequent urination, a wound or sore that is red, warm, or won’t heal, drainage from a skin wound, general weakness, extreme exhaustion, or a sick feeling; flu- or cold-like symptoms; pain or swelling in the neck, groin, or armpits; white patches in the mouth or throat; cold sores; blisters; headache or earache; or other indications of infection.

You may be more likely to experience progressive multifocal leukoencephalopathy if you use mycophenolate. 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.

Your chance of acquiring some cancers, including as skin cancer and lymphoma, which grow in the lymphatic system, may increase if you receive mycophenolate injection. 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). 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; discomfort or swelling in the neck, groin, or armpits; a mole that has changed in size or color; a dark or black skin lesion (sore) with irregular margins or a lesion where one section does not resemble the other; Skin changes, wounds that do not heal, a fever that does not go away, persistent fatigue, weight loss, or any other changes to your health should 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 injection, your doctor will request a number of lab tests.

Ask your doctor about the dangers of obtaining an injection of mycophenolate.

Why is this medication prescribed?

Mycophenolate injection is used in conjunction with other medications to help adults and children 3 months of age and older who have had kidney, heart, or liver transplants but are unable to take oral medication avoid transplant organ rejection when oral treatment is not an option. The medication class of immunosuppressive agents includes mycophenolate. It works by suppressing the body’s immune system so that it won’t fight against and reject the transplanted organ.

How should this medicine be used?

A doctor or nurse must mix powdered mycophenolate injection with fluids before administering it intravenously (into a vein) over the course of at least two hours. It is often administered twice daily for up to 14 days or as long as you are unable to swallow mycophenolate pills, capsules, or oral suspension.

Mycophenolate injection can be administered at a hospital, or the drug can be taken at home. Your doctor will demonstrate how to utilize the drug if you will be having mycophenolate injection at home. Make sure you comprehend these instructions, and if you have any issues, consult your healthcare professional.

Other uses for this medicine

As a treatment for Crohn’s disease, mycophenolate is also used. Before using this drug to treat your disease, discuss any potential dangers with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving mycophenolate injection,

  • If you have any allergies, including to mycophenolate, mycophenolic acid, any drugs, or any of the chemicals in mycophenolate injection, notify your doctor right away. 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.
  • Inform your doctor if you have or have ever had ulcers, any disease affecting your stomach, intestines, or digestive system, kidney or liver disease, anemia (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 behavior).
  • If you are breastfeeding, let your doctor know.
  • Avoid getting any shots without first consulting your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What side effects can this medication cause?

Side effects from mycophenolate injection could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Injection discomfort such as burning, warmth, swelling, or redness
  • Constipation
  • Nausea
  • Vomiting
  • Having trouble falling or staying asleep
  • The back, muscles, or joints in particular
  • Headache
  • Gas
  • Rash
  • The sensation of prickling, stinging, or burning on the skin
  • Edema of the lower legs, lower arms, feet, ankles, or hands
  • Tremor

Certain adverse effects can be very harmful. Call your doctor right away if you suffer any of the following symptoms or those detailed in the IMPORTANT CAUTION section:

  • Abrupt, excruciating stomach discomfort, persistent stomach pain, or diarrhea
  • 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

Further negative consequences of mycophenolate injection are possible. 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 program online or by phone if you have a serious side event.

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
  • Infection symptoms like a fever, sore throat, chills, cough, and others

What other information should I know?

Inform the lab staff and your doctor that you are receiving mycophenolate injection prior to any laboratory test.

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®
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