Mycophenolate Mofetil - Injection

Uses

Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for immune system disorders.

How To Use

Read the Medication Guide provided by your pharmacist before you start using mycophenolate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein (IV) by a healthcare professional. It is given as directed by your doctor, usually twice daily. It is injected slowly over at least two hours. Mycophenolate must not be given by bolus or rapid IV injection. When you are able to take medications by mouth, you may be switched to an oral form of this medication.

The injection form of this medication should not be used for longer than 2 weeks unless you are directed to do so by the doctor.

Avoid getting the prepared liquid on your skin or in your eyes. If contact occurs, wash the affected skin area well with soap and water or rinse your eyes with plain water.

Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. The dosage is based on your medical condition and response to treatment.

Keep using this medication even if you feel well. Do not stop using mycophenolate without first talking to your doctor.

Side Effects

See also Warning section.

Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, dizziness, drowsiness, trouble sleeping, tremor, or redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• unusual tiredness
• fast/irregular heartbeat
• easy bleeding/bruising
• swelling of the feet or ankles
• joint pain/stiffness
• muscle pain

Get medical help right away if you have any very serious side effects, including:

• stomach/abdominal pain that doesn't go away
• black stools
• vomit that looks like coffee grounds
• chest pain
• shortness of breath/rapid breathing

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure
• vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before using mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid; or to mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients (such as Polysorbate 80), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• cancer
• liver disease (such as hepatitis B, hepatitis C)
• kidney disease
• current/past infections (such as herpes, shingles)
• stomach/intestinal problems (such as ulcers)
• rare genetic disorders (such as Lesch-Nyhan or Kelley-Seegmiller syndromes)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Mycophenolate can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mycophenolate mofetil before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not donate blood while using mycophenolate and for 6 weeks after stopping this drug. Do not donate sperm while using mycophenolate and for 90 days after stopping this drug.

Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication, after 8 to 10 days on treatment, and during routine follow-up visits. You should not become pregnant while using mycophenolate. Mycophenolate may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 weeks after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• cholestyramine
• colestipol
• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. If you are using hormonal birth control, you should use an additional non-hormonal form of birth control while using this medication. Discuss your options with your doctor or pharmacist. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as blood counts, drug levels, kidney function, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Attend a transplant education class or support group. Learn to recognize the signs and symptoms of organ rejection and tell your doctor right away if they occur.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic and will not be stored at home.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).