Pronunciation:

mye-koe-FEN-oh-late MOE-fe-til hye-droe-KLOR-ide

Brand Names:

• Cellcept

Dosage Forms:

• Powder for Solution

Warnings:

Embryofetal Toxicity, Malignancies and Serious InfectionsUse during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning.Increased risk of development of lymphoma and other malignancies, particularly of the skin.Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes .

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

Mycophenolate injection belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines (eg, cyclosporine, steroid medicine) to lower the body's natural immunity in patients who receive organ transplants (eg, kidney, heart, or liver).

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate injection prevents the white blood cells from rejecting the transplanted organ.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate injection in children receiving heart or liver transplants. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate injection.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amoxicillin
• Cholestyramine
• Ciprofloxacin
• Clavulanic Acid
• Colesevelam
• Colestipol
• Cyclosporine
• Desogestrel
• Dexlansoprazole
• Dienogest
• Drospirenone
• Esomeprazole
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Isavuconazonium Sulfate
• Lansoprazole
• Levonorgestrel
• Mestranol
• Metronidazole
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Omeprazole
• Pantoprazole
• Rabeprazole
• Rifampin
• Telmisartan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lanthanum Carbonate
• Sevelamer

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, neutropenia) or
• Hepatitis B or C infection or
• Stomach or bowel problems (eg, ulcers, bleeding)—Use with caution. May make these conditions worse.

• Infection (eg, bacteria, fungus, or virus), active—May decrease your body's ability to fight an infection.

• Kelley-Seegmiller syndrome (rare genetic disease) or
• Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any questions about this, talk to your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine. Your doctor will do blood tests to make sure that mycophenolate injection is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby or cause a miscarriage during the first 3 months. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, including a condom, diaphragm, or contraceptive foam or jelly. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not donate sperm during treatment and for at least 90 days after the last dose.

Mycophenolate injection can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may increase your risk of developing rare and serious virus infections, including shingles, herpes, cytomegalovirus (CMV) infection, polyomavirus associated nephropathy (PVAN), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble with breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may cause reactivation of hepatitis B or C infection. Check with your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

Check with your doctor right away if you have difficulty in moving, fever, muscle pain or stiffness, or pain, swelling, or redness in the joints. These may be symptoms of acute inflammatory (swelling) syndrome.

While you are receiving mycophenolate injection, and after you stop, do not have any immunizations (vaccines) without your doctor's approval. Mycophenolate injection will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may cause serious stomach or bowel problems (eg, ulcers, bleeding). Check with your doctor right away if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, or burning, trouble breathing, or vomiting of blood or material that looks like coffee grounds.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blood in the urine

chest pain or discomfort

cough or hoarseness

difficulty in moving

fever or chills

increased cough

loss of strength or energy

lower back or side pain

muscle pain, cramps, stiffness, or weakness

pain in the joints

painful or difficult urination

swelling of the feet or lower legs

trouble breathing

Less common

Black, tarry stools

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at injection site

bloody vomit

enlarged gums

irregular heartbeat

joint pain

pinpoint red spots on the skin

red, inflamed, or bleeding gums

sores inside the mouth

stomach pain

trembling or shaking of the hands or feet

unusual bleeding or bruising

white patches on the mouth, tongue, or throat

Incidence not known

Back pain

bloody, black, tarry stools

blue lips, fingernails, or skin

blurred vision

chronic or occasional diarrhea

clumsiness

confusion

coughing or spitting up blood

difficulty speaking or understanding what others say

dizziness

drowsiness

general feeling of illness or nausea

headache

heart murmur

irregular, fast or slow, or shallow breathing

loss of coordination

memory loss

night sweats

seizures

severe headache

sore throat

stiff neck or back

stomach distention

stools that float, are foul smelling, or "fatty"

sudden high fever or low-grade fever for months

unusual tiredness or weakness

vision changes

weakness in the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

diarrhea

heartburn

nausea

vomiting

weakness

Less common

Acne

skin rash

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.