Cellcept (Intravenous)

Mycophenolate injection is part of a group of medicines called immunosuppressive agents. It is used alongside other medicines (for example, cyclosporine, steroid medicine) to reduce the body's natural immunity in patients who receive organ transplants (such as kidney, heart, or liver).

When a patient gets an organ transplant, the body's white blood cells may try to reject the transplanted organ. Mycophenolate injection stops the white blood cells from rejecting the transplanted organ.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor checks your progress while you are receiving this medicine. Your doctor will do blood tests to ensure 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 become pregnant, 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, such as 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 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 (e.g., 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or packaging ingredients carefully.

Pediatric

Current studies have not shown any specific problems in children that would limit the use of mycophenolate in those receiving kidney transplants. However, safety and effectiveness have not been established in infants younger than 3 months old.

Studies have not been performed to assess the effects of mycophenolate injection in children receiving heart or liver transplants. Safety and effectiveness in this group have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of mycophenolate injection. However, older patients may have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for those receiving mycophenolate injection.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In such cases, your doctor may want to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions are important and are not necessarily a complete list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Lanthanum Carbonate
• Sevelamer

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain types of food due to potential interactions. Using alcohol or tobacco with specific medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., neutropenia) or
• Hepatitis B or C infection or
• Stomach or bowel issues (e.g., ulcers, bleeding)—Use with caution. This may worsen these conditions.

• Active infections (e.g., bacteria, fungus, or virus)—May reduce your body's ability to fight an infection.

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

• Severe kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all side effects may happen, but if they do, 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. 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.

In the U.S.

• Cellcept

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immune Suppressant

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.