Mycophenolate (Intravenous)

Mycophenolate injection is part of a group of medicines called immunosuppressive agents. It is used along with other medicines (like cyclosporine and steroid medicine) to reduce the body's natural immunity in patients who have 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 helps stop the white blood cells from rejecting the transplanted organ.

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

It is very important for your doctor to monitor your progress while you are receiving this medicine. Your doctor will perform blood tests to ensure that mycophenolate injection is working correctly and to check for side effects.

Using this medicine during pregnancy can harm your unborn baby or cause a miscarriage in the first 3 months. If you are a woman who can become pregnant, your doctor may perform a pregnancy test before you start this medicine to confirm you are not pregnant. Your birth control pills may not be as effective while using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, throughout your treatment, and for 6 weeks after your last dose. Use birth control pills along 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 might be pregnant while using this medicine, tell your doctor immediately.

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

Mycophenolate injection can temporarily reduce the number of white blood cells in your blood, which increases the risk of infections. If possible, avoid contact with people who are sick. Contact your doctor right away if you suspect you are getting an infection or if you have a fever or chills, cough or hoarseness, pain in your lower back or side, or painful or difficult urination.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body stops making red blood cells, leading to severe anemia. Contact your doctor immediately 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 a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Contact your doctor right away if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding, or weakness in your legs.

This medicine may raise your risk of developing rare and serious viral infections, including shingles, herpes, cytomegalovirus (CMV) infection, polyomavirus associated nephropathy (PVAN), and BK virus-associated nephropathy (BKVAN). The BK virus may affect your kidney function and lead to transplant failure. Contact your doctor immediately if you have bloody urine, urinate less often or in smaller amounts, increased thirst, loss of appetite, pain in your lower back or side, nausea, swelling of your face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

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

Contact your doctor immediately if you have trouble moving, fever, muscle pain or stiffness, or pain, swelling, or redness in your joints. These may be signs of acute inflammatory (swelling) syndrome.

While receiving mycophenolate injection, and after stopping, do not have any vaccinations without your doctor's approval. Mycophenolate injection will weaken your immune system, increasing your risk of getting the infection that the vaccination is meant to prevent.

Using this medicine may increase your risk of getting skin cancer or lymphoma (cancer of the lymph system). Discuss any concerns about this risk with your doctor.

This medicine may cause serious stomach or bowel issues (e.g., ulcers, bleeding). Contact your doctor immediately if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, burning, trouble breathing, or vomiting blood or material that looks like coffee grounds.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 regularly when outdoors. Wear protective clothing and hats and avoid direct sunlight, especially between 10 a.m. and 3 p.m. Stay away from sunlamps and tanning beds.

Do not take any other medicines unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. Here are some important points about this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other kinds of allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

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

Studies have not been done to determine the effects of mycophenolate injection in children receiving heart or liver transplants. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems that would limit the use of mycophenolate injection in older adults. However, older patients are more likely to have age-related issues with the liver, kidneys, or heart, 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 to this medicine should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected based on their potential importance and are not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust 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 mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, 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. May worsen these conditions.

• Active infection (e.g., bacteria, fungus, or virus)—May lower 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. 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. Although not all of these side effects may occur, 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. 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.

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.