Cellcept and hair loss

Cellcept

SIDE EFFECTS

The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection (see WARNINGS: Serious Infections and WARNINGS: New Or Reactivated Viral Infections).

The adverse event profile associated with the administration of CellCept Intravenous has been shown to be similar to that observed after administration of oral dosage forms of CellCept.

CellCept Oral

The incidence of adverse events for CellCept was determined in randomized, comparative, double-blind trials in prevention of rejection in renal (2 active, 1 placebo-controlled trials), cardiac (1 active-controlled trial), and hepatic (1 active-controlled trial) transplant patients.

Geriatrics

Elderly patients (≥65 years), particularly those who are receiving CellCept as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared to younger individuals (see PRECAUTIONS).

Safety data are summarized below for all active-controlled trials in renal (2 trials), cardiac (1 trial), and hepatic (1 trial) transplant patients. Approximately 53% of the renal patients, 65% of the cardiac patients, and 48% of the hepatic patients have been treated for more than 1 year. Adverse events reported in ≥20% of patients in the CellCept treatment groups are presented below.

Table 9 Adverse Events in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Allograft Rejection (Reported in ≥20% of Patients in the CellCept

The placebo-controlled renal transplant study generally showed fewer adverse events occurring in ≥20% of patients. In addition, those that occurred were not only qualitatively similar to the azathioprine-controlled renal transplant studies, but also occurred at lower rates, particularly for infection, leukopenia, hypertension, diarrhea and respiratory infection.

The above data demonstrate that in three controlled trials for prevention of renal rejection, patients receiving 2 g/day of CellCept had an overall better safety profile than did patients receiving 3 g/day of CellCept. The above data demonstrate that the types of adverse events observed in multicenter controlled trials in renal, cardiac, and hepatic transplant patients are qualitatively similar except for those that are unique to the specific organ involved.

Sepsis, which was generally CMV viremia, was slightly more common in renal transplant patients treated with CellCept compared to patients treated with azathioprine. The incidence of sepsis was comparable in CellCept and in azathioprine-treated patients in cardiac and hepatic studies.

In the digestive system, diarrhea was increased in renal and cardiac transplant patients receiving CellCept compared to patients receiving azathioprine, but was comparable in hepatic transplant patients treated with CellCept or azathioprine.

Patients receiving CellCept alone or as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see WARNINGS: Lymphoma And Malignancy). The incidence of malignancies among the 1483 patients treated in controlled trials for the prevention of renal allograft rejection who were followed for ≥1 year was similar to the incidence reported in the literature for renal allograft recipients.

Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving CellCept (2 g or 3 g daily) with other immunosuppressive agents in controlled clinical trials of renal, cardiac, and hepatic transplant patients followed for at least 1 year (see WARNINGS: Lymphoma And Malignancy). Non-melanoma skin carcinomas occurred in 1.6% to 4.2% of patients, other types of malignancy in 0.7% to 2.1% of patients. Threeyear safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.

In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.

Severe neutropenia (ANC <0.5 x 103/μL) developed in up to 2.0% of renal transplant patients, up to 2.8% of cardiac transplant patients and up to 3.6% of hepatic transplant patients receiving CellCept 3 g daily (see WARNINGS: Neutropenia, PRECAUTIONS: Laboratory Tests and DOSAGE AND ADMINISTRATION).

All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load (see WARNINGS: Serious Infections and WARNINGS: New Or Reactivated Viral Infections). Table 10 shows the incidence of opportunistic infections that occurred in the renal, cardiac, and hepatic transplant populations in the azathioprine-controlled prevention trials:

Table 10 Viral and Fungal Infections in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Transplant Rejection

The following other opportunistic infections occurred with an incidence of less than 4% in CellCept patients in the above azathioprine-controlled studies: Herpes zoster, visceral disease; Candida, urinary tract infection, fungemia/disseminated disease, tissue invasive disease; Cryptococcosis; Aspergillus/Mucor; Pneumocystis carinii.

In the placebo-controlled renal transplant study, the same pattern of opportunistic infection was observed compared to the azathioprine-controlled renal studies, with a notably lower incidence of the following: Herpes simplex and CMV tissue-invasive disease.

In patients receiving CellCept (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients (see WARNINGS: Serious Infections). In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with CellCept than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with CellCept.

The following adverse events were reported with 3% to <20% incidence in renal, cardiac, and hepatic transplant patients treated with CellCept, in combination with cyclosporine and corticosteroids.

Table 11 Adverse Events Reported in 3% to <20% of Patients Treated With CellCept in Combination With Cyclosporine and Corticosteroids

Body System
Body as a Whole abdomen enlarged, abscess, accidental injury, cellulitis, chills occurring with fever, cyst, face edema, flu syndrome, hemorrhage, hernia, lab test abnormal, malaise, neck pain, pelvic pain, peritonitis
Hematologic and Lymphatic coagulation disorder, ecchymosis, pancytopenia, petechia, polycythemia, prothrombin time increased, thromboplastin time increased
Urogenital acute kidney failure, albuminuria, dysuria, hydronephrosis, hematuria, impotence, kidney failure, kidney tubular necrosis, nocturia, oliguria, pain, prostatic disorder, pyelonephritis, scrotal edema, urine abnormality, urinary frequency, urinary incontinence, urinary retention, urinary tract disorder
Cardiovascular angina pectoris, arrhythmia, arterial thrombosis, atrial fibrillation, atrial flutter, bradycardia, cardiovascular disorder, congestive heart failure, extrasystole, heart arrest, heart failure, hypotension, pallor, palpitation, pericardial effusion, peripheral vascular disorder, postural hypotension, pulmonary hypertension, supraventricular tachycardia, supraventricular extrasystoles, syncope, tachycardia, thrombosis, vasodilatation, vasospasm, ventricular extrasystole, ventricular tachycardia, venous pressure increased
Metabolic and Nutritional abnormal healing, acidosis, alkaline phosphatase increased, alkalosis, bilirubinemia, creatinine increased, dehydration, gamma glutamyl transpeptidase increased, generalized edema, gout, hypercalcemia, hypercholesteremia, hyperlipemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypochloremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, hypovolemia, hypoxia, lactic dehydrogenase increased, respiratory acidosis, SGOT increased, SGPT increased, thirst, weight gain, weight loss
Digestive anorexia, cholangitis, cholestatic jaundice, dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, gum hyperplasia, hepatitis, ileus, infection, jaundice, liver damage, liver function tests abnormal, melena, mouth ulceration, nausea and vomiting, oral moniliasis, rectal disorder, stomach ulcer, stomatitis
Respiratory apnea, asthma, atelectasis, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, lung edema, lung disorder, neoplasm, pain, pharyngitis, pleural effusion, pneumonia, pneumothorax, respiratory disorder, respiratory moniliasis, rhinitis, sinusitis, sputum increased, voice alteration
Skin and Appendages acne, alopecia, fungal dermatitis, hemorrhage, hirsutism, pruritus, rash, skin benign neoplasm, skin carcinoma, skin disorder, skin hypertrophy, skin ulcer, sweating, vesiculobullous rash
Nervous agitation, anxiety, confusion, convulsion, delirium, depression, dry mouth, emotional lability, hallucinations, hypertonia, hypesthesia, nervousness, neuropathy, paresthesia, psychosis, somnolence, thinking abnormal, vertigo
Endocrine Cushing’s syndrome, diabetes mellitus, hypothyroidism, parathyroid disorder
Musculoskeletal arthralgia, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis
Special Senses abnormal vision, amblyopia, cataract (not specified), conjunctivitis, deafness, ear disorder, ear pain, eye hemorrhage, tinnitus, lacrimation disorder

Pediatrics

The type and frequency of adverse events in a clinical study in 100 pediatric patients 3 months to 18 years of age dosed with CellCept oral suspension 600 mg/m2 bid (up to 1 g bid) were generally similar to those observed in adult patients dosed with CellCept capsules at a dose of 1 g bid with the exception of abdominal pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis, respiratory tract infection, hypertension, leukopenia, and anemia, which were observed in a higher proportion in pediatric patients.

CellCept Intravenous

The adverse event profile of CellCept Intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral CellCept in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of CellCept Intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of CellCept Intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.

Adverse events attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CellCept Intravenous.

In the active controlled study in hepatic transplant patients, 2 g/day of CellCept Intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous CellCept was similar to that of intravenous azathioprine.

Postmarketing Experience

Congenital Disorders: Embryofetal Toxicity: Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate mofetil during pregnancy (see PRECAUTIONS: Pregnancy).

Digestive: Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy.

Hematologic and Lymphatic: Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia have been reported in patients treated with CellCept in combination with other immunosuppressive agents.

Infections (see WARNINGS: Serious Infections, New Or Reactivated Viral Infections):

  • Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally.
  • There is evidence of a higher frequency of certain types of serious infections such as tuberculosis and atypical mycobacterial infection.
  • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with CellCept. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function.
  • Polyomavirus associated neuropathy (PVAN), especially due to BK virus infection, has been observed in patients receiving immunosuppressants, including CellCept. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
  • Viral reactivation has been reported in patients infected with HBV or HCV.

Respiratory: Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in posttransplant patients receiving CellCept.

Read the entire FDA prescribing information for Cellcept (Mycophenolate Mofetil)

mycophenolate mofetil (oral/injection) (CellCept)

What should I discuss with my healthcare provider before using mycophenolate mofetil (CellCept)?

You should not use this medicine if you are allergic to mycophenolate mofetil, mycophenolic acid (Myfortic), or to an ingredient called Polysorbate 80.

Talk with your doctor about the risks and benefits of mycophenolate mofetil. This medicine can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Tell your doctor if you have ever had:

  • a stomach ulcer or problems with digestion;
  • hepatitis B or C;
  • phenylketonuria, or PKU (the liquid form of this medicine may contain phenylalanine); or
  • a rare inherited enzyme deficiency such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome.

Mycophenolate mofetil can cause a miscarriage or birth defects when used during pregnancy. You will need to have a negative pregnancy test before and during treatment with this medicine. If you are able to get pregnant, you must use specific forms of birth control to prevent pregnancy while using mycophenolate mofetil, and for at least 6 weeks after your last dose.

You are considered able to get pregnant (even if you are not sexually active) from the age of puberty until you have been in menopause for at least 12 months in a row.

If you are a man, use effective birth control if your sex partner is able to get pregnant. Mycophenolate mofetil can also harm an unborn baby if the father is using this medicine. Keep using birth control for at least 90 days after your last dose.

This medicine can make birth control pills less effective. Follow all patient instructions about using effective non-hormonal forms of birth control.

If a pregnancy occurs during treatment, do not stop using mycophenolate mofetil. Call your doctor for instructions. Also call the Mycophenolate Pregnancy Registry (1-800-617-8191).

Mycophenolate mofetil is sometimes given to pregnant women. Your doctor will decide whether you should use this medicine if you are are unable to use other needed transplant medications.

You should not breast-feed while using mycophenolate mofetil.

How should I use mycophenolate mofetil (CellCept)?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You must remain under the care of a doctor while you are using mycophenolate mofetil.

Mycophenolate mofetil injection is given as an infusion into a vein. A healthcare provider will give you this injection.

Take oral mycophenolate mofetil on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the pill whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Mycophenolate mofetil (CellCept) and mycophenolic acid (Myfortic) are not absorbed equally in the body. Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

You will need frequent medical tests.

If you’ve ever had hepatitis B or C, using mycophenolate mofetil can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid that is older than 60 days.

The liquid medicine may also be stored in the refrigerator. Do not freeze.

SLIDESHOW

Addicted to Pills: The Health Risks of Drug Abuse See Slideshow

Cellcept is a powerful medicine that requires regular blood tests to monitor for more serious side effects.

Side-effects of Cellcept include:

  • Nausea & feeling unwell – Some patients feel sick to their stomach or develop diarrhea when they take Cellcept. They should tell their doctor if this happens.
  • Headaches – Cellcept can cause headaches, dizziness, and difficulty sleeping.
  • Sores in the mouth
  • Rare brain infection – Some patients have very rarely developed a rare brain infection called Progressive Multifocal Leukoencephalopathy while taking Cellcept.
  • Cancer – When used for long periods of time, Cellcept may be associated with a small increased risk of skin or blood cancers.

People taking Cellcept should talk to their doctor if they are concerned about any side effects.

Cellcept can simply be stopped and does not need to be “weaned off”. Patients should tell their doctor if they stop taking this medicine.

Cellcept is not normally used in pregnancy. Patients who become pregnant or are breastfeeding while taking this medicine should tell their doctor.

Lupus & Medications: An HSS Facebook Chat

The following is a partial transcript of the chat, with answers provided by rheumatology interdisciplinary team members.

What are the best treatments currently for lupus patients?

Dr. Emma MacDermott: The treatments used in lupus depend on your type of disease, and they also differ depending on the part of the body affected.

I have a lupus blog and have heard that Plaquenil and CellCept are used successfully together. What has been your experience?

Dr. Michael Lockshin: Your blog is correct. In fact, Plaquenil can be used with almost any medication used for lupus.

What are some of the side effects of Plaquenil? Must it be taken for the duration of a patient’s life?

Dr. Emma MacDermott: Plaquenil or hydroxychloroquine is a very well-tolerated and useful medication in lupus. As well as its anti-inflammatory properties, it is felt to have some use in delaying disease progression. Most people have no problems on the medication. One of the side effects can be inflammation of the back of the eye, and so regular screening by an ophthalmologist while on this medication is important. This is a rare side effect. Many patients are on Plaquenil for the long term.

When a patient takes too much prednisone and is diagnosed with avascular necrosis (AVN), what are the next steps for these patients? Is there any way for AVN to be avoided while on steroids?

Dr. Emma MacDermott: AVN is an unpredictable occurrence. While it is usually seen after a longer period on steroids, it can occur after even a small dose. Maintaining bone health both before and in the event of AVN is important. In addition careful follow up with input from orthopedics and physical therapy may be useful.

What medications are most often used in conjunction with Benlysta?

Dr. Jane Salmon: Patients generally continue their Plaquenil and prednisone when they begin Benlysta.

I was wondering, having been on Benlysta for so long, I don’t feel that kick I once did right after treatment. Does that mean that my body has gotten used to it and it’s not working as well?

Dr. Michael Lockshin: I can’t answer that directly, but it could be it’s lost its kick or it could be something else. You will need a full evaluation to tell.

Is there anything specific you look for to see if Benlysta is beneficial to the patient?

Monica Richey, NP: In regards to Benlysta, we look for a clinical response, meaning an improvement in the symptoms and also in our laboratory test results. The best sign for a response to Benlysta is a decrease in your symptoms.

I have read that Benlysta has taken flare symptoms away completely for some users. Is this still a maintenance medication (taken forever) or is it taken until a result is achieved and then discontinued?

Dr. Jane Salmon: For the present, we are continuing Benlysta. There are no studies to guide us as to when it is safe to discontinue the medication.

What are some of the negative side effects of Benlysta? Is there a high remission rate with this medication? Are there others like it available? Thanks.

Dr. Michael Lockshin: The biggest problem with Benlysta, like all immunosuppressive drugs, is infection – sometimes rare or unusual infections. Fortunately they are uncommon. We don’t generally think of remission rate with this drug. It’s best use is to get people off steroids and control the illness, but since they stay on medication, it isn’t a complete remission. There are no drugs (yet) just like Benlysta. Rituximab has some similarity. There are lots of new drugs of this class in development, so keep watching!

Are there any new medications being tested by the FDA just for SLE that sound promising?

Dr. Jane Salmon: This is an exciting time for research on new targets to treat lupus, but all are in early stages and not yet near presentation to the FDA.

I am on Hydroxychloroquine-200mg twice daily and take 1-2 Aleve daily to try to alleviate pain and swelling in joints, along with many vitamin supplements. Is there any natural supplement anyone could suggest to help with daily pain? I also now am in need of a left hip replacement but would still have some constant pain due to arthritis and lupus. Do you feel that chiropractic care and/or acupuncture can help with this type of pain without the use of further drugs?

Dr. Jane Salmon: There is no evidence that vitamins help treat pain, but people do sometimes respond to acupuncture. Hip replacements are a definitive treatment when pain from arthritis becomes unmanageable and the joint damage is severe.

What medications are used to treat Shrinking Lung Syndrome in lupus or Sjogrens?

Dr. Michael Lockshin: That’s a hard problem. Usually you start with high dose steroid. Some patients, if they do not respond, can try immunosuppressives. I have one patient who responded brilliantly to rituximab, but every patient is different.

What about the patient who has osteonecrosis already? Would you suggest bypassing the steroids and going directly to immunosuppressants?

Dr. Michael Lockshin: No, I would not. Despite the osteonecrosis, immunosuppressives work better when combined with steroids. Using them alone is iffy in terms of getting a good response.

Does a lupus/rheumatoid arthritis/Sjogren’s combination have any impact on tendons? I have small tears in my Achilles.

Dr. Michael Lockshin: All of those can affect tendons, but so can long-term or high dose steroid and especially the class of antibiotics that include Cipro and Levaquin.

And one more question – I am at a loss at what to do when I am in a flare. If I see my primary care doctor, they refer me to my rheumatologist or dermatologist and neither of them can see me quickly. As a result, I just suffer through it and never really get the flare under control. This is really frustrating. Any suggestions?

Dr. Jane Salmon: Make a plan with your rheumatologist for what to do when you flare. Perhaps you can make more frequent regular appointments and prevent flares with closer follow up.

My-Lan Tran, LCSW: It’s an emotionally challenging experience when our body seems to fail us. Working with out health care providers closely is one key in getting our physical health back on track. Being connected with peers and support programs is another key to keep our body, mind, and spirit together in the face of living with lupus.

Is there any way to manage lupus without medication?

Monica Richey, NP: Unfortunately there is not a way to manage lupus without medication. Medication can help keep your lupus under control and avoid flares and complications. Having a healthy lifestyle and diet and moderate amount of physical activity can help.

How is CellCept used for lupus patients and what are the benefits?

Dr. Emma MacDermott: CellCept is one of the immunosuppressives used in lupus. For instance, it is often used as a maintenance therapy after induction with agents such as cyclophosphamide and has the advantage for patients of being an oral medication.

Hello, I have been diagnosed with SLE for about three years now. We have tried many different medications and my body has seemed to reject many of the medications. I was taken off of prednisone about eight months ago because of having very bad side effects. My rheumatologist explained it as prednisone has become my enemy. We started Cytoxan; I took it for eight months and would be sick for two weeks and then all the lupus symptoms would come back. I suffer from extreme fatigue, chronic pain in my joints, high fevers, and skin rashes. I am now taking Plaquenil and Imuran but the flare is still there. My rheumatologist calls me her puzzle as we are not sure what treatment to try next. Do you have any suggestions for treatment to help the flare that I’ve been experiencing for almost a year?

Dr. Michael Lockshin: I really can’t answer a personal question about treatment, but it sounds like you’re having a horrible time. There are some experimental trials going on now. Sometimes there are other factors that interfere with a medication’s efficacy – digestive problems, for instance, or drugs that interact with one another. One thing you might consider is having a completely independent opinion – not to take you away from your doctor, but to have fresh eyes to see if something has been missed.

What is the indication for Rituxan?

Monica Richey, NP: The indication for Rituxan is for lupus nephritis and sometimes refractory lupus (it’s not FDA approved for these uses, but many rheumatologists have found it useful for in these settings).

Are there any actually effective treatments for peripheral neuropathy?

Monica Richey, NP: Neurontin is a medication that is indicated to treat neuropathy. It is taper-up medication, so you start at the smallest dose and work up until you find your dose. Lyrica is also used to treat neuropathy and works in the same way as Neurontin.

My rheumatologist also explained that my lupus is refractory. What exactly does that mean?

Dr. Emma MacDermott: Refractory disease means that your disease isn’t responding in a predictable or usual fashion to the usual medications taken for the disease. Everybody’s lupus is different and sometimes it takes time to find a combination of drugs that works best for you.

Thank you, Emma. I see my rheumatologist almost four times a month and we have been trying many different treatments. I’m just hoping we find the right medications. I’m just worried that I am a lost cause. Has there ever been cases where lupus was always refractory?

Dr. Emma MacDermott: We never consider any patient a lost cause. Lupus is unpredictable and can have ups and downs. Depending upon which organ systems are involved, different combinations of medications are needed. This sounds like a very frustrating time for you, but you should keep positive and keep trying to find your best combination. In addition, you should continue to maintain a healthy diet, exercise, and stay positive. It may be helpful to talk with others who have similar problems. Have you considered speaking to one of the lupus support groups?

Thank you, Dr. MacDermott. I am in a support group and see a therapist and it does help a lot. You are right – it’s very frustrating, especially when my family members don’t understand how complex this disease is and how hard it is to find the right treatment, but I try my hardest to keep pushing through. I just hope we can soon find the right treatment. I thank you for all your help in answering my questions.

My-Lan Tran, LCSW: Hi, hang in there! You are not a lost cause. This is not a time to be on our own when we are down, be it physically and/or emotionally. It’s time to reach out and create a supportive community with others who have been there. Please visit our Lupus Support Programs and we will talk.

Is there any particular diet that someone with lupus, fibromyalgia, and rheumatoid arthritis should follow? Are there any good exercise regimens as well? I’ve been on prednisone for years and have gained a lot of weight and I would love to lose it.

Monica Richey, NP: The best diet is a diet rich in fruits, vegetables, and oily fish like salmon. You should avoid fried, processed, and frozen foods. Try to exercise lightly on a daily basis. For fibromyalgia, the best exercise is swimming or water aerobics.

I’ve had SLE for six years now. I’ve tried everything from methotrexate, Plaquenil, CellCept, and Cytoxan, and am now gone into kidney failure and started dialysis. I don’t know what to do.

Dr. Michael Lockshin: Think of two things: lupus often quiets down when you are on dialysis and patients who get kidney transplants do well in the long run. The first several months on dialysis are the roughest, but things get better.

I am dealing with congestive heart failure and hypertension. I currently take prednisone, many blood pressure medications, Lasix, warfarin, and Keppra.

Dr. Michael Lockshin: That sort of story is common when patients first suffer from kidney failure. Really meticulous management—I’m talking about both the nephrologist and the rheumatologist, and probably others as well – can get you through this hard part, and most of the problems you mention can and probably will improve.

I realize everyone is different in terms of effective pain management, but what non-narcotic medications do you find are most effective for pain management in lupus patients?

Dr. Jane Salmon: It depends why you hurt and where you have pain. Fibromyalgia responds to Lyrica. Arthritis responds to acetaminophen or non-steroidal anti-inflammatory medications such as naproxen. It is important to discuss these drugs with your physician before beginning to take them because they can affect the kidneys or liver.

Can Orencia be used successfully to treat lupus?

Dr. Emma MacDermott: For a patient in whom arthritis is a major component of their disease, Orencia can be useful.

Do you think it is a good idea with a patient with SLE that has tried many medications that just didn’t work, participate in a clinical trial for SLE? I have been asked to participate in one for Epratuzumab.

Dr. Michael Lockshin: Clinical trials have very strict criteria about who can and cannot participate, so your prior problems may not allow you to participate. However, clinical trials are a good option for people who are difficult to treat. Most clinical trials include a “placebo” arm. That part involves no drugs at all, but rather standard-of-care therapy, so you will be treated no matter which arm you are in. I can’t tell you whether it’s a good idea for you, but it is for many patients.

Thank you for answering regarding the clinical trial. I felt hat this may be my only option as I have tried many other medications that aren’t working. I would love to participate in helping get a drug specifically for systemic lupus approved by the FDA.

Dr. Michael Lockshin: Thank you for that generous thought. It’s people like you who will get us all to a real cure.

Would you have any tips or tricks for dealing with the summer heat and drastic changes in the weather?

Monica Richey, NP: For the summer use sunscreen 50-70 SPF and wear long-sleeved shirts while outside. Keep yourself hydrated at all times, walk around with a water bottle. Make sure you have air conditioning to keep the humidity and heat out. If you have to go outside, go early in the morning or later in the afternoon when the sun is weaker.

Are there any medications or treatments that are used to help chronic fatigue?

Dr. Michael Lockshin: The first thing is hydroxychloroquine if the fatigue is due to lupus. Otherwise, we sometimes use stimulants, such as modafinil or armodafinil, but these drugs have very restricted use and should be carefully discussed with your doctor before trying.

I am a patient with severe lupus and connective tissue disease with a great number of symptoms for two years, including joint pains and inflammation. I was hospitalized with infections and pancreatitis and have kidney problems but no blood work history positive for lupus. Is my only option Plaquenil and methotrexate (eight pills once a week)?

Dr. Jane Salmon: There are overlaps between lupus, rheumatoid arthritis, and other connective tissue diseases. This makes treatment decisions more complex. We generally treat the manifestations. If Plaquenil and methotrexate are not sufficient, there are other immunosuppressive drugs. It’s most important to figure out which organ system is active – that can guide therapy.

I’ve been on Coumadin for years. I have had several blood clots. Will I ever be able to stop taking this or will I always be on it?

Dr. Michael Lockshin: People who have had repeated clots stay on anticoagulation, so at the moment the answer is no. However, this field is moving very fast and new and safer anticoagulation medications are being tested. We may even be able to identify people who are no longer at risk so they can stop medication. This won’t happen today, but it will very soon.

As a lupus patient and advocate, thank you so much for having this chat. How do you feel alternative therapies (acupuncture, massage, meditation, herbs and supplements) help a lupus patients manage their condition?

Monica Richey, NP: Alternative treatment can help reduce pain and fatigue sometimes associated with lupus. Be sure to check with your physician to make sure there are no interactions with your medications.

Are there any medications or treatments for chronic high fevers due to lupus?

Dr. Jane Salmon: It is unusual to have persistent high fevers. You and your doctors should make sure this is from your lupus.

Is there a specific medication used to treat valve (aortic) regurgitation due to lupus?

Dr. Emma MacDermott: There are no specific medications to treat valve disease. You should continue to follow with your cardiologist.

I’m pregnant with lupus and am having many complications. How can I be sure I can take certain medications?

Dr. Michael Lockshin: You give a lot of hints but not enough detail. It depends on how far along you are, what types of complications you’re talking about, what your own blood tests show and a lot of other things. Very briefly, prednisone, azathioprine (Imuran) and hydroxychloroquine (Plaquenil) are all considered safe and routinely used during pregnancy. Other medications have to be looked at one by one, and with much more detail about your specific situation. Please consult with your physician to determine treatment.

How do I get rid of scalp sores? They just pop up and are very painful and itchy.

Dr. Michael Lockshin: Are the scalp scores due to lupus? There are many other causes and if they’re not lupus sores, the answers might be different. We usually use hydroxychloroquine (Plaquenil). There are some medications to add if Plaquenil is not successful, such as Atabrine or Dapsone if there is an extensive rash elsewhere. Dermatologists use topical steroid and sometimes “intra-lesional” steroid injections. There are also steroid shampoos that you can use. It depends a lot on what has already been done and how difficult the sores have been to treat. Some are very easy to get rid of and some take a lot of trying of different medications. Please consult with your physician to determine treatment.

Remember that if you have any questions based on anything you read during this chat, you should consult with your health care providers. If you are interested in setting up an appointment with any HSS’s providers, please contact Physician Referral Services at 877.606.1555.

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The information provided in this chat is for informational and educational purposes, and doesn’t constitute medical or health advice for any individual problem. Please consult with your health care providers for any health problem and/or prior to starting any new medication or changing or discontinuing any medication you have been prescribed. This chat is not intended to create a doctor-patient relationship, or any other duty, between you and any member of HSS’s Rheumatology Interdisciplinary Team.

Posted: 7/27/2012

Authors

Michael D. Lockshin, MD
Attending Rheumatologist, Hospital for Special Surgery
Director, Barbara Volcker Center for Women and Rheumatic Disease

Jane E. Salmon, MD
Attending Physician, Hospital for Special Surgery
Senior Scientist, Hospital for Special Surgery

Emma MacDermott, MD
Pediatric Rheumatologist
Hospital for Special Surgery
Monica Richey, NP
Rheumatology Nurse Practitioner
Hospital for Special Surgery
Emily Dorfman, LMSW
Adult Rheumatology Social Worker
Hospital for Special Surgery
My-Lan Tran, LCSW
Manager, LANtern (Lupus Asian Network) Program
Hospital for Special Surgery

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Mycophenolate

Risk of birth defects:

Mycophenolate must not be taken by women who are pregnant or who may become pregnant. There is a high risk that mycophenolate will cause miscarriage (loss of the pregnancy) during the first 3 months of pregnancy or will cause the baby to be born with birth defects (problems that are present at birth).

You should not take mycophenolate if you are pregnant or if you may become pregnant. You must have a negative pregnancy test before starting your treatment with mycophenolate, again 8 to 10 days later, and at routine follow-up appointments. You must use acceptable birth control during your treatment, and for 6 weeks after you stop taking mycophenolate. Your doctor will tell you which forms of birth control are acceptable for you to use. Mycophenolate may decrease the effectiveness of oral contraceptives (birth control pills), so it is especially important to use a second form of birth control along with this type of contraceptive.

If you are a male with a female partner who may become pregnant, you should use acceptable birth control during treatment and for at least 90 days after your last dose. Do not donate sperm during your treatment and for at least 90 days after your last dose.

Call your doctor right away if you think you or your partner, is pregnant or if you miss a menstrual period.

Because of the possibility that your donation may go to a female who may be or become pregnant, do not donate blood during your treatment and for at least 6 weeks after your last dose.

Risks of serious infections:

Mycophenolate weakens the body’s immune system and may decrease your ability to fight infection. Wash your hands often and avoid people who are sick while you are taking this medication. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, or cough; unusual bruising or bleeding; pain or burning during urination; frequent urination; wound or sore that is red, warm, or won’t heal; drainage from a skin wound; general weakness, extreme tiredness, or sick feeling; symptoms of the ”flu” or a ”cold”; pain or swelling in the neck, groin, or armpits; white patches in the mouth or throat; cold sores; blisters; headache or earache; or other signs of infection.

You may be infected with certain viruses or bacteria but not have any signs of infection. Taking mycophenolate increases the risk that these infections will become more severe and cause symptoms. Tell your doctor if you have any type of infection, such as Hepatitis B or C, including an infection that does not cause symptoms.

Mycophenolate may increase the risk that you will develop progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Tell your doctor if you have or have ever had PML, or another condition that affects your immune system such as human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS); sarcoidosis (a condition that causes swelling in the lungs and sometimes in other parts of the body); leukemia (cancer that causes too many blood cells to be produced and released into the bloodstream); or lymphoma. If you experience any of the following symptoms, call your doctor immediately: weakness on one side of the body or in the legs; difficulty or inability to control your muscles; confusion or difficulty thinking clearly; unsteadiness; memory loss; difficulty speaking or understanding what others say; or a lack of interest or concern for usual activities or things you usually care about.

Mycophenolate may increase your risk of developing certain types of cancer, including lymphoma (a type of cancer that develops in the lymph system) and skin cancer. Tell your doctor if you or anyone in your family has or has ever had skin cancer. Avoid unnecessary or prolonged exposure to real and artificial sunlight (tanning beds, sunlamps) and light therapy and wear protective clothing, sunglasses, and sunscreen (with a SPF factor of 30 or above). This will help to decrease your risk of developing skin cancer. Call your doctor if you experience any of the following symptoms: pain or swelling in the neck, groin, or armpits; a new skin sore or bump; a change in the size or color of a mole; a brown or black skin lesion (sore) with uneven edges or one part of the lesion that does not look like the other; skin changes; sores that do not heal; unexplained fever; tiredness that does not go away; or weight loss.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with mycophenolate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website http://www.fda.gov/Drugs to obtain the Medication Guide.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to mycophenolate.

Talk to your doctor about the risks of taking mycophenolate.

Mycophenolic Acid Side Effects

More common

Abdominal or stomach pain or cramps

black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

body aches or pain

bone pain

burning or stinging of the skin

chest pain

cloudy urine

confusion

constipation

convulsions

cough

decrease in the amount of urine

decreased frequency or amount of urine

depression

difficult, burning, or painful urination

dizziness or lightheadedness

drowsiness

dry mouth

ear congestion

fainting

fast, pounding, or irregular heartbeat or pulse

fever or chills

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

incoherent speech

increase in heart rate

increased blood pressure

increased hunger

increased thirst

increased urination

joint pain, stiffness, or swelling

loss of appetite

loss of consciousness

loss of voice

lower back, side, or stomach pain

metallic taste

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms or twitching

muscle weakness

nausea or vomiting

nervousness

noisy, rattling breathing

numbness and tingling around the mouth, fingertips, hands, or feet

painful blisters on the trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

pinpoint red spots on the skin

rapid breathing

red, tender, or oozing skin at incision

runny nose

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sunken eyes

sweating

swelling

swollen glands

thirst

tightness in the chest

tremor

trouble breathing at rest or with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

What is Cellcept used for?

  • Preventing the body rejecting a transplanted heart, liver or kidney (in combination with ciclosporin and corticosteroids).

How does Cellcept work?

Cellcept tablets, capsules, suspension and intravenous infusion all contain the active ingredient mycophenolate mofetil, which is a type of medicine called an immunosuppressant. Immunosuppressant medicines reduce the activity of the body’s immune system. Mycophenolate is broken down in the body to the active medicine called mycophenolic acid.

The cells that make up the immune system normally protect the body by recognising and attacking foreign or abnormal cells, for example bacteria that cause infections. However, the same cells in the immune system will also recognise and attack transplanted organs, because the immune system recognises the new organ as a foreign substance. When the immune system attacks a transplanted organ this is known as “transplant rejection”.

The cells in the immune system that are responsible for regulating and triggering immune responses are white blood cells called T- and B-lymphocytes. Mycophenolate works by reducing the production of these white blood cells. It does this by blocking the action of a compound called inosine monophosphate dehydrogenase, which is needed for their production.

By reducing the production of these cells, mycophenolate makes the body less likely to reject foreign material such as transplanted organs.

Mycophenolate is used together with other immunosuppressive medicines (ciclosporin and corticosteroids) as part of the transplant regimen to prevent rejection of heart, kidney and liver transplants.

How is Cellcept given?

  • Cellcept may be given as a drip into a vein for the first few days following the transplant. After this you will usually be transferred onto treatment by mouth.
  • Cellcept is usually taken twice a day by mouth. However, it is important that you always follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine. If you are not clear about any aspect of taking your medicine you should talk to your pharmacist or transplant team.
  • Cellcept can be taken either with or without food.
  • Cellcept capsules and tablets must be swallowed whole with a drink.
  • CellCept capsules should not be opened or crushed and CellCept tablets should not be broken or crushed. If a capsule has broken open or split, avoid touching or inhaling the powder. If any powder gets on your skin, wash the skin thoroughly with soap and water. If powder gets in your eyes, rinse the eyes immediately with plain water.
  • If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. In this case leave out the forgotten dose and take your next dose as usual. Do not take a double dose to make up for a missed dose.
  • Keep taking this medicine regularly for as long as your doctor tells you to.

Important information about Cellcept

  • As this medicine reduces the activity of your immune system it will make you more susceptible to getting infections. It is important to try and avoid contact with people who have an infection while you are taking this medicine. You must consult your doctor immediately if you develop a sore throat, high temperature, any other signs of infections, or begin to feel generally unwell while taking it.
  • Due to the reduced activity of your immune system, people having long-term or intensive immunosuppressive treatment are also at increased risk of developing lymphomas and other cancers, particularly skin cancer. To reduce the risk of skin cancer you should minimise your exposure to sunlight by covering your skin with clothing and using a sunscreen with a high protection factor. You should not use sun beds and avoid excessive unprotected sun exposure. Discuss this with your doctor.
  • This medicine may decrease the normal amounts of blood cells in the blood. For this reason you will need to have regular blood tests to monitor the levels of your blood cells. This should be weekly for the first month, twice a month for the 2nd and 3rd months and then monthly through the first year of treatment. If your white blood cell count falls below a certain level during treatment, your doctor may ask you to stop taking this medicine. You should consult your doctor immediately if you experience any of the following symptoms during treatment, as they may be signs of a problem with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness.
  • This medicine has been associated with certain lung problems. For this reason, if you develop a persistent cough, shortness of breath or difficulty breathing while taking this medicine you should consult your doctor.
  • This medicine can cause serious birth defects and increases the risk of miscarriage. For this reason, this medicine must not be started in women who could get pregnant until they have had a pregnancy test which has come back negative. Women must use two effective methods of contraception to prevent pregnancy during treatment with this medicine. This contraception should be continued for at least six weeks after stopping treatment.
  • This medicine may pass into semen and could cause birth defects in a baby fathered during treatment. For this reason, men (including those who have had a vasectomy) should use condoms during treatment and for at least 90 days after stopping treatment with this medicine. Women with a male partner who is taking this medicine should also use an effective method of contraception to prevent pregnancy and for 90 days after their partner has stopped treatment.
  • Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
  • You must not donate blood while you are taking this medicine and for at least six weeks after stopping treatment. This is because if a pregnant woman was given the blood, the medicine could harm the development of the baby.

Cellcept should be used with caution in

  • Elderly people.
  • People with a history of hepatitis B or C.
  • People with a serious digestive system disease that is currently active.
  • Rare hereditary diseases where there is a deficiency of an enzyme called HGPRT, eg Lesch-Nyhan or Keelley-Seegmiller syndrome.
  • Cellcept suspension contains aspartame and should be used with caution in people with an inherited disorder of protein metabolism called phenylketonuria.

Cellcept should not be used in

  • People with a known allergy to mycophenolate mofetil or mycophenolic acid.
  • Women who could get pregnant, unless they are using two effective methods of contraception and have had a pregnancy test which has come back negative (see above).
  • Women who are breastfeeding.
  • Cellcept suspension contains sorbitol and should not be taken by people with fructose intolerance.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • This medicine may be harmful to a developing baby. It can cause serious birth defects and increases the risk of miscarriage.
  • This medicine should not be used in women who are pregnant, unless considered essential by your doctor because there are no suitable alternative treatments to prevent transplant rejection. Seek further medical advice from your doctor.
  • Women who could get pregnant must use two effective methods of contraception to prevent pregnancy during treatment with this medicine. Contraception should be continued for at least six weeks after stopping treatment.
  • Men (including those who have had a vasectomy) should use condoms during treatment and for at least 90 days after stopping treatment with this medicine. Women with a male partner who is taking this medicine should also use an effective method of contraception to prevent pregnancy. This should be continued for 90 days after their partner has stopped treatment.
  • If you want to plan a pregnancy or think you could be pregnant at any point while taking this medicine it is important to consult your doctor straight away.
  • This medicine may pass into breast milk. It should not be used during breastfeeding as it could be harmful to a nursing infant. Mothers who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Possible side effects of Cellcept

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

  • Disturbances of the gut such as diarrhoea, nausea, vomiting or abdominal pain.
  • Decrease in the number of white blood cells, platelets or red blood cells in the blood (leucopenia, thrombocytopenia or anaemia). See important information above.
  • Infections such as urinary tract infections, blood infections (sepsis), thrush infections in the gut, shingles, cold sores. See important information above.

Common (affect between 1 in 10 and 1 in 100 people)

  • Infections of the airways and lungs, such as coughs, colds, flu, pneumonia, bronchitis, pharyngitis, sinusitis.
  • Gastroenteritis.
  • Vaginal thrush.
  • Fungal skin infections.
  • Skin cancer or benign growths on the skin. See important information above.
  • Disturbances in the levels of electrolytes such as potassium in the blood.
  • Increased level of uric acid in the blood and development of gout.
  • Alteration in taste and loss of appetite.
  • Depression, anxiety.
  • Confusion.
  • Difficulty sleeping (insomnia).
  • Pins and needles sensations (paraesthesia).
  • Tremor or rigidity.
  • Convulsions.
  • Dizziness.
  • Headache.
  • Sleepiness.
  • Changes in blood pressure, increased heart rate, flushing.
  • Cough or shortness of breath. See important information section above.
  • Disturbances of the gut such as constipation, indigestion or wind.
  • Ulceration or bleeding in the stomach or intestines.
  • Inflammation of the foodpipe (oesophagitis), stomach (gastritis) or bowel (colitis).
  • Inflammation of the liver (hepatitis), jaundice.
  • Kidney problems.
  • Excessive fluid retention in the body tissues, resulting in swelling (oedema).
  • Pain in the joints.
  • Rash, acne, hair loss.
  • Feeling weak or generally unwell.

The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it’s necessary they’ll report it for you.You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard

.

How can Cellcept affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The manufacturer of this medicine recommends that it should not be used in combination with azathioprine, as they have not studied the effect of this combination.

The body’s response to vaccinations is reduced by medicines such as mycophenolate, which suppress the immune system and so prevent the body forming adequate antibodies. This means vaccines may less effective in people taking this medicine. Live vaccines may cause infection in people taking this medicine and these should therefore be avoided during treatment. Live vaccines include the following: oral polio; rubella; measles, mumps and rubella (MMR); BCG; yellow fever and oral typhoid vaccines.

The following medicines reduce the absorption of mycophenolate from the gut and may therefore reduce the amount in the blood. As this could make it less effective, these medicines should not be taken within two to three hours of taking mycophenolate (ask your pharmacist for more advice):

  • colestyramine
  • iron tablets or liquids
  • sevelamer.

The following medicines may also decrease the amount of this medicine in the blood:

  • ciclosporin
  • ciprofloxacin
  • co-amoxiclav
  • norfloxacin and metronidazole used together
  • rifampicin.

If people with decreased kidney function take any of the following medicines in combination with mycophenolate, the blood levels of both medicines may increase. If you have any kidney problems you should be closely monitored for side effects if you are prescribed one of these medicines while you are taking mycophenolate:

  • aciclovir
  • ganciclovir
  • valaciclovir
  • valganciclovir.

Other medicines containing the same active ingredient

Mycophenolate mofetil tablets and capsules are also available without a brand name, ie as the generic medicine.

Myfortic contains mycophenolate sodium. However, Cellcept and Myfortic are not interchangeable, because the body handles these different brands of mycophenolate in slightly different ways. Switching between the two should be avoided.

Further reading

For background information about our medicine factsheets, including the references used to produce them, .

Last updated 16.12.2015

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