In recent years, doctors have been increasing compelled to take risk into account in their practices. From the courses malpractice companies allow doctors to take to get a 5% to 10% discount on their malpractice premiums to the iPLEDGE program, the desire to decrease “risky” behavior on the part of doctors is but one sign the times in which physicians practice are achangin’. One lesser-known program is the Risk Evaluation and Mitigation Strategy (REMS). The program mandated by the FDA is a strategy to manage a known or potential serious risk associated with a drug or biological product. This article will review the REMS program with a focus on mycophenolate mofetil (CellCept) and litigation associated with the drug.
Mycophenolate mofetil, also available in a delayed-release form called mycophenolic acid (Myfortic), was originally indicated in combination with a calcineurin inhibitor (cyclosporine or tacrolimus) and prednisone for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. It has found other uses in the treatment of lupus (in particular for lupus nephritis), pemphigus, immunoglobulin A nephropathy, small vessel vasculitides, severe atopic dermatitis and chronic idiopathic urticaria among other dermatological diseases.1 Initially, it seemed a very safe steroid sparing agent and it remains safer for long-term use with high doses of corticosteroids.
Mycophenolate mofetil, which first started as a pregnancy category C drug, has become a pregnancy category D drug (doxycycline and minocycline are pregnancy category D drugs) and is now part of the REMS program, along with mycophenolic acid. Mycophenolate mofetil’s most common side effect is gastrointestinal upset. The side effects of this drug have been outlined in its package insert.2 Since mycophenolate mofetil first entered the market, additional warnings have been included in the package insert noting that it can cause:
• Birth defects
• Progressive multifocal leukoencephalopathy (PML). In 2008, 16 patients developed PML but it is not clear if mycophenolate mofetil was the cause
• Aplastic anemia in particular when used with other immunosuppressive drugs
The package insert also notes that mycophenolate mofetil can increase the risk of lymphoma when used with other immunosuppressive medications. In addition, the FDA issued an alert that patients on mycophenolate mofetil and mycophenolic acid are at increased risk of opportunistic infections such as activation of latent viral infections, including shingles, other herpes infections, cytomegalovirus and BK virus associated nephropathy. Interstitial lung disorders, including fatal pulmonary fibrosis, also have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving mycophenolate mofetil.
One difficulty in assessing these side effects is that they reflect mycophenolate mofetil use in conjunction with other drugs. I reported a case of aplastic anemia in a patient who was on corticosteroid with mycophenolate mofetil with an eye towards switching the patient to mycophenolate mofetil only.3 The patient also could not tolerate dapsone and was a success on intravenous immunoglobulin (IVIG) and now only wants IVIG despite the significant cost of therapy.
Mycophenolic acid preparations are one of the most commonly used immunosuppressants in the United States. However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects.4
To ensure that the benefits of mycophenolic acid outweigh the risks, the FDA required all manufacturers of mycophenolic acid products to propose REMS. Four years after initially calling for proposals, the FDA approved a single shared REMS system in September 2012. The mycophenolic acid REMS include a medication guide and elements to assure safe use (ETASU). The medication guide, which was FDA approved in 2008, should continue to be distributed to patients, and the ETASU requires physicians to complete training and obtain patient signatures on the Patient-Prescriber Acknowledgement form. A single, national, voluntary pregnancy registry is available, and pregnant patients should be encouraged to participate. Although the impact of the mycophenolic acid REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with mycophenolic acid products among patients and possibly practitioners.4 Other drugs subject to a REMS-type program are noted in Table 1.5 All require physician enrollment to prescribe the drugs.
The Mycophenolate REMS is a program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. The goals of the Mycophenolate REMS program are to prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure to mycophenolate by informing prescribers and females of reproductive potential about the increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy. It also emphasizes the importance of pregnancy prevention and planning to minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry.6 The training materials for the Mycophenolate REMS program are outlined in Table 2.
Mycophenolate Mofetil and Litigation
One case reported in the Deseret News in 2011 claims that mycophenolate mofetil caused harm through its immunosuppression. Carlos Chavez, of Salt Lake County, Utah, claims that he can no longer eat and drink normally due to the hole in his face.7 Instead of going down his throat, food and water goes up his nose into his eye, causing severe headaches. Chavez has undergone 6 surgeries in the past 4 years, including removal of the bone around his nose, part of his jaw and 7 teeth.
In a federal lawsuit, Chavez contends that he developed a extensive fungus infection in his face from taking mycophenolate mofetil that his doctor prescribed for him. He is suing the maker of the drug, Roche Laboratories Inc, for at least $500,000 in medical expenses and lost wages and an unspecified amount for general damages.7 The outcome of the case has not been reported.
Prior to the implementation of the REMA program, a case involving a dermatologist who prescribed a patient mycophenolate mofetil for atopic dermatitis without her using birth control and with documenting she should not get pregnant was brought to court. Eight days after starting the program she got pregnant and without speaking to the dermatologist immediately had an abortion. No evidence of birth defects was documented at the time of the abortion. The patient sued for damages and the case was settled out of court.
With the REMS program now in place no dermatologist should ever prescribe MM without having a patient recognizing that birth defects are possible and should likely advise the patient to be on birth control of one or even better 2 types. Mycophenolate mofetil is a useful medication in dermatology, but it should be used wisely. If a patient is female, she should enroll in the REMS program and discuss and sign the REMS documentation forms. For all patients, a complete blood work monthly should be preformed and for fertile women a monthly pregnancy test seems prudent (but is not required).
In our risk adverse society, we must always grapple with prudent risk management, obey FDA dictates and monitor our patients regularly physically and with appropriate lab testing. Mycophenolate mofetil is an effective treatment for chronic idiopathic urticaria,8 but is not indicated for this use. Furthermore with the approval of omalizumab (Xolair) for chronic idiopathic urticaria,9 it not clear whether it will remain a likely first treatment for chronic idiopathic urticaria. It is also a useful medication for severe atopic dermatitis with a response rate of 66% to 90%.10,11 While not as intrusive as iPLEDGE, the REMS program for mycophenolate mofetil compels the patient and physician to engage in a therapeutic alliance that maximizes benefits and minimizes risks.
For more information about the Mycophenolate REMS and to obtain training materials, please visit https://www.mycophenolaterems.com/ or call 800-617-8191.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and Yale Medical School in 1997. He is an assistant clinical professor in the Department of Dermatology at Weill Cornell Medical College in New York, NY.
Disclosure: The author reports no relevant financial relationships.
References
1. Wolverton S. Comprehensive Dermatologic Drug Therapy. 3rd ed. Philadelphia, PA: Saunders; 2013.
2. CellCept [package insert]. South San Francisco, CA: Genentech USA, Inc. https://www.gene.com/download/pdf/cellcept_prescribing.pdf.
Accessed April 23, 2014.
3. Scheinfeld N. Red blood cell anemia in a patient with pemphigus vulgaris induced by the use of mycophenolate mofetil and prednisone. J Dermatolog Treat. 2007;18(4):243-245.
4. Kim M, Rostas S, Gabardi S. Mycophenolate fetal toxicity and risk evaluation and mitigation strategies. Am J Transplant. 2013;13(6):1383-1389.
5. FDA.gov. https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed April 23, 2014.
6. Mycophenolate REMS. https://www.mycophenolaterems.com/. Accessed April 23, 2014.
7. Romboy D. Salt Lake County man sues drug company after developing face-eating fungus. Deseret News. November 8, 2011. https://www.deseretnews.com/article/705393972/Salt-Lake-County-man-sues-drug-company-after-developing-face-eating-fungus.html?pg=all. Accessed April 23, 2014.
8. Zimmerman AB, Berger EM, Elmariah SB, Soter NA. The use of mycophenolate mofetil for the treatment of autoimmune and chronic idiopathic urticaria: experience in 19 patients. J Am Acad Dermatol. 2012;66(5):767-770.
9. Novartis announces FDA approval of Xolair (omalizumab) for chronic idiopathic urticaria (CIU), a form of hives [news release]. New York, NY: Novartis Pharmaceuticals Corporation; March 21, 2014. https://www.novartis.com/newsroom/media-releases/en/2014/1770973.shtml. Accessed April 23, 2014.
10. Waxweiler WT, Agans R, Morrell DS. Systemic treatment of pediatric atopic dermatitis with azathioprine and mycophenolate mofetil. Pediatr Dermatol. 2011;28(6):689-694.
11. Heller M, Shin HT, Orlow SJ, Schaffer JV. Mycophenolate mofetil for severe childhood atopic dermatitis: experience in 14 patients. Br J Dermatol. 2007;157(1):127-132.
In recent years, doctors have been increasing compelled to take risk into account in their practices. From the courses malpractice companies allow doctors to take to get a 5% to 10% discount on their malpractice premiums to the iPLEDGE program, the desire to decrease “risky” behavior on the part of doctors is but one sign the times in which physicians practice are achangin’. One lesser-known program is the Risk Evaluation and Mitigation Strategy (REMS). The program mandated by the FDA is a strategy to manage a known or potential serious risk associated with a drug or biological product. This article will review the REMS program with a focus on mycophenolate mofetil (CellCept) and litigation associated with the drug.
Mycophenolate mofetil, also available in a delayed-release form called mycophenolic acid (Myfortic), was originally indicated in combination with a calcineurin inhibitor (cyclosporine or tacrolimus) and prednisone for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. It has found other uses in the treatment of lupus (in particular for lupus nephritis), pemphigus, immunoglobulin A nephropathy, small vessel vasculitides, severe atopic dermatitis and chronic idiopathic urticaria among other dermatological diseases.1 Initially, it seemed a very safe steroid sparing agent and it remains safer for long-term use with high doses of corticosteroids.
Mycophenolate mofetil, which first started as a pregnancy category C drug, has become a pregnancy category D drug (doxycycline and minocycline are pregnancy category D drugs) and is now part of the REMS program, along with mycophenolic acid. Mycophenolate mofetil’s most common side effect is gastrointestinal upset. The side effects of this drug have been outlined in its package insert.2 Since mycophenolate mofetil first entered the market, additional warnings have been included in the package insert noting that it can cause:
• Birth defects
• Progressive multifocal leukoencephalopathy (PML). In 2008, 16 patients developed PML but it is not clear if mycophenolate mofetil was the cause
• Aplastic anemia in particular when used with other immunosuppressive drugs
The package insert also notes that mycophenolate mofetil can increase the risk of lymphoma when used with other immunosuppressive medications. In addition, the FDA issued an alert that patients on mycophenolate mofetil and mycophenolic acid are at increased risk of opportunistic infections such as activation of latent viral infections, including shingles, other herpes infections, cytomegalovirus and BK virus associated nephropathy. Interstitial lung disorders, including fatal pulmonary fibrosis, also have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving mycophenolate mofetil.
One difficulty in assessing these side effects is that they reflect mycophenolate mofetil use in conjunction with other drugs. I reported a case of aplastic anemia in a patient who was on corticosteroid with mycophenolate mofetil with an eye towards switching the patient to mycophenolate mofetil only.3 The patient also could not tolerate dapsone and was a success on intravenous immunoglobulin (IVIG) and now only wants IVIG despite the significant cost of therapy.
Mycophenolic acid preparations are one of the most commonly used immunosuppressants in the United States. However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects.4
To ensure that the benefits of mycophenolic acid outweigh the risks, the FDA required all manufacturers of mycophenolic acid products to propose REMS. Four years after initially calling for proposals, the FDA approved a single shared REMS system in September 2012. The mycophenolic acid REMS include a medication guide and elements to assure safe use (ETASU). The medication guide, which was FDA approved in 2008, should continue to be distributed to patients, and the ETASU requires physicians to complete training and obtain patient signatures on the Patient-Prescriber Acknowledgement form. A single, national, voluntary pregnancy registry is available, and pregnant patients should be encouraged to participate. Although the impact of the mycophenolic acid REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with mycophenolic acid products among patients and possibly practitioners.4 Other drugs subject to a REMS-type program are noted in Table 1.5 All require physician enrollment to prescribe the drugs.
The Mycophenolate REMS is a program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. The goals of the Mycophenolate REMS program are to prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure to mycophenolate by informing prescribers and females of reproductive potential about the increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy. It also emphasizes the importance of pregnancy prevention and planning to minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry.6 The training materials for the Mycophenolate REMS program are outlined in Table 2.
Mycophenolate Mofetil and Litigation
One case reported in the Deseret News in 2011 claims that mycophenolate mofetil caused harm through its immunosuppression. Carlos Chavez, of Salt Lake County, Utah, claims that he can no longer eat and drink normally due to the hole in his face.7 Instead of going down his throat, food and water goes up his nose into his eye, causing severe headaches. Chavez has undergone 6 surgeries in the past 4 years, including removal of the bone around his nose, part of his jaw and 7 teeth.
In a federal lawsuit, Chavez contends that he developed a extensive fungus infection in his face from taking mycophenolate mofetil that his doctor prescribed for him. He is suing the maker of the drug, Roche Laboratories Inc, for at least $500,000 in medical expenses and lost wages and an unspecified amount for general damages.7 The outcome of the case has not been reported.
Prior to the implementation of the REMA program, a case involving a dermatologist who prescribed a patient mycophenolate mofetil for atopic dermatitis without her using birth control and with documenting she should not get pregnant was brought to court. Eight days after starting the program she got pregnant and without speaking to the dermatologist immediately had an abortion. No evidence of birth defects was documented at the time of the abortion. The patient sued for damages and the case was settled out of court.
With the REMS program now in place no dermatologist should ever prescribe MM without having a patient recognizing that birth defects are possible and should likely advise the patient to be on birth control of one or even better 2 types. Mycophenolate mofetil is a useful medication in dermatology, but it should be used wisely. If a patient is female, she should enroll in the REMS program and discuss and sign the REMS documentation forms. For all patients, a complete blood work monthly should be preformed and for fertile women a monthly pregnancy test seems prudent (but is not required).
In our risk adverse society, we must always grapple with prudent risk management, obey FDA dictates and monitor our patients regularly physically and with appropriate lab testing. Mycophenolate mofetil is an effective treatment for chronic idiopathic urticaria,8 but is not indicated for this use. Furthermore with the approval of omalizumab (Xolair) for chronic idiopathic urticaria,9 it not clear whether it will remain a likely first treatment for chronic idiopathic urticaria. It is also a useful medication for severe atopic dermatitis with a response rate of 66% to 90%.10,11 While not as intrusive as iPLEDGE, the REMS program for mycophenolate mofetil compels the patient and physician to engage in a therapeutic alliance that maximizes benefits and minimizes risks.
For more information about the Mycophenolate REMS and to obtain training materials, please visit https://www.mycophenolaterems.com/ or call 800-617-8191.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and Yale Medical School in 1997. He is an assistant clinical professor in the Department of Dermatology at Weill Cornell Medical College in New York, NY.
Disclosure: The author reports no relevant financial relationships.
References
1. Wolverton S. Comprehensive Dermatologic Drug Therapy. 3rd ed. Philadelphia, PA: Saunders; 2013.
2. CellCept [package insert]. South San Francisco, CA: Genentech USA, Inc. https://www.gene.com/download/pdf/cellcept_prescribing.pdf.
Accessed April 23, 2014.
3. Scheinfeld N. Red blood cell anemia in a patient with pemphigus vulgaris induced by the use of mycophenolate mofetil and prednisone. J Dermatolog Treat. 2007;18(4):243-245.
4. Kim M, Rostas S, Gabardi S. Mycophenolate fetal toxicity and risk evaluation and mitigation strategies. Am J Transplant. 2013;13(6):1383-1389.
5. FDA.gov. https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed April 23, 2014.
6. Mycophenolate REMS. https://www.mycophenolaterems.com/. Accessed April 23, 2014.
7. Romboy D. Salt Lake County man sues drug company after developing face-eating fungus. Deseret News. November 8, 2011. https://www.deseretnews.com/article/705393972/Salt-Lake-County-man-sues-drug-company-after-developing-face-eating-fungus.html?pg=all. Accessed April 23, 2014.
8. Zimmerman AB, Berger EM, Elmariah SB, Soter NA. The use of mycophenolate mofetil for the treatment of autoimmune and chronic idiopathic urticaria: experience in 19 patients. J Am Acad Dermatol. 2012;66(5):767-770.
9. Novartis announces FDA approval of Xolair (omalizumab) for chronic idiopathic urticaria (CIU), a form of hives [news release]. New York, NY: Novartis Pharmaceuticals Corporation; March 21, 2014. https://www.novartis.com/newsroom/media-releases/en/2014/1770973.shtml. Accessed April 23, 2014.
10. Waxweiler WT, Agans R, Morrell DS. Systemic treatment of pediatric atopic dermatitis with azathioprine and mycophenolate mofetil. Pediatr Dermatol. 2011;28(6):689-694.
11. Heller M, Shin HT, Orlow SJ, Schaffer JV. Mycophenolate mofetil for severe childhood atopic dermatitis: experience in 14 patients. Br J Dermatol. 2007;157(1):127-132.
In recent years, doctors have been increasing compelled to take risk into account in their practices. From the courses malpractice companies allow doctors to take to get a 5% to 10% discount on their malpractice premiums to the iPLEDGE program, the desire to decrease “risky” behavior on the part of doctors is but one sign the times in which physicians practice are achangin’. One lesser-known program is the Risk Evaluation and Mitigation Strategy (REMS). The program mandated by the FDA is a strategy to manage a known or potential serious risk associated with a drug or biological product. This article will review the REMS program with a focus on mycophenolate mofetil (CellCept) and litigation associated with the drug.
Mycophenolate mofetil, also available in a delayed-release form called mycophenolic acid (Myfortic), was originally indicated in combination with a calcineurin inhibitor (cyclosporine or tacrolimus) and prednisone for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. It has found other uses in the treatment of lupus (in particular for lupus nephritis), pemphigus, immunoglobulin A nephropathy, small vessel vasculitides, severe atopic dermatitis and chronic idiopathic urticaria among other dermatological diseases.1 Initially, it seemed a very safe steroid sparing agent and it remains safer for long-term use with high doses of corticosteroids.
Mycophenolate mofetil, which first started as a pregnancy category C drug, has become a pregnancy category D drug (doxycycline and minocycline are pregnancy category D drugs) and is now part of the REMS program, along with mycophenolic acid. Mycophenolate mofetil’s most common side effect is gastrointestinal upset. The side effects of this drug have been outlined in its package insert.2 Since mycophenolate mofetil first entered the market, additional warnings have been included in the package insert noting that it can cause:
• Birth defects
• Progressive multifocal leukoencephalopathy (PML). In 2008, 16 patients developed PML but it is not clear if mycophenolate mofetil was the cause
• Aplastic anemia in particular when used with other immunosuppressive drugs
The package insert also notes that mycophenolate mofetil can increase the risk of lymphoma when used with other immunosuppressive medications. In addition, the FDA issued an alert that patients on mycophenolate mofetil and mycophenolic acid are at increased risk of opportunistic infections such as activation of latent viral infections, including shingles, other herpes infections, cytomegalovirus and BK virus associated nephropathy. Interstitial lung disorders, including fatal pulmonary fibrosis, also have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in post-transplant patients receiving mycophenolate mofetil.
One difficulty in assessing these side effects is that they reflect mycophenolate mofetil use in conjunction with other drugs. I reported a case of aplastic anemia in a patient who was on corticosteroid with mycophenolate mofetil with an eye towards switching the patient to mycophenolate mofetil only.3 The patient also could not tolerate dapsone and was a success on intravenous immunoglobulin (IVIG) and now only wants IVIG despite the significant cost of therapy.
Mycophenolic acid preparations are one of the most commonly used immunosuppressants in the United States. However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects.4
To ensure that the benefits of mycophenolic acid outweigh the risks, the FDA required all manufacturers of mycophenolic acid products to propose REMS. Four years after initially calling for proposals, the FDA approved a single shared REMS system in September 2012. The mycophenolic acid REMS include a medication guide and elements to assure safe use (ETASU). The medication guide, which was FDA approved in 2008, should continue to be distributed to patients, and the ETASU requires physicians to complete training and obtain patient signatures on the Patient-Prescriber Acknowledgement form. A single, national, voluntary pregnancy registry is available, and pregnant patients should be encouraged to participate. Although the impact of the mycophenolic acid REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with mycophenolic acid products among patients and possibly practitioners.4 Other drugs subject to a REMS-type program are noted in Table 1.5 All require physician enrollment to prescribe the drugs.
The Mycophenolate REMS is a program to tell doctors, nurses, pharmacists and patients about the risks of taking mycophenolate during pregnancy. The goals of the Mycophenolate REMS program are to prevent unplanned pregnancy in patients using mycophenolate and to minimize fetal exposure to mycophenolate by informing prescribers and females of reproductive potential about the increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy. It also emphasizes the importance of pregnancy prevention and planning to minimize the risks associated with fetal exposure to mycophenolate by collecting information on pregnancy outcomes through the Mycophenolate Pregnancy Registry.6 The training materials for the Mycophenolate REMS program are outlined in Table 2.
Mycophenolate Mofetil and Litigation
One case reported in the Deseret News in 2011 claims that mycophenolate mofetil caused harm through its immunosuppression. Carlos Chavez, of Salt Lake County, Utah, claims that he can no longer eat and drink normally due to the hole in his face.7 Instead of going down his throat, food and water goes up his nose into his eye, causing severe headaches. Chavez has undergone 6 surgeries in the past 4 years, including removal of the bone around his nose, part of his jaw and 7 teeth.
In a federal lawsuit, Chavez contends that he developed a extensive fungus infection in his face from taking mycophenolate mofetil that his doctor prescribed for him. He is suing the maker of the drug, Roche Laboratories Inc, for at least $500,000 in medical expenses and lost wages and an unspecified amount for general damages.7 The outcome of the case has not been reported.
Prior to the implementation of the REMA program, a case involving a dermatologist who prescribed a patient mycophenolate mofetil for atopic dermatitis without her using birth control and with documenting she should not get pregnant was brought to court. Eight days after starting the program she got pregnant and without speaking to the dermatologist immediately had an abortion. No evidence of birth defects was documented at the time of the abortion. The patient sued for damages and the case was settled out of court.
With the REMS program now in place no dermatologist should ever prescribe MM without having a patient recognizing that birth defects are possible and should likely advise the patient to be on birth control of one or even better 2 types. Mycophenolate mofetil is a useful medication in dermatology, but it should be used wisely. If a patient is female, she should enroll in the REMS program and discuss and sign the REMS documentation forms. For all patients, a complete blood work monthly should be preformed and for fertile women a monthly pregnancy test seems prudent (but is not required).
In our risk adverse society, we must always grapple with prudent risk management, obey FDA dictates and monitor our patients regularly physically and with appropriate lab testing. Mycophenolate mofetil is an effective treatment for chronic idiopathic urticaria,8 but is not indicated for this use. Furthermore with the approval of omalizumab (Xolair) for chronic idiopathic urticaria,9 it not clear whether it will remain a likely first treatment for chronic idiopathic urticaria. It is also a useful medication for severe atopic dermatitis with a response rate of 66% to 90%.10,11 While not as intrusive as iPLEDGE, the REMS program for mycophenolate mofetil compels the patient and physician to engage in a therapeutic alliance that maximizes benefits and minimizes risks.
For more information about the Mycophenolate REMS and to obtain training materials, please visit https://www.mycophenolaterems.com/ or call 800-617-8191.
Dr. Scheinfeld graduated from Harvard Law School in 1989 and Yale Medical School in 1997. He is an assistant clinical professor in the Department of Dermatology at Weill Cornell Medical College in New York, NY.
Disclosure: The author reports no relevant financial relationships.
References
1. Wolverton S. Comprehensive Dermatologic Drug Therapy. 3rd ed. Philadelphia, PA: Saunders; 2013.
2. CellCept [package insert]. South San Francisco, CA: Genentech USA, Inc. https://www.gene.com/download/pdf/cellcept_prescribing.pdf.
Accessed April 23, 2014.
3. Scheinfeld N. Red blood cell anemia in a patient with pemphigus vulgaris induced by the use of mycophenolate mofetil and prednisone. J Dermatolog Treat. 2007;18(4):243-245.
4. Kim M, Rostas S, Gabardi S. Mycophenolate fetal toxicity and risk evaluation and mitigation strategies. Am J Transplant. 2013;13(6):1383-1389.
5. FDA.gov. https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed April 23, 2014.
6. Mycophenolate REMS. https://www.mycophenolaterems.com/. Accessed April 23, 2014.
7. Romboy D. Salt Lake County man sues drug company after developing face-eating fungus. Deseret News. November 8, 2011. https://www.deseretnews.com/article/705393972/Salt-Lake-County-man-sues-drug-company-after-developing-face-eating-fungus.html?pg=all. Accessed April 23, 2014.
8. Zimmerman AB, Berger EM, Elmariah SB, Soter NA. The use of mycophenolate mofetil for the treatment of autoimmune and chronic idiopathic urticaria: experience in 19 patients. J Am Acad Dermatol. 2012;66(5):767-770.
9. Novartis announces FDA approval of Xolair (omalizumab) for chronic idiopathic urticaria (CIU), a form of hives [news release]. New York, NY: Novartis Pharmaceuticals Corporation; March 21, 2014. https://www.novartis.com/newsroom/media-releases/en/2014/1770973.shtml. Accessed April 23, 2014.
10. Waxweiler WT, Agans R, Morrell DS. Systemic treatment of pediatric atopic dermatitis with azathioprine and mycophenolate mofetil. Pediatr Dermatol. 2011;28(6):689-694.
11. Heller M, Shin HT, Orlow SJ, Schaffer JV. Mycophenolate mofetil for severe childhood atopic dermatitis: experience in 14 patients. Br J Dermatol. 2007;157(1):127-132.
