Risk Evaluation and Mitigation Strategy (REMS) Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs
Drug-Specific Content for Patient Interview Guide
Alemtuzumab [Lemtrada]
Indication: Relapsing multiple sclerosis
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Alemtuzumab was required to have a REMS program because of an increased risk of autoimmune conditions, infusion reactions, stroke, and certain cancers. As part of the alemtuzumab REMS program, patients must have regular skin exams and laboratory tests, and agree to monitoring for side effects during treatment and for a period of time after treatment has stopped.
Ambrisentan [Letairis]
Indication: Pulmonary arterial hypertension
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Ambrisentan was required to have a REMS program because of its risk of birth defects in case of pregnancy. As part of the ambrisentan REMS program, female patients that can get pregnant must undergo regular pregnancy testing and commit to an approved form of birth control.
Bosentan [Tracleer]
Indication: Pulmonary arterial hypertension
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Bosentan was required to have a REMS program because of its risk of birth defects in case of pregnancy, as well as its risk of liver damage. As part of the bosentan REMS program, patients must have regular liver function testing and female patients that can get pregnant must have routine pregnancy testing and commit to an approved form of birth control.
Clozapine [Versacloz/Fazaclo/Clozaril]
Indication: Treatment-resistant schizophrenia
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Clozapine was required to have a REMS program due to the risk of severe neutropenia, in which abnormally low numbers of a specific white blood cell can increase the chance of life-threatening infections. As part of the clozapine REMS program, patients must have regular blood tests.
Isotretinoin [Accutane]
Indication: Severe recalcitrant nodular acne
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Isotretinoin was required to have a REMS program because of its risk of birth defects in case of pregnancy. As part of the isotretinoin REMS program, female patients that can get pregnant must have regular pregnancy testing and commit to two approved forms of birth control.
Lenalidomide [Revlimid]
Indication: Multiple myeloma and some types of lymphoma
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Lenalidomide was required to have a REMS program because of its risk of birth defects in case of pregnancy. As part of the lenalidomide REMS program, female patients that can get pregnant must have regular pregnancy testing, complete periodic patient surveys, commit to two approved forms of birth control, and other safe-use rules.
Pomalidomide [Pomalyst]
Indication: Treatment-resistant multiple myeloma; AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy or in patients with Kaposi sarcoma who are HIV-negative.
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Pomalidomide was required to have a REMS program because of its risk of birth defects in case of pregnancy. As part of the pomalidomide REMS program, female patients that can get pregnant must have regular pregnancy testing, complete periodic patient surveys, commit to two approved forms of birth control, and other safe-use rules.
Thalidomide [Thalomid]
Indication: Multiple myeloma; erythema nodosum leprosum (ENL)
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Thalidomide was required to have a REMS program because of its risk of birth defects in case of pregnancy. As part of the thalidomide REMS program, female patients that can get pregnant must have regular pregnancy testing, complete periodic patient surveys, commit to use two approved forms of birth control and other safe-use rules.
Pegvaliase-pqpz [Palynziq]
Indication: Phenylketonuria
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Pegvaliase-pqpz was required to have a REMS program because of the risk of severe allergic reaction, also called anaphylaxis. As part of the pegvaliase-pqpz REMS program, patients must agree to a number of safe use rules, including obtaining auto-injectable epinephrine.
Sodium Oxybate [Xyrem]
Indication: Cataplexy or excessive daytime sleepiness
The FDA’s safety program is called Risk Evaluation and Mitigation Strategies or REMS. The purpose of a REMS program is to make sure a drug with safety concerns is used in a way that its benefits outweigh its risks. Sodium oxybate was required to have a REMS program because of its risk of central nervous system depression, and the potential for abuse and misuse. As part of the sodium oxybate REMS program, the drug can only be obtained through mail order from a single specialty pharmacy.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Mayookha Mitra-Majumdar |
| File Modified | 0000-00-00 |
| File Created | 2022-06-06 |