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Table 2 Characteristics of selected REMS programs at time of original approval, active January 2019

From: Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Type

Drug (active ingredient)**

Year

ETASU***

Indication (Benefit)

Risk(s) requiring Risk Mitigation

Number of Assessment Items

ANDA

Clozapine

2015

A, B, D, E, F

treatment-resistant schizophrenia; reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder

Neutropenia

22

Alosetron

2016

A

severe diarrhea-prominent irritable bowel syndrome in women

Ischemic colitis and serious complications of constipation

10

Sodium Oxybate

2017

A, B, D (MG)

treatment of cataplexy or excessive daytime sleepiness in narcolepsy

Serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion

71

Vigabatrin

2017

A, B, D, E

treatment of refractory complex partial seizures in adults and infantile spasms

Vision loss

23

Emtricitabine/Tenofovir Disoproxil Fumarate

2017

A

treatment of HIV-1 infection

Acquiring HIV-1 infection

8

BLA

Myalept

(metreleptin)

2014

A, B, D

treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy

Lymphoma & anti-metreleptin antibodies that neutralize endogenous leptin and/or Myalept

26

Lemtrada

(alemtuzumab)

2014

A, B, C, D (CP)

treatment of patients with relapsing forms of multiple sclerosis

Autoimmune conditions, infusion reactions, and malignancies

36

Natpara

(parathyroid hormone)

2015

A, B, D

an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism

Osteosarcoma

21

Zinbryta

(daclizumab)

2017

A, B, D, E, F (CP)

treatment of adult patients with relapsing forms of multiple sclerosis

Hepatic injury & immune mediated disorders

27

Siliq

(brodalumab)

2017

A, B, D

treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

Suicidal ideation and behavior, including completed suicides

31

Kymriah

(tisagenlecleucel)

2017

B, C

treatment of: Pediatric and Young Adult Relapsed or Refractory (r/r) B-cell Acute Lymphoblastic Leukemia & Adult Relapsed or Refractory (r/r) Diffuse Large B-Cell Lymphoma

Cytokine release syndrome & neurological toxicities

21

Yescarta

(axicabtagene ciloleucel)

2017

B, C

treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy

Cytokine release syndrome & neurological toxicities

21

Palynziq

(pegvaliase-pqpz)

2018

A, B, D

reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management

Anaphylaxis

31

Ultomiris

(ravulizumab-cwvz)

2018

A

treatment of adult patients with paroxysmal nocturnal hemoglobinuria

Meningococcal infections

10

NDA

Aveed (testosterone undecanoate)

2014

A, B, C

testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

Autoimmune conditions, infusion reactions, and malignancies

36

Xyrem

(Sodium oxybate)

2015

A, B, D (MG)

treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy

Serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion

57

Ionsys

(fentanyl iontophoretic) transdermal system)

2015

B, C

short-term management of acute postoperative pain severe enough to require an opioid analgesic in the hospital and for which alternative treatments are inadequate

Respiratory depression resulting from accidental exposure

29

Addyi (flibanserin)

2015

A, B

treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder, as characterized by low sexual desire that causes marked distress or interpersonal difficulty

Hypotension and syncope due to interaction with alcohol

32

Probuphine

(buprenorphine hydrochloride)

2016

A, B, C, E (MG)

maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product

Migration, protrusion, expulsion and nerve damage associated with insertion and removal & accidental overdose, misuse and abuse

22

Sublocade

(buprenorphine extended-release)

2017

B

treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days

Intravenous self-administration

20

Jynarque

(tolvaptan)

2018

A, B, D, E, F (CP)

slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease

Liver injury

42

Tegsedi

(Inotersen)

2018

A, B, D, E, F

treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Bleeding with thrombocytopenia & glomerulonephritis

57

Dsuvia

(sufentanil)

2018

B, C

use in adults in certified medically supervised healthcare settings for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Respiratory depression from accidental exposure

35

  1. ANDA, Abbreviated New Drug Application; BLA, Biologic License Application; NDA, New Drug Application; ETASU, Elements to Assure Safe Use; CP, Communication Plan; MG, Medication Guide
  2. ** REMS programs were selected January 2019
  3. ***ETASU A, training or certification of prescribers; ETASU B, training or certification of dispensers; ETASU C, dispensing/administering the drug in certain settings; ETASU D, requiring evidence or documentation of safe use conditions; ETASU E, monitoring of patients; ETASU F, enrolling patients in a registry
  4. Data source: Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). Available from: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm (REMS@FDA). Also available from Drugs@FDA