REMS DRUGS FDA Naplex

Adasuve

loxapine

Indication: Acute agitation with schizophrenia or bipolar type I

BBW: Bronchospasm

Addyi

filbanserin tablet

Indication: Treatment of premenopausal women with hypoactive sexual desire disorder (HSDD)

Risk: Hypotension and Syncope due to an interaction with alcohol

Adempas

riociguat

IndicationPAH

Due to its teratogenicity, prescribers, female patients, and pharmacies must be enrolled in the Adempas® REMS program.

Teratogenicity

Lotronex

alosetron

diarrhea-predominant irritable bowel syndrome (IBS)

BBW: Ischemic colitis

Apadaz

benzohydrocodone/APAP

MG

short term management of acute pain - no more than 14 days

Soliris

Eculizumab is a monoclonal antibody indicated:

a. Atypical hemolytic uremic syndrome (aHUS) in patients > 18 years of age

b. Paroxysmal nocturnal hemoglobinuria (PNH)

Patients receive immunization with a meningococcal vaccine at least 2 weeks prior to receiving the first dose

c. Patients receive the Soliris® medication guide prior to each infusion

***meningococcal infections!

(Opsumit®)

Macitentan

PAH

Due to its teratogenicity, prescribers, female patients, and pharmacies must be enrolled in the Opsumit® REMS program.

Capresla

vandetanib

Indication: medullary thyroid cancer

The goal is to educate prescribers and inform

Indication:

BBW: Long QT syndrome

Aveed

testosterone injection

Risk: Pulmonary oil microembolism (POME) and anaphylaxis, and the need to remain at the healthcare setting for 30 minutes following each injection.

Axiron

testosterone solution

MG

Blincyto

(blinatumomab)

Indication: acute lymphoblastic leukemia (ALL)

Risks: Cytokine Release syndrome

Manifestations of CRS include fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase, increased aspartate aminotransferase, increased total bilirubin, and disseminated intravascular coagulation (DIC).

#2 Neurological Toxicities

Entereg

Alvimopan

mechanism: peripherally-selective, mu-opioid receptor antagonist

Indication: Shorten GI recovery

following bowel surgery

BBW: Increase incidence of MI

Gattex

Teduglutide

Indication: Short bowel syndrome who are dependent on parenteral support.

Possible acceleration of neoplastic growth and enhancement of

colon polyp growth, GI obstruction, biliary and pancreatic

disorders

Juxtapid

Lomitapide

Indication: Homozygous familial

hypercholesterolemia

BBW: Hepatotoxicity

Kynamro

Mipomerson

Indication: Homozygous familial

hypercholesterolemia

BBW: Hepatotoxicity

Letairis

Ambrisentan

Indication: Pulmonary arterial

hypertension

BBWSerious birth defects

Lumizyme

Alglucosidase alpha

Indication: Pompe disease

BBW: Anaphylaxis

Korlym, Mifeprex

Mifepristone

Indication: Medical termination of

pregnancy

BBW: Life-threatening bleeding, infections, or other problems

CellCept, Myfortic

Mycophenolate

Indication: Prophylaxis of organ

transplant rejection

BBW: Pregnancy loss and congenital malformations, other serious risks

Nplate

Romiplostim

Indication: Chronic immune

thrombocytopenia

no black box: Progression of myelodysplasia and acute myeloid leukemia,

thromboembolism, marrow fibrosis

Pomalyst

Pomalidomide

Indication: Multiple myeloma

BBW: Risk of embryo fetal exposure and other risks

#1In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.

Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.

#2 Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST

Promacta

Eltrombopag

Indication: Chronic immune

thrombocytopenia

BBW: Hepatotoxicity, bone marrow fibrosis, thromboembolism

Qsymia

Phentermine/topiramate

MG

Indication: Chronic weight

management

BBW: Birth defect (cleft lift/cleft palate)

Revlimid

lenalidomide

Indication: multiple myeloma when used with dexamethasone

Myelodysplastic

syndrome, mantle cell

lymphoma

BBW: Embryo-fetal toxicity

Sabril

Vigabatrin

Indication: Refractory complex partial seizure, Infantile Spasms (IS)

BBW:Vision loss

Thalomid

Thalidomide

Indication: Multiple myeloma

Erythema nodosum

BBW: Embryo-fetal toxicity

Tikosyn

Dofetilide

NOTES REMS REMOVED in 2016

Indication: Atrial fibrillation, Flutter

BBW: Arrhythmia

Tracleer

bosentan

Indication: Pulmonary arterial

hypertension

Risk: Birth defects, hepatotoxicity

Truvada

Emtricitabine/

tenofovir/disoproxil

Indication:Pre-exposure prophylaxis

of HIV-1

BBW: Adherence to regimen, control of HIV-1 status, counseling

Tysabri

natalizumab

MG

Indication: Multiple sclerosis

BBW: Progressive multifocal leukoencephalopathy

Xiaflex

Collagenase clostridium histolyticum

Indications: Dupuytren disease

Peyronie's disease

BBW: Tendon rupture, anaphylaxis,

Risks of corporal rupture (penile fracture)

Zyprexa Relprevv

Olanzapine (injection)

MG

Indication: Schizophrenia

BBW: Mitigate risk of post-injection delirium/sedation syndrome

Sucraid

Sacrosidase

Indication: Sucrase-isomaltase

deficiency

No BBW: Severe allergic reaction

Myalept

Metreleptin

Indicatin: Generalized lipodystrophy

BBW: Neutralizing antibodies, risk of lymphoma

Lemtrada

Alemtuzumab

Indication: Relapsing multiple

sclerosis

BBW: Auto-immune conditions, infusion reactions, malignancies

Xyrem

Sodium oxybate

Indication: Narcolepsy

BBW:CNS and respiratory depression, potential abuse/misuse, CI with

hypnotics and alcohol, handling and storage

Epogen, Procrit

Epoetin Alfa

Indication: Anemia of chronic kidney

disease and chemotherapy

BBW: Shortened survival, increased risk of tumor progression/recurrence

Aranesp

Darbapoetin alfa

Indication: Anemia of chronic kidney

disease and chemotherapy

BBW: Shortened survival, increased risk of tumor progression/

recurrence

Absorica, Accutane, Amnesteem, Claravis, Sotret

isotretinoin

Indication: Severe recalcitrant nodular

acne

BBW: Severe birth defects

rosiglitazone

Rosiglitazone and its combinations

metformin/rosi = Avadamet

glimep/rosi = Avandaryl

Indication: Type 2 diabetes

BBW: Ischemic cardiovascular risk

Clozaril

Clozapine

ANC

Farydak

panobinostat

Indication: FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.

REMS: SEVERE DIARRHEA AND CARDIAC ISCHEMIC DISEASE

Severe Diarrhea

Cardiac Toxicities

Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes occurred with

Do not start FARYDAK if patient has

Recent myocardial infarction

Unstable angina

QTcF ≥450 msec

Clinically significant ST-segment or T-wave abnormalities

Fortesta

tesosterone gel

MG

Ionsys

fentanyl iontophoretic transdermal system

Jynarque

tolvaptan

Indication:JYNARQUE is a prescription medicine used to slow kidney function decline in adults who are at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Risks:JYNARQUE can cause serious liver problems that can lead to the need for a liver transplant or can lead to death

Kymriah

tisagenlecleucel), suspension, for intravenous infusion

Indication: KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Warnings:

1. Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab.

2. Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed.

Natpara

parathyroid hormone, injection, powder, lyophilized, for solution

OSTEOSARCOMA

NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.

Because of the potential risk of osteosarcoma, NATPARA is only recommended for patients who cannot be well-controlled on calcium and active forms of vitamin D alone and for whom the potential benefits are considered to outweigh this potential risk.

NATPARA is not a parathyroid hormone replacement.

Omontys

peginesatide

To inform healthcare professionals that OMONTYS Injection is indicated only for use in the treatment of patients with anemia due to chronic kidney disease on dialysis.

To inform healthcare professionals of the serious risks associated with the use of OMONTYS Injection including potentially fatal cardiovascular and/or thromboembolic adverse events, and the increased risk of these events in nondialysis patients.

Palynziq

pegvaliase-pqpz), injection, solution

Indication:

PALYNZIQ™ (Pal-lin-zeek) (pegvaliase-pqpz) Injection is a prescription medication used to lower blood levels of Phe (phenylalanine) in adults with PKU (phenylketonuria) who have uncontrolled blood Phe levels above 600 micromol/L (10 mg/dL) on their current treatment.

Risks: PALYNZIQ can cause a severe allergic reaction (anaphylaxis) that may be life-threatening and can happen any time during treatment with PALYNZIQ.

Probuphine

buprenorphine hydrochloride), implant

MG

Prolia

denosumab

Indication: help increase bone density and protect bones from fracture.

Prolia® helps strengthen bones by stopping cells that damage them.

RISKS:

Hypocalcemia

Osteonecrosis of the jaw

Atypical femoral fractures

Serious infections

Dermatologic reactions

Saxenda

liraglutide

Risks:

Potential Risk of Medullary Thyroid Carcinoma

Acute Pancreatitis

Siliq

brodalumab

Indication: moderate to severe plaque psoriasis

Risks:

risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.

Sublocade

buprenorphine extended-release, injection

Suboxone/Subutex

buprenorphine and naloxone/buprenorphine, film, soluble; tablet

MG

Testim

testosterone gel

MG

Vivitrol

naltrexone

MG

Indication:

Treatment of alcohol dependence

Prevention of relapse to opioid dependence

Risks:

Risk of opioid overdose

Severe injection site reactions

Precipitation of opioid withdrawal during initiation and re-initiation of VIVITROL

Hepatotoxicity

Patients may not feel the therapeutic effects of opioid-containing medicines for pain, cough or cold, or diarrhea while taking VIVITROL

Vogelxo

testosterone gel

Yescarta

axicabtagene ciloleucel), suspension, for intravenous infusion

Indication: CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma

Risks: cytokine release syndrome (CRS) and neurological toxicities

Hospitals and their associated clinics must be enrolled in the YESCARTA® REMS Program

Successfully complete a YESCARTA® REMS Program Knowledge Assessment.

Zinbryta

daclizumab

Indication: relapsing forms of multiple sclerosis (MS)

Risks: severe and fatal hepatic injury and serious immune mediated disorders

Need for appropriate baseline and monthly monitoring

Zydelig

idelalisib

Indication: kinase inhibitor indicated for the treatment of patients with:

- Relapsed chronic lymphocytic leukemia (CLL)

- Follicular B-cell non-Hodgkin lymphoma (FL)

- Small lymphocytic lymphoma (SLL) in patients

Risks: SERIOUS OR FATAL

hepatotoxicity

serious and severe diarrhea or colitis

pneumonitis

infections

intestinal perforation