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Recent FDA Approvals
New Medications
Trade Name
(generic name) Manufacturer
Dosage Form
Strength Indication(s) Approval Date
Olumiant
(baricitinib)
Eli Lilly and
Company
Tablets,
2 mg
For the treatment of adult patients
with moderately to severely active
rheumatoid arthritis who have had
an inadequate response to one or
more TNF antagonist therapies.
May 31, 2018
Fulphila
(pegfilgrastim-
jmdb)
Mylan
Institutional
LLC
Injection,
6 mg/0.6 mL
To decrease the incidence of
infection, as manifested by febrile
neutropenia, in patients with non-
myeloid malignancies receiving
myelosuppressive anti-cancer drugs
associated with a clinically
significant incidence of febrile
neutropenia.
June 4, 2018
Moxidectin
(moxidectin)
Medicines
Development
for Global
Health
Tablets,
2 mg
For the treatment of onchocerciasis
due to Onchocerca volvulus in
patients aged 12 years and older.
June 13, 2018
Zemdri
(plazomicin)
Achaogen,
Inc.
Injection,
500 mg/10 mL
For the treatment of patients 18
years of age or older with
Complicated Urinary Tract Infections
(cUTI) including Pyelonephritis.
June 25, 2018
Epidiolex
(cannabidiol)
Greenwich
Biosciences,
Inc.
Oral Solution,
100 mg/mL
For the treatment of seizures
associated with Lennox-Gastaut
syndrome or Dravet syndrome in
patients 2 years of age and older.
June 25, 2018
Braftovi
(encorafenib)
Array
BioPharma
Inc.
Capsules,
50 mg and 75
mg
For use in combination with
binimetinib for the treatment of
patients with unresectable or
metastatic melanoma with a BRAF
V600E or V600K mutation, as
detected by an
FDA-approved test.
June 27, 2018
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Trade Name
(generic name) Manufacturer
Dosage Form
Strength Indication(s) Approval Date
Mektovi
(binimetinib)
Array
BioPharma
Inc.
Tablets,
15 mg
For use in combination with
encorafenib for the treatment of
patients with unresectable or
metastatic melanoma with a BRAF
V600E or V600K mutation, as
detected by an FDA-approved test.
June 27, 2018
New Combinations and Formulations
Trade Name
(generic name) Manufacturer
Dosage Form
Strength Indication(s) Approval Date
LymePak
(doxycycline
hyclate)
Chartwell
Pharmaceuticals,
LLC.
Tablets,
100 mg
For the treatment of early
Lyme disease (as evidenced
by erythema migrans) due to
Borrelia burgdorferi in adults
and pediatric patients 8 years
of age and older weighing 45
kg and above.
June 15, 2018
Nocdurna
(desmopressin
acetate)
Ferring
Pharmaceuticals
Inc.
Sublingual
Tablets,
27.7 mcg and
55.3 mcg
For the treatment of nocturia
due to nocturnal polyuria in
adults who awaken at least 2
times per night to void.
June 21, 2018
Ablysinol
(dehydrated
alcohol)
Belcher
Pharmaceuticals,
LLC
Injection,
To induce controlled cardiac
septal infarction to improve
exercise capacity in adults
with symptomatic hypertrophic
obstructive cardiomyopathy
who are not candidates for
surgical myectomy.
June 21, 2018
New Generics
Generic Name Trade Name Dosage Form Manufacturer(s) Approval Date
Clindamycin
Phosphate and
Benzoyl Peroxide
Onexton Topical Gel Taro Pharmaceuticals Inc. June 5, 2018
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Generic Name Trade Name Dosage Form Manufacturer(s) Approval Date
Buprenorphine
Hydrochloride and
Naloxone
Hydrochloride
Suboxone
Sublingual
Film
Sublingual Film
Dr. Reddy's Laboratories
SA; Mylan Technologies
Inc.
June 14, 2018
Pipeline
New Medication Pipeline
Drug Name Generic Name Route Mechanism of
Action Indication(s)
Anticipated
Approval Date
Jatenzo Testosterone
Undecanoate
Oral Androgens Hypogonadism 1H 2018
Azedra Ultratrace
Iobenguane I-131
Injectable Electron transport
inhibitor
Neuroendocrine
tumors
07/30/2018
Tpoxx Tecovirimat Oral
Intravenous
Orthopoxvirus egress
inhibitor
Smallpox 08/08/2018
ALN-TTR02 Patisiran Intravenous Antisense
oligonucleotide
Familial amyloid
polyneuropathy
08/11/2018
Galafold Migalastat Oral Chemical chaperone Fabry disease 08/13/2018
AG-120 Ivosidenib Oral Isocitrate
dehydrogenase 1
(IDH1) inhibitor
Acute myeloid
leukemia
08/21/2018
Stannsoporfin Stannsoporfin Intramuscular Heme oxygenase
inhibitors
Hyperbilirubinemia 08/22/2018
S-888711 Lusutrombopag Oral Thrombopoietin
Receptor Agonists
Thrombocytopenia 08/26/2018
SHP643 Lanadelumab Subcutaneous Plasma kallikrein
inhibitor
Prophylaxis against
angioedema attacks in
hereditary
angioedema
08/26/2018
Eravacycline Eravacycline Oral
Intravenous
Fluorocycline
antibiotic
Infections 08/28/2018
Volanesorsen Volanesorsen Subcutaneous Antisense
apolipoprotein
inhibitor
Familial
chylomicronemia
syndrome
08/30/2018
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Drug Name Generic Name Route Mechanism of
Action Indication(s)
Anticipated
Approval Date
PF-06463922 Lorlatinib Oral Tyrosine kinase
inhibitor
Non-small cell lung
cancer
08/2018
Tafenoquine Tafenoquine Oral Antimalarials Prophylaxis of malaria 08/2018
KW-0761 Mogamulizumab Intravenous Anti-CCR4 antibody Cutaneous T-cell
lymphoma
09/04/2018
TEV-48125 Fremanezumab Subcutaneous Calcitonin gene-
related peptide
(CGRP) inhibitor
Migraine; Cluster
headache
09/16/2018
Arikayce Liposomal
amikacin
Inhaled Aminoglycoside
antibiotic
Nontuberculous
mycobacteria lung
infections
09/28/2018
Dacomitinib Dacomitinib Oral Tyrosine kinase
inhibitor
Non-small cell lung
cancer
09/2018
BAY 94-9027 Coagulation
Factor VIII
Intravenous Coagulation factor
VIII (recombinant)
Hemophilia A 3Q 2018
CAT-8015 Moxetumomab
Pasudotox
Intravenous Cytotoxic agent Anti-
CD22 antibody
Chronic lymphocytic
leukemia
3Q 2018
Elagolix Elagolix Oral Luteinizing hormone
releasing hormone
(LHRH) antagonist
Endometriosis 3Q 2018
Symtuza Darunavir;
Cobicistat;
Emtricitabine;
Tenofovir
Alafenamide
Oral Protease inhibitor
Nucleoside analogue
reverse transcriptase
inhibitor (NRTI)
Pharmacokinetic
enhancer
HIV-1 infection 3Q 2018
Baremsis Amisulpride Intravenous Atypical antipsychotic Postoperative nausea
and vomiting
10/05/2018
Duvelisib Duvelisib Oral Phosphoinositide 3-
kinase (PI3K)
inhibitor
Chronic lymphocytic
leukemia
10/05/2018
Tegsedi Inotersen Subcutaneous Protein synthesis
inhibitor
Familial amyloid
polyneuropathy
10/06/2018
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Drug Name Generic Name Route Mechanism of
Action Indication(s)
Anticipated
Approval Date
DOR/3TC/TDF Doravirine;
Lamivudine;
Tenofovir
Disoproxil
Fumarate
Oral Nucleoside analogue
reverse transcriptase
inhibitor (NRTI) Non-
nucleoside reverse
transcriptase inhibitor
(NNRTI)
HIV-1 infection 10/23/2018
MK-1439 Doravirine Oral Non-nucleoside
reverse transcriptase
inhibitor (NNRTI)
HIV infection 10/23/2018
REGN2810 Cemiplimab Intravenous Programmed cell
death 1 (PD-1)
inhibitor
Cutaneous squamous
cell carcinoma
10/28/2018
LY2951742 Galcanezumab Subcutaneous Calcitonin gene-
related peptide
(CGRP) inhibitor
Migraine; Cluster
headache
10/2018
PTK 0796 Omadacycline Oral
Intravenous
Aminomethylcycline
antibiotic
Acute Bacterial Skin
and Skin Structure
Infections;
Community-acquired
bacterial pneumonia
10/2018
Olinvo Oliceridine Intravenous Opioid agonist Acute pain 11/02/2018
Yutiq Fluocinolone
Acetonide
Intravitreal Corticosteroid Non-infectious uveitis 11/05/2018
TD-4208 Revefenacin Inhaled Long-acting
muscarinic antagonist
(LAMA)
Chronic obstructive
pulmonary disease
11/13/2018
Zemcolo Rifamycin-SV Oral Rifamycin
antibacterial
Diarrhea caused by
certain organisms
11/16/2018
NI-0501 Emapalumab Intravenous Type II interferon
inhibitor
Hemophagocytic
lymphohistiocytosis
11/20/2018
LOXO-101 Larotrectinib Oral Tropomyosin
receptor kinases
(TRK) inhibitor
Solid tumors
Hematological
malignancies
11/26/2018
Firdapse Amifampridine
Phosphate
Oral Potassium Channel
Inhibitor
Lambert-Eaton
myasthenic syndrome
11/28/2018
ASP2215 Gilteritinib Oral Receptor tyrosine
kinase inhibitor
Acute myeloid
leukemia
11/29/2018
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Drug Name Generic Name Route Mechanism of
Action Indication(s)
Anticipated
Approval Date
SAGE-547 Brexanolone Intravenous GABA Modulators Postpartum
depression
12/19/2018
JZP-110 Solriamfetol Oral CNS stimulant Excessive sleepiness
in narcolepsy;
Excessive daytime
sleepiness in
obstructive sleep
apnea
12/20/2018
Resolor Prucalopride Oral 5-HT4 serotonin
receptor agonist
Chronic idiopathic
constipation
12/21/2018
Calaspargase
pegol
Calaspargase
Pegol
Intravenous Antineoplastic
enzymes
Acute lymphocytic
leukemia
12/22/2018
Xofluza Baloxavir
marboxil
Oral Endonuclease
inhibitor
Acute uncomplicated
influenza
12/24/2018
PF-04449913 Glasdegib Oral Hedgehog signalling
pathway inhibitor
Acute myeloid
leukemia
12/2018
Talazoparib Talazoparib Oral Poly (ADP-ribose)
polymerase (PARP)
inhibitor
Breast cancer 12/2018
Dextenza Dexamethasone Ophthalmic
Implant
Corticosteroid Post-operative pain 4Q 2018
VivaGel BV Astodrimer
Sodium
Intravaginal Anti-infective Bacterial vaginosis 4Q 2018
Seysara Sarecycline Oral Tetracycline antibiotic Acne vulgaris 2H 2018
ALKS 5461 Buprenorphine;
Samidorphan
Oral Opioid antagonist
Opioid partial agonist
Major depressive
disorder
01/31/2019
Zynquista Sotagliflozin Oral SGLT1 and SGLT2
inhibitor
Diabetes Mellitus 03/22/2019
Rekynda Bremelanotide Injectable Peptide melanocortin
receptor agonist
Female sexual
dysfunction
03/23/2019
N8-GP Coagulation
Factor VIII
(Recombinant)
Intravenous Coagulation factor
VIII (recombinant)
Hemophilia A 1Q 2019
BI 655066 Risankizumab Subcutaneous Interleukin 23
antagonist
Moderate to severe
plaque psoriasis
2Q 2019
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Drug Name Generic Name Route Mechanism of
Action Indication(s)
Anticipated
Approval Date
Duaklir Aclidinium
Bromide;
Formoterol
Inhaled Long-acting beta-2
adrenoreceptor
agonist (LABA) Long-
acting muscarinic
antagonist (LAMA)
Chronic obstructive
pulmonary disease
2Q 2019
Elzonris Tagraxofusp Injectable Antineoplastics Blastic plasmacytoid
dendritic cell
neoplasm
2Q 2019
Iclaprim Iclaprim Intravenous Diaminopyrimidine
antibiotic
Acute Bacterial Skin
and Skin Structure
Infections
2Q 2019
IMMU-132 Sacituzumab
Govitecan
Intravenous Cytotoxic agent Anti-
Trop2 antibody
Breast cancer 2Q 2019
NKTR-181 TBD Oral Opioid agonist Moderate to severe
chronic low back pain
2Q 2019
Scenesse Afamelanotide Implant Alpha-melanocyte
stimulating hormone
(alpha-MSH) analog
Erythropoietic
protoporphyria
2Q 2019
2018 New Generic Pipeline
(*loss of 180 day exclusivity)
Anticipated
Launch Date Brand Name Generic Name
Brand
Manufacturer(s) Indication(s)
2017 U.S.
Sales
07/2018 ACANYA Benzoyl Peroxide;
Clindamycin
Phosphate
Dow Pharmaceutical
Sciences; Valeant
Acne vulgaris $44M
07/2018 LETAIRIS Ambrisentan Gilead Pulmonary arterial
hypertension
$215M
07/2018 RESTASIS Cyclosporine Allergan Dry eye $1,769M
08/12/2018 LOCOID (lotion) Hydrocortisone
Butyrate
PreCision
Dermatology;
Valeant
Atopic dermatitis $15M
08/19/2018 SOLODYN
(115 mg)*
Minocycline
Hydrochloride
Medicis; Valeant Acne vulgaris $375M
08/19/2018 SOLODYN
(65 mg)*
Minocycline
Hydrochloride
Medicis; Valeant Acne vulgaris $375M
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Anticipated
Launch Date Brand Name Generic Name
Brand
Manufacturer(s) Indication(s)
2017 U.S.
Sales
09/16/2018 NORVIR (tablets)* Ritonavir AbbVie HIV-1 infection $208M
09/19/2018 ALOXI (0.25 mg/5
mL injection)*
Palonosetron
Hydrochloride
Helsinn Healthcare;
Eisai
Nausea or vomiting TBD
09/20/2018 EPIVIR-HBV
(5 mg/ml oral
solution)
Lamivudine GSK; ViiV
Healthcare
Chronic hepatitis B $2M
09/24/2018 MOVIPREP Ascorbic Acid;
Polyethylene
Glycol 3350;
Potassium
Chloride; Sodium
Ascorbate; Sodium
Chloride; Sodium
Sulfate
Salix; Valeant Bowel cleansing $38M
09/27/2018 CIALIS Tadalafil Eli Lilly Benign Prostatic
Hyperplasia; Erectile
Dysfunction
$1,933M
09/30/2018 ZYPREXA
RELPREVV
Olanzapine
Pamoate
Eli Lilly Schizophrenia $10M
3Q 2018 ABSTRAL Fentanyl Citrate Sentynl; Orexo Acute breakthrough
cancer pain
$7M
3Q 2018 ADCIRCA Tadalafil Eli Lilly; United
Therapeutics
Pulmonary arterial
hypertension
$495M
3Q 2018 LEVITRA (2.5, 5,
10, 20 mg)
Vardenafil
Hydrochloride
Bayer Erectile Dysfunction $127M
3Q 2018 REMODULIN Treprostinil United Therapeutics Pulmonary arterial
hypertension
TBD
3Q 2018 SENSIPAR Cinacalcet
Hydrochloride
Amgen Thyroid Cancer $1,722M
10/21/2018 ONFI (oral
suspension)
Clobazam H. Lundbeck A/S Epilepsy: Lennox-
Gastaut syndrome
$215M
10/21/2018 ONFI (tablets) Clobazam H. Lundbeck A/S Epilepsy: Lennox-
Gastaut syndrome
$538M
10/22/2018 VIVLODEX Meloxicam Iroko; iCeutica Osteoarthritis $24M
10/31/2018 STAXYN Vardenafil
Hydrochloride
Bayer Erectile Dysfunction $8M
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Anticipated
Launch Date Brand Name Generic Name
Brand
Manufacturer(s) Indication(s)
2017 U.S.
Sales
11/18/2018 FINACEA GEL Azelaic Acid Bayer Rosacea $120M
11/26/2018 NEXIUM 24HR
(tablet)
Esomeprazole
Magnesium
AstraZeneca; Pfizer Gastroesophageal Reflux
Disease
$81M
12/15/2018 CANASA Mesalamine Forest; Allergan Ulcerative colitis $244M
12/27/2018 ELIDEL Pimecrolimus Valeant Atopic dermatitis $186M
4Q 2018 PYLERA Bismuth Subcitrate
Potassium;
Metronidazole;
Tetracycline
Aptalis; Allergan Eradication of
Heliobacter pylori
$30M
4Q 2018 RAPAFLO Silodosin Allergan Benign Prostatic
Hyperplasia
$206M
2H 2018 DELZICOL Mesalamine Allergan Ulcerative colitis $147M
2H 2018 FLECTOR Diclofenac
Epolamine
IBSA Institut
Biochemique; Pfizer
Acute pain $127M
2018 ANDROGEL
(1.62%) (packets)
Testosterone AbbVie Hypogonadism TBD
2018 ANDROGEL
(1.62%) (pump)
Testosterone AbbVie Hypogonadism $952M
2018 ASTAGRAF XL Tacrolimus Astellas Complications of
Transplanted Organs
and Tissues
$12M
2018 BYETTA Exenatide
Synthetic
AstraZeneca Diabetes Mellitus $244M
2018 CUPRIMINE
(250 mg)
Penicillamine Aton; Valeant Cystinuria $120M
2018 KALETRA
(tablets)
Lopinavir; Ritonavir AbbVie HIV-1 infection $90M
2018 LOTEMAX
(gel)
Loteprednol
Etabonate
Bausch + Lomb;
Valeant
Post-operative
inflammation and pain
following ocular surgery
$114M
2018 LOTEMAX
(suspension)
Loteprednol
Etabonate
Bausch + Lomb;
Valeant
Ocular Pain $85M
2018 NUVARING Ethinyl Estradiol;
Etonogestrel
Organon; Merck &
Co
Contraception $822M
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Anticipated
Launch Date Brand Name Generic Name
Brand
Manufacturer(s) Indication(s)
2017 U.S.
Sales
2018 PROVENTIL-HFA Albuterol Sulfate 3M; Merck & Co Asthma $207M
2018 TRACLEER (film-
coated tablet)
Bosentan Actelion; Janssen Pulmonary arterial
hypertension
$83M
2018 TRISENOX Arsenic Trioxide Cephalon; Teva Leukemia $67M
Medication with Significant Label Changes
Trade Name
(generic name) Summary of Label Changes
Aciphex, Aciphex
Sprinkle
(raberprazole
sodium)
5 Warnings and Precautions Newly created subsection: 5.10 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Argatroban in
Sodium Chloride
(argatroban)
5 Warnings and Precautions 5.2 Use in Hepatic Impairment Additions and/or revisions underlined: When administering argatroban to patients with hepatic impairment, start with a lower dose and carefully titrate until the desired level of anticoagulation is achieved. Achievement of steady-state aPTT levels may take longer and require more argatroban dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function … Avoid the use of high doses of argatroban in patients undergoing PCI who have clinically significant hepatic disease …
Austedo
(deutetrabenazine)
Boxed Warning Additions and/or warnings underlined: WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO can increase the risk of depression … 4 Contraindications Additions and/or warnings underlined:
With Huntington’s disease who are suicidal … Taking tetrabenazine (XENAZINE®) or valbenazine
5 Warnings and Precautions Additions and/or warnings underlined: 5.1 Depression and Suicidality in Patients with Huntington’s Disease Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality) … 5.2 Clinical Worsening and Adverse Events in Patients with Huntington’s Disease Huntington’s disease is a progressive disorder …
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Trade Name
(generic name) Summary of Label Changes
5.3 QTc Prolongation Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase (about 8 msec) in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur … For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. The use of AUSTEDO in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO doses greater than 24 mg per day who are using AUSTEDO with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO or other medications that are known to prolong QTc. AUSTEDO should also be avoided in patients with congenital long QT syndrome … 5.5 Akathisia, Agitation, and Restlessness AUSTEDO may increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease and tardive dyskinesia. In a 12-week, double-blind, placebo-controlled trial in Huntington’s disease patients, akathisia, agitation, or restlessness was reported by 4% of patients treated with AUSTEDO, compared to 2% of patients on placebo; in patients with tardive dyskinesia, 2% of patients treated with AUSTEDO and 1% of patients on placebo experienced these events … 5.6 Parkinsonism in Patients with Huntington’s Disease 5.7 Sedation and Somnolence … In a 12-week, double-blind, placebo-controlled trial examining patients with Huntington’s disease, 11% of AUSTEDO- treated patients …
Benlysta
(belimumab)
5 Warnings and Precautions Additions and/or revisions underlined: 5.1 Mortality There were more deaths reported with BENLYSTA than with placebo during the controlled period of the intravenous clinical trials. Out of 2,133 patients … cardiovascular disease, and suicide. In the controlled trial of BENLYSTA administered subcutaneously (N equals 836), a total of 5 deaths occurred during the placebo-controlled, double-blind treatment period (0.7% [2/280] of patients receiving placebo and 0.5% [3/556] of patients receiving BENLYSTA). Infection was the most common cause of death. 5.2 Serious Infections … In the controlled clinical trials of BENLYSTA administered intravenously, the overall incidence … and in 0.1% (1/675) of patients receiving placebo. In the controlled trial of BENLYSTA administered subcutaneously (N equals 836), the overall incidence of infections was 55% in patients treated with BENLYSTA compared with 57% in patients who received placebo (serious infections: 4.1% with BENLYSTA and 5.4% with placebo). The most commonly reported infections with BENLYSTA administered subcutaneously were similar to those reported with BENLYSTA administered intravenously. 5.3 Hypersensitivity Reactions, including Anaphylaxis … In the controlled clinical trials of BENLYSTA administered intravenously, hypersensitivity … BENLYSTA for intravenous use should be administered … and for an appropriate period of time after intravenous administration of BENLYSTA. In the controlled trial of BENLYSTA administered subcutaneously (N equals 836), systemic hypersensitivity reactions were similar to those observed in the intravenous clinical trials. Patients receiving BENLYSTA should be informed of the signs and symptoms … 5.4 Infusion Reactions In the controlled clinical trials of BENLYSTA administered intravenously, adverse events …
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Trade Name
(generic name) Summary of Label Changes
BENLYSTA for intravenous use should be administered … 5.5 Depression In the controlled clinical trials of BENLYSTA administered intravenously, psychiatric events … in patients receiving BENLYSTA. In the controlled trial of BENLYSTA administered subcutaneously (N equals 836), psychiatric events were reported in 6% of patients treated with BENLYSTA and in 11% of patients who received placebo. Depression-related events were reported in 2.7% of patients receiving BENLYSTA and 3.6% of patients receiving placebo. Serious psychiatric events were reported in 0.2% of patients receiving BENLYSTA and in no patients receiving placebo. There were no serious depression- related events or suicides reported in either group. 5.6 Malignancy In the controlled clinical trials of BENLYSTA administered intravenously, malignancies (including non-melanoma skin cancers) were reported in 0.4% … In the intravenous controlled clinical trials, malignancies, excluding non-melanoma skin cancers, were observed … In the controlled clinical trial of BENLYSTA administered subcutaneously (N equals 836), the data were similar. The mechanism of action …
Bonjesta
(doxylamine
succinate;
pyridoxine
hydrochloride)
5 Warnings and Precautions Addition to following subsection title underlined: 5.1 Somnolence and Severe Drowsiness Addition of the following subsection 5.3 Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use.
Celebrex
(celecoxib)
5 Warnings and Precautions 5.1 Cardiovascular Thrombotic Events (additions underlined) … In the APC (Adenoma Prevention with Celecoxib) trial, there was about a threefold increased risk of the composite endpoint of cardiovascular death, MI, or stroke for the CELEBREX 400 mg twice daily and CELEBREX 200 mg twice daily treatment arms compared to placebo. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction. A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non- selective NSAIDs naproxen and ibuprofen. Celecoxib 100 mg twice daily was non-inferior to naproxen 375 to 500 mg twice daily and ibuprofen 600 to 800 mg three times daily for the composite endpoint of the Antiplatelet Trialists’ Collaboration (APTC), which consists of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke.
Chantix
(verenicline
tartrate)
5 Warnings and Precautions 5.5 Cardiovascular Events Extensive revisions to this subsection; as below: A comprehensive evaluation of cardiovascular (CV) risk with CHANTIX suggests that patients with underlying CV disease may be at increased risk; however, these concerns must be balanced with the health benefits of smoking cessation. CV risk has been assessed for CHANTIX in randomized controlled trials (RCT) and meta-analyses of RCTs. In a smoking cessation trial in patients with stable CV disease, CV events were infrequent overall; however, nonfatal myocardial infarction (MI) and nonfatal stroke occurred more frequently in patients treated with CHANTIX compared to placebo. All-cause and CV mortality was lower in patients treated with
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Trade Name
(generic name) Summary of Label Changes
CHANTIX. This study was included in a meta-analysis of 15 CHANTIX efficacy trials in various clinical populations that showed an increased hazard ratio for Major Adverse Cardiovascular Events (MACE) of 1.95; however, the finding was not statistically significant (95% CI: 0.79, 4.82). In the large postmarketing neuropsychiatric safety outcome trial, an analysis of adjudicated MACE events was conducted for patients while in the trial and during a 28-week non-treatment extension period. Few MACE events occurred during the trial; therefore, the findings did not contribute substantively to the understanding of CV risk with CHANTIX. Instruct patients to notify their healthcare providers of new or worsening CV symptoms and to seek immediate medical attention if they experience signs and symptoms of MI or stroke.
Darzalex
(daratumumab)
4 Contraindications Addition of the following: DARZALEX is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation. 5 Warnings and Precautions Additions and/or revisions underlined: 5.1 Infusion Reactions DARZALEX can cause severe and/or serious infusion reactions including anaphylactic reactions. In clinical trials, approximately half of all patients experienced an infusion reaction. Most infusion reactions occurred during the first infusion and were Grade 1-2 … … Permanently discontinue DARZALEX therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions …
Desogen
(desogestrel;
ethinyl estradiol)
Boxed Warning (Additions and/or revisions are underlined) WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age, and smoke. 4 Contraindications (Additions and/or revisions are underlined)
Inherited or acquired hypercoagulopathies Smoke, if over age 35 Receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
due to the potential for ALT elevations. 5 Warnings and Precautions (Extensive changes; please refer to labeling)
Dexilant
(dexlansoprazole)
5 Warnings and Precautions Newly created subsection: 5.10 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Diclegis 5 Warnings and Precautions
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Trade Name
(generic name) Summary of Label Changes
(doxylamine
succinate;
pyridoxine
hydrochloride)
Newly created subsection: 5.3 Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP) There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use.
Eliquis
(apixaban)
5 Warnings and Precautions 5.2 Risk of Bleeding (additions underlined) … Reversal of Anticoagulant Effect An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Partial reversal of prothrombin time prolongation has been seen after administration of prothrombin complex concentrates (PCCs) in healthy volunteers. The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.
Erbitux
(cetuximab)
Boxed Warning Additions and/or revisions underlined: WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions. Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. 5 Warnings and Precautions Additions and/or revisions underlined in the following subsections: 5.1 Infusion Reactions ERBITUX can cause serious and fatal infusion reactions. Infusion reactions of any grade occurred in 8.4% of 1373 patients who received ERBITUX across clinical trials. Severe (Grades 3 and 4) infusion reactions occurred in 2.2% of patients. Signs and symptoms included rapid onset … The risk of anaphylactic reactions may be increased in patients with a history of tick bites, red meat allergy, or in the presence of IgE antibodies directed against galactose-?-1,3-galactose (alpha-gal). … with the first infusion despite premedication with antihistamines. Infusion reactions may occur during or several hours following completion of the infusion. Premedicate with a histamine-1(H1) receptor antagonist as recommended. Monitor patients for at least 1 hour following each ERBITUX infusion, in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. In patients requiring treatment for infusion reactions, monitor for more than 1 hour to confirm resolution of the reaction. Interrupt the infusion and upon recovery, resume the infusion at a slower rate or permanently discontinue ERBITUX based on severity. 5.2 Cardiopulmonary Arrest ERBITUX can cause cardiopulmonary arrest. Cardiopulmonary arrest or sudden death … BONNER replaces Study 1 EXTREME replaces Study 2 … of 219 patients treated with a cetuximab product in combination with platinum-based therapy and fluorouracil. … or platinum-based therapy with fluorouracil in patients with SCCHN with a history of coronary … 5.3 Pulmonary Toxicity
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(generic name) Summary of Label Changes
ERBITUX can cause interstitial lung disease … ERBITUX in clinical trials. Monitor patients for signs and symptoms of pulmonary toxicity. Interrupt or permanently discontinue ERBITUX for acute onset … 5.4 Dermatologic Toxicity … Acneiform rash occurred in 82% of the 1373 patients who received ERBITUX across clinical trials. Severe (Grades 3 or 4) acneiform rash occurred in 9.7% of patients. Acneiform rash usually developed within the first two weeks of therapy; the rash lasted more than 28 days after stopping ERBITUX in most patients. … Instruct patients to limit sun exposure during ERBITUX therapy. Withhold, reduce dose or permanently discontinue ERBITUX based on severity of acneiform rash or mucocutaneous disease. 5.5 Risks Associated with Use in Combination with Radiation and Cisplatin … Adverse reactions with fatal outcome were reported in 4% of patients in the ERBITUX combination arm … The addition of ERBITUX to radiation and cisplatin did not improve PFS. ERBITUX is not indicated for the treatment of SCCHN in combination with radiation and cisplatin. 5.6 Hypomagnesemia and Accompanying Electrolyte Abnormalities ERBITUX can cause hypomagnesemia … receiving ERBITUX in Study CA225-025 and two other clinical trials in patients with colorectal cancer (CRC) or head and neck cancer, including Grades 3 and 4 in 6% to 17%. In EXTREME, where a cetuximab product was administered in combination … resulted in an increased incidence of hypomagnesemia of any grade (14%) and of Grade 3 or 4 hypomagnesemia (7%). Hypomagnesemia of any grade occurred in 4% of patients who received cetuximab, carboplatin, and fluorouracil. Hypomagnesemia and accompanying electrolyte abnormalities can occur days to months after initiating ERBITUX. Monitor patients weekly during treatment for hypomagnesemia. 5.7 Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with Ras-Mutant mCRC … hereafter is referred to as “Ras” or when the Ras status is unknown. CRYSTAL replaces Study 4 … resulted in no clinical benefit with treatment related toxicity. Confirm Ras mutation status in tumor specimens prior to initiating ERBITUX.
Esomeprazole
Strontium
(esomoprazole
strontium)
5 Warnings and Precautions Newly created subsection: 5.12 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Evista
(raloxifene
hydrochloride)
5 Warnings and Precautions 5.4 Premenopausal Use (additions underlined) There is no indication for premenopausal use of EVISTA. Safety of EVISTA in premenopausal women has not been established and its use is not recommended. Additionally, there is concern regarding inadvertent drug exposure in pregnancy in women of reproductive potential who become pregnant, due to risk of fetal harm.
Gleolan 5 Warnings and Precautions 5.1 Risk of Phototoxic Reaction (Additions and/or revisions are underlined)
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Trade Name
(generic name) Summary of Label Changes
(aminilevulinic acid
hydrochloride)
Due to the risk of phototoxic reactions, do not administer phototoxic drugs for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.
Hycodan
(homatropine
methylbromide;
hydrocodone
bitartrate)
Boxed Warning (section updated) WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse HYCODAN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve HYCODAN for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing HYCODAN, prescribe HYCODAN for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of HYCODAN. Monitor for respiratory depression, especially during initiation of HYCODAN therapy or when used in patients at higher risk. Accidental Ingestion Accidental ingestion of even one dose of HYCODAN, especially by children, can result in a fatal overdose of hydrocodone. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering HYCODAN. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering HYCODAN. Cytochrome P450 3A4 Interaction The concomitant use of HYCODAN with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of HYCODAN in patients taking a CYP3A4 inhibitor or inducer. 4 Contraindications (additions underlined) HYCODAN is contraindicated for:
All children younger than 6 years of age HYCODAN is also contraindicated in patients with:
Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Known or suspected gastrointestinal obstruction, including paralytic ileus Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in HYCODAN
5 Warnings and Precautions (PLR conversion: subsections created as below, see label for complete information) 5.1 Addiction, Abuse, and Misuse 5.2 Life-Threatening Respiratory Depression 5.3 Risks with Use in Pediatric Populations
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(generic name) Summary of Label Changes
5.4 Risks with Use in Other At-Risk Populations 5.5 Risk of Accidental Overdose and Death due to Medication Errors 5.6 Activities Requiring Mental Alertness: Risks of Driving and Operating Machinery 5.7 Risks from Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers 5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants 5.9 Risks of Use in Patients with Gastrointestinal Conditions 5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors 5.11 Increased Risk of Seizures in Patients with Seizure Disorders 5.12 Severe Hypotension 5.13 Neonatal Opioid Withdrawal Syndrome 5.14 Adrenal Insufficiency 5.15 Drug/Laboratory Test Interactions
Keytruda
(pembrolizumab)
5 Warnings and Precautions 5.7 Other Immune-Mediated Adverse Reactions (Additions and/or revisions are underlined) Immune mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA. While immune-mediated adverse reactions usually occur during treatment with PD-1/PD-L1 blocking antibodies, they may occur after discontinuation of treatment.
Kyprolis
(carfilzomib)
5 Warnings and Precautions 5.4 Pulmonary Toxicity Approximately replaces less than
Lamictal,
Lamictal CD,
Lamictal ODT,
Lamictal XR
(lamotrigine)
5 Warnings and Precautions 5.2 Hemophagocytic Lymphohistiocytosis (new subsection added) Hemophagocytic lymphohistiocytosis (HLH) has occurred in pediatric and adult patients taking LAMICTAL for various indications. HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. It is associated with high mortality rates if not recognized early and treated. Common findings include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms, cytopenias, high serum ferritin, and liver function and coagulation abnormalities. In cases of HLH reported with LAMICTAL, patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported to occur within 8 to 24 days following the initiation of treatment. Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
LAMICTAL should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Merrem
(meropenem)
5 Warnings and Precautions 5.2 Severe Cutaneous Adverse Reactions Newly added subsection: Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving MERREM
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(generic name) Summary of Label Changes
IV. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.
Mircera
(methoxy
polyethylene
glycol-epoetin
beta)
5 Warnings and Precautions Additions and/or revisions underlined: 5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism Table 3: Randomized Controlled Trials Showing Adverse Cardiovascular Outcomes in Patients With CKD 5.2 Randomized, Controlled Trials with Decreased Survival and/or Decreased Locoregional Control Table 4: Randomized, Controlled Trials with Decreased Survival and/or Decreased Locoregional Control some changes to this table; please refer to label for complete information. Newly added subsection: 5.8 Severe Cutaneous Reactions Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Mircera) in the postmarketing setting. Discontinue Mircera therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
Nasonex
(mometasone
furoate)
5 Warnings and Precautions 5.2 Glaucoma and Cataracts Additions and/or revisions underlined: Glaucoma and cataracts may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use NASONEX long term.
Neulasta
(pegfilgrastim)
5 Warnings and Precautions Additions and/or revisions underlined: 5.5 Use in Patients with Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue Neulasta if sickle cell crisis occurs. Newly created subsections: 5.11 Aortitis Aortitis has been reported in patients receiving Neulasta. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta if aortitis is suspected. 5.12 Nuclear Imaging Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Neupogen
(filgrastim)
5 Warnings and Precautions Additions and/or revisions underlined: 5.4 Sickle Cell Disorders Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue NEUPOGEN if sickle cell crisis occurs.
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(generic name) Summary of Label Changes
Addition of the following: 5.15 Aortitis Aortitis has been reported in patients receiving NEUPOGEN. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NEUPOGEN if aortitis is suspected.
Nexium
(esomeprazole
magnesium)
5 Warnings and Precautions Newly created subsection: 5.12 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Novolin 70/30
(insulin
recombinant
human; insulin
susp isophane
recombinant
human)
Novolin N
(insulin susp
isophane
recombinant
human)
Novolin R
(insulin
recombinant
human)
4 Contraindications PLR conversion; as below: NOVOLIN N is contraindicated:
During episodes of hypoglycemia In patients who have hypersensitivity reactions to NOVOLIN N or any of its excipients
5 Warnings and Precautions PLR Conversion; subsections as below; please refer to label for complete information. 5.1 Never Share a NOVOLIN N FlexPen or Syringe Between Patients 5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen 5.3 Hypoglycemia 5.4 Hypoglycemia Due to Medication Errors 5.5 Hypersensitivity and Allergic Reactions 5.6 Hypokalemia 5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma agonists
Pepcid
(famotidine)
4 Contraindications PLR conversion; revised as below: PEPCID is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H2 receptor antagonists. 5 Warnings and Precautions PLR conversion; subsections created as below (please see label for complete information): 5.1 Central Nervous System Adverse Reactions 5.2 Concurrent Gastric Malignancy
Phenergan VC
w/Codeine
Boxed Warning (extensive additions, please refer to label)
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Trade Name
(generic name) Summary of Label Changes
(codeine
phosphate;
phenylephrine
hydrochloride;
promethazine
hydrochloride)
Phenergan
w/Codeine
(codeine
phosphate;
promethazine
hydrochloride)
4 Contraindications (additions underlined) Promethazine HCl and Codeine Phosphate Oral Solution is contraindicated for:
o All children younger than 12 years of age. o Postoperative pain management in children younger than 18 years of age following tonsillectomy and/or
adenoidectomy. Promethazine HCl and Codeine Phosphate Oral Solution is also contraindicated in patients with: o Significant respiratory depression. o Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. o Known or suspected gastrointestinal obstruction, including paralytic ileus. o A history of an idiosyncratic reaction to promethazine or to other phenothiazines o Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days. o Hypersensitivity to codeine, promethazine, or any of the inactive ingredients in Promethazine HCl and
Codeine Phosphate Oral Solution.Persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine.
5 Warnings and Precautions (PLR conversion: subsections created as below, see label for complete information) 5.1 Addiction, Abuse, and Misuse 5.2 Life-Threatening Respiratory Depression 5.3 Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children 5.4 Promethazine and Respiratory Depression 5.5 Risks with Use in Pediatric Populations 5.6 Risks with Use in Other At-Risk Populations 5.7 Risk of Accidental Overdose and Death due to Medication Errors 5.8 Activities Requiring Mental Alertness: Risks of Driving and Operating Machinery 5.9 Risks of Interactions with Drugs Affecting Cytochrome P450 Isoenzymes 5.10 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants 5.11 Risks of Use in Patients with Gastrointestinal Conditions 5.12 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors 5.13 Risk of Neuroleptic Malignant Syndrome 5.14 Risk of Paradoxical Reactions, including Dystonias 5.15 Increased Risk of Seizures in Patients with Seizure Disorders 5.16 Co-administration with Monoamine Oxidase Inhibitors (MAOIs) 5.17 Bone-Marrow Depression 5.18 Severe Hypotension 5.19 Neonatal Opioid Withdrawal Syndrome 5.20 Adrenal Insufficiency 5.21 Drug/Laboratory Test Interactions
Prevacid
(lansoprazole)
Prevpac
5 Warnings and Precautions Newly created subsection: 5.9, 5.11, or 5.12 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use,
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Trade Name
(generic name) Summary of Label Changes
(amoxicillin;
clarithromycin;
lansoprazole)
Prilosec
(omeprazole
magnesium)
Protonix,
Protonix IV
(pantoprazole
sodium)
especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Prezcobix
(cobicistat;
darunavir
ethanolate)
4 Contraindications Additions and/or revisions underlined: PREZCOBIX is contraindicated in patients receiving the following co-administered drugs: Table 1: Drugs That Are Contraindicated with Prezcobix reformatted to a bulleted line listing; please refer to label for complete information.
Remicade
(infliximab)
5 Warnings and Precautions 5.1 Serious Infections Additions and/or revisions underlined: … Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, cryptococcosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis and tuberculosis have been reported with TNF-blockers …
Remodulin
(treprostinil)
5 Warnings and Precautions Addition of the following two subsections: 5.4 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension. 5.5 Risk of Bleeding Remodulin inhibits platelet aggregation and increases the risk of bleeding.
Rituxan
(rituximab)
5 Warnings and Precautions Additions and/or revisions underlined: 5.1 Infusion Reactions … For RA and PV patients … 5.12 Concomitant Use with Other Biologic Agents and DMARDS other than Methotrexate in RA, GPA, MPA, and PV … has not been studied in GPA or MPA or PV patients exhibiting peripheral …
Stelara
(ustekinumab)
5 Warnings and Precautions Newly created subsection: 5.9 Noninfectious Pneumonia
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(generic name) Summary of Label Changes
Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA®. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA® and institute appropriate treatment.
Tussionex
Pennkinetic
(chlorpheniramine
polistirex;
hydrocodone
polistirex)
Boxed Warning (extensive additions, please refer to label) 4 Contraindications (additions underlined)
All children younger than 6 years of age. TUSSIONEX Pennkinetic is also contraindicated in patients with:
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected gastrointestinal obstruction, including paralytic ileus.
Hypersensitivity to hydrocodone, chlorpheniramine, or any of the inactive ingredients in TUSSIONEX Pennkinetic. 5 Warnings and Precautions (PLR conversion: subsections created as below, see label for complete information) 5.1 Addiction, Abuse, and Misuse 5.2 Life-Threatening Respiratory Depression 5.3 Risks of Use in Pediatric Populations 5.4 Risks of Use in Other At-Risk Populations 5.5 Risk of Accidental Overdose and Death due to Medication Errors 5.6 Activities Requiring Mental Alertness: Risks of Driving and Operating Machinery 5.7 Risks from Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers 5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants 5.9 Risks of Use in Patients with Gastrointestinal Conditions 5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors 5.11 Increased Risk of Seizures in Patients with Seizure Disorders 5.12 Severe Hypotension 5.13 Neonatal Opioid Withdrawal Syndrome 5.14 Adrenal Insufficiency 5.15 Drug/Laboratory Test Interactions
Venclexta
(venetoclax)
4 Contraindications Additions and/or revisions underlined: Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp- up phase is contraindicated due to the potential for increased risk of tumor lysis syndrome. 5 Warnings and Precautions 5.1 Tumor Lysis Syndrome Additions and/or revisions underlined: Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with previously treated CLL with high tumor burden when treated with VENCLEXTA. With the current (5 week) dose ramp-up, TLS prophylaxis and monitoring, the rate of TLS was 2% in the VENCLEXTA monotherapy studies. The rate of TLS remained consistent with VENCLEXTA in combination with rituximab. With a 2-3-week
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dose ramp-up and higher starting dose in patients with CLL, the TLS rate was 13% and included deaths and renal failure. 5.2 Neutropenia Additions and/or revisions underlined: Grade 3 or 4 neutropenia developed in 64% (124/194) of patients and Grade 4 neutropenia developed in 31% of patients treated with VENCLEXTA in combination with rituximab (see Table 8). Grade 3 or 4 neutropenia developed in 63% (216/344) of patients and Grade 4 neutropenia developed in 33% of patients treated with VENCLEXTA monotherapy (see Table 10). Febrile neutropenia occurred in 4% of patients treated with VENCLEXTA in combination with rituximab and in 6% of patients treated with VENCLEXTA monotherapy.
Vimovo
(esomeprazole
magnesium;
naproxen)
5 Warnings and Precautions Newly created subsection: 5.27 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Xarelto
(rivaroxaban)
5 Warnings and Precautions 5.2 Risk of Bleeding (additions underlined) … Reversal of Anticoagulant Effect
An agent to reverse the anti-factor Xa activity of rivaroxaban is available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. Partial reversal of prothrombin time prolongation has been seen after administration of prothrombin complex concentrates (PCCs) in healthy volunteers. The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.
Xgeva
(denosumab)
5 Warnings and Precautions Additions and/or revisions underlined: 5.6 Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in Xgeva-treated patients with giant cell tumor of bone and patients with growing skeletons. Hypercalcemia has been reported within the first year after treatment discontinuation. After treatment is discontinued, monitor patients for signs and symptoms of hypercalcemia, assess serum calcium periodically, reevaluate the patient’s calcium and vitamin D supplementation requirements and manage patients as clinically appropriate.
Yosprala
(aspirin;
omeprazole)
Zegerid
5 Warnings and Precautions Newly created subsection: 5.20 and 5.13 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use,
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Trade Name
(generic name) Summary of Label Changes
(omeprazole;
sodium
bicarbonate)
especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.
Treatment Guideline Updates
Title Citation/Link
Hypothalamic–Pituitary and Growth
Disorders in Survivors of Childhood
Cancer: An Endocrine Society Clinical
Practice Guideline
Charles A Sklar, Zoltan Antal, Wassim Chemaitilly, Laurie E Cohen, Cecilia
Follin, Lillian R Meacham, M Hassan Murad; Hypothalamic–Pituitary and
Growth Disorders in Survivors of Childhood Cancer: An Endocrine Society
Clinical Practice Guideline, The Journal of Clinical Endocrinology &
Metabolism, https://doi.org/10.1210/jc.2018-01175
USPSTF Screening for Osteoporosis
to Prevent Fractures
Screening for Osteoporosis to Prevent Fractures. US Preventative Services
Task Force Recommndation Statement. JAMA. 2018; 319 (24):2521-2531.
Doi: 10.1001/jama.2018.7498
Update of Recommendations for Use
of Once-Weekly Isoniazid-Rifapentine
Regimen to Treat Latent
Mycobacterium tuberculosis Infection
Borisov AS, Bamrah Morris S, Njie GJ, et al. Update of Recommendations for
Use of Once-Weekly Isoniazid-Rifapentine Regimen to Treat Latent
Mycobacterium tuberculosis Infection. MMWR Morb Mortal Wkly Rep
2018;67:723–726. DOI: http://dx.doi.org/10.15585/mmwr.mm6725a5