DOPATREE
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DOPATREE
PRODUCTS
DRUGS AND BIOLOGICS-ALL (DRUG-DEVICE, BIOLOGIC-DEVICE COMBOS, COMBINATIONS, MEDICINES, THERAPEUTICS)
DRUGS AND BIOLOGICS / RELATED / US
DRUG SAFETY AND BIOLOGIC SAFETY (PHARMACOVIGILANCE, PV, CLINICAL, POSTMARKETING, SERIOUS ADVERSE EVENT, SAE, IND, 7-DAY, 15-DAY, EXPEDITED, SIDE EFFECTS, ICSR, PSUR, LITERATURE, SURVEILLANCE, E2B, SAFETY REPORTING, DATA, MEDICATION)
DRUG SAFETY AND BIOLOGIC SAFETY / RELATED / US
DRUG AND BIOLOGIC RISK MITIGATIONS-ALL (WARNINGS AND PRECAUTIONS)
DRUG AND BIOLOGIC RISK MITIGATIONS / RELATED
MITIGATION
Parents
DRUG AND BIOLOGIC RISK MITIGATIONS / RELATED
RISK MANAGEMENT / RELATED
Children
ACCEPTABLE RISK DUE TO PRECEDENT PRODUCT
ACCESS ACCOUNT MANAGERS, FIELD REIMBURSEMENT SPECIALISTS, TRAINING AND DEPLOYMENT
ACCESS AND REIMBURSEMENT
ADDITIONAL MONITORING (BLACK TRIANGLE, RECENT APPROVALS, BIOLOGICS)
ADDITIONAL REGULATORY REPORTING AND/OR FOLLOWUP (INCLUDING ENHANCED PHARMACOVIGILANCE)
ADHERE TO PREMEDICATION AND REQUIRED EYE CARE BEFORE, DURING, AND AFTER INFUSION
ADJUST DOSES OF CONCURRENT ANTIHYPERLYCEMIC DRUGS IN DIABETICS
ADJUSTING THE DOSE OR STOPPING THE TREATMENT WHEN ADVERSE EVENTS ARE OBSERVED OR LABORATORY PARAMETERS CHANGE
ADJUSTING THE DOSE OR STOPPINGTHE TREATMENT WHEN ADVERSE EVENTS ARE OBSERVED OR LABORATORY PARAMETERS CHANGE
ADMINISTER PRODUCT IN A MONITORED SETTING
ADMINISTER PRODUCT IN A MONITORED SETTING FOR 1ST CYCLE OR DOSE
ADVISE FEMALES OF REPRODUCTIVE POTENTIAL TO POTENTIAL RISK TO FETUS
ADVISE GOOD ORAL HYGIENE
ADVISE NOT TO BREASTFEED DURING TREATMENT AND FOR 8 WEEKS AFTER THE FINAL DOSE
ADVISE NOT TO DRIVE OR OPERATE MACHINERY UNTIL THEY HAVE GAINED SUFFICIENT EXPERIENCE WITH PRODUCT
ADVISE PATIENT TO URINATE FREQUENTLY DURING AND AFTER DRUG ADMINISTRATION
ADVISE TO AVOID DRIVING OR USING MACHINERY IF THEY EXPERIENCE DIZZINESS, SOMNOLENCE OR HALLUCINATION
ADVISE TO NOT DRIVE OR OPERATE DANGEROUS MACHINERY UNTIL THE TREATMENT EFFECT ON THE ABILITY TO DRIVE OR OPERATE MACHINERY IS KNOWN
ADVISE USE OF EFFECTIVE CONTRACEPTION UNTIL SET PERIOD AFTER LAST DOSE
ADVISE, INSTRUCT, EDUCATE, WARN, AND/OR CAUTION PATIENTS
AVOID ABRUPT INTERRUPTION OR DISCONTINUATION OF TREATMENT, GRADUALLY REDUCE DOSAGE WHEN POSSIBLE
AVOID CO-ADMINISTRATION WITH OTHER RELATED TREATMENTS
AVOID SPECIFIC CONCOMITANT MEDICATION USE
AVOID USE IN PATIENTS EGRF <30 ML/MIN
AVOID USE IN PATIENTS WITH ACTIVE BLEEDING
AVOID USE IN PATIENTS WITH BASELINE QTC >480 MSEC
AVOID USE IN PATIENTS WITH SEVERE, ACUTE, OR UNSTABLE CARDIOVASCULAR DISEASE
AVOID USE OF CONCOMITANT DRUGS KNOW TO PROLONG QTC INTERVAL
AVOID USE OF LIVE VACCINES BEFORE, DURING, AND AFTER TREATMENT
AVOID USE OF TREATMENT IN PATIENTS WITH ACTIVE SERIOUS INFECTION, INCLUDING LOCALIZED INFECTIONS
AVOID USE WITH NARCOTICS, HYPNOTICS, OR SEDATIVES
AVOID USE WITH OTHER TREATMENTS THAT MAY EXACERBATE ADVERSE REACTIONS
AWARENESS OF ADVERSE EVENT
BIOANALYTICS AND BIOMARKER SOLUTIONS
BOXED WARNING
BRAND AND COMPANY PUBLIC RELATIONS - ADVERTISING - DATA SCIENCE - DIGTAL - SOCIAL MEDIA
CAUTION AGAINST NEXT-DAY DRIVING
CAUTION AGAINST NEXT-DAY DRIVING AND ACTIVITIES REQUIRING MENTAL ALERTNESS
CLINICAL MONITORING
COMMERCIAL STRATEGY - PORTFOLIO STRATEGY - CORPORATE DEVELOPMENT
COMMITMENT TO ESTABLISH AN IN-VITRO DIAGNOSTIC DEVICE FOR THE SUBSTANCE
CONDUCT OF A FEASIBILITY ASSESSMNT OF A SURVEY STUDY FOR RMM EFFECTIVENESS
CONSIDER EFFECTS ON RESPIRATORY FUNCTION
CONSIDER PANCREATITIS IN PATIENTS WITH PERSISTENT SEVERE ABDOMINAL PAIN
CONSIDER TREATMENT DISCONTINUATION IF CONFIRMED
CONTACT SPONSOR IF OCCURS
CONTROLLED ACCESS PROGRAMS (LABORATORY TESTS, EKG, BLOOD TESTS, PREGNANCY TESTS)
CONTROLLED DISTRIBUTION SYSTEMS (PRESCRIPTION TRACKING, PHARMACY TRACKING, DISTRIBUTION CHAIN)
CORRECT HYPOKALEMIA PRIOR TO AND DURING TREATMENT ADMINISTRATION
COUNSELING AND EVALUATION (UNINTENTIONAL EVENTS)
CUMULATIVE REVIEWS OF ADVERSE EVENTS OF INTEREST
DEA DRUG SCHEDULING
DELAY ADMINISTRATION OF TREATMENT TO PATIENTS WITH AN ACTIVE INFECTION
DEVELOPMENT OF A SPECIAL DOSE OR FORMULATION
DIETARY MODIFICATIONS
DIRECT HEALTHCARE PROFESSIONAL COMMUNICATIONS (DHPCS)
DISCONTINUE TREATMENT IF CLINICALLY SIGNIFICANT
DISCONTINUE TREATMENT IF CONDITION CANNOT BE MANAGED
DISCONTINUE TREATMENT IF PULMONARY INFILTRATES OR PULMONARY FUNCTION IMPAIRMENT
DISCONTINUE TREATMENT IF SEVERE RENAL IMPAIRMENT DEVELOPS
DISCONTINUE TREATMENT IF SIGNS OR SYMPTOMS OCCUR
DISCONTINUE TREATMENT IMMEDIATELY
DISEASE STATE EDUCATION AND PATIENT LEXICON
DO NOT DISCONTINUE PRODUCT ABRUPTLY, DECREASE GRADUALLY
DO NOT INITIATE IF LVEF <55%
DTC PATIENT EDUCATION AND ADHERENCE PROGRAMMING
ECHOCARDIGRAM ASSESSMENTS OF LVEF BEFORE AND DURING PRODUCT USE
EDUCATIONAL PROGRAMS- MATERIALS FOR HEALTHCARE PROFESSIONALS AND-OR PATIENTS (E.G., ADMINISTRATION GUIDE, CHECKLIST FOR PRESCRIBING, PATIENT CARD, PATIENT EDUCATIONAL LEAFET)
EFECTIVENESS OF RMMS SHOULD BE ASSESSED IN ACCORDANCE WITH GVP MODULE XVI|
EKG MONITORING
ENSURE PATIENTS ARE VACCINATED AGAINST ENCAPSULATED BACTERIA
EVALUATE CHILDREN WITH ONSET OF A LIMP OR PERSISTENT HIP OR KNEE PAIN
EVALUATE EYE SYMPTOMS PROMPTLY AND DISCONTINUE IF NEW OR WORSENING SYMPTOMS
EVALUATE FOR PANCREATITIS WHEN LIPASE ELEVANATION IS ACCOMPANIED BY ABDOMINAL SYMPTOMS
EXCLUDE PREEXISTING PAPILLEDEMA
FDA’S ACTIVE RISK IDENTIFICATION AND ANALYSIS (ARIA)
FORMULATION WITH INTRANASAL ABUSE-DETERRENT FEATURES
FORMULATION WITH INTRAVENOUS ABUSE-DETERRENT FEATURES
HIGHLIGHT CONTRAINDICATED MEDICATIONS
HOLD TREATMENT PRIOR TO ANY PLANNED SURGICAL PROCEDURES
ICF / STUDY DESIGN AND OPERATIONS PLAN
IF PATIENTS BECOME INFECTED WHILE ON THERAPY, DISCONTINUE THERAPY UNTIL PARASITIC INFECTION RESOLVES
IF SERIOUS INFECTION OCCURS, ADMINISTER TREATMENT AND CONSIDER WITHHOLDING TREATMENT UNTIL RESOLVES
INCREASE FLUID AND ELECTROLYTE INTAKE
INITIATE TREATMENT IMMEDIATELY AS CLINICALLY INDICATED
INTERRUPT AND REDUCE TREATMENT IN PATIENTS WHO HAVE A QTCF >500 SEC
INTERRUPT IF LVEF <50% OR CLINICALLY WORSEN
INTERRUPT INFUSION AND TREAT WITH ANTIHISTAMINES
INTERRUPT, REDUCE, OR DISCONTINUE TREATMENT DOSE OR RATE DEPENDING ON SEVERITY
LABEL HIGHLIGHTS, E.G. WARNINGS AND PRECAUTIONS
LABORATORY MONITORING
LIMITATION OF USE STATEMENT
MANAGE CONDITION PROMPTLY
MANAGE INFECTIONS PROMPTLY
MANAGE WITH ANTI-DIARRHEALS, DOSE REDUCTION, OR DOSE INTERRUPTION
MARKET ACCESS - PRICING AND CONTRATEGY STRATEGY - HEALTH ECONOMIC MODELS - PAYER COMMUNICATIONS
MEDICAL FIELD TEAM RECRUITMENT, TRAINING, AND DEPLOYMENT
MEDICAL STRATEGY - EVIDENCE GENERATION - MEDICAL COMMUNICATIONS - CONGRESSES - DISEASE AWARENESS - STAKEHOLDER ENGAGEMENT - TRAINING AND EDUCATION
MEDICATION GUIDE (NON-REMS)
MINIMIZE RADIATION EXPOSURE DURING AND AFTER TREATMENT CONSISTENT WITH SAFETY PRACTICES AND PROCEDURES
MONITOR BLOOD PRESSURE AND AS CLINICALLY INDICATED
MONITOR CALCULATED CREATININE CLEARANCE
MONITOR CARDIAC FUNCTION, INCLUDING LEFT VENTRICULAR EJECTION FRACTION, AT BASELINE AND DURING TREATMENT
MONITOR COMPLETE BLOOD COUNTS DURING THERAPY
MONITOR CREATININE AT BASELINE AND DURING TREATMENT
MONITOR DNA LEVELS AND CHECK FOR TREATMENT RESISTANCE
MONITOR ELECTROLYTES
MONITOR FOR SIGNS AND SYMPTOMS OF INFECTION WHILE ON TREATMENT
MONITOR FOR SIGNS, EVALUATE, AND TREAT PROMPTLY
MONITOR GLUCOSE LEVELS PERIODICALLY
MONITOR LABS
MONITOR LABS AT BASELINE AND DURING TREATMENT
MONITOR LIVER ENZYMES AT BASELINE AND DURING TREATMENT
MONITOR MORE FREQUENTLY FOR THOSE WITH RISK FACTORS
MONITOR OTHER TREATMENT DRUG LEVELS THROUGHOUT THE TREATMENT AND ADJUST THE DOSE AS NEEDED
MONITOR PATIENT WITH HISTORY OF RISK FACTORS FOR SIGNS AND SYMPTOMS MORE FREQUENTLY
MONITOR PATIENTS FOR REDUCED SERUM CORTISOL LEVELS
MONITOR PATIENTS FOR SECONDARY CANCER
MONITOR PATIENTS FOR SIGNS AND SYMPTOMS
MONITOR PATIENTS FOR SUICIDAL BEHAVIOR AND THOUGHTS
MONITOR PATIENTS NEED FOR GLUCOCORTICOID DOSE INCREASES IN THOSE WITH KNOWN HYPOADRENALISM
MONITOR PATIENTS TAKING CYP450 SUBSTRATES WITH A NARROW THERAPEUTIC INDEX FOR ADVERSE REACTIONS TO INFORM DOSE ADJUSTMENT
MONITOR PATIENTS WHO ARE RECEIVING A COMBINATION OF TREATMENTS FOR EXCESSIVE CNS TOXICITY
MONITOR PATIENTS WITH PREEXISTING TUMORS FOR PROGRESSION OR RECURRENCE
MONITOR SERUM CREATININE AT BASELINE AND DURING THERAPY
MONITOR SERUM LIPASE AND AMYLASE
MONITOR SERUM TRIGLYCERIDES BEFORE AND INTERMITTENTLY DURING TREATMENT AND MANAGE WHEN ELEVATED
MONITOR THYROID FUNCTION AT BASELINE AND DURING TREATMENT
MONITOR WITH EKG AND ELECTROLYTES AT BASELINE AND DURING TREATMENT
MONITORING FOR SPECIFIC SIGNS AND SYMPTOMS
MONITORING FOR SPECIFIC SIGNS AND SYMPTOMS
MONITORING OF LABORATORY PARAMETERS DURING TREATMENT
MONITORING OF LABORATORY PARAMETERS DURING TREATMENT
NAMING AND BRANDING ASSETS AND STUDIES
NURSE EDUCATORS
OBSERVED VERSUS EXPECTED ANALYSES
PAC, PATIENT EXPERT AND INFLUENCER MAPPING
PASSIVE SURVEILLANCE SYSTEMS
PATIENT ALERT CARDS
PATIENT AMBASSADORS / MENTORS
PATIENT PACKAGE INSERT
PATIENTS SHOULD REPORT NEW ONSET OR WORSENING SYMPTOMS TO PROVIDER WHILE ON TREATMENT
PERFORM BLOOD COUNTS AT BASELINE, DURING TITRATION, AND DURING TREATMENT MAINTENANCE
PERFORM EYE EXAMS BEFORE AND DURING TREATMENT, PRIOR TO EACH DOSE AND AS CLINICALLY INDICATED
PERFORM REGULAR DENTAL EXAMINATIONS
PERFORMING A TEST BEFORE START OF TREATMENT
PERFORMING A TEST BEFORE THE START OF TREATMENT
PERFORMING A WASH-OUT PROCEDURE AFTER TREATMENT INTERRUPTION
PERFORMING A WASH‐OUT PROCEDURE AFTER TREATMENT INTERRUPTION
PHASE 1 CLINICAL DEVELOPMENT
PHASE 1 PROOF OF CONCEPT DEVELOPMENT
PHASE 2A-PHASE 3 CLINICAL DEVELOPMENT
PLAIN LANGUAGE SCIENTIFIC COMMUNICATIONS
POST-APPROVAL ASSAY AND TEST CONFIRMATIONS
POST-APPROVAL CLINICAL STUDY
POST-APPROVAL DATABASE STUDY
POST-APPROVAL HUMAN FACTORS STUDY
POST-APPROVAL NON-CLINICAL STUDY
POST-APPROVAL OBSERVATIONAL STUDY
POST-APPROVAL PK ONLY OR CLINICAL PHARMACOLOGY STUDY
POST-APPROVAL REGISTRY
PRE-ADMINISTRATION TESTING AND/OR SCREENING
PRE-MEDICATION, SUPPLEMENTATION, PROPHYLAXIS
PREGNANCY PREVENTION PROGRAMME (PROGRAMS, PPP)
PREGNANCY REGISTRY
PREPARATION AND ADMINISTRATION BY HEALTHCARE PROVIDER
PRESCRIPTION LIMITS (30-DAY SUPPLY)
PRODUCT PROFILE, STUDY GOALS, RISK-BENEFIT
PROHIBITING THE USE OF OTHER MEDICINES WHILE TAKING THE PRODUCT
PROHIBITING THE USE OF OTHER MEDICINES WHILE TAKING THE PRODUCT
PROVIDER EDUCATION AND/OR TRAINING
PROVIDING CONTRACEPTION RECOMMENDATIONS
PROVIDING CONTRACEPTION RECOMMENDATIONS
RADIOLOGIC MONITORING (E.G. CT SCAN, MRI, ETC.)
REAL WORLD DATA CLINICAL TRIAL DESIGN - REAL WORLD DATA REGULATORY SUBMISSIONS
REAL WORLD EVIDENCE LABEL EXTENSION AND VALUE-BASED CONTRACTING
RECOMMENDING LONG-TERM CLINICAL FOLLOW-UP TO IDENTIFY IN EARLY STAGES DELAYED ADVERSE EVENTS
RECOMMENDING LONG‐TERM CLINICAL FOLLOW‐UP TO IDENTIFY DELAYED ADVERSE EVENTS IN EARLY STAGES
REDUCE OR INTERRUPT TREATMENT DOSE
REEVALUATE IF CO-MORBID DIAGNOSES EXISTS
REGULATORY STRATEGY, SUBMISSIONS, AND OPERATIONS
REMS (1-A) - HCP HAVE TRAINING OR ARE CERTIFIED
REMS (2-B) - DISPENSING ENTITIES ARE CERTIFIED
REMS (3-C) - DISPENSED ONLY IN CERTAIN SETTINGS
REMS (4-D) - DISPENSED WITH DOCUMENTED SAFE-USE CONDITIONS
REMS (5-E) - PATIENT IS MONITORED
REMS (6-F) - PATIENT IS ENROLLED IN REGISTRY
REMS (CP) - COMMUNICATION PLAN
REMS WITH ETASU (UNSPECIFIED)
REMS-MEDICATION GUIDE
RESCUE MEDICATION READINESS
RISK EVALUATION AND MITIGATION AND EDUCATION
RISK MITIGATION - REPUTATION MANAGEMENT - PUBLIC AFFAIRS - POLICY AND ADVOCACY - STAKEHOLDER ENGAGEMENT
RMMS INCLUDED IN THE RMP SHOULD BE RE-EVALUATED PERIODICALLY
ROUTINE PHARMACOVIGILANCE
SALES REPS - TELEDETAILING - TRAINING - SALES OPERATIONS
SPECIALTY CENTER REFERRAL
SPECIFIC ADVERSE REACTION FOLLOW-UP QUESTIONNAIRES
SPECIFIC DISPENSING INSTRUCTIONS
SPECIFIC DOSE GUIDANCE
SPECIFIC PATIENT INSTRUCTION AND GUIDANCE
SPECIFIC PATIENT SELECTION
SPECIFIC PREPARATION AND/OR ADMINISTRATION REQUIREMENTS
SPECIFIC PRESCRIBING INSTRUCTIONS
SPECIFIC STORAGE INSTRUCTIONS
STABILITY TESTING (PHOTOSTABILITY, STUDY)
STARTER PACKAGE
SUPPLEMENT IF DEFICIENCY IS OBSERVED
TREAT BASED ON PERSISTENCE AND SEVERITY
TREAT PATIENTS WITH PRE-EXISTING PARASITIC INFECTIONS BEFORE THERAPY
TREATING OR PREVENTING THE RISK FACTORS THAT MAY LEAD TO AN ADVERSE EVENT OF THE PRODUCT
TREATING OR PREVENTING THE RISK FACTORS THAT MAY LEAD TO AN ADVERSE EVENT OF THE PRODUCT
USE RECOMMENDED SPECIFIC DILUENT
WITHDRAW PRODUCT GRADUALLY TO MINIMIZE THE RISK OF INCREASED FREQUENCY OR SEVERITY OF THE UNTREATED CONDITION
WITHHOLD TREATMENT AND INITIATE APPROPRIATE ANTI-INFECTIVE THERAPY