FDA on Omontys FULL PRESCRIBING INFORMATION–CONTENTS*
FULL PRESCRIBING INFORMATION–CONTENTS*
WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
1 INDICATIONS AND USAGE
1.1 Anemia Due to Chronic Kidney Disease
1.2 Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Evaluation of Iron Stores and Nutritional Factors
2.2 Patients with Chronic Kidney Disease
2.3 Initiation of Treatment and Starting Dose
2.4 Conversion from epoetin alfa or darbepoetin alfa to OMONTYS in patients with CKD on dialysis
2.5 General Guidance including Dose Adjustments
2.6 Preparation and Administration of OMONTYS 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
5.2 Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer Receiving ESAs
5.4 Lack or Loss of Response to OMONTYS
5.5 Dialysis Management
5.6 Laboratory Monitoring
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Stability and Storage
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
OMONTYS is packaged as single use vials, single use pre-filled syringes, and multiple use vials. OMONTYS packaged in single use vials and single use pre-filled syringes contains no preservatives. OMONTYS is administered either subcutaneously or intravenously.
Use the single use vial or single use pre-filled syringe only one time. Discard unused portion of OMONTYS in single use vials.
Store unused portions of OMONTYS in multiple use vials at 36 °F to 46 °F (2 °C to 8 °C). Discard 28 days after first use.
Protect OMONTYS from light. Store OMONTYS vials or pre-filled syringes in their cartons until time of use.
Do not use if tamper-evident seal on carton is broken or missing.
Do not dilute OMONTYS and do not administer in conjunction with other drug solutions.