"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
Anemia Due to Chronic Kidney Disease
Limitations of Use
OMONTYS is not indicated and is not recommended for use:
- In patients with CKD not on dialysis because of safety concerns in this population [see WARNINGS AND PRECAUTIONS].
- In patients receiving treatment for cancer and whose anemia is not due to CKD, because ESAs have shown harm in some settings and the benefit-risk factors for OMONTYS in this setting have not been evaluated [see WARNINGS AND PRECAUTIONS].
- As a substitute for RBC transfusions in patients who require immediate correction of anemia.
- OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life.
DOSAGE AND ADMINISTRATION
Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating OMONTYS [see WARNINGS AND PRECAUTIONS].
Patients with Chronic Kidney Disease
Individualize dosing and use the lowest dose of OMONTYS sufficient to reduce the need for RBC transfusions [see WARNINGS AND PRECAUTIONS]. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see BOXED WARNING and Clinical Studies].
Initiation of Treatment and Starting Dose
Initiate OMONTYS treatment when the hemoglobin level is less than 10 g/dL.
The recommended starting dose for the treatment of anemia in patients who are not currently treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly.
Conversion from Epoetin Alfa or Darbepoetin Alfa to OMONTYS in Patients with CKD on Dialysis
OMONTYS is administered once monthly, either subcutaneously or intravenously.
In patients previously receiving epoetin alfa or darbepoetin alfa, estimate the starting monthly dose of OMONTYS for patients on the basis of the weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution (see Table 1). Maintain the route of administration (intravenous or subcutaneous injection).
- For patients previously receiving epoetin alfa, the first dose of OMONTYS should be administered one week after the last epoetin alfa dose was administered.
- For patients previously receiving darbepoetin alfa, the first dose of OMONTYS should be administered at the next scheduled dose in place of darbepoetin alfa.
Table 1 : Estimated OMONTYS Starting Doses for
Patients Based on Previous Weekly ESA Dose
|Previous Total Weekly Epoetin Alfa Dose (U/week)||Previous Weekly Darbepoetin Alfa Dose (mcg/week)||OMONTYS Dose Once Monthly (mg/month)|
|Less than 2,500||Less than 12||2|
|2,500 to less than 4,300||12 to less than 18||3|
|4,300 to less than 6,500||18 to less than 25||4|
|6,500 to less than 8,900||25 to less than 35||5|
|8,900 to less than 13,000||35 to less than 45||6|
|13,000 to less than 19,000||45 to less than 60||8|
|19,000 to less than 33,000||60 to less than 95||10|
|33,000 to less than 68,000||95 to less than 175||15|
|greater than or equal to 68,000||greater than or equal to 175||20|
General Guidance including Dose Adjustments
Monitor hemoglobin levels at least every 2 weeks until stable, then monitor at least monthly. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
- Do not increase the dose more frequently than once every 4 weeks.
- If the hemoglobin rises rapidly (e.g., more than 1 g/dL in the 2 weeks prior to the dose or more than 2 g/dL in 4 weeks), reduce the dose of OMONTYS by 25% or more as needed to reduce rapid responses.
- If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of OMONTYS. After a dose has been withheld and once the hemoglobin begins to decrease, OMONTYS may be restarted at a dose approximately 25% below the previously administered dose.
- For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, increasing the OMONTYS dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue OMONTYS if responsiveness does not improve [see WARNINGS AND PRECAUTIONS].
- If a dose of OMONTYS is missed, administer the missed dose as soon as possible and restart OMONTYS at the prescribed once monthly dosing frequency.
When treating dialysis patients who have chronic kidney disease and cancer, physicians should refer to WARNINGS AND PRECAUTIONS.
Refer patients who self-administer OMONTYS to the Instructions for Use [see PATIENT INFORMATION].
Preparation and Administration of OMONTYS
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.
- OMONTYS should be inspected visually for particulate matter and coloration prior to administration. Do not use any vials or pre-filled syringes of OMONTYS exhibiting particulate matter or a coloration other than colorless to slightly yellow.
Dosage Forms And Strengths
|Single use vials (preservative-free)||2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL|
|Single use pre-filled syringes (preservative-free)||1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL|
|Multiple use vials (with preservative)||10 mg/mL and 20 mg/2 mL|
OMONTYS is available in single use vials, single use pre-filled syringes, and multiple use vials. The vial caps and plungers of the pre-filled syringes are designated with unique colors for each dosage strength. The single use pre-filled syringes are supplied with a 27 gauge, ½ inch needle. To reduce the risk of accidental needle sticks after application, each single use pre-filled syringe is equipped with a safety device that activates and covers the needle once the dose has been given.
OMONTYS is available in the following pack sizes:
|Single use vials||Single use pre-filled syringes with a 27 gauge, ½ inch needle with an UltraSafe Passive® Needle Guard||Multiple use vials|
|1 Vial/Carton||1 Syringe/Carton||1 Vial/Carton|
|2 mg/0.5 mL
|1 mg/0.5 mL
|3 mg/0.5 mL
|2 mg/0.5 mL
|20 mg/2 mL
|4 mg/0.5 mL
|3 mg/0.5 mL
|5 mg/0.5 mL
|4 mg/0.5 mL
|6 mg/0.5 mL
|5 mg/0.5 mL
|6 mg/0.5 mL
Stability and Storage
The recommended storage temperature is refrigerated at 2 °C to 8 °C (36 °F to 46 °F). Protect from light. Retain in carton until time of use.
Storage of single use vials, single use pre-filled syringes or multiple use vials over the recommended temperature (2 °C to 8 °C), when necessary, is permissible only for temperatures up to 25 °C (77 °F) and for no more than 30 days.
After first use, the multiple use vials should be stored at 2 °C to 8 °C, and then discarded after 28 days.
Marketed by: Affymax, Inc. Palo Alto, CA 94304. Distributed and Marketed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: December 2012
Last reviewed on RxList: 12/19/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Omontys Information
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