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Mircera

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Mircera

Mircera

INDICATIONS

Mircera (methoxy polyethylene glycol-epoetin beta) is indicated for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and not on dialysis.

Mircera (methoxy polyethylene glycol-epoetin beta) is not indicated for the treatment of anemia due to cancer chemotherapy [see Warnings and PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Important Dosing Information

The dose of Mircera (methoxy polyethylene glycol-epoetin beta) should be reduced as the hemoglobin approaches 12 g/dL or increases by more than 1 g/dL in any 2-week period [see Warnings and PRECAUTIONS]. During therapy, hematological parameters should be monitored regularly. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Mircera (methoxy polyethylene glycol-epoetin beta) is administered either intravenously (IV) or subcutaneously (SC). The IV route is recommended for patients receiving hemodialysis because the IV route may be less immunogenic [see ADVERSE REACTIONS]. When administered SC, Mircera (methoxy polyethylene glycol-epoetin beta) should be injected in the abdomen, arm or thigh.

Starting Dose

Patients Not Currently Treated with an ESA

The recommended starting dose of Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia in adult CRF patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks.

Mircera (methoxy polyethylene glycol-epoetin beta) should be dosed to achieve and maintain hemoglobin between 10 and 12 g/dL. Once the hemoglobin has been maintained within this range, Mircera (methoxy polyethylene glycol-epoetin beta) may be administered once monthly using a dose that is twice that of the every-two-week dose and subsequently titrated as necessary.

Patients Currently Treated with an ESA

Mircera (methoxy polyethylene glycol-epoetin beta) can be administered once every two weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA (see Table 1). The dose of Mircera (methoxy polyethylene glycol-epoetin beta) , given as a single IV or SC injection, should be based on the total weekly ESA dose at the time of conversion.

Table 1: Mircera (methoxy polyethylene glycol-epoetin beta) Starting Doses for Patients Currently Receiving an ESA

Previous Weekly
Epoetin alfa
Dose
(units/week)
Previous Weekly
Darbepoetin alfa Dose
(mcg/week)
Mircera Dose
Once Monthly (meg/month) Once Every Two Weeks
(mcg/every two weeks)
< 8000 < 40 120 60
8000-16000 40-80 200 100
> 16000 > 80 360 180

Monitoring and Dose Adjustment

When Mircera (methoxy polyethylene glycol-epoetin beta) therapy is initiated or adjusted, the hemoglobin should be monitored every two weeks until stabilized, and every two to four weeks thereafter. For patients whose hemoglobin does not attain a level within the range of 10 to 12 g/dL despite the use of appropriate Mircera (methoxy polyethylene glycol-epoetin beta) dose titrations over a 12-week period:

  • Do not administer higher Mircera (methoxy polyethylene glycol-epoetin beta) doses and use the lowest dose that will maintain a hemoglobin level sufficient to avoid the need for recurrent RBC transfusions
  • Evaluate and treat for other causes of anemia
  • Thereafter, continue to monitor the hemoglobin level and if responsiveness improves, make Mircera (methoxy polyethylene glycol-epoetin beta) dose adjustments as described above; discontinue Mircera (methoxy polyethylene glycol-epoetin beta) if responsiveness does not improve and the patient needs recurrent RBC transfusions [see Warnings and PRECAUTIONS].

Dose adjustments should not be made more often than once a month. A significant change in hemoglobin may not be observed for several weeks after the dose is adjusted. If a dose adjustment is necessary to maintain the recommended hemoglobin level, the dose may be increased or decreased by approximately 25%, as needed.

During Mircera (methoxy polyethylene glycol-epoetin beta) therapy, if the increase in hemoglobin is greater than 1 g/dL in 2 weeks or if the hemoglobin is increasing and approaching 12 g/dL, the dose should be reduced by approximately 25%. If the hemoglobin continues to increase, Mircera (methoxy polyethylene glycol-epoetin beta) should be discontinued until the hemoglobin begins to decrease. Mircera (methoxy polyethylene glycol-epoetin beta) may then be restarted at a dose approximately 25% below the previously administered dose.

For patients not converted from another ESA, if the increase in hemoglobin is less than 1 g/dL over the initial 4 weeks of treatment and iron stores are adequate, the dose of Mircera may be increased by approximately 25% [see Warnings and PRECAUTIONS].

If a dose of Mircera (methoxy polyethylene glycol-epoetin beta) is missed, administer the missed dose as soon as possible and restart Mircera (methoxy polyethylene glycol-epoetin beta) at the prescribed dosing frequency.

Preparation and Administration of Mircera (methoxy polyethylene glycol-epoetin beta)

Mircera (methoxy polyethylene glycol-epoetin beta) is packaged as single use vials and prefilled syringes. Mircera (methoxy polyethylene glycol-epoetin beta) contains no preservatives. Discard any unused portion. Do not pool unused portions from the vials or prefilled syringes. Do not use the vial or prefilled syringe more than one time.

Always store Mircera (methoxy polyethylene glycol-epoetin beta) vials or prefilled syringes in their original cartons. Vigorous shaking or prolonged exposure to light should be avoided.

Do not mix Mircera (methoxy polyethylene glycol-epoetin beta) with any parenteral solution.

Parenteral drug products should be inspected visually for particulate matter and coloration prior to administration. Do not use any vials or prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish.

For administration using the prefilled syringe, the plunger must be fully depressed during injection in order for the needle guard to activate. Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered.

See "Patient Instructions for Use" for complete instructions on the preparation and administration of Mircera (methoxy polyethylene glycol-epoetin beta) . Examine each vial or prefilled syringe for the expiration date. Do not use Mircera (methoxy polyethylene glycol-epoetin beta) after the expiration date.

HOW SUPPLIED

Dosage Forms And Strengths

Single use vials are available containing 50, 100, 200, 300, 400, 600 or 1000 meg of Mircera (methoxy polyethylene glycol-epoetin beta) in 1 mL solution.

Single use prefilled syringes are available containing 50, 75, 100, 150, 200, or 250 meg of Mircera (methoxy polyethylene glycol-epoetin beta) in 0.3 mL solution and 400, 600 or 800 meg of Mircera (methoxy polyethylene glycol-epoetin beta) in 0.6 mL solution.

Mircera (methoxy polyethylene glycol-epoetin beta) is available in single use vials and single use prefilled syringes. The vial caps and plungers of prefilled syringes are designated with unique colors for each dosage strength. The prefilled syringes are supplied with a 27 gauge, ½ inch needle. To reduce the risk of accidental needlesticks after application, each prefilled syringe is equipped with a needle guard that covers the needle during disposal.

Mircera (methoxy polyethylene glycol-epoetin beta) is available in the following pack sizes

Single Use Vial:   Single Use Prefilled Syringe (PFS) with a
Needle Guard. A 27 Gauge, Vi Inch Needle is
also provided:
1 Vial/Pack50 mcg/1 mL
(NDC 0004-0411-09)
12 Vials/Pack50 mcg/1 mL
(NDC 0004-0411-06)
1 PFS/Pack50 mcg/0.3 mL
(NDC 0004-0401-09)
100 mcg/1 mL
(NDC 0004-0413-09)
100 mcg/1 mL
(NDC 0004-0413-06)
75 mcg/0.3 mL
(NDC 0004-0402-09)
200 mcg/1 mL
(NDC 0004-0415-09)
200 mcg/1 mL
(NDC 0004-0415-06)
100 mcg/0.3 mL
(NDC 0004-0403-09)
300 mcg/1 mL
(NDC 0004-0417-09)
300 mcg/1 mL
(NDC 0004-0417-06)
150 mcg/0.3 mL
(NDC 0004-0404-09)
400 mcg/1 mL
(NDC 0004-0418-09)
400 mcg/1 mL
(NDC 0004-0418-06)
200 mcg/0.3 mL
(NDC 0004-0405-09)
600 mcg/1 mL
(NDC 0004-0419-09)
600 mcg/1 mL
(NDC 0004-0419-06)
250 mcg/0.3 mL
(NDC 0004-0406-09)
1000 mcg/1 mL
(NDC 0004-0420-09)
1000 mcg/1 mL
(NDC 0004-0420-06)
400 mcg/0.6 mL
(NDC 0004-0408-09)
600 mcg/0.6 mL
(NDC 0004-0409-09)
800 mcg/0.6 mL
(NDC 0004-0410-09)

Stability and Storage

The recommended storage temperature is at 2° to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.

Storage of 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 7 days.

Storage of prefilled syringes 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.

Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110-1199 Issued: November 200. FDA Rev date: 11/14/2007

Last reviewed on RxList: 12/20/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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