methoxypolyethylene glycol-epoetin beta

(redirected from Mircera)

methoxypolyethylene glycol-epoetin beta

(meh-thok-see-pah-lee-eh-thih-leen gly-kol ee-poh-eh-tin bay-ta) ,

Mircera

(trade name)

Classification

Therapeutic: antianemics
Pharmacologic: hormones
Pregnancy Category: C

Indications

Anemia due to chronic renal failure.

Action

Stimulates erythropoesis (production of red blood cells).

Therapeutic effects

Maintains and may elevate RBCs, decreasing the need for transfusions.

Pharmacokinetics

Absorption: Well absorbed (62%) following subcutaneous administration; IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 134 hr.

Time/action profile (effect on hemoglobin)

ROUTEONSETPEAKDURATION
IV, Subcut7–15 daysunknown2–4 wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Uncontrolled hypertension; Treatment of anemia due to cancer chemotherapy.
Use Cautiously in: Patients with hypertension or cardiovascular disease (monitor closely); Dialysis patients (IV route recommended to decrease immunogenecity); Predialysis patients (may require lower doses); Geriatric: Use lower doses, consider age related decrease in metabolic function, concurrent disease states and medications; Obstetric / Lactation: Use during pregnancy only if maternal benefit outweighs fetal risk; Pediatric: Safe use not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • headaches (most frequent)

Cardiovascular

  • cardiovascular and thrombotic events (life-threatening)
  • hypertension (most frequent)
  • hypotension

Gastrointestinal

  • diarrhea (most frequent)
  • constipation
  • vomiting

Hematologic

  • pure red aplasia (life-threatening)

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • fistula complications

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Subcutaneous Intravenous (Adults) 0.6 mcg/kg once every two wk, dosing based on hemoglobin values. Once every-two-wk dose is determined, may be given monthly at twice the every-two-wk dose.

Availability

Vials of solution for injection: 50 mcg/mL, 100 mcg/mL, 200 mcg/mL, 300 mcg/mL, 400 mcg/mL, 600 mcg/mL, 1000 mcg/mL
Prefilled syringes of solution: 50 mcg/0.3 mL, 75 mcg/0.3 mL, 100 mcg/0.3 mL, 150 mcg/0.3 mL, 200 mcg/0.3 mL, 250 mcg/0.3 mL, 400 mcg/0.6 mL, 600 mcg/0.6 mL, 800 mcg/0.6 mL

Nursing implications

Nursing assessment

  • Monitor BP closely before and during therapy, especially in patients with history of CV disease or hypertension. If BP cannot be controlled, dose should be reduced or medication held.
  • Monitor for signs of allergic reactions (tachycardia, pruritis, rash, wheezing, dyspnea, dizziness, fainting, swelling of around mouth or eyes, sweating). If signs occur, discontinue therapy and provide supportive care.
  • May cause seizure. Assess neurological status periodically during therapy, especially if hemoglobin increases >1 g/dL in any 2–wk period.
  • Monitor response for symptoms of anemia (fatigue, dyspnea, pallor).
  • Lab Test Considerations: Monitor hematocrit before and every 2 wks during initial therapy or dose adjustments until stabilized, and every 2–4 wks thereafter. Maintain hemoglobin between 10–12 g/dL. Do not adjust dose more often than once monthly; may require up to 6 wks for significant changes to occur. To adjust dose, increase or decrease by 25% as needed. During therapy, if hemoglobin approaches 12 g/dL or increases by >1 g/dL in any 2–wk period, reduce dose by 25%. If hemoglobin continues to increase, discontinue medication until hemoglobin begins to decrease, then restart at a dose 25% lower than previous dose. For patients not converted from another erythropoesis-stimulating agents (ESA), if the hemoglobin increase is <1 g/dL over the initial 4 wks and iron stores are adequate, may increase dose by 25%. If hemoglobin dose not reach 10–12 g/dL despite dose titration over 12 wks, do not administer higher doses and use lowest dose that will maintain hemoglobin sufficient to avoid recurrent RBC transfusions, evaluate and treat for other causes of anemia (deficiencies of iron, folic acid, vitamin B12, and discontinue methoxy polyethylene glycol-epoetin beta if responsiveness does not improve and recurrent RBC transfusions are needed.
    • May cause pure red cell aplasia (PRCA) and anemia. If a sudden loss of response to medication accompanied by severe anemia and low reticulocyte counts occur evaluate for development of neutralizing antibodies to erythropoetin. Obtain serum samples at least 1 mo after last dose to prevent interference with assay. If anti-erythropoetin antibody-associated anemia is suspected, withhold ESAs until confirmed. If confirmed, discontinue permanently all ESAs.
    • Serum ferritin, transferrin, and iron levels should also be monitored to assess need for concurrent iron therapy. Transferrin saturation should be at least 20% and ferritin should be at least 100 mcg/mL.
    • Monitor renal function studies and electrolytes closely.

Potential Nursing Diagnoses

Activity intolerance (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • When converting patients from other ESAs dose can be administered once every 2 wks or once monthly based on the total weekly at the time of conversion. Patients receiving epoetin <8000 units or darbopoietin <40 mcg in the previous week should receive 120 mcg/month or 60 mcg of Mircera every 2 wks. Patients receiving epoetin 8000–16000 units or darbopoetin 40–80 mcg in the previous week should receive 200 mcg/month or 100 mcg Mirceraevery 2 wks. Patients receiving epoetin >16000 units or darbopoetin >80 mcg in the previous week should receive 360 mcg/month or 180 mcg Mirceraevery 2 wks.
    • Patients not requiring dialysis may require lower maintenance doses.
    • If a dose is missed, administer missed dose as soon as possible and restart at the previous dosing frequency.
    • Transfusions are still required for severe symptomatic anemia. Supplemental iron should be continued throughout therapy.
    • Avoid shaking or prolonged exposure to light; inactivation of medication may occur. Store in refrigerator; do not freeze. Vials are stable for up to 7 days and prefilled syringes for up to 30 days at room temperature. Discard vial or syringe immediately after withdrawing dose. Discard unused portions; do not pool or reuse. Solution is colorless to slightly yellow; do not administer solutions that are discolored or contain particulate matter.
  • Subcutaneous: May be administered in outer area of upper arms, front of middle thighs, or abdomen, except for two-inch area around navel. Do not inject in areas that are tender, red, bruised, hard, or that has scars or stretch marks. Pinch skin and inject at a 45° or 90° angle.
    • For administration using prefilled syringe, plunger must be fully depressed and full dose given during injection in order for the needle guard to activate. Following administration, remove needle from injection site and release plunger to allow the needle guard to move up until entire needle is covered.
  • Administer undiluted.
  • Rate: May be administered as direct injection or bolus into venous port of dialysis tubing at end of dialysis session.
  • Additive Incompatibility: Do not mix with any parenteral solution.

Patient/Family Teaching

  • Explain rationale for concurrent iron therapy (increased red blood cell production requires iron).
    • Discuss ways of preventing self-injury in patients at risk for seizures. Driving and activities requiring continuous alertness should be avoided.
  • Stress importance of compliance with dietary restrictions, medications, and dialysis. Foods high in iron and low in potassium include liver, pork, veal, beef, mustard and turnip greens, peas, eggs, broccoli, kale, blackberries, strawberries, apple juice, watermelon, oatmeal, and enriched bread. Medication will result in increased sense of well-being, but it does not cure underlying disease.
  • Instruct patient to consult health care professional before taking any Rx, OTC, or vitamins, herbal products during therapy.
  • Advise patient to notify health care professional immediately if chest pain; difficulty breathing or shortness of breath; pain in legs with or without swelling; a cool or pale arm or leg; sudden confusion or trouble speaking or understanding speech; sudden numbness or weakness of face, arm, or leg, especially in one side of body; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination, loss of consciousness; sudden severe headache with no known cause; seizures; or blood clots in hemodialysis vascular access occur.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
  • Emphasize the need for regular BP monitoring and lab tests for hemoglobin to decrease risks of serious of serious CV adverse effects.
  • Home Care Issues: Home dialysis patients determined to be able to safely and effectively administer medication and should be taught proper dose, administration technique, and disposal of equipment. Inform patient that injection site reactions (redness, swelling, itching) may occur. Advise patient to rotate injection sites and to notify health care professional if a lump, swelling, or bruising at the injection site occurs and does not go away. Medication Guide and Patient Instructions for Use should be provided to patient along with medication. Caution patient not to give medication to others, even if they have the same symptoms; may cause harm.

Evaluation/Desired Outcomes

  • Increase in hemoglobin and maintenance of 10–12 g/dL with improvement in symptoms of anemia in patients with chronic renal failure.
References in periodicals archive ?
Our sales predictions also cover these products: - AmBisome - MIRCERA - Pegasys - Emend - Renagel - Ritalin.
Our sales predictions also cover these products: -- AmBisome -- MIRCERA -- Pegasys -- Emend -- Renagel -- Ritalin.
FDA--Approved Pegylated Therapeutics Commercial Name Drug Name Native Compound PegIntron Peginterferon Interferon alpha-2b alpha-2b Pegasys Peginterferon Interferon alpha-2a alfa-2a Adagen Pegadamase Adenosine deaminase Oncaspar Pegaspargase Asparaginase Krystexxa Pegloticase Mammalian urate oxidase Neulasta Pegfilgrastim Granulocyte colony-stimulating factor Cimzia Certolizumab Therapeutic pegol monoclonal antibody Mircera Polyethylene Epoetin beta glycol-epoetin beta Somavert Pegvisomant Growth hormone receptor antagonist Half- Half- life of life of Native Pegylated Commercial Clinical Compound Compound Name Indication (hours) (hours) PegIntron Hepatitis C, gliomas 9 28 Pegasys Hepatitis C 8 65 Adagen Severe combined 0.
The assessment affects nineteen centrally authorised medicines as well as various medicines that have been nationally authorised: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon, Herceptin, Invirase, Mabthera, Mircera, Neorecormon, Pegasys, Roactemra, Tamiflu, Tarceva, Viracept, Xeloda, Xenical and Zelboraf.
He admitted to using erythropoietin and Mircera to stimulate red blood cell production, which in turn allowed collection and storage of his blood for later reinfusion.
The country's first Olympic champion's sample was re-analysed by the International Olympic Committee and was one of three to test positive for the banned blood booster MIRCERA.
The Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's decision that Roche's peg-EPO product, Mircera, infringes four Amgen, Inc.
The world's biggest maker of cancer medicines, was barred by an appeals court from selling the anemia drug Mircera in the U.
Mircera, the brand name for CERA made by Swiss-based Roche Holdings, helps users produce more red blood cells, company spokeswoman Claudia Schmitt said.
Open-label clinical trials randomizing patients to Mircera or a comparator ESA have demonstrated comparable efficacy in hemoglobin effect.
Judge William Young in Boston granted Amgen's motion for summary judgment that Mircera, which is undergoing U.
Roche, Basel, Switzerland, has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorization be granted for MIRCERA for the treatment of anaemia associated with chronic kidney disease.