methoxy polyethylene glycol-epoetin beta

Contraindicated in:

Hypersensitivity;
Uncontrolled hypertension;
Treatment of anemia due to cancer chemotherapy;
Pure red cell aplasia.

Use Cautiously in:

Patients with hypertension or cardiovascular disease (monitor closely);
History of seizures;
Dialysis patients (IV route recommended to ↓ immunogenicity);
Predialysis patients (may require lower doses);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <5 yr (safety and effectiveness not established);
Geri: Use lower doses in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, HF, hypotension, MI, THROMBOEMBOLIC EVENTS (ESPECIALLY WITH HEMOGLOBIN >11 G/DL)

Derm: STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

GI: diarrhea, constipation, vomiting

Hemat: PURE RED CELL APLASIA

Neuro: headache, SEIZURES, STROKE

Misc: fistula complications, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), ↑MORTALITY AND ↑ TUMOR GROWTH (WITH HEMOGLOBIN >12 G/DL)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 30 mcg/0.3 mL; 50 mcg/0.3 mL; 75 mcg/0.3 mL; 100 mcg/0.3 mL; 120 mcg/0.3 mL; 150 mcg/0.3 mL; 200 mcg/0.3 mL; 250 mcg/0.3 mL; 360 mcg/0.6 mL

Route/Dosage ⬆ ⬇

SC IV (Adults ): Hemodialysis: Initiate treatment when hemoglobin <10 g/dL (IV preferred). 0.6 mcg/kg every 2 wk; once hemoglobin stabilized, may be given monthly at twice the every 2-wk dose. If hemoglobin approaches or exceeds 11 g/dL, ↓ dose or interrupt therapy. Do not ↑ dose more frequently than every 4 wk. Not on hemodialysis: Consider treatment when hemoglobin <10 g/dL. 1.2 mcg/kg once monthly SUBQ or0.6 mcg/kg every 2 wk IV or SUBQ (once hemoglobin stabilized, may be given monthly at twice the every 2-wk dose). If hemoglobin exceeds 10 g/dL, ↓ dose or interrupt therapy. Do not ↑ dose more frequently than every 4 wk.
IV (Children 5–17 yr): Hemoglobin previously stabilized with epoetin alfa: Dose (in mcg) to be administered every 4 wk = (4 x weekly dose of epoetin alfa [in units])/125; Hemoglobin previously stabilized with darbepoetin alfa: Dose (in mcg) to be administered every 4 wk = (4 x weekly dose of epoetin alfa [in mcg])/0.55;

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Stimulates erythropoiesis (production of red blood cells).

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: antianemics

Pharmacologic Classification: hormones

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (62%) following SUBQ administration; IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 134 hr.

Time/Action Profile ⬆ ⬇

(effect on hemoglobin)

ROUTE	ONSET	PEAK	DURATION
IV, SUBQ	7–15 days	unknown	2–4 wk

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, vitamins, herbal products during therapy.
Advise patient to notify health care professional immediately if chest pain; difficulty breathing or shortness of breath; rash, itching, or 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.
Rep: Advise females of reproductive potential 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.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇