Procrit (Epoetin Alfa) Infusion Therapy in New York

Procrit (epoetin alfa) is an erythropoiesis-stimulating agent, or ESA. Its FDA-approved labeling opens with a boxed warning — the most serious warning the FDA can require on a prescription drug — and it is reproduced here in full, ahead of everything else on this page, because it governs whether Procrit should be used at all. The heading, exactly as printed in the current prescribing information (revised 4/2024), reads:

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease

• In controlled trials, patients with chronic kidney disease (CKD) 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.
• Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
• To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
• Use ESAs only for anemia from myelosuppressive chemotherapy.
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• Discontinue following the completion of a chemotherapy course.

Perisurgery

• Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.

The second bullet under Chronic Kidney Disease is the one to read twice. The label does not say there is a safe hemoglobin target that avoids these risks; it says no trial has found one. Nothing on this page, and no monitoring schedule, changes that. The single governing instruction the boxed warning repeats in both the CKD and the cancer sections is to use the lowest dose sufficient to reduce the need for red blood cell transfusion.

Procrit has four FDA-approved indications, and in each one the stated purpose is to decrease the need for red blood cell (RBC) transfusion — not to raise a hemoglobin number as an end in itself, and not to relieve symptoms. Conditions are written into the indications themselves.

• Anemia due to chronic kidney disease — the label covers CKD "including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion."
• Anemia due to zidovudine in patients with HIV infection — only where zidovudine is administered at 4200 mg/week or less and endogenous serum erythropoietin is 500 mUnits/mL or less.
• Anemia due to concomitant myelosuppressive chemotherapy — in patients with non-myeloid malignancies, and only where, at initiation, "there is a minimum of two additional months of planned chemotherapy."
• Reduction of allogeneic red blood cell transfusion in elective, noncardiac, nonvascular surgery — for patients with perioperative hemoglobin greater than 10 and up to 13 g/dL who are at high risk for perioperative blood loss.

The label follows those indications with a section headed Limitations of Use. It is quoted here in full, because it is the part a provider page most often leaves out and the part that most protects a reader:

"PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being. PROCRIT is not indicated for use:

• In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
• In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
• In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
• In patients scheduled for surgery who are willing to donate autologous blood.
• In patients undergoing cardiac or vascular surgery.
• As a substitute for RBC transfusions in patients who require immediate correction of anemia."

Any other use — including anemia of chronic disease, myelodysplastic syndromes, or anemia of cancer not caused by chemotherapy — is off-label. The 2019 ASCO/ASH clinical practice guideline update similarly states that ESAs "should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent."

The thresholds are unusually specific, and they are the practical heart of prescribing this drug. In CKD and in chemotherapy-induced anemia the label sets the starting line at a hemoglobin below 10 g/dL, and it sets a separate ceiling at which the dose must be reduced or interrupted. All of the following are from the prescribing information.

One dose-adjustment rule runs across settings: "If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT by 25% or more." The same 25% reduction applies in cancer chemotherapy if hemoglobin increases by more than 1 g/dL in any 2-week period, or reaches a level needed to avoid transfusion. The label also directs that the dose not be increased more frequently than once every 4 weeks, and that hemoglobin in CKD be monitored "at least weekly until stable, then monitor at least monthly." For CKD not on dialysis, the KDIGO 2026 anemia guideline states that "for most people, the Hb threshold for initiation should be 8.5 to 10.0 g/dl."

Route depends on the indication, and that distinction matters more than most patients are told. For anemia due to chronic kidney disease, Procrit may be given intravenously or subcutaneously, and the label states that "the intravenous route is recommended for patients on hemodialysis." For anemia due to concomitant myelosuppressive chemotherapy, adult dosing is subcutaneous while pediatric dosing is intravenous. For surgery, dosing is subcutaneous. For anemia due to zidovudine in patients with HIV infection, either route is labeled.

Two label requirements come before the first dose. Iron status must be evaluated in all patients before and during treatment, with supplemental iron therapy administered when serum ferritin is less than 100 mcg/L or transferrin saturation is less than 20%. And other causes of anemia — vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding — must be corrected or excluded before Procrit is started. In pregnant women, lactating women, neonates and infants the label directs use of single-dose vials only, because multiple-dose vials contain benzyl alcohol.

Stopping rules are part of the labeled regimen, not an afterthought. In chemotherapy, if there is no response measured by hemoglobin after 8 weeks, or transfusions are still required, the label directs discontinuation; the boxed warning separately directs discontinuation following completion of a chemotherapy course. In surgery patients, "deep venous thrombosis prophylaxis is recommended during PROCRIT therapy."

Rates observed in one drug's clinical trials cannot be compared directly with rates from another drug's trials and may not reflect the rates observed in practice. With that caveat, the figures below are from Procrit's own label.

In patients with CKD on dialysis (Procrit n=148, placebo n=96):

In patients with cancer receiving chemotherapy (Procrit n=168, placebo n=165), reported reactions included nausea 35% versus 30%, vomiting 20% versus 16%, myalgia 10% versus 5%, arthralgia 10% versus 6%, stomatitis 10% versus 8%, weight decrease 9% versus 5%, bone pain 7% versus 4%, insomnia 6% versus 2%, dysphagia 5% versus 2%, and thrombosis 5% versus 3%. In patients with CKD not on dialysis, reported reactions included hypertension 13.7% versus 10.1% and arthralgia 12.2% versus 7.6%. In zidovudine-treated patients with HIV infection (n=144 versus n=153), pyrexia was 42% versus 34%, cough 26% versus 14%, rash 19% versus 7%, and pulmonary embolism was reported in 1% of Procrit-treated patients. In the first of the label's two surgery studies, deep vein thrombosis was reported in 6% of patients at 300 Units/kg and 3% at 100 Units/kg, against 3% on placebo.

Reactions identified after approval include seizures, pure red cell aplasia, serious allergic reactions, injection site irritation and pain, porphyria, and severe cutaneous reactions. Procrit is contraindicated in uncontrolled hypertension, in pure red cell aplasia that begins after treatment with Procrit or other erythropoietin protein drugs, and after serious allergic reactions to Procrit. Multiple-dose vials, which contain benzyl alcohol, are contraindicated in neonates, infants, pregnant women and lactating women.

No. The ESA APPRISE Oncology REMS has been discontinued, and there is no Risk Evaluation and Mitigation Strategy for epoetin alfa today. If you have read older material describing prescriber enrollment, hospital or practice certification, or a REMS-specific patient consent form, that requirement no longer exists.

FDA released the requirement on 13 April 2017. The agency's supplement approval letter states that "a REMS is no longer required," on findings that healthcare providers demonstrate acceptable knowledge of the product risks of decreased survival and increased risk of tumor progression or recurrence, and that prescribing use is consistent with the labeled indication — concluding that the risks can be conveyed adequately through the current product labeling. Contemporaneous reporting in ASH Clinical News confirms the action covered both epoetin alfa and darbepoetin alfa for anemia related to myelosuppressive chemotherapy. The current prescribing information contains no mention of a REMS anywhere in it.

What did not change. The boxed warning above did not change. The Limitations of Use did not change. The Medication Guide remains part of FDA-approved labeling and is provided to the patient; the label's Highlights section directs readers to the Patient Counseling Information and Medication Guide. Clinically, the label still restricts use to anemia from myelosuppressive chemotherapy, still excludes patients whose cancer treatment is curative in intent, and still directs discontinuation after the chemotherapy course.

And "no REMS" does not mean "no paperwork." Payer requirements are entirely separate from REMS and were unaffected by the 2017 action. Medicare's national coverage conditions and commercial prior-authorization and step-therapy rules all still apply — those are covered in the next section.

Three different rules can apply, depending on the payer and the setting, and the first is a common surprise.

A commercial plan may require a different ESA first. UnitedHealthcare's commercial medical benefit drug policy 2026D0028Y, effective and last revised 1 April 2026, states that "Retacrit is the preferred ESA product." Coverage of Procrit under that policy requires either documented trial and failure of an adequate dose of Retacrit, or documented intolerance or contraindication to Retacrit, in each case with physician attestation. Note the units: that policy states its thresholds in hematocrit, not hemoglobin — hematocrit below 30% at initiation for CKD, continuation while hematocrit remains below 33% on dialysis and below 30% not on dialysis, and for chemotherapy an initial hematocrit of 30% or less with documentation of normal iron stores. UnitedHealthcare also states that "Listing of a code in this policy does not imply any right to reimbursement or guarantee claim payment." Choosing between an originator and a biosimilar is a prescriber decision interacting with plan policy.

Medicare, dialysis. Under the ESRD Prospective Payment System, the per-treatment bundled rate for renal dialysis services expressly includes erythropoiesis-stimulating agents. For a Medicare beneficiary receiving epoetin alfa as part of dialysis, the ESA sits inside that bundle and is not separately billable — which is why dialysis patients receive it at the dialysis facility rather than at an infusion center.

Medicare, cancer and CKD. National Coverage Determination 110.21 covers ESAs for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma and lymphocytic leukemia when hemoglobin is "less than 10 g/dL (or the hematocrit is less than 30%)", requires a rise of at least 1 g/dL within 4 weeks for treatment to continue, and includes "the 8 weeks following the final dose" of chemotherapy in each course. It does not cover prophylactic use, anemia of cancer unrelated to cancer treatment, anemia associated only with radiotherapy, or anemia with uncontrolled hypertension. For CKD there is no national coverage determination — CMS declined to issue one in June 2011, leaving CKD coverage to local contractor policy. New York's Medicare contractor is National Government Services, Jurisdiction K.

Prime Infusions administers physician-ordered infusion therapy at thirteen New York centers plus one in Atlanta: Brooklyn and Boro Park; Fresh Meadows, Astoria, Jamaica and Howard Beach in Queens; the Upper East Side in Manhattan; Staten Island; Great Neck in Nassau County and Inwood in the Five Towns; Port Jefferson Station in Suffolk County; and New City in Rockland County and Monroe in Orange County. Per-center product availability is not published here, so our care team confirms which location can accommodate a given order. Coverage, prior authorization and out-of-pocket cost are determined solely by your health plan; our team verifies benefits and submits the authorization request, and we cannot guarantee approval. Physicians can start a referral at Treatment Referrals; patients can reach us through Contact Us or at 718-443-4000.