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Epoetin Alfa-Epbx (Retacrit)

Trade Name : RETACRIT

Pfizer Laboratories Div Pfizer Inc

INJECTION, SOLUTION

Strength 2000 [iU]/mL

ERYTHROPOIETIN Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Epoetin Alfa-Epbx (Retacrit) which is also known as RETACRIT and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 2000 [iU]/mL per ml. Read more

Epoetin Alfa-Epbx (Retacrit) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE
  • See full prescribing information for complete boxed warning.
  • Chronic Kidney Disease:
  • Cancer:
  • Perisurgery:
  • RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
  • Limitations of Use
  • RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being ().
  • RETACRIT is not indicated for use:
  • No data
  • Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment ().
  • Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis ().
  • Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly ().
  • Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients u2265 5 years) ().
  • Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly ().
  • Injection
  • 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials.
  • Injection
  • 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL in single-dose vials ()
  • RETACRIT is contraindicated in patients with:
  • Uncontrolled hypertension ()
  • Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs ()
  • Serious allergic reactions to RETACRIT or other epoetin alfa products ()
  • No data
  • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( and ). Use caution in patients with coexistent cardiovascular disease and stroke ().
  • Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer ().
  • Hypertension: Control hypertension prior to initiating and during treatment with RETACRIT ().
  • Seizures: Epoetin alfa products increase the risk for seizures in patients with CKD (). Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms ().
  • PRCA: If severe anemia and low reticulocyte count develop during RETACRIT treatment, withhold RETACRIT and evaluate for PRCA ().
  • Serious Allergic Reactions: Discontinue RETACRIT and manage reactions ().
  • Severe Cutaneous Reactions: Discontinue RETACRIT ().
  • Phenylketonurics: Contains phenylalanine ().
  • The following serious adverse reactions are discussed in greater detail in other sections of the label:
  • To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc., a Pfizer company, at 1-800-438-1985, or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch
  • .
  • Patients with CKD: Adverse reactions in u2265 5% of epoetin alfa-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection ().
  • Patients on Zidovudine due to HIV-infection: Adverse reactions in u2265 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation ().
  • Patients with Cancer on Chemotherapy: Adverse reactions in u2265 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis ().
  • Surgery Patients: Adverse reactions in u2265 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension ().
  • No data
  • RETACRIT overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of RETACRIT dosage and/or with phlebotomy, as clinically indicated . Cases of severe hypertension have been observed following overdose with ESAs .
  • Epoetin alfa-epbx is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin.
  • RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in single-dose vials, formulated with an isotonic sodium chloride/sodium phosphate-buffered solution.
  • Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP.
  • Each 1 mL vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP.
  • No data
  • The carcinogenic potential of epoetin alfa products has not been evaluated.
  • Epoetin alfa was not mutagenic or clastogenic under the conditions tested: epoetin alfa was negative in the bacterial reverse mutation assay (Ames test), in the mammalian cell gene mutation assay (the hypoxanthine-guanine phosphoribosyl transferase [HGPRT] locus), in an chromosomal aberration assay in mammalian cells, and in the mouse micronucleus assay.
  • When administered intravenously to male and female rats prior to and during mating, and to females through the beginning of implantation (up to gestational day 7; dosing stopped prior to the beginning of organogenesis), doses of 100 and 500 Units/kg/day of epoetin alfa caused slight increases in pre-implantation loss, post-implantation loss and decreases in the incidence of live fetuses. It is not clear whether these effects reflect a drug effect on the uterine environment or on the conceptus. This animal dose level of 100 Units/kg/day approximates the clinical recommended starting dose, depending on the patient's treatment indication, but may be lower than the clinical dose in patients whose doses have been adjusted.
  • No data
  • RETACRIT (epoetin alfa-epbx) injection is a sterile, preservative-free, clear, and colorless solution in single-dose vials available as:
  • Store at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C). Do not freeze.
  • Do not shake. Do not use RETACRIT that has been shaken or frozen.
  • Store RETACRIT vials in the original carton until use to protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)n
  • Inform patients:
  • Instruct patients who self-administer RETACRIT of the:
  • Manufactured by Hospira, Inc., a subsidiary of Pfizer Inc., Lake Forest, IL 60045 USAUS License No. 1974Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10017 USA
  • This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
  • LAB-0826-3.0
  • No data
  • RETACRITu2122 (n- )
  • Use these Instructions for Use if you or your caregiver has been trained to give RETACRIT injections at home. Do not give yourself the injection unless you have received training from your healthcare provider. If you are not sure about giving the injection or you have questions, ask your healthcare provider for help.
  • Before reading these Instructions for Use, read the Medication Guide that comes with RETACRIT for the most important information you need to know.
  • When you receive your RETACRIT vial make sure that:
  • How should I prepare for an injection of RETACRIT?
  • Only use disposable syringes and needles. Use the syringes and needles only one time and then throw them away as instructed by your healthcare providern- .
  • Important: Follow these instructions exactly to help avoid infections.
  • Preparing the dose:
  • Selecting and preparing the injection site:
  • RETACRIT can be injected into your body using two different ways (routes) as described below. Follow your healthcare provider's instructions about how you should inject RETACRIT. In patients on hemodialysis, the intravenous (IV) route is recommended.
  • How should I dispose of the vials, syringes, and needles?
  • Do not reuse the single-dose vials, syringes, or needles. Throw away the vials, syringes, and needles as instructed by your healthcare provider or by following these steps:
  • Keep RETACRIT and all medicines out of reach of children.
  • These Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Manufactured by Hospira, Inc., a subsidiary of Pfizer Inc., Lake Forest, IL 60045 USAUS License No. 1974Distributed by Pfizer Labs, a division of Pfizer Inc., New York, NY 10017 USA
  • LAB-0828-2.0
  • Issued: 1/2020
  • NDC 0069-1305-01Rx only
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 2,000 Units/mL
  • 1 mL single-dose vial
  • Pfizer Biosimilars
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 2,000 Units/mL
  • NDC 0069-1305-10Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE10 x 2,000 Units/mL single-dose vials (containing 1 mL)
  • Phenylketonurics: Contains Phenylalanine,0.5 mg per mL
  • For Intravenous or Subcutaneous Use Only
  • Single-dose vial
  • Discard unused portion
  • Pfizer Biosimilars
  • NDC 0069-1306-01Rx only
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 3,000 Units/mL
  • 1 mL single-dose vial
  • Pfizer Biosimilars
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 3,000 Units/mL
  • NDC 0069-1306-10Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE10 x 3,000 Units/mL single-dose vials (containing 1 mL)
  • Phenylketonurics: Contains Phenylalanine,0.5 mg per mL
  • For Intravenous or Subcutaneous Use Only
  • Single-dose vial
  • Discard unused portion
  • Pfizer Biosimilars
  • NDC 0069-1307-01Rx only
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 4,000 Units/mL
  • 1 mL single-dose vial
  • Pfizer Biosimilars
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 4,000 Units/mL
  • NDC 0069-1307-10Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE10 x 4,000 Units/mL single-dose vials (containing 1 mL)
  • Phenylketonurics: Contains Phenylalanine,0.5 mg per mL
  • For Intravenous or Subcutaneous Use Only
  • Single-dose vial
  • Discard unused portion
  • Pfizer Biosimilars
  • NDC 0069-1308-01Rx only
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 10,000 Units/mL
  • 1 mL single-dose vial
  • Pfizer Biosimilars
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 10,000 Units/mL
  • NDC 0069-1308-10Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE10 x 10,000 Units/mL single-dose vials (containing 1 mL)
  • Phenylketonurics: Contains Phenylalanine,0.5 mg per mL
  • For Intravenous or Subcutaneous Use Only
  • Single-dose vial
  • Discard unused portion
  • Pfizer Biosimilars
  • NDC 0069-1309-01Rx only
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 40,000 Units/mL
  • 1 mL single-dose vial
  • Pfizer Biosimilars
  • Retacritu2122Epoetin Alfa-epbxrecombinant
  • 40,000 Units/mL
  • NDC 0069-1309-04Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE4 x 40,000 Units/mL single-dose vials (containing 1 mL)Phenylketonurics: Contains Phenylalanine, 0.5 mg per mLFor Intravenous or Subcutaneous Use OnlySingle-dose vialDiscard unused portion
  • Pfizer Biosimilars

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