3月27日FDA批准Omontys用于治疗透析慢性肾脏病（CKD）成年患者贫血的新药.
Omontys是新型ESA，是一种合成的聚乙二醇肽，它可结合和激活促红细胞生成素受体，因此同红细胞生成刺激药物一样起治疗作用。
批准基于2项Ⅲ期临床研究，在透析的CKD 贫血患者中进行的EMERALD 1和EMERALD 2两项Ⅲ期临床研究涉及1608名透析的CKD贫血患者，研究结果表明，相比于促红细胞生成素，peginesatide在10-12g/dL剂量下能够安全、有效的维持患者的血红蛋白水平。超过10%接受Peginesatide治疗的透析患者中，常见的副作用为腹泻、呕吐、高血压及关节疼痛。
Omontys的标签中包含一则加框警告，指出使用ESA会增加死亡、心肌梗死、卒中、血栓栓塞、血栓形成，以及肿瘤进展或复发的风险。在对照试验中，当ESA治疗的目标血红蛋白水平11 g/dl时，患者的死亡、严重心血管不良反应和卒中风险升高。
未接受透析的CKD患者、正在接受抗癌治疗的患者，以及贫血与CKD无关的患者，均不属于Omontys的适用人群，也不建议对这些患者使用该药。对于需要立即纠正贫血的患者，该药也不可作为输注红细胞的替代治疗。Omontys禁忌用于高血压未得到控制的患者。Omontys并不能改善症状、身体功能或健康相关性生活质量。
接受Omontys治疗的患者可能需要加强肝素抗凝，以预防血液透析期间体外环路发生凝血。
这是10余年来首个获批准的贫血症治疗药物。与以往的贫血症药物相比，Omontys的优势在于只需每月注射一次，而市场上已有的同类药物至少需每周注射一次。

Omontys
Generic Name: peginesatide
Dosage Form: injection solution
Indications and Usage for Omontys
Anemia Due to Chronic Kidney Disease
Omontys® is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
Limitations of Use
Omontys is not indicated and is not recommended for use:
•In patients with CKD not on dialysis because of safety concerns in this population [see Warnings and Precautions (5.1)].
•In patients receiving treatment for cancer and whose anemia is not due to CKD, because ESAs have shown harm in some settings and the benefit-risk factors for Omontys in this setting have not been evaluated [see Warnings and Precautions (5.2)].
•As a substitute for RBC transfusions in patients who require immediate correction of anemia.
•Omontys has not been shown to improve symptoms, physical functioning or health-related quality of life.
Omontys Dosage and Administration
Evaluation of Iron Stores and Nutritional Factors
Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Omontys [see Warnings and Precautions (5.7)].
Patients with Chronic Kidney Disease
Individualize dosing and use the lowest dose of Omontys sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. In controlled trials, patients 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. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)].
Initiation of Treatment and Starting Dose
Initiate Omontys treatment when the hemoglobin level is less than 10 g/dL.
The recommended starting dose for the treatment of anemia in patients who are not currently treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly.
Conversion from Epoetin Alfa or Darbepoetin Alfa to Omontys in Patients with CKD on Dialysis
Omontys is administered once monthly, either subcutaneously or intravenously.
In patients previously receiving epoetin alfa or darbepoetin alfa, estimate the starting monthly dose of Omontys for patients on the basis of the weekly dose of epoetin alfa or darbepoetin alfa at the time of substitution (see Table 1). Maintain the route of administration (intravenous or subcutaneous injection).
•For patients previously receiving epoetin alfa, the first dose of Omontys should be administered one week after the last epoetin alfa dose was administered.
•For patients previously receiving darbepoetin alfa, the first dose of Omontys should be administered at the next scheduled dose in place of darbepoetin alfa.
General Guidance including Dose Adjustments
Monitor hemoglobin levels at least every 2 weeks until stable, then monitor at least monthly. When adjusting therapy, consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.
•Do not increase the dose more frequently than once every 4 weeks.
•If the hemoglobin rises rapidly (e.g., more than 1 g/dL in the 2 weeks prior to the dose or more than 2 g/dL in 4 weeks), reduce the dose of Omontys by 25% or more as needed to reduce rapid responses.
•If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Omontys. After a dose has been withheld and once the hemoglobin begins to decrease, Omontys may be restarted at a dose approximately 25% below the previously administered dose.
•For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
•For patients who do not respond adequately over a 12-week escalation period, increasing the Omontys dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Omontys if responsiveness does not improve [see Warnings and Precautions (5.5)].
•If a dose of Omontys is missed, administer the missed dose as soon as possible and restart Omontys at the prescribed once monthly dosing frequency.
When treating dialysis patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2).
Refer patients who self-administer Omontys to the Instructions for Use [see Patient Counseling Information (17)].
Preparation and Administration of Omontys
Omontys is packaged as single use vials, single use pre-filled syringes, and multiple use vials. Omontys packaged in single use vials and single use pre-filled syringes contains no preservatives. Omontys is administered either subcutaneously or intravenously.
•Use the single use vial or single use pre-filled syringe only one time. Discard unused portion of Omontys in single use vials.
•Store unused portions of Omontys in multiple use vials at 36 °F to 46 °F (2 °C to 8 °C). Discard 28 days after first use.
•Protect Omontys from light. Store Omontys vials or pre-filled syringes in their cartons until time of use.
•Do not use if tamper-evident seal on carton is broken or missing.
•Do not dilute Omontys and do not administer in conjunction with other drug solutions.
•Omontys should be inspected visually for particulate matter and coloration prior to administration. Do not use any vials or pre-filled syringes of Omontys exhibiting particulate matter or a coloration other than colorless to slightly yellow.
Contraindications
Omontys is contraindicated in patients with:
•Uncontrolled hypertension [see Warnings and Precautions (5.3)].
•​Serious allergic reactions to Omontys which may include anaphylaxis [see Warnings and Precautions (5.4)].
Warnings and Precautions
Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism
•In controlled clinical trials of other ESAs in patients with CKD comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL) (see Table 2), increased risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events was observed in the higher target groups.
•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. Use caution in patients with coexistent cardiovascular disease and stroke [see Dosage and Administration (2.2)]. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.
•In controlled clinical trials of ESAs in patients with cancer, increased risk for death and serious adverse cardiovascular reactions was observed. These adverse reactions included myocardial infarction and stroke.
•In controlled clinical trials, ESAs increased risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and deep venous thrombosis (DVT) was observed in patients undergoing orthopedic procedures.
The design and overall results of 3 large trials comparing higher and lower hemoglobin targets are shown in Table 2 (Normal Hematocrit Study (NHS), Correction of Hemoglobin Outcomes in Renal Insufficiency (CHOIR) and Trial to Reduce Cardiovascular Events with Aranesp® Therapy (TREAT)).
Patients with Chronic Kidney Disease Not on Dialysis
Omontys is not indicated and is not recommended for the treatment of anemia in patients with CKD who are not on dialysis.
A higher percentage of patients (22%) who received Omontys experienced a composite cardiovascular safety endpoint event compared to 17% who received darbepoetin alfa in two randomized, active-controlled, open-label, multi-center trials of 983 patients with anemia due to CKD who were not on dialysis. The trials had a pre-specified, prospective analysis of a composite safety endpoint consisting of death, myocardial infarction, stroke, or serious adverse events of congestive heart failure, unstable angina or arrhythmia (hazard ratio 1.32, 95% CI: 0.97, 1.81).
Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer receiving ESAs
Omontys is not indicated and is not recommended for reduction of RBC transfusions in patients receiving treatment for cancer and whose anemia is not due to CKD because ESAs have shown harm in some settings and the benefit-risk factors for Omontys in this setting have not been evaluated.
The safety and efficacy of Omontys have not been established for use in patients with anemia due to cancer chemotherapy. Results from clinical trials of ESAs in patients with anemia due to cancer therapy showed decreased locoregional control, progression-free survival and/or decreased overall survival. The findings were observed in clinical trials of other ESAs administered to patients with: breast cancer receiving chemotherapy, advanced head and neck cancer receiving radiation therapy, lymphoid malignancy, cervical cancer, non-small cell lung cancer, and with various malignancies who were not receiving chemotherapy or radiotherapy.
Hypertension
Omontys is contraindicated in patients with uncontrolled hypertension.
Appropriately control hypertension prior to initiation of and during treatment with Omontys. Reduce or withhold Omontys if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions [see Patient Counseling Information (17)].
Serious Allergic Reactions
​Serious allergic reactions, including anaphylactic reactions, hypotension, bronchospasm, angioedema and generalized pruritus, may occur in patients treated with Omontys. Immediately and permanently discontinue Omontys and administer appropriate therapy if a serious allergic reaction occurs.
Lack or Loss of Response to Omontys
For lack or loss of hemoglobin response to Omontys, initiate a search for causative factors (e.g., iron deficiency, infection, inflammation, bleeding). If typical causes of lack or loss of hemoglobin response are excluded, evaluate the patient for the presence of antibodies to peginesatide. In the absence of antibodies to peginesatide, follow dosing recommendations for management of patients with an insufficient hemoglobin response to Omontys therapy [see Dosage and Administration (2.2)].
Contact Affymax, Inc. (1-855-466-6689) to perform assays for binding and neutralizing antibodies.
Dialysis Management
Patients may require adjustments in their dialysis prescriptions after initiation of Omontys. Patients receiving Omontys may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Laboratory Monitoring
Evaluate transferrin saturation and serum ferritin prior to and during Omontys treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20% [see Dosage and Administration (2.1)]. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Following initiation of therapy and after each dose adjustment, monitor hemoglobin every 2 weeks until the hemoglobin is stable and sufficient to minimize the need for RBC transfusion. Thereafter, hemoglobin should be monitored at least monthly provided hemoglobin levels remain stable.
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
•Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions (5.1)].
•Hypertension [see Warnings and Precautions (5.3)].
•Serious allergic reactions [see Warnings and Precautions (5.4)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Omontys cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.
Patients with Chronic Kidney Disease
Adverse reactions were determined based on pooled data from two active controlled studies of 1066 dialysis patients treated with Omontys and 542 treated with epoetin, including 938 exposed for at least 6 months and 825 exposed for greater than one year to Omontys. The population for Omontys was 20 to 93 years of age, 58.5% male, and the percentages of Caucasian, Black (including African Americans), and Asian patients were 57.9%, 37.4%, and 3.1%, respectively. The median weight adjusted dose of Omontys was 0.07 mg/kg and 113 U/week/kg of epoetin.
Seizures have occurred in patients participating in Omontys clinical studies. During the first several months following initiation of Omontys, blood pressure and the presence of premonitory neurologic symptoms should be monitored closely.
Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms, or change in seizure frequency.
Allergic and infusion-related reactions have been reported in patients treated with Omontys.
Postmarketing Experience
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious allergic reactions have been reported during postmarketing use of Omontys [see Warnings and Precautions (5.4)].
Immunogenicity
Of the 2357 patients tested during clinical trials, 29 (1.2%) had detectable levels of peginesatide-specific binding antibodies. There was a higher incidence of peginesatide-specific binding antibodies in patients dosed subcutaneously (1.9%) as compared to those dosed intravenously (0.7%). Peginesatide neutralizing antibodies were detected in vitro using a cell-based functional assay in 21 of these patients (0.9%). In approximately half of all antibody-positive patients, the presence of antibodies was associated with declining hemoglobin levels, the requirement for increased doses of Omontys to maintain hemoglobin levels, and/or transfusion for anemia of CKD. No cases of pure red cell aplasia (PRCA) developed in patients receiving Omontys during clinical trials.
Drug Interactions
No formal drug/drug interaction studies have been performed. Peginesatide does not bind to serum albumin or lipoproteins as demonstrated in in vitro protein binding studies in rat, monkey and human sera. In vitro studies conducted with human hepatocytes or microsomes have shown no potential for peginesatide to induce or inhibit CYP450 enzymes.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Peginesatide was teratogenic and caused embryofetal lethality when administered to pregnant animals at doses and/or exposures that resulted in polycythemia. Omontys should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Administration of peginesatide by intravenous injection to rats and rabbits during organogenesis was associated with embryofetal toxicity and malformations. Dosing was every third day in rats for a total of 5 doses and every fifth day in rabbits for a total of 3 doses (0.01 to 50 mg/kg/dose). In rats and rabbits, adverse embryofetal effects included reduced fetal weight, increased resorption, embryofetal lethality, cleft palate (rats only), sternum anomalies, unossification of sternebrae and metatarsals, and reduced ossification of some bones. Embryofetal toxicity was evident in rats at peginesatide doses of ≥ 1 mg/kg and the malformations (cleft palate and sternoschisis, and variations in blood vessels) were mostly evident at doses of ≥ 10 mg/kg. The dose of 1 mg/kg results in exposures (AUC) comparable to those in humans after intravenous administration at a dose of 0.35 mg/kg in patients on dialysis. In a separate embryofetal developmental study in rats, reduced fetal weight and reduced ossification were seen at a lower dose of 0.25 mg/kg. Reduced fetal weight and delayed ossification in rabbits were observed at ≥ 0.5 mg/kg/dose of peginesatide. In a separate embryofetal developmental study in rabbits, adverse findings were observed at lower doses and included increased incidence of fused sternebrae at 0.25 mg/kg. The effects in rabbits were observed at doses lower (5% - 50%) than the dose of 0.35 mg/kg in patients.
Nursing Mothers
It is not known whether peginesatide is excreted in human milk. Because many drugs are excreted into human milk, caution should be exercised when Omontys is administered to a nursing woman.
Pediatric Use
The safety and efficacy of Omontys in pediatric patients have not been established.
Geriatric Use
Of the total number of dialysis patients in Phase 3 clinical studies of Omontys, 32.5% were age 65 and over, while 13% were age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Overdosage
Omontys overdosage can elevate hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Omontys dosage and/or with phlebotomy, as clinically indicated [see Pharmacodynamics (12.2)]. Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions (5.3)].
Omontys Description
Peginesatide is an ESA that is a synthetic, pegylated dimeric peptide comprised of two identical, 21-amino acid chains covalently bonded to a linker derived from iminodiacetic acid and β-alanine. Peginesatide is manufactured as an acetate salt. The dimeric peptide (approximate MW 4,900 daltons) is covalently linked to a single lysine-branched bis-(methoxypoly(ethylene glycol)) (PEG) chain (approximate MW 40,000 daltons). The structure is provided in Figure 1; peginesatide has no amino acid sequence homology to erythropoietin. The empirical formula is C2031H3950N62O958S6 (free base). The total molecular weight is approximately 45,000 daltons.
Omontys (peginesatide) Injection is formulated as a sterile, colorless to slightly yellow preservative-free solution and a sterile, colorless to slightly yellow preserved solution for intravenous or subcutaneous administration.
Single use, preservative-free injectable solutions of Omontys in vials and pre-filled syringes are supplied in multiple strengths. Each 0.5 mL vial or pre-filled syringe contains peginesatide, 23.5 mg sorbitol, 1.5 mg sodium phosphate monobasic (dihydrate), 0.06 mg sodium phosphate dibasic, 0.02 mg polysorbate 20, and water for injection, USP. Sodium hydroxide added to adjust pH. The pH is 6.0 ± 0.3.
Multiple use, preserved injectable solutions of Omontys in vials are supplied in two fill volumes: 1 mL and 2 mL. Each mL contains 10 mg peginesatide, 47 mg sorbitol, 5 mg phenol, 1.5 mg L-methionine, 0.6 mg glacial acetic acid, and water for injection, USP. Sodium hydroxide added to adjust pH. The pH is 5.4 ± 0.5.
Omontys - Clinical Pharmacology
Mechanism of Action
Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in vitro.
Pharmacodynamics
Peginesatide increases the reticulocyte count, followed by increases in hemoglobin. The rate of hemoglobin increase varies among patients and is dependent upon the dose of peginesatide administered.
Effect on Cardiac Repolarization
The effect of Omontys (0.1 mg/kg intravenously) on QTc interval was evaluated in a randomized, double-blind, double-dummy, three-period crossover thorough QT study in 65 healthy subjects. A dose of 0.1 mg/kg administered intravenously did not delay cardiac repolarization compared to placebo. The dose of 0.1 mg/kg is adequate to represent the median dose (0.07 mg/kg) in the phase 3 trials, however is not sufficient to represent doses higher than 0.1 mg/kg in the intended patients.
Pharmacokinetics
Following single intravenous and subcutaneous injections at doses ranging from 0.03 to 0.1 mg/kg to dialysis patients, maximal plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) increase with dose. Following subcutaneous administration, the maximum concentrations of peginesatide are reached in approximately 48 hours. The bioavailability of peginesatide following subcutaneous administration is approximately 46%.
No mass balance study has been conducted in humans. Preclinical radiolabeled peginesatide study indicated that peginesatide is not metabolized and that urinary excretion was the predominant route of elimination following either intravenous or subcutaneous dosing.
The mean half-life is 25.0 ± 7.6 hours following intravenous administration and 53.0 ± 17.7 hours following subcutaneous administration in healthy subjects. The mean half-life in dialysis patients is 47.9 ± 16.5 hours following intravenous administration. Mean systemic clearance is 0.5 ± 0.2 mL/hr•kg and mean volume of distribution is 34.9 ± 13.8 mL/kg following intravenous administration in dialysis patients. No accumulation is observed following administration every 4 weeks following intravenous or subcutaneous administration. The pharmacokinetics of peginesatide in patients with CKD on dialysis are not altered by age, gender or race based on population pharmacokinetic analyses.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Peginesatide was not carcinogenic in a 2-year study in rats at doses up to 0.25 mg/kg administered every 3 weeks by intravenous injection. This dose is approximately 14% the human exposure (AUC) at a dose of 0.35 mg/kg in patients on dialysis. Peginesatide was not carcinogenic in a 26-week study in rasH2 transgenic mice when administered by intravenous injection at doses of 0.1, 0.25, or 0.5 mg/kg/dose every 3 weeks.
Peginesatide was not mutagenic or clastogenic in the in vitro Ames assay, in vitro mammalian chromosome aberration assay, and an in vivo mouse erythrocyte micronucleus assay.
When peginesatide was administered intravenously to male and female rats at weekly intervals prior to and during mating, and treated rats mated, fertility was reduced at ≥ 0.1 mg/kg (approximately 5% of the dose of 0.35 mg/kg in patients) and was most evident at doses ≥ 1.0 mg/kg of peginesatide. Adverse effects in males included reduced weight of seminal vesicles and prostate. Decreased viable fetuses at ≥ 0.1 mg/kg in females appeared to be due to pre- and post-implantation losses. There was no apparent drug-related effect on estrous cycles or number of corpora lutea.
Clinical Studies
The efficacy and safety of Omontys in patients with CKD on dialysis were demonstrated in two randomized, active-controlled, open-label, multi-center clinical studies that evaluated Omontys in the maintenance of hemoglobin concentrations in patients who were being treated with another ESA (epoetin alfa or epoetin beta) at the time of study entry. The primary efficacy endpoint for each study was the change in hemoglobin from Baseline to the Evaluation Period (Weeks 29 to 36) using a non-inferiority comparison with epoetin. In Study 1, patients received epoetin via the intravenous route of administration and continued to use this route after randomization to either Omontys or epoetin. The average patient exposure year [PEY] per patient was 1.14 years for Omontys and the average PEY per patient was 1.25 years for epoetin. In Study 2, the route of administration previously used for epoetin (intravenous or subcutaneous) was used. The average PEY per patient was 1.17 years for Omontys and the average PEY per patient was 1.16 years for epoetin. The median dose of Omontys was 0.07 mg/kg administered once monthly and the median dose of epoetin was 113 units/kg administered weekly (in 1 to 3 doses).
Patients were randomized (2 to 1) to receive Omontys once monthly, or to continue on their current ESA treatment 1 to 3 times per week. The Omontys starting dose was based on the patient's total weekly ESA dose during the last week of the screening period. As shown in Table 4, treatment with Omontys once monthly and treatment with epoetin 1-3 times per week maintained hemoglobin concentrations within the study pre-specified hemoglobin range (10 to 12 g/dL). In both studies, the proportion of patients receiving transfusions was similar in each treatment group.
Studies 1 and 2 had a pre-specified, prospective, pooled analysis of a composite cardiovascular safety endpoint consisting of death, myocardial infarction, stroke, or serious adverse events of congestive heart failure, unstable angina or arrhythmia. In patients receiving Omontys, 22.8% experienced one of these events compared to 24.4% receiving epoetin (hazard ratio 0.95, 95% CI 0.77, 1.17).
How Supplied/Storage and Handling
How Supplied
Omontys is available in single use vials, single use pre-filled syringes, and multiple use vials. The vial caps and plungers of the pre-filled syringes are designated with unique colors for each dosage strength. The single use pre-filled syringes are supplied with a 27 gauge, ½ inch needle. To reduce the risk of accidental needle sticks after application, each single use pre-filled syringe is equipped with a safety device that activates and covers the needle once the dose has been given.
Stability and Storage
The recommended storage temperature is refrigerated at 2 °C to 8°C (36°F to 46°F). Protect from light. Retain in carton until time of use.
Storage of single use vials, single use pre-filled syringes or multiple use 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 30 days.
After first use, the multiple use vials should be stored at 2 °C to 8 °C, and then discarded after 28 days.

OMONTYS 10 MG/M 1ML VIAL (PEGINESATIDE) SP ORDER FDA APPROVED OMONTYS TO TREAT ANEMIA IN ADULT PATIENTS ON DIALYSIS
(PEGINESATIDE)

OMONTYS 20 MG/2 ML 2ML VIAL (PEGINESATIDE) SP ORDE FDA APPROVED OMONTYS TO TREAT ANEMIA IN ADULT PATIENTS ON DIALYSIS