Coagulation factor IX, GlycoPEGylated (Rebinyn)

Coagulation factor IX, GlycoPEGylated (Rebinyn)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Yashasvi Aryaputra[2];

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Overview

Coagulation factor IX, GlycoPEGylated (Rebinyn) is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1

• Dosing Information

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Condition 2

• Dosing Information

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

Non–Guideline-Supported Use

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

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Condition 2

• Dosing Information

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Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

Non–Guideline-Supported Use

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

Contraindications

• REBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins).

Warnings

Hypersensitivity Reactions

• Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with REBINYN. The product may contain traces of hamster proteins which in some patients may cause allergic reactions. Early signs of allergic reactions, which can progress to anaphylaxis, may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Observe patients for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of exposure to the product. Discontinue use of REBINYN if allergic- or anaphylactic - type reactions occur, and initiate appropriate treatment.

Inhibitors

• The formation of inhibitors (neutralizing antibodies) to Factor IX may occur during Factor replacement therapy in the treatment of hemophilia B. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors.

• An association between the development of Factor IX inhibitors and allergic reactions has been reported. Evaluate patients experiencing allergic reactions for the presence of an inhibitor. Patients with Factor IX inhibitors may be at an increased risk of severe allergic reactions with subsequent exposure to Factor IX.

Thrombotic Events

• The use of Factor IX-containing products has been associated with thrombotic complications. Due to the potential risk of thrombotic complications, monitor patients for early signs of thrombotic and consumptive coagulopathy when administering this product to patients with liver disease, post-operatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation (DIC). In each of these situations, the benefit of treatment with REBINYN should be weighed against the risk of these complications.

Nephrotic Syndrome

• Nephrotic syndrome has been reported following immune tolerance induction therapy with Factor IX products in hemophilia B patients with Factor IX inhibitors, often with a history of allergic reactions to Factor IX. The safety and efficacy of using REBINYN for immune tolerance induction have not been established.

Monitoring Laboratory Tests

• If monitoring of Factor IX activity is performed, use a chromogenic assay or selected one-stage clotting assay validated for use with REBINYN.

• The one-stage clotting assay results can be significantly affected by the type of activated partial thromboplastin time (aPTT) reagent used, which can result in over- or under-estimation of Factor IX activity. Avoid the use of silica-based reagents, as some may overestimate the activity of REBINYN. If a validated one-stage clotting or chromogenic assay is not available locally, then use of a reference laboratory is recommended.

• If bleeding is not controlled with the recommended dose of REBINYN, or if the expected Factor IX activity levels in plasma are not attained, then perform a Bethesda assay to determine if Factor IX inhibitors are present.

Adverse Reactions

Clinical Trials Experience

• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

• During the clinical development program, 115 previously treated male patients received at least one dose of REBINYN. A previously treated patient was defined as a subject with a history of at least 150 exposure days to other Factor IX products (adolescent/adult subjects) or 50 exposure days to other Factor IX products (pediatric subjects), and no history of inhibitors. There were a total of 8801 exposure days, equivalent to 170 patient-years. A total of 40 patients (35%) were treated for more than 2 years.

• Adverse reactions are shown in Table 3.

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Immunogenicity

• Subjects were monitored for inhibitory antibodies to factor IX prior to dosing, on a monthly basis for the first three months, every two months up to one year, every three months for an additional year, and then every 6 months until end of trial.

• No inhibitors were reported in the clinical trials in previously treated patients.

• In an ongoing trial in previously untreated patients, anaphylaxis has occurred with development of a factor IX inhibitor following treatment with REBINYN. Inhibitor development and anaphylactic reactions are more likely to occur during the early phases of factor IX replacement therapy.

• The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

Neurologic Considerations

• Animals administered repeat doses of REBINYN showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown. The physician should consider whether the patient may be vulnerable, such as infants and children who have developing brains and patients who are cognitively impaired. Physician’s discretion is advised with regard to neurocognitive assessments, taking into consideration factors such as duration of use, cumulative dose, age of the patient and related comorbidities that are likely to increase the risks to patients. Adverse neurologic reactions should be reported.

Postmarketing Experience

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Risk Summary

• There are no data with REBINYN use in pregnant women to determine whether there is a drug-associated risk. Animal reproduction studies have not been conducted with REBINYN. It is unknown whether REBINYN can cause fetal harm when administered to a pregnant woman or can affect fertility. REBINYN should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Coagulation factor IX, GlycoPEGylated (Rebinyn) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Coagulation factor IX, GlycoPEGylated (Rebinyn) during labor and delivery.

Nursing Mothers

Risk Summary

• There is no information regarding the presence of REBINYN in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for REBINYN and any potential adverse effects on the breastfed infant from REBINYN or from the underlying maternal condition.

Pediatric Use

• Safety and efficacy of REBINYN were evaluated in 43 previously treated pediatric patients. Twelve of these subjects (28%) were 1 to 6 years of age; 13 subjects (30%) were 7 to 12 years of age; and 18 subjects (42%) were 13 to 17 years of age. Pharmacokinetic parameters were evaluated for 28 of these subjects who were treated with REBINYN 40 IU/kg.

• No difference in the safety profile of REBINYN was observed between previously treated pediatric subjects and adult subjects. Body weight-adjusted clearance was higher for pediatric subjects than for adult subjects. Fixed doses were studied in the clinical trials and no dose adjustment was required for pediatric subjects.

• Twenty-eight of the forty-three previously treated pediatric subjects (1 to 17 years old) were treated with REBINYN for 137 bleeding episodes. Results are provided in Table 4.

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• Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection; Good: Noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection;

• Moderate: Probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours;

• Poor: No improvement, or worsening of symptoms within 8 hours after the second of two injections.

• Animals administered repeat doses of REBINYN showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown. No adverse neurologic effects of PEG have been reported in infants, children, and adolescents exposed to REBINYN during clinical trials. The potential consequences of long term exposure have not been fully evaluated.

Geriatic Use

• Clinical studies of REBINYNdid not include sufficient numbers of subjects age 65 and over to determine whether or not they respond differently than younger subjects.

• Animals administered repeat doses of REBINYN showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown. No adverse neurologic effects of PEG have been reported in adults exposed to REBINYN during clinical trials, however use in older adults with baseline cognitive dysfunction has not been fully evaluated.

Gender

There is no FDA guidance on the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Coagulation factor IX, GlycoPEGylated (Rebinyn) in patients who are immunocompromised.

Administration and Monitoring

Administration

Intravenous

• Bring vial and prefilled diluent syringe to room temperature prior to use.

• Slowly add diluent from the prefilled syringe to the vial and then swirl the assembly gently until powder in vial is dissolved.

• Resulting solution should be clear and have no particles.

• Administer immediately or store in the vial with the vial adapter and syringe attached for up to 4 hours at room temperature, 30 degrees C (86 degrees F) or lower.

• Do not administer in same tubing or container with other medicinal products.

• The prefilled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector.

• Reconstituted product may be also withdrawn into standard 10 mL Luer-lock plastic syringe for use with need<ss connectors for IV catheders that are incompatible with the diluent syringe.

• Attach the syringe to Luer end of infusion needle set and administer reconstituted product IV slowly over 1 to 4 minutes.

• Dispose of any unused product.

Monitoring

• Control of bleeding episodes and management of perioperative bleeding in patients with hemophilia B indicates efficacy.

• Factor IX activity: Use a chromogenic assay or selected one-stage clotting assay validated for use with Rebinyn(R) to avoid over- or under-estimation of Factor IX activity; Avoid the use of silica-based reagents, which may result in an over-estimation.

• Development of inhibitors (neutralizing antibodies): Use both clinical evaluation and laboratory testing; if bleeding is not controlled with the recommended dosage, or if the expected Factor IX activity levels in plasma are not attained, used a Bethesda assay to determine if Factor IX inhibitors are present.

• Early signs of thrombotic and consumptive coagulopathy: When administering to patients with liver disease, postoperatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation.

• Signs and symptoms of an acute hypersensitivity reaction: Especially during the early phases of exposure.

IV Compatibility

There is limited information regarding the compatibility of Coagulation factor IX, GlycoPEGylated (Rebinyn) and IV administrations.

Overdosage

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Coagulation factor IX, GlycoPEGylated (Rebinyn)
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Mechanism of Action

• Patients with hemophilia B are deficient in coagulation Factor IX, which is required for effective hemostasis. Treatment with REBINYN temporarily replaces the missing coagulation Factor IX.

• The Factor IX in REBINYN is conjugated to a 40-kDa polyethylene glycol molecule, which slows down its removal from the blood circulation.

Structure

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Structure in the drug label.

Pharmacodynamics

• The administration of REBINYN increases plasma levels of Factor IX and can temporarily correct the coagulation defect in hemophilia B patients, as reflected by a decrease in aPTT.

Pharmacokinetics

• Pharmacokinetic (PK) parameters of REBINYN were evaluated in previously treated subjects, including a subset of subjects in the adult/adolescent trial and all subjects in the main phase of the pediatric trial. PK samples were collected prior to dosing and at multiple time points up to 168 hours after dosing. The analysis of plasma samples was conducted using the one-stage clotting assay.

• Steady state pharmacokinetic parameters for adolescents and adults following once-weekly prophylactic treatment of REBINYN 40 IU/kg are shown in Table 5.

This image is provided by the National Library of Medicine.

• The mean steady state pre-dose trough levels and post-dose peak levels across the clinical trials for all previously treated subjects are shown in Table 6.

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• Single-dose pharmacokinetic parameters of REBINYN in children, adolescents and adults are listed in Table 7.

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• Pharmacokinetics were investigated in 9 subjects in the adult/adolescent trial, of which 5 were normal weight (body mass index (BMI) 18.5 to 24.9 kg/m2) and 4 were overweight (BMI 25 to <29.9 kg/m2). The pharmacokinetic parameters were not affected by BMI.

• The Factor IX activity following 80 IU/kg infusion in major surgery is shown in Table 8.

This image is provided by the National Library of Medicine.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Studies in animals to evaluate the carcinogenic or genotoxic potential of REBINYN, or studies to determine the effects of REBINYN on fertility, have not been performed.

Animal Toxicology and/or Pharmacology

• REBINYN was intraveneously administered in repeat-dose toxicity studies in immune-deficient rats (40-1200 IU/kg/week for 26 weeks) and immune-competent monkeys (350-3750 IU/kg/week for four weeks). Accumulation of the 40-kDa polyethylene-glycol (PEG) was detected by immunohistochemical staining in epithelial cells of the choroid plexus in the brain of the majority of animals. This finding was not associated with morphological changes or abnormal clinical signs.

Clinical Studies

• Four multicenter, non-controlled trials were conducted to evaluate the safety and efficacy of REBINYN in routine treatment, on-demand treatment and control of bleeding episodes, and perioperative management in previously treated male patients with hemophilia B (Factor IX activity ≤ 2%). Previously treated patients were defined as patients receiving treatment with other Factor IX products for ≥150 exposure days for adolescents and adults, and ≥50 exposure days for pediatric patients. The key exclusion criteria across trials included known or suspected hypersensitivity to trial or related products, known history of Factor IX inhibitors or current inhibitor ≥0.6 BU, HIV-positive with a viral load ≥400,000 copies/mL or CD4+ lymphocyte count ≤200/μL, additional congenital or acquired coagulation disorders, previous arterial thrombotic events, and recipients of immune modulating or chemotherapeutic medication.

• The efficacy evaluation included 105 subjects: 62 adults (18 to 65 years old), 18 adolescents (13 to 17 years old), and 25 children (1 to 12 years old).

• Adult/adolescent trial: The trial included 74 adolescent and adult previously treated patients. There were two routine treatment arms, with single-blind randomization to either 10 IU/kg or 40 IU/kg once-weekly for approximately 52 weeks, and an open-label on-demand treatment arm for approximately 28 weeks.

• Surgery trial: The surgery trial included 13 previously treated adolescent and adult patients who received one infusion of REBINYN 80 IU/kg on the day of surgery, and post-operatively received infusions of 40 IU/kg, at the investigator’s discretion, for up to 3 weeks after surgery.

• Adult/adolescent extension trial: There were 71 subjects from the adult/adolescent trial and surgery trial who continued routine treatment or on-demand treatment with REBINYN in an open-label extension trial, with the possibility to switch regimens during the trial.

• Pediatric trial: The main phase of the pediatric trial included 25 pediatric previously treated patients (1-12 years old) in which subjects received routine treatment with REBINYN 40 IU/kg once-weekly for approximately 52 weeks.

Treatment of Bleeding Episodes

• A total of 597 bleeding episodes were reported in 79 out of 105 subjects in the clinical program in previously treated patients. Bleeding episodes were treated with REBINYN at 40 IU/kg for minor or moderate bleeds or 80 IU/kg for major bleeds, with additional doses of 40 IU/kg as needed. The median dose to treat a bleeding episode was 42.3 IU/kg.

• An overall assessment of efficacy was performed by the subject (for home treatment) or the study site investigator (for treatment under medical supervision) using a 4-point scale of excellent, good, moderate, or poor. The overall success rate (defined as excellent or good) for treatment of bleeding episodes was 93.2% as shown in Table 9.

• The success rate and dose needed for treatment of bleeding episodes were independent of the location of the bleeding. The success rate for treatment of bleeding episodes was also independent of whether the bleed was traumatic or spontaneous.

This image is provided by the National Library of Medicine.

• Efficacy assessment was based on 591 evaluated bleeding episodes (data missing for six bleeding episodes). Efficacy was assessed according to a four-point scale using:

• Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection; Good: Noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection;

• Moderate: Probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours;

• Poor: No improvement, or worsening of symptoms within 8 hours after the second of two injections.

• In the on-demand arm there were 143 bleeding episodes in 14 of 15 subjects. The overall success rate was 95.1% (135 of 142 evaluated bleeds). A total of 120 bleeds (83.9%) of the 143 bleeding episodes were treated with one injection, and 20 (14.0%) were treated with two injections.

Perioperative Management

• In the surgery trial, the efficacy analysis of REBINYN in perioperative management included 13 surgical procedures of which 9 were major and performed in 13 previously treated adolescent and adult patients. The procedures included 9 orthopedic, 1 gastrointestinal and 3 in the oral cavity.

• The hemostatic effect during surgery was evaluated on a four-point scale of excellent, good, moderate, or poor. The intraoperative hemostatic effect was rated as excellent or good for the 13 surgeries, for a success rate of 100%. A pre-operative dose of 80 IU/kg REBINYN was effective, and no subjects required additional doses on the day of surgery. The median number of additional 40 IU/kg doses in the post-operative period was 2.0 for Days 1 to 6, 1.5 for Days 7-13, and 3.0 for Days 1 to 13. The mean total consumption of REBINYN in the pre- and post-operative period was 241 IU/kg (range: 81 to 460 IU/kg). There was no unexpected postoperative bleeding.

• Three additional major surgeries and 18 minor surgery procedures were evaluated in the extension trial for REBINYN in previously treated patients. The hemostatic effect during major and minor surgery was confirmed with a success rate of 100%.

How Supplied

• REBINYN is supplied in packages comprised of a single-use vial containing nominally 500, 1000, or 2000 IU of Factor IX potency; a MixPro ® pre-filled diluent syringe containing 10 mM histidine solution (1.6 mg/mL), and a sterile vial adapter with 25 micrometer filter, which serves as a needleless reconstitution device.

• The actual Factor IX potency in IU is stated on each REBINYN carton and vial.

This image is provided by the National Library of Medicine.

• The REBINYN vials are made of glass, closed with a chlorobutyl rubber stopper (not made with natural rubber latex), and sealed with an aluminum cap.

• The pre-filled diluent syringes are made of glass, with a siliconised bromobutyl rubber plunger (not made with rubber latex).

• The closed vials and pre-filled diluent syringes are equipped with a tamper-evident snap-off cap which is made of polypropylene.

Storage

• Store REBINYN in the original package in order to protect from light.

• Store REBINYN under refrigeration at a temperature of 36°F-46°F (2°C – 8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label.

• REBINYN may be stored at room temperature not to exceed 86°F (30°C) for up to 6 months within the 24-month time period. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator.

• Do not use REBINYN after the end of the 6-month period at room temperature storage, or after the expiration date stated on the vial, whichever occurs earlier.

• Do not freeze REBINYN.

• Use REBINYN within 4 hours after reconstitution when stored at room temperature. Store the reconstituted product in the vial.

• Discard any unused reconstituted product stored at room temperature for more than 4 hours.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• Inform patients of the early signs of hypersensitivity reactions including rash, hives, itching, facial swelling, tightness of the chest and wheezing. Advise patients to discontinue use of the product and contact their healthcare provider if these symptoms occur.

• Advise patients to contact their healthcare provider for further treatment and/or assessment if they experience a lack of a clinical response to Factor IX therapy, as in some cases this may be a manifestation of an inhibitor.

• Advise patients to contact their healthcare provider if they experience any thrombotic complications.

• Advise patients to follow the recommendations regarding proper sharps disposal provided in the FDA-approved Instructions for Use.

Precautions with Alcohol

Alcohol-Coagulation factor IX, GlycoPEGylated (Rebinyn) interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

• Rebinyn

Look-Alike Drug Names

There is limited information regarding Coagulation factor IX, GlycoPEGylated (Rebinyn) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.