Xyntha

Xyntha

factor viii

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Plasma/albumin-free recombinant coagulation factor VIII.
Description
Each single-use vial contains nominally 250, 500, 1000, or 2000 IU of XYNTHA.
The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is secreted by a genetically engineered Chinese hamster ovary (CHO) cell line. The cell line is grown in a chemically defined cell culture medium that contains recombinant insulin, but does not contain any materials derived from human or animal sources.
The rAHF in XYNTHA is a purified glycoprotein, with an approximate molecular mass of 170 kDa consisting of 1,438 amino acids, which does not contain the B-domain. The amino acid sequence of the rAHF is comparable to the 90 + 80 kDa form of human coagulation factor VIII.
The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a patented synthetic peptide affinity ligand. The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step.
The potency expressed in International Units (IU) is determined using the chromogenic assay of the European Pharmacopoeia. The Wyeth manufacturing reference standard for potency has been calibrated against the World Health Organization (WHO) International Standard for factor VIII activity using the one-stage clotting assay. The specific activity of XYNTHA is 5,500 to 9,900 IU per milligram of protein.
XYNTHA is formulated as a sterile, non-pyrogenic, no preservative, lyophilized powder preparation for intravenous injection. Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride, and polysorbate 80.
Each XYNTHA vial has the actual recombinant factor VIII (rFVIII) potency in International Units stated on the label.
Action
Pharmacology: Mechanism of Action: XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.
Pharmacodynamics: The activated partial thromboplastin time (aPTT) is prolonged in patients with hemophilia. Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII. Treatment with XYNTHA normalizes the aPTT over the effective dosing period.
Clinical Studies: Safety and Efficacy Study: In an open label safety and efficacy study (n=94), subjects received XYNTHA in a routine prophylaxis treatment regimen with on-demand treatment administered as clinically indicated. All 94 subjects were treated with at least one dose and all are included in the intent-to-treat (ITT) population. All subjects had been previously treated (previously treated patients or PTPs) with factor VIII. Eighty-nine (89) subjects accrued ≥50 exposure days (EDs). Median age for the 94 treated subjects was 24 years (mean 27.7 and range 12-60 years). All subjects had ≥150 previous exposure days with baseline FVIII activity level of ≤2%.
Of the 94 subjects enrolled in this study, 30 evaluable subjects participated in a randomized crossover pharmacokinetics study. Twenty-five (25/30) of these subjects with FVIII:C ≤ 1% completed both the first (PK1) and the second (PK2) pharmacokinetic assessments [see Pharmacology as previously mentioned].
For routine prophylaxis, XYNTHA was administered at a dose of 30 ± 5 IU/kg 3 times a week with provisions for dose escalation based on pre-specified criteria. Seven dose escalations were prescribed for 6 subjects during the course of the study. Forty-three subjects (43/94 or 45.7%) reported no bleeding while on routine prophylaxis. The median annualized bleeding rate (ABR) for all bleeding episodes was 1.9 (mean 3.9, range 0-42.1).
Fifty-three subjects (53/94) received XYNTHA on-demand treatment for a total of 187 bleeding episodes Seven of these bleeding episodes occurred in subjects prior to switching to a prophylaxis treatment regimen. One hundred ten of 180 bleeds (110/180 or 61.1%) occurred ≤48 hours after the last dose and 38.9% (70/180 bleeds) occurred >48 hours after the last dose. The majority of bleeds reported to occur ≤48 hours after the last prophylaxis dose were traumatic (64/110 bleeds or 58.2%). Forty-two bleeds (42/70 or 60%) reported to occur >48 hours after the last prophylaxis dose were spontaneous. The on-demand treatment dosing regimen was determined by the investigator. The median dose for on-demand treatment was 30.6 IU/kg (range 6.4 to 74.4 IU/kg).
The majority of bleeding episodes (173/187 or 92.5%) resolved with 1 or 2 infusions (Table 5). Subjects rated the outcomes of infusions on a pre-specified four (4) point hemostatic efficacy scale. One hundred thirty-two of 187 bleeding episodes (132/187 or 70.6%) treated with XYNTHA were rated excellent or good in their response to initial treatment, 45 (24.1%) were rated moderate. Five (2.7%) were rated no response, and 5 (2.7%) were not rated. (See Table 1.)

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Perioperative Management Study In an open-label study (n=30) for surgical prophylaxis in subjects with hemophilia A, XYNTHA was administered to 25 efficacy-evaluable PTPs with severe or moderately severe (FVIII:C ≤ 2%) hemophilia A undergoing major surgical procedures (11 total knee replacements, 1 hip replacement, 5 synovectomies, 1 left ulnar nerve transposition release, 1 ventral hernia repair/scar revision, 1 knee arthroscopy, 1 revision and debridement of the knee after a total knee replacement, 1 hip arthroplasty revision, 1 stapes replacement, 1 ankle arthrodesis, and 1 pseudotumor excision).
The results of the hemostatic efficacy ratings for these subjects are presented in Table 6. Investigator's ratings of efficacy at the end of surgery and at the end of the initial postoperative period were "excellent" or "good" for all assessments. Intraoperative blood loss was reported as "normal" or "absent" for all subjects. Thirteen of the subjects (13/25 or 52%) had blood loss in the postoperative period. The postoperative blood loss was rated as "normal" for ten of these cases while three cases were rated "abnormal" (1 due to hemorrhage following surgical trauma to the epigastric artery, 1 due to an 800 mL blood loss after hip replacement surgery, and 1 after an elbow synovectomy where the blood loss could not be measured by the investigator). (see Table 2).

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Pharmacokinetics: The pharmacokinetic parameters of XYNTHA 30 previously treated adult patients (PTP) 12 to 60 years old, who received a single infusion of 50 IU/kg XYNTHA are summarized in Table 5.
In addition, 25 of the same subjects later received a single infusion of 50 IU/kg of XYNTHA for a 6-month follow-up pharmacokinetic study. The parameters were comparable between baseline and 6 months, indicating no time-dependent changes in the pharmacokinetics of XYNTHA.
In a separate study, 8 of 30 subjects at least 12 years old with hemophilia A undergoing elective major surgery received a single 50 IU/kg infusion of XYNTHA. The pharmacokinetic parameters in these subjects are also are summarized in Table3. (See Table 3.)

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Table 4 shows the pharmacokinetic parameters of nine children; four aged 14 or 15 years of age, who are also included in the summary for the adults as previously mentioned, along with five children aged 3.7-5.8 years after single 50 IU/kg doses of XYNTHA. Compared to adults, the half-life of XYNTHA is shorter in children and the clearance (based on per kg body weight) is approximately 40% higher in children. (See Table 4.)

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Toxicology: Nonclinical Toxicology: Carcinogenicity, Mutagenicity, Impairment of Fertility: No studies have been conducted with XYNTHA to assess its mutagenic or carcinogenic potential. XYNTHA has been shown to be comparable to the predecessor product with respect to its biochemical and physicochemical properties, as well as its nonclinical in vivo pharmacology and toxicology. By inference, predecessor product and XYNTHA would be expected to have equivalent mutagenic and carcinogenic potential. The predecessor product has been shown to be non-genotoxic in the mouse micronucleus assay. No studies have been conducted in animals to assess impairment of fertility or fetal development.
Animal Toxicology and/or Pharmacology: Preclinical studies evaluating XYNTHA in hemophilia A dogs without inhibitors demonstrated safe and effective restoration of hemostasis. XYNTHA demonstrated a toxicological profile that was similar to the toxicological profile observed with the predecessor product. Toxicity associated with XYNTHA was primarily associated with anti-FVIII neutralizing antibody generation first detectable at 15 days of repeat dosing in high (approximately 735 IU/kg/day) level-dosed, non-human primates.
Indications/Uses
Control and Prevention of Bleeding Episodes in Hemophilia A: XYNTHA, Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.
Surgical Prophylaxis in Patients with Hemophilia A: XYNTHA, Antihemophilic Factor (Recombinant), Plasma/Albumin-Free, is indicated for surgical prophylaxis in patients with hemophilia A.
Pediatric Use: Xyntha is appropriate for use in children of all ages, including newborns.
Dosage/Direction for Use
For intravenous use after reconstitution only.
Dose: Initiate treatment with XYNTHA under the supervision of a physician experienced in the treatment of hemophilia A.
Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Titrate the administered doses to the patient's clinical response.
One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL.
The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas: (See Equation 1.)

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or; (See Equation 2.)

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Control and Prevention of Bleeding Episodes: A guide for dosing XYNTHA for the control and prevention of bleeding episodes is provided in Table 1. Maintain the plasma factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1 for the indicated period. (See Table 5.)

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Perioperative Management: A guide for dosing XYNTHA during surgery (perioperative management) is provided in Table 2. Maintain the plasma factor VIII activity level at or above the level (in % of normal or in IU/dL) outlined in Table 2 for the indicated period. Monitor the replacement therapy by means of plasma factor VIII activity. (See Table 6.)

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Preparation and Reconstitution: Preparation: Always wash hands before performing the following procedures.
Use aseptic technique during the reconstitution procedures.
Use all components in the reconstitution and administration of this product as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.
Note: If the patient uses more than one vial of XYNTHA per infusion, reconstitute each vial according to the following instructions. Remove the diluent syringe, leaving the vial adapter in place. Use a separate 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of each vial. Do not detach the diluent syringe or the large luer lock syringe until ready to attach the large luer lock syringe to the next vial adapter [see Dosage & Administration].
Reconstitution: Allow the XYNTHA vial and the prefilled diluent syringe to reach room temperature.
Remove the plastic flip-top cap from the XYNTHA vial to expose the central portions of the rubber stopper.
Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any surface. factor VIII activity.
Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
Place the XYNTHA vial on a flat surface. While holding the adapter package, place the vial adapter over the XYNTHA vial and press down firmly on the package until the adapter spike penetrates the vial stopper.
Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.
Break off the tamper-resistant plastic tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if not administering reconstituted XYNTHA immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated.
Lift the package away from the adapter and discard the package.
Place the XYNTHA vial, with the adapter attached, on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.
Slowly depress the plunger rod to inject all the diluent into the XYNTHA vial.
Without removing the syringe, gently swirl the contents of the XYNTHA vial until the powder is dissolved.
Note: The final solution should be inspected visually for particulate matter before administration. The solution should be clear to slightly opalescent and colorless. If it is not, discard the solution and use a new kit.
Invert the XYNTHA vial and slowly draw the solution into the syringe.
Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Discard the empty XYNTHA vial with the adapter attached.
Note: If the solution is not used immediately, carefully replace the syringe cap. Do not touch the syringe tip or the inside of the cap.
Store the reconstituted solution at room temperature prior to administration, but use within 3 hours after reconstitution.
XYNTHA, when reconstituted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of XYNTHA, including storage time elapsed in a PVC container following reconstitution. The tubing of the infusion set included with this kit does not contain DEHP.
Administration: For intravenous infusion after reconstitution only.
Inspect the final XYNTHA solution visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear to slightly opalescent and colorless. If it is not, discard the solution and use a new kit.
Use the tubing and the prefilled diluent syringe provided in this kit or a single sterile disposable plastic syringe. Do not administer XYNTHA in the same tubing or container with other medicinal products.
Attach the syringe to the luer end of the infusion set tubing provided.
Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.
Remove the protective needle cover and perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. Verify proper needle placement.
Inject the reconstituted XYNTHA product intravenously over several minutes. The rate of administration should be determined by the patient's comfort level.
After infusing XYNTHA, remove and discard the infusion set. The amount of drug product left in the infusion set will not affect treatment.
Note: Dispose of all unused solution, the empty vial(s), and other used medical supplies in an appropriate container.
Overdosage
No symptoms of overdosage have been reported.
Contraindications
XYNTHA is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.
Special Precautions
Hypersensitivity Reactions: Allergic type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients of the early signs or symptoms of hypersensitivity reactions (including hives [rash with itching], generalized urticaria, chest tightness, wheezing, and hypotension) and anaphylaxis. Discontinue XYNTHA if hypersensitivity symptoms occur and administer appropriate emergency treatment.
XYNTHA contains trace amounts of hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
Neutralizing Antibodies: Inhibitors have been reported following administration of XYNTHA. Monitor patients for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration to determine if a factor VIII inhibitor is present [see Monitoring: Laboratory Tests as follows].
Monitoring Laboratory Tests: Use individual factor VIII values for recovery and, if clinically indicated, other pharmacokinetic characteristics to guide dosing and administration.
Monitor plasma factor VIII activity levels by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained, when clinically indicated [see Dosage & Administration].
Monitor for development of factor VIII inhibitors. Perform assay to determine if factor VIII inhibitor is present when expected factor VIII activity plasma levels are not attained, or when bleeding is not controlled with the expected dose of XYNTHA. Use Bethesda Units (BU) to titer inhibitors.
Use in Pregnancy & Lactation: Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with XYNTHA. It is not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.
Labor and Delivery: There is no information available on the effect of factor VIII replacement therapy on labor and delivery. XYNTHA should be used only if clinically indicated.
Nursing Mothers: It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if XYNTHA is administered to nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated.
Use in Children: In the completed open label safety and efficacy study of XYNTHA (n=94), 17 adolescent subjects 12 to <16 years of age with severe or moderately severe hemophilia A (FVIII:C ≤ 2%), who were previously treated with at least 150 EDs to FVIII products, received XYNTHA for on-demand and follow-up treatment. The median dose per infusion was 47 IU/kg (min-max: 24-74) and the median exposure per subject was 6 days (min-max: 1-26).
Of the 17 subjects < 16 yrs of age who received at least 1 dose of XYNTHA, 10 subjects had bleeding episodes during the study. Among the 10 subjects with response assessments, a total of 66 bleeding episodes were treated with on-demand infusions of XYNTHA. The majority of the bleeding episodes (63/66 or 95.5%) resolved with 1 or 2 infusions. Thirty-eight (38) of 66 bleeding episodes (57.6%) were rated excellent or good in their response to initial treatment, 24 (36.4%) were rated as moderate and 4 (6.1%) were not rated.
Additional data are available from a safety and efficacy study of XYNTHA in children < 6 years of age with moderately severe or severe hemophilia A (FVIII:C ≤ 2%) and with at least 20 prior EDs to FVIII products. In this study subjects received XYNTHA for on-demand and follow-up treatment of bleeding episodes. The median dose per infusion was 28 IU/kg and the median exposure per subject was 16 days.
Of the 27 subjects < 6 years of age who received at least 1 dose of XYNTHA, 25 had bleeding episodes during the study. Among the 24 subjects with response assessments there were 493 bleeds. The majority of the bleeding episodes (462/493 or 93.7%) resolved with 1 or 2 infusions. Subjects rated the outcomes of infusions on a pre-specified four (4) point hemostatic efficacy scale. Of 493 bleeding episodes treated with XYNTHA, 468 (94.9%) were rated excellent or good in their response to initial treatment and 22 (4.5%) were rated as moderate.
In comparison to the pharmacokinetic parameters reported in adults, children have shorter half-lives, larger volumes of distribution and lower recovery of factor VIII after XYNTHA administration. The clearance (based on per kg body weight) is approximately 40% higher in children. Higher or more frequent doses may be required to account for the observed differences in pharmacokinetic parameters. [see Pharmacology under Actions].
Use in Elderly: Clinical studies of XYNTHA did not include subjects aged 65 and over. In general, dose selection for an elderly patient should be individualized.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with XYNTHA. It is not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.
Labor and Delivery: There is no information available on the effect of factor VIII replacement therapy on labor and delivery. XYNTHA should be used only if clinically indicated.
Nursing Mothers: It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if XYNTHA is administered to nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated.
Adverse Reactions
The most common adverse reactions (≥10%) with XYNTHA in adult and pediatric PTPs were headache, arthralgia, pyrexia,, and cough.
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 the clinical trials of another drug and may not reflect the rates observed in clinical practice.
XYNTHA was evaluated in five clinical studies (N=155), four completed studies with adult and pediatric PTPs and one ongoing study in pediatric PTPs < 6 years of age.
The safety and efficacy of XYNTHA was evaluated in two completed pivotal studies. In the first study (n=94), safety and efficacy were examined in previously treated patients (PTPs) with hemophilia A (factor VIII activity in plasma [FVIII:C] ≤ 2%) who received XYNTHA for routine prophylaxis and on demand treatment. Ninety-four subjects received at least one dose of XYNTHA, resulting in a total of 6,775 infusions [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. The second study (n=30) examined the use of XYNTHA for surgical prophylaxis in previously treated patients with severe or moderately severe hemophilia A (FVIII:C ≤ 2%) who required elective major surgery and were expected to receive XYNTHA replacement therapy for at least 6 days post-surgery. All subjects received at least one dose of XYNTHA, resulting in 1161 infusions. One subject received XYNTHA for a pre-surgery pharmacokinetic assessment only and did not undergo surgery [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Across all studies, safety was evaluated in 48 previously treated pediatric patients <16 years of age (28 children, < 6 years of age and 20 adolescents, 12 to <16 years of age). A total of 7,150 infusions of XYNTHA were administered with a median dose per infusion of 29 IU/kg (min, max: 9,108 IU/kg).
Across all studies, the most common adverse reactions (≥ 10%) with XYNTHA in adult and pediatric PTPs were headache (26% of subjects), arthralgia (25%), pyrexia (21%), cough (11%). Other adverse reactions reported in ≥ 5% of subjects were: diarrhea (8%), vomiting (7%), asthenia (7%), and nausea (6%).
Immunogenicity: There is a potential for immunogenicity with therapeutic proteins. The development of factor VIII inhibitors with XYNTHA was evaluated in 144 adult and pediatric PTPs with at least 50 EDs. Laboratory-based assessments for FVIII inhibitor (partial Nijmegen modification of the Bethesda inhibitor assay) were conducted in the clinical studies. The criterion for a positive FVIII result test result was ≥ 0.6 BU/mL. Across all studies, 3 subjects developed factor VIII inhibitors (2.1%).
The clinical studies for XYNTHA examined 124 subjects (94 for bleeding and 30 for surgery) who had previously been treated with factor VIII (PTPs). In the safety and efficacy study, two subjects with inhibitors were observed in 89 subjects (2.2%) who completed ≥50 exposure days. In a Bayesian statistical analysis, results from this study were used to update PTP results from a prior supporting study using XYNTHA manufactured at the initial facility (with one de novo and two recurrent inhibitors observed in 110 subjects) and the experience with predecessor product (with one inhibitor observed in 113 subjects). The Bayesian analysis indicated that the population inhibitor rate for XYNTHA, an estimate of the 95% upper limit of the true inhibitor rate, was 4.17%.
None of the PTPs developed anti-CHO (Chinese hamster ovary) or anti-TN8.2 antibodies. One PTP developed anti-FVIII antibodies; but, this subject did not develop an inhibitor.
In the surgery study, one low titer persistent inhibitor and one transient false-positive inhibitor were reported. In this study, one surgical subject developed anti-CHO cell antibodies with no associated allergic reaction. One subject developed anti-FVIII antibodies; but, this patient did not develop an inhibitor.
Across all studies, safety was evaluated in 40 previously treated pediatric patients <16 years of age with at least 50 EDs (25 children, <6 years of age and 15 adolescents, 12 to <16 years of age). Of these, one pediatric subject developed an inhibitor.
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. For these reasons, comparisons of the incidence of antibodies to XYNTHA with the incidence of antibodies to other products may be misleading.
Post-marketing Experience: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following post-marketing adverse reactions have been reported for XYNTHA: Anaphylaxis, Inadequate Therapeutic Response.
Caution For Usage
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product: No special requirements.
Incompatibilities: Not applicable.
Storage
Product as packaged for sale: XYNTHA should be stored under refrigeration at a temperature of 2°C to 8°C (36°F to 46°F) for up to 3 years.
Within the expiration date, XYNTHA also may be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. After room temperature storage, XYNTHA can be returned to the refrigerator until the expiration date. Do not store XYNTHA at room temperature and return it to the refrigerator more than once.
The diluents syringe may be stored at 2°C to 25°C (36°F to 77°F). Freezing should be avoided to prevent damage to the pre-filled diluents syringe. During storage, avoid prolonged exposure of XYNTHA vial to light.
Product after reconstitution: The reconstituted solution may be stored at room temperature prior to administration. The product does not contain a preservative and should be used within 3 hours.
MIMS Class
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Powd for inj (white to off-white, lyophilized powder in vial) 250 IU x 1's. 500 IU x 1's. 1,000 IU x 1's. 2,000 IU x 1's.
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