Xyntha

Last updated on RxList: 2/16/2021
Xyntha Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xyntha?

Xyntha [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free] is a recombinant coagulation factor VIII used to control and prevent bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). Xyntha does not treat von Willebrand's disease.

What Are Side Effects of Xyntha?

Common side effects of Xyntha include:

Dosage for Xyntha

Dosage and duration of treatment with Xyntha depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.

What Drugs, Substances, or Supplements Interact with Xyntha?

Xyntha may interact with other drugs. Tell your doctor all medications and supplements you use.

Xyntha During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Xyntha. Consult your doctor before breastfeeding.

Additional Information

Our Xyntha [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is hemophilia? See Answer
Xyntha Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • increased bleeding episodes;
  • any bleeding that will not stop;
  • chest pain; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nose bleeds;
  • nausea, vomiting, diarrhea;
  • headache, dizziness;
  • muscle or joint pain;
  • rash;
  • flushing (sudden warmth, redness, or tingly feeling);
  • fever, chills;
  • cough;
  • weakness; or
  • pain, swelling, itching, or redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xyntha (Antihemophilic Factor)

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Xyntha Professional Information

SIDE EFFECTS

The most common adverse reactions (≥10%) with XYNTHA in adult and pediatric previously treated patients (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 completed clinical studies (N=178), comprising four studies with adult and pediatric PTPs.

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 PTPs with severe to moderately severe hemophilia A (factor VIII activity in plasma [FVIII:C] ≤2%) who received XYNTHA for routine prophylaxis and ondemand treatment. Ninety-four subjects received at least one dose of XYNTHA, resulting in a total of 6,775 infusions [see Clinical Studies]. The second study (n=30) examined the use of XYNTHA for surgical prophylaxis in PTPs with severe to 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 1,161 infusions. One subject received XYNTHA for a pre-surgery pharmacokinetic assessment only and did not undergo surgery [see Clinical Studies].

Across all studies, safety was evaluated in 72 pediatric PTPs <17 years of age (46 subjects, <6 years of age (4 subjects were 0 to <2 years of age), 4 subjects 6 to <12 years of age, and 22 adolescents, 12 to <17 years of age). A total of 13,109 infusions of XYNTHA were administered with a median dose per infusion of 28 IU/kg (min-max: 6-108 IU/kg).

Across all studies, the most common adverse reactions (≥10%) with XYNTHA in adult and pediatric PTPs were headache (24%), arthralgia (23%), pyrexia (23%), and cough (12%). Other adverse reactions reported in ≥5% of subjects were: diarrhea (8%), vomiting (8%), and asthenia (6%).

Immunogenicity

There is a potential for immunogenicity with therapeutic proteins. The development of factor VIII inhibitors with XYNTHA was evaluated in 167 adult and pediatric PTPs with at least 50 exposure days (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, 4 subjects developed factor VIII inhibitors (2.4%).

The completed clinical studies for XYNTHA examined 178 subjects (30 for surgical prophylaxis) who had previously been treated with factor VIII (PTPs). In the first safety and efficacy study, factor VIII inhibitors were detected in two of 89 subjects (2.2%) who completed ≥50 EDs. 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 subject did not develop an inhibitor.

Across all studies, immunogenicity was evaluated in 64 pediatric PTPs <17 years of age with at least 50 EDs (43 children <6 years of age, 4 subjects 6 to <12 years of age, and 17 adolescents, 12 to <17 years of age). Of these, 2 pediatric subjects 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.

Postmarketing 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 postmarketing adverse reaction has been reported for XYNTHA:

Inadequate therapeutic response

Read the entire FDA prescribing information for Xyntha (Antihemophilic Factor)

© Xyntha Patient Information is supplied by Cerner Multum, Inc. and Xyntha Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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