Xyntha

Generic name: antihemophilic factor (recombinant)
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by  A Ras MD.

What is Xyntha used for?

Xyntha is a prescription medicine that is used to treat hemophilia. It is used to treat or prevent bleeding.

Before taking Xyntha, tell your doctor:

  • If you are allergic to Xyntha; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you are allergic to hamsters, talk with the doctor.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Xyntha with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Description

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.13 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.14 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, nonpyrogenic, no preservative, lyophilized powder preparation for intravenous injection. Each single-use prefilled dual-chamber syringe (named XYNTHA SOLOFUSE) contains nominally 250, 500, 1000, 2000, or 3000 IU of XYNTHA. Upon reconstitution, the product is a clear to slightly opalescent, colorless solution that contains sodium chloride, sucrose, L-histidine, calcium chloride and polysorbate 80.

 Mechanism of Action

XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.

What are some things I need to know or do while I take Xyntha?

  • Tell all of your health care providers that you take Xyntha. This includes your doctors, nurses, pharmacists, and dentists.
  • Allergic side effects may rarely happen.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Call the doctor right away if the normal dose does not work as well.
  • Talk with the doctor before you travel. You will need to bring enough of Xyntha for use during travel.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Xyntha best taken?

Use Xyntha as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Wash your hands before and after use.
  • If stored in a refrigerator, let Xyntha come to room temperature before mixing. Do not heat Xyntha.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Most products will be clear and colorless after mixing. Some products may be clear to slightly cloudy and colorless after mixing. Some products may be colorless to a faint yellow after mixing. Be sure you know what the product will look like after mixing.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • After mixing, do not refrigerate.
  • After mixing, be sure you know how long the product is good for and how to store it. Ask your doctor or pharmacist if you are not sure.
  • Throw away any part of opened vial not used after use.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of Xyntha that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color of mouth to blue.
  • Chest pain or pressure or a fast heartbeat.
  • Dizziness or passing out.
  • Feeling cold.
  • Fever or chills.
  • Flushing.
  • Pale skin.
  • Restlessness.
  • Shortness of breath.
  • Upset stomach or throwing up.

What are some other side effects of Xyntha?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where the shot is given.
  • Headache.
  • Diarrhea.
  • Feeling tired or weak.
  • Cough.
  • Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Xyntha?

All products:

  • If Xyntha is given at home, store unopened containers in a refrigerator. Do not freeze.
  • Store in the original container to protect from light.
  • If needed, you may store at room temperature.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • If stored at a temperature higher than room temperature, talk with the doctor to see if Xyntha may still be used.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Xyntha:

  • If stored at room temperature, return Xyntha vials to the refrigerator after 3 months or throw away any unused part. You may return vials to the refrigerator only 1 time.

Xyntha Solofuse:

  • If stored at room temperature, throw away any unused vials after 3 months or after the expiration date, whichever comes first.
  • Do not put Xyntha back in the refrigerator after it has been stored at room temperature.

 

Label

PRINCIPAL DISPLAY PANEL – KIT CARTON – 1000 IU

  • One Single-Use, Prefilled Dual-Chamber Syringe
    NDC 58394-024-03
  • xyntha® solofuse®
    Antihemophilic Factor (Recombinant)
  • 1000 IU Range
  • Single-Use,
    Dual-Chamber
    Syringe, Prefilled
    with XYNTHA
    and Diluent
  • For Factor VIII Replacement
    Therapy Only
  • For Intravenous Administration.
    Rx only
  • Pfizer
PRINCIPAL DISPLAY PANEL - Kit Carton - 1000 IU

PRINCIPAL DISPLAY PANEL – 250 IU SYRINGE LABEL

  • NDC 58394-122-03
  • Rx only
  • Xyntha® Solofuse®
  • Antihemophilic Factor
    (Recombinant)
    For IV Administration
    Dual-Chamber Syringe
    No Preservatives. Single Use.
  • Refrigerate. Protect from light.
  • Wyeth Pharmaceuticals LLC
    Philadelphia, PA 19101
    US Govt. License No. 3
  • 250 IU Range
  • For Factor VIII Replacement
Principal Display Panel - 250 IU Syringe Label

SRC: NLM .

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