Autoplex-T

DRUG DESCRIPTION

Autoplex® T*, Anti-Inhibitor Coagulant Complex, Heat Treated, is a sterile product prepared from pooled human plasma with subsequent alcohol fractionation to Cohn Fraction IV1. It contains, in concentrated form, variable amounts of activated and precursor vitamin K-dependent clotting factors. Factors of the kinin generating system are also present. The product is standardized by its ability to correct the clotting time of Factor VIII deficient plasma or Factor VIII deficient plasma which contains inhibitors to Factor VIII.

When reconstituted, this product contains a maximum of 2 units per mL of heparin and a residual amount of polyethylene glycol (2 mg per mL, maximum). It also contains 0.02 M sodium citrate and the sodium content is 177 ± 15 milliequivalents per liter.

Laboratory testing of several lots of Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, has shown the presence of Factor VIII coagulant antigen (VIII:CAg). Although anamnestic response to this antigen following administration of the product was not observed during the clinical trials, the possibility of such a response does exist.

Each lot of Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, is assayed and labeled for units of Hyland Factor VIII correctional activity. Factor VIII correctional activity may not be exclusively related to the efficacious component(s). (See CLINICAL PHARMACOLOGY.)

During the manufacturing process, this product was heated for 6 days at 60°C. This heating step is designed to reduce the risk of transmission of hepatitis and other viral diseases. However, no procedure has been shown to be totally effective in removing hepatitis infectivity from Anti-Inhibitor Coagulant Complex.

Autoplex® T, Anti-Inhibitor Coagulant Complex, Heat Treated, must be administered intravenously.

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Autoplex-T »

What are the precautions when taking anti-inhibitor coagulant complex, heat treated (Autoplex-T)?

Consult your...

Read All Potential Precautions of Autoplex-T »

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Autoplex-T »

What are the precautions when taking anti-inhibitor coagulant complex, heat treated (Autoplex-T)?

Consult your...

Read All Potential Precautions of Autoplex-T »


Autoplex-T Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Autoplex-T Patient Information Including Side Effects

Brand Names: Autoplex T, Feiba VH

Generic Name: anti-inhibitor coagulant complex (injectable) (Pronunciation: an TEE in HIH bih tor coe AG you lant COM plex)

  • What is anti-inhibitor coagulant complex (Autoplex-T)?
  • What are the possible side effects of anti-inhibitor coagulant complex (Autoplex-T)?
  • What is the most important information I should know about anti-inhibitor coagulant complex (Autoplex-T)?
  • What should I discuss with my healthcare provider before using anti-inhibitor coagulant complex (Autoplex-T)?
  • How should I use anti-inhibitor coagulant complex (Autoplex-T)?
  • What happens if I miss a dose (Autoplex-T)?
  • What happens if I overdose (Autoplex-T)?
  • What should I avoid while using anti-inhibitor coagulant complex (Autoplex-T)?
  • What other drugs will affect anti-inhibitor coagulant complex (Autoplex-T)?
  • Where can I get more information?

What is anti-inhibitor coagulant complex (Autoplex-T)?

Anti-inhibitor coagulant complex is made up of proteins normally present in the blood that allow the blood to clot.

Anti-inhibitor coagulant complex is used to treat or prevent bleeding in people with hemophilia and Factor VIII inhibitors.

Anti-inhibitor coagulant complex may also be used for purposes other than those listed here.

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex-T)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

If you experience any of the following serious side effects, contact your healthcare provider immediately or seek emergency medical attention:

  • an allergic reaction (shortness of breath; wheezing; tightness of the chest; closing of the throat; hives; swelling of the lips, face, or tongue; hives or rash; dizziness or fainting);
  • changes in pulse rate or blood pressure;
  • difficulty breathing, chest pain, or cough; or
  • pain, redness, or swelling at the injection site.

Other, less serious side effects may be more likely to occur. Continue to use anti-inhibitor coagulant complex and talk to your doctor if you experience

  • headache; or
  • flushing.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about anti-inhibitor coagulant complex (Autoplex-T)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

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