Wilate

Generic name: antihemophilic and von Willebrand factor complex
Brand names: Alphanate, Humate-P, Wilate
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by  A Ras MD.

What is Wilate used for?

Wilate is a prescription medicine that is used to treat von Willebrand disease. It is used to treat or prevent bleeding. Some products are used to treat hemophilia. Talk with the doctor.

Wilate may be given to you for other reasons.

Description

Wilate is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Complex (Human). Wilate is supplied as a lyophilized powder for reconstitution for intravenous injection.

Wilate is labeled with the actual VWF:RCo and FVIII activities in IU per vial. The VWF activity (VWF:RCo) is determined using a manual agglutination method referenced to the current “WHO International Standard for von Willebrand Factor Concentrate”. The FVIII activity is determined using a chromogenic substrate assay referenced to the current “WHO International Standard for Human Coagulation Factor VIII Concentrate”. The assay methodologies are according to European Pharmacopoeia (Ph.Eur.).

Wilate contains no preservative. The diluent for reconstitution of the lyophilized powder is Water for Injection with 0.1% Polysorbate 80.

No albumin is added as a stabilizer. The resulting specific activity of Wilate is ≥ 60 IU VWF:RCo and ≥ 60 IU FVIII activities per mg of total protein.

 

The nominal composition of Wilate is as follows:

Component Quantity/ 5 mL vial Quantity/ 10 mL vial

VWF:RCo

500 IU

1000 IU

FVIII

500 IU

1000 IU

Total protein

≤ 7.5 mg

≤ 15.0 mg

Glycine

50 mg

100 mg

Sucrose

50 mg

100 mg

Sodium chloride

117 mg

234 mg

Sodium citrate

14.7 mg

29.4 mg

Calcium chloride

0.8 mg

1.5 mg

Water for injection

5 mL

10 mL

Polysorbate 80

1 mg/mL

1 mg/mL

Wilate is derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers. All plasma donations are tested for viral markers in compliance with requirements of EU CPMP and FDA guidances. In addition, the limit for the titer of human parvovirus B19 DNA in the manufacturing pool is set not to exceed 10 4 IU/mL.

The product is manufactured from cryoprecipitate, which is reconstituted in a buffer and treated with aluminum hydroxide followed by two different chromatography steps, ultra- and diafiltration, and sterile filtration. The manufacturing process includes two virus inactivation steps, namely, treatment with an organic solvent/detergent (S/D) mixture, composed of tri-n-butyl phosphate (TNBP) and Octoxynol-9, and a terminal dry heat (TDH) treatment of the lyophilized product in final container [at +100°C (212°F) for 120 minutes at a specified residual moisture level of 0. 7 – 1.6%]. In addition, the ion-exchange chromatography step utilized during Wilate manufacturing also removes some viruses [ 7 ]. The mean cumulative virus reduction factors of these steps are summarized in TABLE 2 .

 

Table 2 Virus Reduction During Wilate Manufacturing

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na: not applicable

nd: not done (S/D reagents present)

HIV-1: Human Immunodeficiency Virus – 1

SBV: Sindbis Virus

BVDV: Bovine Viral Diarrhea Virus

PRV: Pseudorabies Virus

REO 3: Reovirus Type 3

HAV: Hepatitis A Virus

PPV: Porcine Parvovirus

Mechanism of Action

VWF and FVIII are normal constituents of human plasma. VWF is a multimeric protein with two key functions. It is an adhesive molecule, which mediates the binding between platelets and damaged sub-endothelial tissues. It is also a carrier protein, involved in the transport and stabilization of FVIII. Patients suffering from VWD have a deficiency or abnormality of VWF. This reduction in VWF concentration in the bloodstream result in a correspondingly low FVIII activity and an abnormal platelet function thereby resulting in excessive bleeding. [ 8 ]

The VWF in Wilate is derived from normal human plasma and is expected to behave in the same way as endogenous VWF. Thus, administration of VWF allows correction of the hemostatic abnormalities in VWD patients at two levels:

  • The VWF re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium and to the platelet membrane), providing primary hemostasis, as shown by the shortening of the bleeding time. This effect occurs immediately.
  • The VWF induces correction of the associated FVIII deficiency in VWD. Administered intravenously, VWF binds endogenous FVIII (which is produced normally by the patient), and by stabilizing this factor, avoids its rapid degradation. This action is slightly delayed. However, administration of a FVIII-containing VWF preparation like Wilate rapidly restores the FVIII activity level to normal.[ 8 ]

Before taking Wilate, tell your doctor:

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

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 Wilate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

  • Tell all of your health care providers that you take Wilate. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Blood clots have happened with Wilate. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
  • Call the doctor right away if the normal dose does not work as well.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Talk with the doctor before you travel. You will need to bring enough of Wilate for use during travel.
  • If you are 65 or older, use Wilate with care. You could have more side effects.
  • 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 Wilate best taken?

Use Wilate 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.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Do not use if solution changes color.
  • Throw away any part of the opened vial not used after the shot is given.
  • 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.
  • If stored in a refrigerator, let Wilate come to room temperature before mixing. Do not heat Wilate.
  • Use right away after mixing.
  • Do not use if the solution is cloudy, leaking, or has particles.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of Wilate 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.
  • Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
  • Flushing.
  • Very bad dizziness or passing out.
  • A burning, numbness, or tingling feeling that is not normal.
  • Stinging.
  • Swelling.
  • Very upset stomach or throwing up.
  • Restlessness.
  • Dark urine or yellow skin or eyes.
  • A fast heartbeat.
  • Change in color of mouth to blue.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Wilate?

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:

  • Upset stomach.
  • Constipation.
  • Feeling dizzy, tired, or weak.
  • Headache.
  • Back 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 Wilate?

  • Store at room temperature or in a refrigerator. Do not freeze.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • If stored at room temperature, throw away any unused vials after 6 months or after the expiration date, whichever comes first.
  • Do not put Wilate back in the refrigerator after it has been stored at room temperature.
  • Store in the original container to protect from light.
  • 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.

 

Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

  • von Willebrand Factor/Coagulation Factor VIII Complex (Human)
  • Octapharma Pharmazeutika Produktionsges.m.b.H
  • 500IU/5mL
  • NDC 67467-182-01

 

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1000IU/10mL

NDC 67467-182-02

 

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SRC: NLM .

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