Wilate: How to use, Side Effects, Dosage

Wilate: How to use, Side Effects, Dosage

What is Wilate?

Wilate is an injection medication containing antihemophilic and von Willebrand factors is used for prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients. VWD is a complex congenital bleeding disorder that affects one to two percent of the general population or approximately 3 million people in the United States.

The newly approved product label expands the FDA license for WILATE, which formerly included only the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Octapharma USA is a subsidiary of global human protein products manufacturer Octapharma AG, which develops and manufactures high-purity coagulation factor concentrates for patients with bleeding disorders.

“Preventing excessive intra- and post-operative bleeding in pediatric and adult VWD patients is a continuing challenge,” said Octapharma USA President Flemming Nielsen. “We are extremely pleased that WILATE is now available for medical providers managing this important issue. Octapharma is committed to providing lifesaving and enhancing therapeutic options for the bleeding disorders community.”

The overall efficacy rate of WILATE treatment for surgical procedures was 96.7% in a global, prospective, open-label, single-arm, uncontrolled, multi-center Phase III clinical study, which included nine U.S. hemophilia treatment centers. The clinical trial observed 28 patients with Type 1, Type 2 and Type 3 VWD from 24 centers in eight countries who underwent 30 surgeries and 280 infusions. WILATE treatment was successful in 100% of minor surgeries and 95.2% of major surgeries. The study reported a 100% success rate in surgical procedures for Type 3 patients, the most serious form of VWD.

Also its better to know that WILATE is a plasma-derived, highly purified concentrate of freeze-dried human von Willebrand factor (VWF) and coagulation factor VIII (FVIII). Two well-established virus inactivation steps are incorporated into the manufacturing process of WILATE specifically a solvent/detergent (S/D) and terminal dry-heat (TDH) treatment.

WILATE is also indicated for the perioperative management of bleeding. WILATE is not indicated for the treatment of hemophilia A.

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How to use Wilate

Use Wilate exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency. You get WILATE as an infusion into your vein after reconstitution of the lyophilized powder by mixing it with the supplied 5 or 10 milliliter sterile solvent (Water for Injection with 0.1% Polysorbate) with the supplied transfer device. Your healthcare provider will instruct you on how to do reconstitutions and infusions using sterile technique on your own or with the help of a family member, and they may watch you give yourself the first dose of WILATE. You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing WILATE so that your treatment will work the best that it can for you. WILATE comes in different dosage strengths. The actual number of international units (IU) of von Willebrand Factor and Factor VIII in the vial will be imprinted on the label and box. Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Contact your healthcare provider right away if bleeding is not controlled after using WILATE. Talk to your healthcare provider before travelling. Plan to bring enough WILATE for your treatment during this time. If you forget to use WILATE, do not inject a double dose to make up for the forgotten dose. Proceed with the next infusion as scheduled. Do not stop using WILATE without consulting with your healthcare provider.

Wilate

Please if you have any questions about Wilate you can ask us by commenting below this text, we'll answer you as soon as possible.

Side effects of Wilate

Like other medications Wilate has some common and some other serious unwanted effects that must be cared and if seen by the patients must be informed to the doctor or not they may lead to other serious problems. Allergic reactions may occur. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives. Because it is made from human blood, there is the risk that WILATE can potentially transmit disease or cause allergic reactions. Tell your healthcare provider if you have low-grade fever, rash, joint pain, nausea, vomiting, and feeling tired, and yellowing of the skin. And some other common side effects are:

More Common

Difficulty with breathing or swallowing

dizziness

fast heartbeat

fever

hives or welts

itching

nausea

reddening of the skin, especially around the ears

shortness of breath

skin rash

swelling of the face, throat, or tongue

unusual tiredness or weakness

hot flashes when the injection is given;

nosebleeds;

numbness or tingling;

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings of Wilate

Hypersensitivity reactions may occur with WILATE. Signs and symptoms include angioedema, burning and stinging at the infusion site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing that may progress to severe anaphylaxis (including shock) with or without fever. Closely monitor patients receiving WILATE and observe for any symptoms throughout the infusion period. Because inhibitor antibodies may occur concomitantly with anaphylactic reactions, evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors.

Wilate

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