Vonvendi (von Willebrand factor (recombinant))

Individualize dose and dosing frequency of von Willebrand factor (recombinant) based on the patient's weight, type and severity of bleeding/surgical intervention, clinical judgment, and appropriate clinical and laboratory measures.

For patients experiencing bleeding, hemostasis cannot be ensured until factor VIII coagulation activity (FVIII:C) has reached 40 international units (IU)/deciliter (dL). Based on a patient's baseline FVIII:C level, a single infusion of von Willebrand factor (recombinant) is expected to lead to an increase in endogenous FVIII:C activity above 40% within 6 hours. If the patient's baseline plasma FVIII:C level is below 40%, or is unknown, administer an approved recombinant factor VIII (rFVIII) with the first infusion of von Willebrand factor (recombinant) to achieve a hemostatic plasma level of FVIII:C. If an immediate rise in FVIII:C is not necessary or if the baseline FVIII:C level is sufficient to ensure hemostasis, administer von Willebrand factor (recombinant) without rFVIII.

Administer von Willebrand factor (recombinant) by IV infusion after reconstitution.

Do not mix von Willebrand factor (recombinant) with other medicinal products.

Use plastic syringes when preparing or administering von Willebrand factor (recombinant) and not glass syringes because proteins in the product tend to stick to the surface of glass.

If the reconstitution solution of von Willebrand factor (recombinant) is not administered immediately, store at room temperature (not to exceed 25degreesC) for up to 3 hours. Discard any unused reconstituted product after 3 hours.

Store unopened vials of von Willebrand factor (recombinant) at refrigerated temperature (2-8degreesC) or room temperature (not to exceed 30degreesC). Do not freeze. Store in the original box and protect from extreme exposure to light.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date with von Willebrand factor (recombinant).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of life-threatening hypersensitivity reactions to von Willebrand factor (recombinant) or its components (mannitol, trehalose-dihydrate, sodium chloride, histidine, tris-sodium citrate-dihydrate, calcium chloride, polysorbate 80, and hamster or mouse proteins).

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Thromboembolic disorder

The most common adverse reactions (>=2%) observed in patients receiving von Willebrand factor (recombinant) in clinical studies were headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, increased ALT, and generalized pruritus.

Less Frequent

• Allergic dermatitis
• Anaphylaxis
• Angioedema
• Dyspnea
• Erythema
• Fibrinogen excess
• Skin rash
• Thrombotic disorder
• Urticaria

Rare or Very Rare

• Acute myocardial infarction
• Cerebrovascular accident
• Chest tightness
• Disseminated intravascular coagulation
• Hemolytic anemia
• Hypersensitivity drug reaction
• Hypertension
• Injection site infection
• Pulmonary thromboembolism
• Thromboembolic disorder
• Wheezing

More Frequent

• Dizziness
• Fever
• Headache disorder
• Injection site sequelae
• Nausea

Less Frequent

• Chest discomfort
• Chills
• Drowsy
• Dyspepsia
• Flushing
• Insomnia
• Lethargy
• Pruritus of skin
• Upper respiratory infection
• Vomiting

Rare or Very Rare

• Acute abdominal pain
• Cough
• Diarrhea
• Dysgeusia
• Fatigue
• Hypotension
• Paresthesia
• Sensation of warmth
• Tachycardia

No enhanced messaging available.

Safety and effectiveness in pediatric patients <18 years of age have not been established.

There are no studies of von Willebrand factor (recombinant) use in pregnant women. Animal reproduction studies have not been conducted with von Willebrand factor (recombinant). It is not known whether von Willebrand factor (recombinant) can cause fetal harm when administered to a pregnant woman or whether it can affect reproduction capacity. Von Willebrand factor (recombinant) should be given to a pregnant woman only if clearly needed.

There is no information regarding the presence of von Willebrand factor (recombinant) in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for von Willebrand factor (recombinant) and any potential adverse effects on the breastfed infant from von Willebrand factor (recombinant) or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Experience in patients >=65 years of age is insufficient to determine whether they respond differently to von Willebrand factor (recombinant) than younger patients.