Altuviiio

Drug overview for ALTUVIIIO (antihemophilic factor rfviii fc-vwf-xten,bdd-ehtl):

Generic name: antihemophilic factor rFVIII Fc-VWF-XTEN,BDD-ehtl (AN-tye-HEE-moe-FIL-ik FAK-tor)
Drug class: Antihemophilic Products
Therapeutic class: Hematological Agents

Antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl is a biosynthetic (recombinant DNA origin) preparation of blood coagulation factor VIII consisting of a single chain B-domain-deleted factor VIII covalently linked to the Fc domain of human immunoglobulin G (IgG), the FVIII-binding D'D3 domain of human von Willebrand factor (VWF), and 2 XTEN polypeptides.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for ALTUVIIIO (antihemophilic factor rfviii fc-vwf-xten,bdd-ehtl) have been approved by the FDA:

Indications:
Bleeding episode in hemophilia A
Bleeding prevention in hereditary factor VIII deficiency
Hemophilia A

Professional Synonyms:
Bleeding prevention in classic hemophilia
Bleeding prevention in congenital factor VIII deficiency
Bleeding prevention in hemophilia A
Bleeding prophylaxis in hemophilia A
Congenital factor VIII deficiency disease
Hemorrhage prophylaxis in hemophilia A
Hemorrhaging in hemophilia A
Prevention of bleeding episode in hemophilia A

Moderate List
No disease contraindications

The following adverse reaction information is available for ALTUVIIIO (antihemophilic factor rfviii fc-vwf-xten,bdd-ehtl):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse effects observed in more than 10% of patients receiving antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl in clinical trials include headache and arthralgia.

There are 20 severe adverse reactions.

More Frequent	Less Frequent
None.	Allergic dermatitis Anaphylaxis Angioedema Dyspnea Erythema Fibrinogen excess Skin rash Thrombotic disorder Urticaria

Rare/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

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Dizziness Fever Headache disorder Injection site sequelae Nausea	Chest discomfort Chills Drowsy Dyspepsia Flushing Insomnia Lethargy Pruritus of skin Upper respiratory infection Vomiting

Rare/Very Rare
Acute abdominal pain Cough Diarrhea Dysgeusia Fatigue Hypotension Paresthesia Sensation of warmth Tachycardia

The following precautions are available for ALTUVIIIO (antihemophilic factor rfviii fc-vwf-xten,bdd-ehtl):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl have been established in pediatric patients <18 years of age. Adolescent subjects were enrolled in the adult and adolescent study and pediatric subjects <12 years of age were enrolled in the pediatric study. Thirty-eight subjects (38.4%) were <6 years of age, 36 (36.4%) subjects were 6 to <12 years of age, and 25 subjects (25.2%) were adolescents (12 to <18 years of age). Clinical data from the pediatric study of the 74 subjects <12 years of age showed that no dosing adjustment was required.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

It is not known whether antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl can cause fetal harm when administered to pregnant women or affect reproductive capacity; the drug should be used during pregnancy only when clearly needed.

It is not known whether antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl is distributed into human milk, or if the drug has any effects on the breastfed infant or milk production. The known benefits of breast-feeding should be considered along with the mother's clinical need for antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl and any potential adverse effects of the drug or disease on the infant.

Clinical studies of antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Clinical experience with other factor VIII products has not identified differences between the elderly and younger patients.

Bleeding episode in hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier
Bleeding prevention in hereditary factor VIII deficiency
D66	Hereditary factor VIII deficiency
Hemophilia A
D66	Hereditary factor VIII deficiency
Z14.02	Symptomatic hemophilia A carrier