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Factor VIII (Recombinate / rAHF, Baxter / rurioctocog alpha)

✓ Approved

Baxter International, Inc. · F8 · Recombinant Proteins

What is Factor VIII?

Factor VIII is a recombinant proteins developed by Baxter International, Inc.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesRecombinate, rAHF, Baxter, rurioctocog alpha
CompanyBaxter International, Inc.
Drug ClassRecombinant Proteins, Cell-based Therapies
Molecular TargetF8
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Mechanism of Action

Molecular Targets

Factor VIII acts on 1 molecular target:

F8coagulation factor VIII (AHF, FVIII)
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Therapeutic Indications

Factor VIII is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Congenital, familial and genetic disordersFactor VIII deficiency✓ Approved

Related Research Articles

PubMedResearch and practice in thrombosis and haemostasis2026-08-30

Coagulation potential of concomitant factor VIII administration in people with hemophilia A receiving emicizumab prophylaxis (CAGUYAMA study): a multicenter, open-label, nonrandomized clinical trial.

Takeyama Masahiro M, Ogiwara Kenichi K, Ozu Naoki N, Sasai Kana K et al.

Emicizumab prophylaxis reduces bleeding in people with hemophilia A. However, factor (F)VIII is still required to manage breakthrough bleeding and for surgical procedures. The optimal additional FVIII dose during such events remains unclear because of emicizumab's baseline hemostatic activity. To assess FVIII-induced changes in global coagulation potential in people with hemophilia A without inhibitors treated with emicizumab and to inform FVIII dosing during prophylaxis. The multicenter "Coagulation potential of concomitant factor VIII administration in people with hemophilia A receiving emicizumab prophylaxis" study enrolled 100 people with hemophilia A (aged ≥4 years) receiving emicizumab at 13 centers in Japan. For eligible bleeding or surgical events, FVIII (standard or extended half-life) was administered at a target dose of 30 IU/kg (allowable range, 25-35 IU/kg). Paired blood samples were obtained pre- and post-FVIII administration. The primary endpoint was the change in clot waveform analysis-adjusted maximum coagulation rate, expressed as IMCR% relative to pooled normal plasma and untreated severe hemophilia A plasma. Secondary endpoints included peak thrombin in the thrombin generation assay, rotational thromboelastometry, clinical hemostasis, and safety. Anti-emicizumab antibodies were used in vitro to isolate the effects of FVIII. Thirty-two FVIII-treated events in 24 people with hemophilia A (15 bleeding events and 17 surgical events) were analyzed. The clot waveform analysis-adjusted maximum coagulation rate increased from 39.4% to 92.1% post-FVIII and from 3.2% to 78.6% under anti-emicizumab conditions. Peak thrombin in the thrombin generation assay increased from 249 to 348 nM (IMCR%: from 55.4% to 88.0%) and from 6.4% to 74.6% under anti-emicizumab conditions. All events achieved effective hemostasis. No thromboembolic events, thrombotic microangiopathy, or hypersensitivity reactions were reported. FVIII administered at a target dose of 30 IU/kg (allowable range, 25-35 IU/kg) improved global coagulation parameters and achieved effective hemostasis without thrombotic complications, warranting evaluation as part of emicizumab prophylaxis.

PubMedCureus2026-08-30

Unmasking Factor XIII Deficiency: Recurrent Intracranial Hemorrhage Despite Normal Coagulation Studies.

Ramesh Karthik K, Hui Gavin G, Shodiya Michael M, Palaskas Nicolaos J NJ

Factor XIII (FXIII) deficiency is a rare bleeding disorder that can be easily missed because routine coagulation tests remain normal. We report a 32-year-old Nicaraguan man who carried a childhood diagnosis of von Willebrand disease and was inadvertently managed with cryoprecipitate for 25 years, a treatment that incidentally corrected his true underlying deficiency due to its high FXIII content. After immigrating and transitioning to von Willebrand factor/Factor VIII concentrate, he developed recurrent life-threatening intracranial hemorrhages. FXIII activity testing ultimately revealed a level of less than 5%, confirming severe FXIII deficiency. He was started on FXIII concentrate prophylaxis with no further bleeding events. This case highlights how diagnostic anchoring and inadvertent treatment with cryoprecipitate can mask FXIII deficiency for decades. Furthermore, it underscores the importance of considering FXIII testing in patients with severe or recurrent bleeding and normal standard coagulation studies.

PubMedPharmacoepidemiology and drug safety2026-08-30

Postpartum Psychotropic Treatment Patterns and Breastfeeding: Nationwide Clustering Study.

Hviid Anders A, Laksafoss Anna A, O'Regan Elisabeth E, Videbech Poul P et al.

Postpartum psychotropic medication use is heterogeneous, comprising continuation of prenatal treatment, initiation, transient use and complex polypharmacy. Prior studies have reported the prevalence of potential infant exposure to psychotropics via breast milk, but characterisations better capturing the heterogeneity of this exposure are lacking. We aimed to identify distinct postpartum psychotropic treatment patterns using hierarchical clustering accounting for medication type, timing and polypharmacy, and to describe breastfeeding characteristics across these patterns. Population-based cohort study of mothers using psychotropics during the first postpartum year using linked Danish national registers 2012-2023. From a source population of 659 866 mother-child pairs with live-born singleton births, 38 528 mothers redeemed at least one psychotropic prescription during the first postpartum year and comprised the study cohort. Weekly psychotropic use was defined by redeemed prescriptions using prescribed daily dose assumptions. Hierarchical agglomerative clustering (tame R package) identified distinct treatment patterns based on medication type, timing and polypharmacy. The number of patterns was determined from interpretability, size and examination of the hierarchical dendrogram. Exclusive breastfeeding prevalence and duration were described across patterns among pairs with recorded breastfeeding habits (64%). Eight distinct treatment patterns were identified, differing in psychotropic type, timing and polypharmacy. Three SSRI-dominated patterns (24 225 pairs, 63%) ranged from increasing SSRI use (Pattern I; n = 11 731), through continued SSRI use with high persistence (Pattern II; n = 7167), to mixed use involving SSRIs and other psychotropics (Pattern III; n = 5327; 48% using three or more medications). The remaining five patterns (14 303 pairs, 37%) were dominated by benzodiazepine-related drugs, other antidepressants, centrally acting sympathomimetics, antipsychotics or complex mixed use, ranging from late-initiated benzodiazepine-related use (Pattern IV; median initiation Week 27; persistence 13%) to early-initiated, highly persistent mixed use (Pattern VIII; median initiation Week 4; persistence 94%). Exclusive breastfeeding duration varied across patterns, with long-duration exclusive breastfeeding (181 days or more) highest in the SSRI-continued pattern (Pattern II, 10.6%) and lowest in the mixed-use-increasing and antipsychotics-sporadic patterns (Patterns III and VII, 5.1% and 5.2%). Postpartum psychotropic treatment patterns are clinically heterogeneous and exclusive breastfeeding practices differ across treatment patterns.

PubMedCochlear implants international2026-08-30

Translation and validation of the extended version of the effort assessment scale for adults with cochlear implant in Turkish language.

Kartal Özcan Ahsen A, Çiprut Ayça A, Aktaş Selman S

Although assessing listening effort is clinically essential, no validated Turkish self-report measure currently exists. This study aimed to translate and culturally adapt the Extended version of the Effort Assessment Scale (EEAS) into Turkish and to evaluate the validity and reliability of the Turkish EEAS (T-EEAS) in adults with typical hearing (TH) and cochlear implant (CI) users. A standardized cross-cultural adaptation protocol was followed. Psychometric properties were evaluated in 567 adults (463 TH and 104 CI users). Construct validity was examined using confirmatory factor analysis. Reliability was assessed using Cronbach's alpha, test-retest correlation, intraclass correlation coefficient (ICC), and Bland-Altman agreement analysis. Discriminant validity was evaluated by comparing T-EEAS scores between groups. Confirmatory factor analysis supported a two-factor structure with good model fit. The T-EEAS showed high internal consistency (Cronbach's alpha = 0.938) and excellent test-retest reliability (Spearman's r = 0.867; ICC = 0.877). CI users reported higher listening effort than the TH group (P < 0.001), with a large effect size (Cliff's δ = 0.838). The T-EEAS captures subjective listening effort in Turkish-speaking populations. The two-factor structure distinguishes effort in quiet versus noise, which may support outcome monitoring in audiological rehabilitation. The higher scores observed in CI users support the discriminant validity of the scale. The T-EEAS is a valid and reliable measure of subjective listening effort in Turkish-speaking adults and can distinguish between TH adults and CI users, supporting its use in clinical and research settings.

PubMedJournal of interpersonal violence2026-08-30

Advancing the Longitudinal Measurement of Physical Aggression from Age 3 to 15: Applications of Moderated Non-Linear Factor Analysis.

Fix Rebecca L RL, Raghunathan Radhika S RS, Iris Luo Xiaoshuang X, Geller Amanda A

Physically aggressive behavior among children and adolescents is a longstanding concern, as documented in a large body of literature examining trajectories of aggressive behavior. However, aggression has been shown to present differently across the life course and is also likely to present differently across population subgroups, complexity that challenges the understanding and prevention of, and intervention in, problem behaviors. We therefore created covariate-informed trajectories of aggressive behaviors and identified subgroups representing heterogeneity in the development of girls' and boys' physically aggressive behaviors from ages 3 to 15 years. We used data from 3,263 families in the Future of Families and Child Well-being Study (waves 3-6, ages 3-15 years), a longitudinal birth cohort study following children born in large cities between 1998 and 2000 to mostly unmarried mothers. We used moderated non-linear factor analysis to generate factor scores of physically aggressive behaviors over time, separately for boys and girls, and then ran sex-separated latent growth models using the covariate-informed factor scores. Both girls and boys had three-class change trajectories. For adolescent girls, there is just one trajectory toward physically aggressive behavior (with the third classification as Desistors). For adolescent boys, there are two trajectories toward aggressive behavior (including Adolescent Onset). While universal programming that is not gender-responsive can meet the needs of young people who were classified as Persistors or in the Low Aggression group, we observed unique possible points of intervention and sex-specific needs. In response, we advise on interventions for young people, adults in youth-serving organizations, and structural-level considerations.

PubMedJournal of interprofessional care2026-08-30

Interprofessional identity development: awareness as the beginning of change.

Cantaert Gabriël Rafaël GR, Lauwerier Emelien E, Reinders Jan-Jaap JJ, Robijn Lenzo L et al.

Developing an interprofessional identity (IPI) enhances intrinsic motivation for interprofessional collaboration, supported by beliefs in diversity that alleviate identity threats within dynamic teams. However, personal experiences and contextual changes, such as transitioning into practice, may hinder openness and disrupt the balance between professional identity and IPI. Since readiness for interprofessional learning is widely used to indicate learners' preparedness for collaborative practice, this study reevaluates whether the Readiness for Interprofessional Learning Scale (RIPLS) captures readiness or a distinct construct within IPI development. We used a pragmatic constructionist approach, combining quantitative and qualitative methods to assess the meaning and utility of the translated Dutch RIPLS in an undergraduate setting. Validity and reliability were assessed through a cross-sectional study with 3,311 participants and two pre-post studies with 330 and 89 participants. We conducted content analysis based on interviews with two teachers and six health sciences trainees. An exploratory factor analysis revealed a one-factor model with eight items explaining 35.35% of the variance (eigenvalue = 3.463) and factor loadings ranging from .512 to .697. This model was relabeled as the Awareness of Interprofessional Learning Scale (AIPLS). A confirmatory factor analysis on posttest data (n = 456) demonstrated excellent fit (SRMR = .018, RMSEA = .068, CFI = .969, TLI = .957), with loadings between .62 and .77. In contrast, unidimensional and four-dimensional RIPLS structures showed poor to reasonable fits. The AIPLS exhibited a high coefficient omega of .81, moderate stability (ICC = .725), and confirmed convergent validity. We rejected the RIPLS due to its overlapping subscales, which fail to accurately represent readiness. In contrast, the AIPLS effectively measures interprofessional awareness, which is essential for developing readiness. This allows us to reevaluate previous research and view interprofessional awareness as a catalyst for self-efficacy, openness, and commitment, key elements of interprofessional education.

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