Altuviiio Drug Information
Generic name: ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL
Uses of Altuviiio
is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding ALTUVIIIO is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment & control of bleeding episodes Perioperative management of bleeding Limitation of Use: ALTUVIIIO is not indicated for the treatment of von Willebrand disease. Limitation of Use ALTUVIIIO is not indicated for the treatment of von Willebrand disease.
Dosage & Administration of Altuviiio
| Single dose of 50 IU/kg | |
| Single dose of 50 IU/kg |
Side Effects of Altuviiio
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ALTUVIIIO in two clinical studies, Study 1 and Study 2 and are pooled for analysis. In Study 1, a total of 159 previously treated patients (PTPs) (134 adults and 25 adolescents) with severe Hemophilia A) received at least one dose of ALTUVIIIO for either routine prophylaxis, on-demand treatment of bleeding episodes or perioperative management.
A total of 152 (96%) patients achieved at least 25 exposure days and 115 (72%) patients achieved at least 50 exposure days with a median of 53.0 (range 2–63) for both exposure days and injections per patient. Overall exposure was monitored for a total of 151.5 patient-years . In Study 2, the safety of ALTUVIIIO was evaluated in 74 male PTPs <12 years of age with severe hemophilia A who received at least one dose of ALTUVIIIO. Sixty-six (89.2%) patients achieved at least 50 exposure days with a median of 53.0 (range 3–72). Adverse events were monitored for a total of 210.7 patient-years in 2 completed clinical studies in PTPs. Adverse drug reactions (ADRs) (summarized in Table 3) were reported in 79 (33.9%) of the 233 patients treated with routine prophylaxis or on-demand therapy.
The most common ADRs (>10%) in adults and adolescents were headache (20.1%) and arthralgia (16.4%). In children below 12 years, pyrexia (12.2%) was the most common ADR (>10%). In the studies, no inhibitors to FVIII were detected and no ADRs of anaphylaxis were reported. The most common adverse reactions (>10% of patients) reported in clinical trials were headache and arthralgia. Table 3: Adverse Reactions with Frequency of ≥3% Reported in ALTUVIIIO Studies Pooled data from Study 1 and Study 2 including 233 patients across the adult and adolescent and pediatric studies.
MedDRA System Organ Class Adverse Drug Reactions Number of Patients n (%) (N = 233) Nervous system disorders Headache 35 Musculoskeletal and connective tissue disorders Arthralgia 31 Pain in extremity 10 Back pain 9 General disorders and administration Pyrexia 10 Gastrointestinal disorders Vomiting 7 Thromboembolic events occurred in 1% (3/261) of patients in the long-term safety extension study; these three patients had pre-existing risk factors.
Postmarketing Experience
The following adverse reactions have been identified during the post approval use of ALTUVIIIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Factor VIII inhibitor development. Immune system disorders: Hypersensitivity reactions, including anaphylaxis.
Warnings & Cautions for Altuviiio
Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have occurred with
ALTUVIIIO . Signs and symptoms include, but not limited to, hives, shortness of breath, chest tightness, wheezing, hypotension, nausea, vomiting, and itching. Discontinue ALTUVIIIO if hypersensitivity reaction occurs and manage symptoms as appropriate.
Neutralizing Antibodies Formation of neutralizing antibodies (inhibitors) to Factor
VIII has been reported following administration of ALTUVIIIO . Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the patient's plasma Factor VIII level fails to increase as expected or if bleeding is not controlled after ALTUVIIIO administration, the presence of an inhibitor (neutralizing antibodies) should be suspected, and appropriate testing performed .
Monitoring Laboratory Tests
If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay . The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level. Use of a reference laboratory is recommended when a qualified one-stage clotting assay or chromogenic assay is not available locally.
Monitor for the development of Factor VIII inhibitors. If bleeding is not controlled with ALTUVIIIO and the expected factor VIII activity plasma levels are not attained, perform an assay to determine if Factor VIII inhibitors are present (use Bethesda Units to titer inhibitors).
Pregnancy Safety for Altuviiio
Pregnancy Risk Summary There are no data with ALTUVIIIO use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive studies have not been conducted with ALTUVIIIO. Therefore, it is not known whether ALTUVIIIO can affect reproductive capacity or cause fetal harm when given to pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
Pediatric Use of Altuviiio
Pediatric Use The safety and effectiveness of ALTUVIIIO for routine prophylaxis, on-demand treatment, and perioperative management of bleeding episodes have been established in pediatric patients <18 years old. The use of ALTUVIIIO for these indications is supported by evidence from two clinical studies which enrolled 99 previously treated patients <18 years of age who received at least one dose of ALTUVIIIO as part of routine prophylaxis, treatment of bleeding episodes, or perioperative management. Thirty-eight patients (38.4%) were <6 years of age, 36 (36.4%) patients were 6 to <12 years of age, and 25 patients (25.2%) were adolescents (12 to <18 years of age). Data from the pediatric study (74 patients) <12 years of age showed that no dosing adjustment was required .
Contraindications for Altuviiio
is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients . Do not use in patients who have had severe hypersensitivity reactions, including anaphylaxis, to ALTUVIIIO or excipients of ALTUVIIIO.
Clinical Studies of Altuviiio
Median
ABR (Q1, Q3) 0 21.1 0 % patients with zero bleeds, n (%) 82 0 20 Treated spontaneous bleeds Mean ABR (95% CI) 0.3 15.8
Median
ABR (Q1, Q3) 0 16.7 0 % patients with zero bleeds, n (%) 103 1 22 Treated joint bleeds Mean ABR (95% CI) 0.5 17.5
Median
ABR (Q1, Q3) 0 18.4 0 % patients with zero bleeds, n (%) 92 0 21 All Bleeds (treated and untreated) Mean ABR (95% CI) 1.1 22.2
Median
ABR (Q1, Q3) 0 21.1 0 % patients with zero bleeds, n (%) 71 0 19 An intra - patient comparison (N = 78) between mean ABR during on-study prophylaxis with ALTUVIIIO and that during pre-study FVIII prophylaxis yielded a 77% reduction in treated bleeds (95% CI: 58%, 87%). All patients with target joints at baseline (defined as ≥3 spontaneous bleeding episodes in a major joint which occurred in a consecutive 6-month period) achieved resolution of all target joints (45/45, 100%) with 12 months of prophylactic treatment with ALTUVIIIO (defined as ≤2 bleeding episodes in the target joint in 12 months). Study 2 (Pediatric Study) Study 2 enrolled 74 male PTPs <12 years of age with severe hemophilia A (38 patients were 1 to 5 years of age and 36 were 6 to 11 years of age). Of the 74 enrolled patients, all received at least 1 dose of ALTUVIIIO. Seventy-two patients were evaluable for efficacy. The efficacy of weekly 50 IU/kg ALTUVIIIO as routine prophylaxis in children <12 years was evaluated as estimated by the mean annualized bleed rate (ABR). A total of 74 children (38 children <6 years of age and 36 children 6 to <12 years of age) were enrolled to receive ALTUVIIIO for routine prophylaxis at a dose of 50 IU/kg IV once weekly for 52 weeks. The ABR in patients evaluable for efficacy with at least 26 weeks of exposure are summarized in Table 7. Table 7: Summary of Annualized Bleeding Rate (ABR) with ALTUVIIIO Prophylaxis in Patients <12 Years of Age (Study 2) Endpoint Reflects all bleeds reported by patients including those where no ALTUVIIIO was administered. <6 years 6 to <12 years Overall N = 37 A patient in the <6 years old age group who had a positive inhibitor result at baseline (pre-exposure to study drug) and was withdrawn after 3 EDs was excluded.
N = 35 A patient in the 6 to <12 years old age group who received an intense consolidation treatment (2 to 3 injections per week) for 15 weeks, after 2 traumatic hip joint bleeds was excluded from the efficacy analysis as the patient did not receive the weekly prophylaxis treatment as specified in the protocol for an extended period. N = 72 ABR = annualized bleed rate; CI = confidence interval; Q1 = 25th percentile, Q3 = 75th percentile. Treated bleeds Mean ABR (95% CI) Based on negative binomial model. 0.5 0.8
Median
ABR (Q1, Q3) 0 0 0 % patients with zero bleeds, n (%) 23 23 46 Treated spontaneous bleeds Mean ABR (95% CI) 0.2 0.2
Median
ABR (Q1, Q3) 0 0 0 % patients with zero bleeds, n (%) 31 32 63 Treated joint bleeds Mean ABR (95% CI) 0.2 0.4
Median
ABR (Q1, Q3) 0 0 0 % patients with zero bleeds, n (%) 33 27 60 All Bleeds (treated and untreated) Mean ABR (95% CI) 2.8 2.3
Median
ABR (Q1, Q3) 0 1.0 0.5 % patients with zero bleeds, n (%) 20 16 36 Efficacy in Control of Bleeding In the adult and adolescent study, a total of 362 bleeding episodes were treated with ALTUVIIIO, most occurring during on-demand treatment in Arm B. Majority of bleeding episodes were localized in joints. Response to the first injection was assessed by patients at least 8 hours after treatment. A 4-point rating scale of excellent, good, moderate, and no response was used to assess response.
Bleeding was resolved with a single 50 IU/kg injection of ALTUVIIIO in 96.7% of bleeding episodes. The median (Q1; Q3) total dose to treat a bleeding episode was
IU/kg (50.0; 51.9). Control of bleeding episodes was similar across the treatment
arms. The efficacy of ALTUVIIIO in control of bleeding in children <12 years of age was assessed in the pediatric study. A total of 43 bleeding episodes were treated with ALTUVIIIO. Bleeding was resolved with a single 50 IU/kg injection of ALTUVIIIO in 95.3% of bleeding episodes.
The median (Q1; Q3) total dose to treat a bleeding episode was
IU/kg (50.0; 55.8). Perioperative Management of Bleeding Perioperative hemostasis was assessed in
14 major surgeries in 13 patients (10 adults and 3 children) across the adult and adolescent and pediatric clinical studies. Of the 14 major surgeries, 13 surgeries required a single pre-operative dose to maintain hemostasis during surgery; for 1 major surgery during routine prophylaxis no pre-operative loading dose was administered on the day of/or before surgery. The median pre-operative dose per surgery was 50 IU/kg (range 12.7 – 61.9). The clinical evaluation of hemostatic response during major surgery was assessed using a 4-point scale of excellent, good, moderate, or poor/none.
The hemostatic effect of ALTUVIIIO was rated as "excellent" in 14 of 14 surgeries (100%). Types of major surgeries assessed include major orthopedic procedures such as arthroplasties (joint replacements of knee, hip, and elbow), joint revisions and ankle fusion. Other major surgeries included molar tooth extractions, dental restoration and tooth extraction, circumcision, and rhinoplasty/mentoplasty. Perioperative hemostasis was assessed in 27 minor surgeries in 23 patients (12 adults and 11 adolescents and children). The hemostatic response was evaluated by the investigator/surgeon in 21 of these minor surgeries; an excellent response was reported in all (100%).
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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