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Advate (Antihemophilic Factor) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions were examined among a total of 96 subjects > 16 years of age and 54 subjects </= 16 years of age who received at least one infusion of ADVATE rAHF-PFM. For subjects > 16 years of age, the mean ± SD and median (range) values for time on study per subject were 319 ± 213 days and 403 days (1 to 654); the mean ± SD and median (range) exposure days to ADVATE rAHF-PFM per subject were 130 ± 84 days and 140 days (1 to 289); and the mean ± SD and median (interquartile range) IU/kg per infusion were 32.0 ± 8.27 IU/kg and 30.7 IU/kg (27.8 to 33.8).

For subjects </= 16 years of age, the mean ± SD and median (range) values for time on study per subject were 321 ± 210 days and 428 days (1 to 651); the mean ± SD and median (range) exposure days to ADVATE rAHF-PFM per subject were 138 ± 93 days and 181 days (1 to 284); and the mean ± SD and median (interquartile range) IU/kg per infusion were 36.5 ± 11.7 IU/kg and 33.4 IU/kg (29.7 to 40.4).

Across all clinical studies, a total of 1304 adverse events were reported among 128 of the 150 subjects who received at least 1 infusion of ADVATE rAHF-PFM. Of the 1304 adverse events, 696 were reported among 85 subjects > 16 years of age and 608 were reported among 43 subjects </= 16 years of age. All adverse events (product-related and unrelated) reported by at least 10% of subjects are shown in Table 6.

Table 6.
Summary of All Adverse Experiences (Product-Related and Unrelated) that Occurred in Greater than or Equal to 10% of Study Subjects
MedDRA System Organ Class MedDRA Preferred Term Number of Events Number of Subjects Percent of Evaluable Subjects a
Gastrointestinal disorders Pharyngolaryngeal pain 22 17 11.3
General disorders and administration site conditions Fall 25 19 12.7
Pyrexia 37 25 16.7
Infections and infestations Nasopharyngitis 32 22 14.7
Injury, poisoning and procedural complications Accident nos 62 26 17.3
Limb injury nos 195 52 34.7
Musculoskeletal and connective tissue disorders Arthralgia 74 35 23.3
Nervous system disorders Headache nos 138 44 29.3
Respiratory, thoracic and mediastinal disorders Cough 37 23 15.3
a Percent relative to 150, the total number of subjects across all studies who received at least one infusion of ADVATE rAHF-PFM

Eighteen of the 1304 adverse events were deemed serious; none were related to the study medication. There were no deaths. Among the 1286 non-serious adverse events, only 28 in 12 subjects were judged by the investigator to be related to the study drug. Severity ratings among the 28 events were mild in 8 cases, moderate in 16 cases, and severe in 4 cases (Table 7).

Table 7.
Summary of Non-Serious, Study-Drug Related
Adverse Events
Severity MedDRA Preferred Term Number of Events
Mild Dysgeusia 3
Pruritis 1
Dizziness 1
Catheter-related infection 1
Rigors 1
Headache nos 1
Total 8
Moderate Dysgeusia 1
Dizziness 2
Headache nos 1
Hot flushes 2
Diarrhoea nos 1
Oedema lower limb 1
Sweating increased 1
Nausea 1
Dyspnoea nos 1
Abdominal pain upper 1
Chest pain 1
Bleeding tendency a 1
Haematocrit decreased 1
Joint Swelling 1
Total 16
Severe Headache nos 1
Pyrexia 1
Haematoma nos 1
Coagulation factor VIII decreased 1
Total 4
a Recorded as prolonged bleeding after postoperative drain removal on the case report form

The unexpected decreased coagulation factor VIII levels occurred in one subject during continuous infusion of ADVATE rAHF-PFM following surgery (postoperative Days 10-14). Hemostasis was maintained at all times during this period and both plasma Factor VIII levels and clearance rates returned to appropriate levels by postoperative Day 15. Factor VIII inhibitor assays performed after completion of continuous infusion and at study termination were negative.

Factor VIII inhibitor testing was performed throughout all studies in the rAHF-PFM clinical program. Among 136 treated subjects >/=10 years of age, all of whom had >/=150 exposure days to Factor VIII products at study entry, 102 had at least 75 exposure days to ADVATE rAHF-PFM. None of these subjects developed an inhibitor. One subject who had < 50 exposure days to ADVATE rAHF-PFM while on study developed an inhibitor. This subject manifested a low titer inhibitor (2.0 BU by the Bethesda assay) after 26 ADVATE rAHF-PFM exposure days. Eight weeks later, the inhibitor was no longer detectable, and in vivo recovery was normal at 1 and 3 hours after infusion of RECOMBINATE rAHF. For the group comprising all subjects with at least 75 exposure days to ADVATE rAHF-PFM and the single subject who developed an inhibitor, the 95% confidence interval (Poisson distribution) for the risk of developing an inhibitor to Factor VIII was 0.02 to 5.4%.



REPORTS OF SUSPECTED ADVATE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Advate. The information is not vetted and should not be considered as verified clinical evidence.

Possible Advate side effects / adverse reactions in 81 year old male

Reported by a pharmacist from Japan on 2011-10-13

Patient: 81 year old male weighing 63.0 kg (138.6 pounds)

Reactions: Marasmus

Adverse event resulted in: death

Suspect drug(s):
Feiba
    Indication: Haemostasis
    Start date: 2011-05-03
    End date: 2011-05-03

Advate
    Indication: Haemostasis
    Start date: 2010-09-01
    End date: 2010-09-01



Possible Advate side effects / adverse reactions in 2 year old male

Reported by a physician from Canada on 2011-10-14

Patient: 2 year old male

Reactions: Factor Viii Inhibition, Therapeutic Product Ineffective FOR Unapproved Indication

Suspect drug(s):
Advate
    Indication: OFF Label USE

Advate
    Indication: Immune Tolerance Induction



Possible Advate side effects / adverse reactions in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-19

Patient: 5 year old male weighing 18.2 kg (40.0 pounds)

Reactions: Laboratory Test Abnormal, Epistaxis

Suspect drug(s):
Advate

Other drugs received by patient: Advate



See index of all Advate side effect reports >>

Drug label data at the top of this Page last updated: 2006-02-18

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