Adverse reactions : תופעות לוואי

8      ADVERSE REACTIONS

8.1    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 of JOENJA reflects exposure based on 38 adult and adolescent patients 12 years of age and older with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) from the placebo-controlled portion of Study 2201 [see Clinical Studies (15)] and additional open-label clinical safety data. Thirty-seven of 38 patients received JOENJA 70 mg orally twice daily for at least 25 weeks and 66% were exposed for 96 weeks or longer. Median duration of JOENJA treatment was approximately 2 years, and 4 patients had more than 5 years of JOENJA exposure.
The data below are based on the 12-week, placebo-controlled portion of Study 2201 in which either JOENJA 70 mg (N=21) or placebo (N=10) was administered twice daily to patients with APDS. Demographics of the patients who participated in this study are summarized in Clinical Studies [see Clinical Studies (15)]. Table 1 presents the number of patients and incidence, rounded to the nearest percent, of adverse reactions that occurred in 2 or more patients treated with JOENJA and for which the incidence in patients treated with JOENJA was greater than the incidence in patients treated with placebo.
The most common adverse reactions (>10%) were headache, sinusitis, and atopic dermatitis.
Table 1         Adverse Reactions Reported by 2 or More JOENJA-Treated Patients and More Frequently than Placebo
Adverse Reactions                           JOENJA          Placebo N=21            N=10 n (%)           n (%)
Headache                                      5 (24)         2 (20) Sinusitis                                     4 (19)           0
Dermatitis atopic1                            3 (14)           0
Tachycardia2                                  2 (10)           0
Diarrhea                                      2 (10)           0
Fatigue                                       2 (10)         1 (10) Pyrexia                                       2 (10)           0
Back pain                                     2 (10)           0
Neck pain                                     2 (10)           0
Alopecia                                      2 (10)           0
1
Dermatitis atopic: including dermatitis atopic and eczema
2
Tachycardia: including tachycardia and sinus tachycardia


Laboratory Abnormalities
Seven (33%) patients receiving JOENJA developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL. No patients developed an ANC <500 cells/microL and there were no reports of infection associated with neutropenia.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il
Additionally, you should also report to Kamada Ltd. to email address: pharmacovigilance@kamada.com