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Infergen (Interferon Alfacon-1) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse experiences that were reported, regardless of attribution to treatment, in at least 5% of patients in the 9 mcg INFERGEN or 3 MIU IFN α-2b groups of the pivotal study are presented in Table 3, listed in decreasing order by the 9 mcg INFERGEN group. The incidence of adverse events is expressed based on the number of patients experiencing each event at least once during treatment or during posttreatment observation.

Most adverse events were mild-to-moderate in severity and abated with cessation of therapy. Flu-like symptoms (i.e., headache, fatigue, fever, rigors, myalgia, sweating increased, and arthralgia) were the most frequently reported treatment-related adverse reactions. Most were short-lived and could be treated symptomatically.

Depression, usually mild-to-moderate in severity, was reported in 26% of patients who received 9 mcg INFERGEN and was the most common adverse event resulting in study drug discontinuation.

In patients who had tolerated previous interferon therapy (9 mcg INFERGEN or 3 MIU IFN α-2b) and failed to normalize ALT, or who had achieved normalization of ALT during the treatment period but who relapsed during the posttreatment observation period, subsequent treatment with 15 mcg TIW of INFERGEN for 24 or 48 weeks was generally tolerated. Adverse experiences of patients receiving subsequent treatment, regardless of attribution to treatment, are reported in Table 3. The higher dose of INFERGEN used in these patients was associated with a greater incidence of leukopenia and granulocytopenia. One or more dose reductions for all causes were required in up to 36% of patients. Patients who do not tolerate initial standard interferon therapy should not receive therapy with 15 mcg TIW of INFERGEN.

Table 3. Patient Incidence of Adverse Events in Phase 3 Clinical Trials Regardless of Attributiona
Initial Treatment b Subsequent Treatment b
INFERGEN IFN α-2b INFERGEN INFERGEN
9 mcg 15 mcg 15 mcg
(n = 231) (n = 236) 24 wks 48 wks
(n = 165) (n = 168)
Body System/Preferred Term % of Patients% of Patients
a. Only events that occurred at a frequency of ≥ 5% in any treatment group are included. Patients can appear more than once in Table 3. Because the 2 studies were conducted at different times with nonidentical patient groups, the adverse events profile for the subsequent treatment study is not directly comparable to the initial treatment study.
b. Adverse events reported in patients during treatment or posttreatment observation in the pivotal initial treatment and subsequent treatment studies are listed regardless of attribution to treatment.
c. Influenza-like symptoms: presumed viral etiology.
APPLICATION SITE
     Injection Site Erythema23151722
     Injection Site Pain93811
     Injection Site Ecchymosis6755
BODY AS A WHOLE
      Fatigue69676571
      Fever61455855
      Rigors57456266
      Body Pain54453951
      Influenza-like Symptomsc151188
      Pain Chest131459
      Hot Flushes13774
      Malaise111025
      Asthenia911107
      Edema Peripheral9843
      Access Pain8911
      Allergic Reaction7534
      Weight Decrease5752
CARDIOVASCULAR
      Hypertension5324
      Palpitation3652
CNS/PNS
      Headache82837880
      Insomnia39302428
      Dizziness22251825
      Paresthesia131099
      Hypoesthesia108810
      Amnesia10625
      Hypertonia71066
      Somnolence4867
      Confusion4645
      Hyperesthesia1115
ENDOCRINE DISORDERS
      Thyroid Test Abnormal9546
GASTROINTESTINAL
      Abdominal Pain41402432
      Nausea40363036
      Diarrhea29242422
      Anorexia24172114
      Dyspepsia21181210
      Vomiting12111311
      Constipation9656
      Flatulence8965
      Tooth Ache7737
      Saliva Decreased6741
      Hemorrhoids6312
      Stomatitis Ulcerative3426
      Gingivitis2315
HEARING/VESTIBULAR
      Tinnitus6442
      Earache5755
      Otitis2513
HEMATOLOGIC
      Granulocytopenia23254239
      Thrombocytopenia19161818
      Leukopenia15131928
      Lymphadenopathy6844
      Ecchymosis6442
      Lymphocytosis57115
      PT Increased3510
      Anemia2326
LIVER AND BILIARY
      Liver Tender5362
      Hepatomegaly3552
METABOLIC/NUTRITION
      Hypertriglyceridemia6755
MUSCULO-SKELETAL
      Myalgia58565155
      Arthralgia51444346
      Back Pain42372923
      Limb Pain26251323
      Skeletal Pain14141012
      Neck Pain141385
      Musculo-skeletal Disorder4474
PSYCHIATRIC DISORDER
      Nervousness31291622
      Depression26251819
      Anxiety1918914
      Emotional Lability121163
      Thinking Abnormal8121020
      Agitation6644
      Libido Decreased5554
      Apathy2345
REPRODUCTIVE (FEMALE)
      Dysmenorrhea9927
      Vaginitis8255
      Menstrual Disorder6525
      Menorrhagia3025
      Moniliasis Genital2620
      Breast Mass0305
      Breast Pain0520
RESISTANCE MECHANISM
      Infection3526
RESPIRATORY
      Pharyngitis34311721
      Infection Upper Respiratory31341618
      Cough22171211
      Sinusitis17221216
      Rhinitis131679
      Respiratory Tract Congestion12749
      Upper Resp. Tract Congestion101479
      Epistaxis81266
      Dyspnea71287
      Bronchitis6621
SKIN AND APPENDAGES
      Alopecia14251013
      Pruritus14141110
      Rash13151310
      Sweating Increased12111311
      Erythema6679
      Skin Dry6525
      Wound4734
SPECIAL SENSES
      Taste Perversion3635
VISION DISORDERS
      Conjunctivitis8846
      Eye Pain5642
      Vision Abnormal3555

Laboratory Values

The following laboratory values were found to be affected by therapy with INFERGEN in the 231 patients who received treatment with 9 mcg INFERGEN.

Hemoglobin and Hematocrit: Treatment with INFERGEN was associated with gradual decreases in mean values for hemoglobin and hematocrit, which were 4% and 5% below baseline at the end of treatment. Decreases from baseline of 20% or more in hemoglobin or hematocrit were seen in 1% of patients or less.

White Blood Cells: INFERGEN treatment was associated with decreases in mean values for both total white blood cell (WBC) count and ANC within the first 2 weeks of treatment. By the end of treatment, mean decreases from baseline of 19% for WBCs and 23% for ANC were observed. These effects reversed during the posttreatment observation period. In 2 INFERGEN-treated patients in the phase 3 trial, decreases in ANC to levels below 500 x 106 cells/L were seen. In both cases, the ANC returned to clinically acceptable levels with reduction of the dose of INFERGEN, and these transient decreases in neutrophils were not associated with infections.

Platelets: INFERGEN treatment was associated with alterations in platelet count. Decreases in mean platelet count of 16% compared to baseline were seen by the end of treatment. These decreases were reversed during the posttreatment observation period. Values below normal were common during treatment with 3% of patients developing values less than 50 x 109 cells/L, usually necessitating dose reduction.

Triglycerides: Mean values for serum triglyceride increased shortly after the start of administration of INFERGEN, with increases of 41%, compared with baseline, at the end of the treatment period. Seven percent of the patients developed values which were at least 3 times above pretreatment levels during treatment. This effect was promptly reversed after discontinuation of treatment.

Thyroid Function: INFERGEN treatment was associated with biochemical changes consistent with hypothyroidism including increases in TSH and decreases in T4 mean values. Increases in TSH to greater than 7 mU/L were seen in 10% of 9 mcg INFERGEN-treated patients either during the treatment period or the 24-week posttreatment observation period. Thyroid supplements were instituted in approximately one-third of these patients.

Laboratory Values for Subsequent Treatment: From a database of 165 patients receiving subsequent treatment with 15 mcg of INFERGEN for 24 weeks, and 168 patients receiving subsequent treatment with 15 mcg of INFERGEN for 48 weeks after failing initial interferon therapy, similar changes in the laboratory values as outlined above were observed. Mean decreases from baseline up to 23% for WBCs and up to 27% for ANC were observed for patients subsequently treated with interferon, which was greater than during initial treatment. Two patients in the 24-week group experienced reversible reductions in ANC to less than 500 x 106 cells/L, which were not associated with infectious complications. No patients discontinued as a result of hematologic toxicity.

Postmarketing Experience

In addition, the following potential adverse reactions have been reported during post-approval use of INFERGEN. Because the reports of these adverse events are voluntary and the population of uncertain size, it is not possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Application site: injection site reaction, including injection site necrosis ulcer, and bruising; Ear and Labyrinth: hearing loss, hearing impairment; Gastrointestinal: abdominal distention, gastrointestinal bleeding, gastritis; Hepatobiliary: hepatic enzyme elevations, including ALT and AST elevation, abnormal hepatic function, hyperbilirubinemia, jaundice, ascites, hepatic encephalopathy; Infections: sepsis; Metabolism and Nutritional: dehydration; Musculoskeletal: rhabdomyolysis, arthritis, bone pain; Nervous: speech disorder, ataxia, gait abnormal, convulsions, loss of consciousness, memory impairment, tremors, visual field defect; Psychiatric: delusions, hallucinations; Skin and Subcutaneous: bruising, pyoderma gangrenosum, toxic epidermal necrolysis; Vascular Disorders: hemorrhage



REPORTS OF SUSPECTED INFERGEN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Infergen side effects / adverse reactions in 58 year old male

Reported by a consumer/non-health professional from United States on 2011-10-19

Patient: 58 year old male

Reactions: Weight Increased, Muscle Atrophy, Depression

Suspect drug(s):
Ribavirin
    Indication: Product Used FOR Unknown Indication

Infergen
    Indication: Product Used FOR Unknown Indication



Possible Infergen side effects / adverse reactions in 61 year old male

Reported by a physician from United States on 2011-11-02

Patient: 61 year old male

Reactions: Anaemia, Obesity, Treatment Failure, Thrombocytopenia, Polyneuropathy

Suspect drug(s):
Ribavirin
    Indication: Hepatitis C
    End date: 2008-01-01

PEG-Intron
    Indication: Hepatitis C

Infergen
    Indication: Hepatitis C
    End date: 2008-01-01



Possible Infergen side effects / adverse reactions in 49 year old male

Reported by a health professional (non-physician/pharmacist) from Greece on 2011-11-23

Patient: 49 year old male

Reactions: Stem Cell Transplant, Neoplasm Progression, Refractory Cytopenia With Multilineage Dysplasia, Multiple Myeloma

Suspect drug(s):
Dexamethasone
    Indication: Multiple Myeloma

Prednisone TAB
    Indication: Multiple Myeloma

Infergen
    Dosage: 3 x 10 iu thrice weekly
    Indication: Multiple Myeloma

Etoposide
    Indication: Multiple Myeloma

Cyclophosphamide
    Indication: Multiple Myeloma

Cytarabine
    Indication: Multiple Myeloma
    Start date: 1998-11-01

Carmustine
    Indication: Multiple Myeloma
    Start date: 1998-11-01

Ifosfamide
    Indication: Multiple Myeloma

Cisplatin
    Indication: Multiple Myeloma

Melphalan Hydrochloride
    Dosage: 10 cycles
    Indication: Multiple Myeloma



See index of all Infergen side effect reports >>

Drug label data at the top of this Page last updated: 2007-12-06

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