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Questions & Answers
Side Effects & Adverse Reactions
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy.
Withdrawal from study for adverse events occurred in 7% of patients initially treated with 9 mcg INFERGEN (including 4% due to psychiatric events). Withdrawal from study due to adverse events occurred in 5% of patients subsequently treated with 15 mcg INFERGEN for 24 weeks and 11% of patients subsequently treated with 15 mcg INFERGEN for 48 weeks.
Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Prior to initiation of INFERGEN therapy, physicians should inform patients of the possible development of depression and patients should be advised to immediately report any sign or symptom of depression and/or suicidal ideation. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted (SeeDOSAGE AND ADMINISTRATION: Dose Reduction).
Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (<0.5 x 109/L) or platelet counts (<50 x 109/L).
Hypertension, tachycardia, palpitation, and tachyarrhythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.8
Serious acute hypersensitivity reactions have been reported in rare instances following treatment with alpha interferons. If hypersensitivity reactions occur (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis), INFERGEN should be discontinued immediately and appropriate medical treatment instituted.
INFERGEN should be administered with caution to patients with a history of endocrine disorders. Occurrence or aggravation of hyperthyroidism or hypothyroidism have been reported with INFERGEN. Hyperglycemia and diabetes mellitus have also been observed in patients treated with INFERGEN. Patients who develop these conditions during treatment that cannot be controlled with medication should not continue INFERGEN therapy.
Development of or exacerbation of autoimmune disorders (e.g., autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN. INFERGEN should not be used in patients with autoimmune hepatitis (seeCONTRAINDICATIONS) and should be used with caution in patients with other autoimmune disorders.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Hemorrhagic/ischemic colitis, sometimes fatal, has been observed within 12 weeks of alpha interferon therapies and has been reported in patients treated with INFERGEN. INFERGEN treatment should be discontinued immediately in patients who develop signs and symptoms of colitis.
Pancreatitis, sometimes fatal, has been observed in patients treated with alpha interferons, including INFERGEN. INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients’ clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed (seeCONTRAINDICATIONS).
Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including INFERGEN. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INFERGEN is indicated for the treatment of chronic HCV infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA. Other causes of hepatitis, such as viral hepatitis B or autoimmune hepatitis, should be ruled out prior to initiation of therapy with INFERGEN. In some patients with chronic HCV infection, INFERGEN normalizes serum ALT, reduces serum HCV RNA concentrations to undetectable quantities (< 100 copies/mL), and improves liver histology.
History
There is currently no drug history available for this drug.
Other Information
Interferon alfacon-1 is a recombinant non-naturally occurring type-I interferon. The 166-amino acid sequence of Interferon alfacon-1 was derived by scanning the sequences of several natural interferon alpha subtypes and assigning the most frequently observed amino acid in each corresponding position.1 Four additional amino acid changes were made to facilitate the molecular construction, and a corresponding synthetic DNA sequence was constructed using chemical synthesis methodology. Interferon alfacon-1 differs from interferon alfa-2b at 20/166 amino acids (88% homology), and comparison with interferon-beta shows identity at over 30% of the amino acid positions. Interferon alfacon-1 is produced in Escherichia coli (E. coli) cells that have been genetically altered by insertion of a synthetically constructed sequence that codes for Interferon alfacon-1. Prior to final purification, Interferon alfacon-1 is allowed to oxidize to its native state, and its final purity is achieved by sequential passage over a series of chromatography columns. This protein has a molecular weight of 19,434 daltons.
INFERGEN is a sterile, clear, colorless, preservative-free liquid formulated with 100 mM sodium chloride and 27 mM sodium phosphate at pH 7.0 ± 0.2. The product is available in single-use vials containing 9 mcg and 15 mcg Interferon alfacon-1 at a fill volume of 0.3 mL and 0.5 mL, respectively. INFERGEN vials contain 0.03 mg/mL Interferon alfacon-1, 5.9 mg/mL sodium chloride, and 3.8 mg/mL sodium phosphate in Water for Injection, USP. INFERGEN is to be administered undiluted by subcutaneous (SC) injection.
Sources
Infergen Manufacturers
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Valeant Pharmaceuticals, Inc.
![Infergen (Interferon Alfacon-1) Injection [Valeant Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Infergen | Valeant Pharmaceuticals, Inc.
The recommended dose of INFERGEN for treatment of chronic HCV infection is 9 mcg TIW administered SC as a single injection for 24 weeks. At least 48 hours should elapse between doses of INFERGEN. (Seeillustrated MEDICATION GUIDE for instructions.)
Patients who tolerated previous interferon therapy and did not respond or relapsed following its discontinuation may be subsequently treated with 15 mcg of INFERGEN TIW administered SC as a single injection for up to 48 weeks. (Seeillustrated MEDICATION GUIDE for instructions.)
There are significant differences in specific activities among interferons. Healthcare providers should be aware that changes in interferon brand may require adjustments of dosage and/or change in route of administration. Patients should be warned not to change brands of interferon without medical consultation. Patients should also be instructed by their physician not to reduce the dosage of INFERGEN prior to medical consultation.
Dose ReductionFor patients who experience a severe adverse reaction on INFERGEN, dosage should be withheld temporarily. If the adverse reaction does not become tolerable, therapy should be discontinued. Dose reduction to 7.5 mcg may be necessary following an intolerable adverse event. In the pivotal study, 11% of patients (26/231) who initially received INFERGEN at a dose of 9 mcg (0.3 mL) were dose-reduced to 7.5 mcg (0.25 mL).
If adverse reactions continue to occur at the reduced dosage, the physician may discontinue treatment or reduce dosage further. However, decreased efficacy may result from continued treatment at dosages below 7.5 mcg.
During subsequent treatment for 48 weeks with 15 mcg of INFERGEN, up to 36% of patients required dose reductions in 3 mcg increments.
Administration of INFERGENIf home use is determined to be desirable by the physician, instructions on appropriate use should be given by a healthcare professional. After administration of INFERGEN, it is essential to follow the procedure for proper disposal of syringes and needles. See theMEDICATION GUIDE for detailed instructions.
StorageJust prior to injection, INFERGEN may be allowed to reach room temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if particulates or discoloration are observed, the container should not be used.
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Kadmon Pharmaceuticals, Llc
Infergen | Kadmon Pharmaceuticals, Llc
2.1 INFERGEN Monotherapy DosingThe recommended dose of INFERGEN monotherapy for the initial treatment of chronic HCV infection is 9 mcg administered three times a week as a single subcutaneous injection for 24 weeks [see Clinical Studies (14.1), Medication Guide for instructions].
The recommended dose of INFERGEN monotherapy for patients who tolerated previous interferon therapy and did not respond or relapsed following its discontinuation is 15 mcg administered three times a week as a single subcutaneous injection for up to 48 weeks [see Clinical Studies (14.2), Medication Guide for instructions]. Patients who do not tolerate initial standard interferon therapy should not be treated with INFERGEN therapy 15 mcg three times a week.
2.2 Combination Treatment with INFERGEN/Ribavirin DosingThe recommended dose of INFERGEN is 15 mcg daily administered as a single subcutaneous injection in combination with weight-based ribavirin at 1,000 mg - 1,200 mg (< 75 kg and ≥75 kg) orally in two divided doses for up to 48 weeks. [see Clinical Studies (14.3), Medication Guide for instructions].
Ribavirin should be taken with food. INFERGEN/ribavirin should not be used in patients with creatinine clearance < 50 mL/min [see CONTRAINDICATIONS (4)].
2.3 Dose ModificationsIf a serious adverse reaction develops during the course of treatment [see WARNINGS AND PRECAUTIONS (5)] discontinue or modify the dosage of INFERGEN and/or ribavirin until the adverse event abates or decreases in severity. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. Upon resolution or improvement of the adverse reaction, resuming INFERGEN and/or ribavirin may be considered.
INFERGEN Monotherapy Dose Modifications
Dose reduction to 7.5 mcg may be necessary following a serious adverse reaction. If serious adverse events continue to occur, dosing should be interrupted or discontinued as the efficacy of lower doses has not been established.
INFERGEN/Ribavirin Combination Therapy Dose Modifications
Stepwise dose reduction from 15 mcg to 9 mcg and from 9 mcg to 6 mcg may be necessary for serious adverse reactions.
Guidelines for INFERGEN/Ribavirin Dose Modifications
Tables 1, 2, and 3 provide guidelines for dose modifications and discontinuation of INFERGEN and/or ribavirin based on depression or laboratory parameters.
Table 1. Guidelines for Dose Modification or Discontinuation of INFERGEN and for Scheduling Visits for Patients with Depression * See DSM-IV for definitions.Depression Severity*
Initial Management
(4–8 Weeks)
Depression
Dose Modification
Visit Schedule
Remains Stable
Improves
Worsens
Mild
No change to INFERGEN dose or ribavirin dose.
Evaluate once weekly by visit and/or phone.
Continue weekly visit schedule.
Resume normal visit schedule.
(See moderate or severe depression)
Moderate
Decrease INFERGEN dose from 15 mcg to 9 mcg; or from 9 mcg to 6 mcg, no change to ribavirin dose.
Evaluate once weekly (office visit at least every other week).
Consider psychiatric consultation. Continue reduced dosing.
If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced INFERGEN dosing or return to normal INFERGEN dose.
(See severe depression)
Severe
Discontinue INFERGEN and ribavirin permanently.
Not applicable.
Psychiatric therapy necessary.
Not applicable.
Not applicable.
Table 2. Guidelines for Dose Modification or Discontinuation of INFERGEN for Hematologic ToxicitiesLaboratory Values
Action
ANC < 0.75 × 109/L
Reduce INFERGEN dose from 15 mcg to 9 mcg, or from 9 mcg to 6 mcg; maintain ribavirin dose at 1200 mg or 1000 mg.
ANC < 0.50 × 109/L
INFERGEN and ribavirin treatment should be suspended until ANC values return to more than 1000/mm3.
Platelet Count < 50 × 109/L
Reduce INFERGEN dose from 15 mcg to 9 mcg or from 9 mcg to 6 mcg; maintain ribavirin dose at 1200 mg or 1000 mg.
Platelet Count < 25 × 109/L
INFERGEN and ribavirin treatment should be discontinued.
Table 3. Guidelines for Dose Modification or Discontinuation of INFERGEN/Ribavirin for the Management of Anemia* * For adult patients with a history of stable cardiac disease receiving INFERGEN in combination with ribavirin, the INFERGEN dose should be reduced from 15 mcg to 9 mcg or 9 mcg to 6 mcg and the ribavirin dose by 200 mg/day if a >2 g/dL decrease in hemoglobin is observed during any 4-week period. Both INFERGEN and ribavirin should be permanently discontinued if patients have hemoglobin levels <12 g/dL after this ribavirin dose reduction.
** 1st dose reduction of ribavirin is by 200 mg/day. 2nd dose reduction of ribavirin (if needed) is by an additional 200 mg/day.Condition
INFERGEN
Ribavirin
Hgb <10 g/dL
History of Cardiac or Cerebrovascular Disease, reduce dose of INFERGEN
Adjust dose**
Hgb <8.5 g/dL
Permanently discontinue
Permanently discontinue
Renal Function: INFERGEN/ribavirin should not be used in patients with creatinine clearance <50 mL/min. [See CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5) and Ribavirin Labeling].
2.4 Discontinuation of TreatmentPatients who fail to achieve at least a 2 log10 drop at 12 weeks or undetectable HCV-RNA at week 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered [See Clinical Studies (14)].
Ribavirin should be discontinued in any patient who temporarily or permanently discontinues INFERGEN.
2.5 Preparation and AdministrationJust prior to injection, INFERGEN may be allowed to reach room temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration; if particulates or discoloration are observed, the vial should not be used.
If home use is determined to be desirable by the physician, instructions on appropriate use should be given by a healthcare professional. After administration of INFERGEN, it is essential to follow the procedure for proper disposal of syringes and needles. [see Medication Guide for detailed instructions].
![Infergen (Interferon Alfacon-1) Injection [Kadmon Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=29ad47ed-cb94-470b-b3ab-9281abf414d5&name=0f25942c-6b2b-41a6-8c31-5f537f346b60-13.jpg)
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