Kogenate FS
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Kogenate FS
Kogenate FS Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kogenate FS in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:
- chest pain;
- easy bruising, increased bleeding episodes; or
- bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
- sore throat, cough, runny nose;
- fever or chills;
- mild nausea, vomiting;
- unusual or unpleasant taste in your mouth;
- skin itching or rash;
- warmth, redness, itching, or tingling under your skin;
- joint pain or swelling;
- dizziness;
- headache; or
- swelling, stinging, or irritation where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kogenate FS (Antihemophilic Factor (Recombinant)) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Kogenate FS Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Kogenate FS (Antihemophilic Factor (Recombinant))»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kogenate FS FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF.
The most common adverse reactions observed in clinical trials (frequency ≥ 4% of patients) are inhibitor formation in previously untreated patients (PUPs) and minimally treated patients (MTPs), skin-related hypersensitivity reactions (e.g., rash, pruritus), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) line-associated infections in patients requiring a CVAD for intravenous administration.
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 clinical trials of another drug and may not reflect the rates observed in clinical practice.
Previously Treated Patients (PTPs)
During the clinical studies conducted in PTPs, 451 adverse events (irrespective of the relationship to the study drug) were reported in the course of 24,936 infusions (1.8%). Twenty-four of the 451 adverse events were assessed as related to Kogenate FS (0.1%).
Adverse reactions reported by ≥ 4% of the patients are listed in Table 3 below.
Table 3 : Adverse Reactions (AR) in Previously Treated
Patients (PTPs) with Frequency of ≥ 4%
| MedDRA Primary SOC | Preferred Term | Total No. of Patients: 73 No. of Patients with AR (%) | Total No. of Infusions: 24,936 AR per Infusion (%) |
| Skin and Subcutaneous Tissue Disorders | Rash, pruritus | 6 (8.2%) | 0.02 |
| General Disorders and Administration Site Conditions | Infusion site reactions | 3 (4.1%) | 0.01 |
Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs)
In clinical studies with pediatric PUPs and MTPs, 726 adverse events were reported in the course of 9,389 infusions (7.7%). Twenty-nine of the 726 adverse events were assessed as related to Kogenate FS (0.3%).
Adverse reactions reported by ≥ 4% of the patients are listed in Table 4 below.
Table 4 : Adverse Reactions (AR) in Previously Untreated
Patients (PUPs) and Minimally Treated Patients (MTPs) with Frequency of ≥
4% (Age Range 2-27 months)
| MedDRA Primary SOC | Preferred Term | Total No. of patients: 61 No. of Patients with AR (%) | Total No. of Infusions: 9,389 AR per Infusion (%) |
| Skin and Subcutaneous Tissue Disorders | Rash, pruritus, urticaria | 10 (16.4) | 0.01 |
| Blood and Lymphatic System Disorders | Factor VIII inhibition | 9 (15)a | N/A |
| General Disorders and Administration Site Conditions | Infusion site reactions | 4 (6.6) | 0.04 |
| a *Denominator for de-novo inhibitors is N=60, since one patient had a pre-existing inhibitor. | |||
Minimally Treated Patients (MTPs) in the Joint Outcome Study
In the Joint Outcome Study with pediatric MTPs treated with routine prophylaxis or episodic enhanced treatment for 5.5 years, 46 of the 65 randomized patients experienced adverse events over the study duration. Adverse events were not assessed for their relationship with Kogenate FS.
Table 5 : Adverse Events (AE) in MTPs in the Joint
Outcome Study (Age Range 0-6 years)
| MedDRA Primary SOC | Preferred Term | Total No. of Prophylaxis Arm Patients: 32 No. of Patients with AE (%) | Total No. of Enhanced Episodic Arm Patients: 33 No. of Patients with AE (%) |
| Surgical and Medical Procedures | Central venous catheterization. Catheter removal | 19 (59) | 18a (55) |
| Infections and Infestations | Central line infection | 6 (19) | 6 (18) |
| General Disorders and Administration Site Conditions | Pyrexia | 1 (3) | 4 (12) |
| a Three patients from the enhanced episodic arm had catheter removal. | |||
Immunogenicity
In clinical studies with 73 PTPs (defined as having more than 100 exposure days), one patient had a pre-existing inhibitor. In the other 72 patients, followed over 4 years, no de-novo inhibitors were observed.
In clinical studies with pediatric PUPs and MTPs, inhibitor development was observed in 9 out of 60 patients (15%), 6 were high titer1 ( > 5BU) and 3 were low-titer inhibitors. Inhibitors were detected at a median number of 7 exposure days (range 2 to 16 exposure days).
In the Joint Outcome Study with Kogenate FS,5 de-novo inhibitor development was observed in 8 of 64 patients with negative baseline values (12.5%), 2 patients developed high titer1 ( > 5 BU) and were withdrawn from the study. Six patients developed low-titer inhibitors. Inhibitors were detected at a median number of 44 exposure days (range 5 to 151 exposure days).
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of Kogenate FS. 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.
Among patients treated with Kogenate FS, cases of serious allergic/hypersensitivity reactions (which may include facial swelling, flushing, hives, blood pressure decrease, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, vomiting) have been reported, particularly in very young patients or patients who have previously reacted to other factor VIII concentrates.
The following table represents the post-marketing adverse reactions as MedDRA Preferred Terms.
Table 6 : Post-Marketing Experience
| MedDRA Primary SOC | Preferred Term |
| Blood and Lymphatic System Disorders | FVIII inhibition |
| Skin and Subcutaneous Tissue Disorders | Pruritus. urticaria. rash |
| General Disorders and Administration Site Conditions | Infusion site reaction |
| Pyrexia | |
| Immune System Disorders | Anaphylactic reaction. other hypersensitivity reactions |
| SOC = System Organ Class |
Read the entire FDA prescribing information for Kogenate FS (Antihemophilic Factor (Recombinant)) »
Additional Kogenate FS Information
Kogenate FS - User Reviews
Kogenate FS User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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