Kogenate FS

Kogenate FS [Antihemophilic Factor (Recombinant) Formulated with Sucrose] is a naturally occurring protein in the blood that helps blood to clot (coagulation factor) used to treat or prevent bleeding episodes in adults and children with hemophilia A. Kogenate FS is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage. Kogenate FS is not for use in people with von Willebrand disease. Kogenate FS is available in generic form. Common side effects of Kogenate FS include:

• flushing of the face (warmth, redness, itching, or tingling under your skin)
• headache
• nausea
• vomiting
• fast heartbeat
• injection site reactions (burning, redness, irritation, swelling, or stinging)
• fever
• chills
• sore throat
• cough
• runny nose
• unusual or unpleasant taste in your mouth
• skin itching or rash
• joint pain or swelling, or
• dizziness

Dosage and duration of Kogenate FS treatment depends on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Kogenate FS may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Kogenate FS should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Kogenate FS [Antihemophilic Factor (Recombinant) Formulated with Sucrose] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Kogenate FS Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• increased bleeding episodes;
• any bleeding that will not stop;
• chest pain; or
• a light-headed feeling, like you might pass out.

Common side effects may include:

• nose bleeds;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• muscle or joint pain;
• rash;
• flushing (sudden warmth, redness, or tingly feeling);
• fever, chills;
• cough;
• weakness; or
• pain, swelling, itching, or redness 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))

 

Kogenate FS Professional Information

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, there were 24 adverse reactions reported in the course of 24,936 infusions.

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
SOC = System Organ Class

Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs)

In clinical studies with pediatric PUPs and MTPs, there were 29 adverse reactions reported in the course of 9,389 infusions.

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)1	N/A
General Disorders and Administration Site Conditions	Infusion site reactions	4 (6.6)	0.04
SOC = System Organ Class 1 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)	181(55)
Infections and Infestations	Central line infection	6 (19)	6 (18)
General Disorders and Administration Site Conditions	Pyrexia	1 (3)	4 (12)
SOC = System Organ Class 1 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
Immune System Disorders	Anaphylactic reaction, other hypersensitivity reactions
Nervous System Disorders	Dysgeusia
SOC = System Organ Class

Read the entire FDA prescribing information for Kogenate FS (Antihemophilic Factor (Recombinant))