Kovaltry
- Generic Name: antihemophilic factor (recombinant) for intravenous administration
- Brand Name: Kovaltry
Kovaltry (Antihemophilic Factor (Recombinant) for Intravenous Administration) side effects drug center
Kovaltry Side Effects Center
Kovaltry [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Kovaltry is not indicated for the treatment of von Willebrand disease. Common side effects of Kovaltry include:
- headache
- fever
- itching
- injection site reactions
- insomnia
- rash
- abdominal pain or discomfort
- indigestion
- swollen lymph nodes
- heart palpitations
- dizziness
- allergic skin reactions
- changes in taste
- hives, and
- flushing.
Kovaltry 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 Kovaltry (Antihemophilic Factor (Recombinant) for Intravenous Administration)
Kovaltry Professional Information
SIDE EFFECTS
The most frequently reported adverse reactions in clinical trials ( ≥ 3%) were headache, pyrexia, and pruritus (see Table 3).
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.
The safety profile of KOVALTRY was evaluated in 193 previously treated patients (PTPs) (inclusive of 51 pediatric patients < 12 years of age) with at least three months of exposure to KOVALTRY. The safety analysis was done using a pooled database from three multi-center, prospective, open-label clinical studies. The median time on study for patients ≥ 12 years of age was 372 days with a median of 159 exposure days (EDs). The median time on study for patients < 12 years of age was 182 days with a median of 73 EDs. Subjects who received KOVALTRY for perioperative management (n=5) with treatment period of 2 to 3 weeks and those who received single doses of KOVALTRY for PK studies (n=6) were excluded from safety analysis. Table 3 lists the adverse reactions reported during clinical studies. The frequency, type, and severity of adverse reactions in children are similar to those in adults.
Table 3: Adverse Reactions in PTPs (N=193)
| MedDRA Primary System Organ Class Preferred term |
Frequency N (%) |
| Blood and the Lymphatic System Disorders | |
| Lymphadenopathy | 2 (1.0%) |
| Cardiac Disorders | |
| Palpitation | 2 (1.0%) |
| Sinus tachycardia | 2 (1.0%) |
| Gastrointestinal Disorders | |
| Abdominal pain | 4 (2.1%) |
| Abdominal discomfort | 3 (1.6%) |
| Dyspepsia | 4 (2.1%) |
| General Disorders and Administration Site Conditions | |
| Pyrexia | 8 (4.1%) |
| Chest discomfort | 2 (1.0%) |
| Injection site reactionsa | 5 (2.6%) |
| Immune System Disorders | |
| Hypersensitivity | 1 (0.5%) |
| Nervous System Disorders | |
| Dizziness | 2 (1.0%) |
| Dysgeusia Headache | 1 (0.5%) 14 (7.3%) |
| Psychiatric Disorders | |
| Insomnia. | 5 (2.6%) |
| Skin and Subcutaneous Tissue Disorders | |
| Dermatitis allergic | 2 (1.0%) |
| Pruritus | 6 (3.1%) |
| Rashb | 5 (2.6%) |
| Urticaria | 1 (0.5%) |
| Vascular disorders | |
| Flushing | 1 (0.5%) |
| aIncludes injection site extravasation and hematoma,
infusion site pain, pruritus, and swelling bIncludes rash, rash erythematous, and rash pruritic |
|
Immunogenicity
All clinical trial subjects were monitored for neutralizing antibodies (inhibitors) to Factor VIII by the modified Bethesda assay using blood samples obtained prior to the first infusion of KOVALTRY, at defined intervals during the studies and at the completion visit.
Clinical trials (Phases 1 through 3) with KOVALTRY evaluated a total of 204 pediatric and adult patients diagnosed with severe hemophilia A (Factor VIII < 1%) with previous exposure to Factor VIII concentrates ≥ 50 EDs, and no history of inhibitors.
In the completed studies, no PTP developed neutralizing antibodies to Factor VIII. In an ongoing extension study, a 13 year old PTP had a titer of 0.6 BU after 550 EDs concurrent with an acute infection and positive IgG anticardiolipin antibodies. The Factor VIII recovery was 2.2 IU/dL per IU/kg, annualized bleeding rate (ABR) was zero, and no change in therapy was required.
In an actively enrolling clinical trial in PUPs, 6 of 14 treated subjects (42.9% with a 95% Confidence Interval of 17.7-71.1%) developed an inhibitor. Of these, 3 subjects (21.4%) had high titer inhibitors, and 3 subjects (21.4%) had transient low titer inhibitors for which no change in therapy was required.
The detection of antibody formation is dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, it may be misleading to compare the incidence of antibodies to KOVALTRY with the incidence of antibodies to other products.
Read the entire FDA prescribing information for Kovaltry (Antihemophilic Factor (Recombinant) for Intravenous Administration)
&Copy; Kovaltry Patient Information is supplied by Cerner Multum, Inc. and Kovaltry Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.