Kovaltry

Last updated on RxList: 3/23/2016
Kovaltry Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/23/2016

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.
Dosage and duration of treatment with Kovaltry depends on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Kovaltry may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Kovaltry should be administered only if prescribed. It is unknown if it will affect a fetus. It is unknown if Kovaltry passes into breast milk. Consult your doctor before breastfeeding. Our Kovaltry [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

What is hemophilia? See Answer
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)

SLIDESHOW

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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)

© 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.

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