Jivi

Last updated on RxList: 9/7/2018
Jivi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/7/2018

Jivi [antihemophilic factor (recombinant), PEGylated-aucl] is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) 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. Common side effects of Jivi include:

  • headache,
  • cough,
  • nausea,
  • fever,
  • vomiting,
  • abdominal pain,
  • rash,
  • hypersensitivity reactions,
  • insomnia,
  • injection site reactions (itching and rash),
  • dizziness,
  • skin redness,
  • itching,
  • flushing, and
  • distorted sense of taste

The required dose (IU) of Jivi for control of bleeding episodes and perioperative management = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected recovery (or observed recovery, if available). The recommended initial regimen of Jivi for routine prophylaxis is 30–40 IU/kg twice weekly. Jivi may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Jivi; it is unknown how it would affect a fetus. It is unknown if Jivi passes into breast milk. Consult your doctor before breastfeeding.

Our Jivi [antihemophilic factor (recombinant), PEGylated-aucl] Lyophilized Powder for Solution, for Intravenous Use 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
Jivi 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 Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl for Injection)

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Jivi Professional Information

SIDE EFFECTS

The most frequently (≥ 5%) reported adverse reactions in clinical trials in previously treated patients (PTPs) ≥ 12 years of age were headache, cough, nausea and fever (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.

A total of 221 subjects constituted the safety population from three studies. Subjects who received Jivi for perioperative management (n=17) with treatment period of 2 to 3 weeks were excluded from pooled safety analysis but included in analysis for inhibitor development. The median EDs for adults and adolescents (≥ 12 years of age) was 131 EDs (range: 1–309) per subject; and the median EDs for subjects < 12 years of age was 53 EDs (range: 1–68) per subject.

Table 3: Adverse Reactions reported for Jivi

MedDRA Standard System Organ Class
Preferred term
All Subjects
n (%)
n=221
Subjects ≥12 years of age
n (%)
n=148
Gastrointestinal Disorders
Abdominal pain 9 (4%) 5 (3%)
Nausea 9 (4%) 8 (5%)
Vomiting 10 (5%) 5 (3%)
General Disorders and Administration Site Conditions
Injection site reactionsa 4 (2%) 2 (1%)
Pyrexia (fever) 20 (9%) 8 (5%)
Immune System Disorders
Hypersensitivity 8 (4%) 3 (2%)
Nervous System Disorders
Dizziness 3 (1%) 3 (2%)
Dysgeusia (distorted sense of taste) 1 (1%) 0
Headache 29 (13%) 21 (14%)
Psychiatric Disorders    
Insomnia 5 (2%) 4 (3%)
Respiratory, Thoracic and Mediastinal Disorders
Cough 18 (8%) 10 (7%)
Skin and Subcutaneous Tissue Disorders
Erythemab (redness) 3 (1%) 2 (1%)
Pruritus (itching) 2 (1%) 1 (1%)
Rashc 9 (4%) 3 (2%)
Vascular Disorders
Flushing 1 (1%) 1 (1%)
a Includes Injection site pruritus and Injection site rash
b Includes Erythema and Erythema multiforme
c Includes Rash and Rash papular

Immunogenicity

Immunogenicity was evaluated during clinical trials with Jivi in 158 (including surgery subjects) previously treated adult and adolescent (≥ 12 years of age) severe hemophilia A (Factor VIII activity < 1%) subjects with previous exposure to Factor VIII concentrates ≥ 150 EDs. There were 73 previously treated pediatric subjects < 12 years of age [see Use In Specific Populations].

Factor VIII Inhibitors

A Factor VIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a Factor VIII inhibitor.

Anti-PEG Antibodies

Immunogenicity against PEG was evaluated by anti-PEG screening and specific IgM anti-PEG ELISA assays. One subject (19 years of age) with asthma, presented at 4 exposure days (EDs) with a clinical hypersensitivity reaction after infusion of Jivi. The subject reported headache, abdominal pain, shortness of breath, and flushing, all of which resolved following his standard asthma treatment. No further medical intervention was required. The event was associated with a transient increase of IgM anti-PEG antibody titer, which was negative upon retest during follow-up within 30 days.

The detection of antibody formation depends 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 Jivi with the incidence of antibodies to other products.

Read the entire FDA prescribing information for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl for Injection)

© Jivi Patient Information is supplied by Cerner Multum, Inc. and Jivi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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