Obizur

Name: Obizur

Side effects

Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction (AR) rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety and efficacy of OBIZUR was evaluated in a multi-center, prospective, open-label, clinical trial that investigated adult patients with acquired hemophilia A. Twenty-nine adult subjects were enrolled in the study, received at least one dose of OBIZUR and were evaluable for safety [see Clinical Studies]. Of the 29 adult subjects, 10 were between the ages of 40 and 65, and 19 were 65 years of age or older (18 Caucasian, 6 African-American, and 5 Asian). Ten (34%) subjects were female.

The most frequently reported adverse reaction in patients with acquired hemophilia A was the development of inhibitors to porcine factor VIII.

Immunogenicity

All subjects were monitored for development of inhibitory antibodies to OBIZUR using the Nijmegen modification of the Bethesda inhibitor assay. A subject was considered to have developed an OBIZUR inhibitor if the titer was ≥ 0.6 Bethesda Units (BU)/mL.

Of the 29 subjects treated with OBIZUR, 19 subjects were negative for anti-porcine factor VIII antibodies at baseline. Five of the 19 (26%) developed anti-porcine factor VIII antibodies following exposure to OBIZUR. Of the 10 subjects with detectable anti-porcine factor VIII antibodies at baseline, 2 (20%) experienced an increase in titer and eight (80%) experienced a decreasing to a non-detectable titer.

All subjects were also monitored for development of binding antibodies to baby hamster kidney (BHK) protein by a validated sequential ELISA (enzyme-linked immunosorbent assay). No patients developed de novo anti-BHK antibodies.

The detection of antibody formation is highly 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, comparison of the incidence of antibodies to OBIZUR with the incidence of antibodies to other products may be misleading.

  • Hemophilia

Obizur Overview

Obizur is a prescription medication used to treat bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

Obizur is an antihemophilic factor that temporarily replaced substances naturally produced by the body to control bleeding.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

The most common side effect of Obizur is the development of inhibitors to Obizur’s active ingredient.

Manufacturer

  • Baxter Healthcare Corporation

Obizur Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Obizur, there are no specific foods that you must exclude from your diet when receiving this medication.

Obizur and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Obizur crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Obizur.

Obizur Pharmacokinetics

Formal pharmacokinetic studies not conducted.3

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Obizur or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Obizur. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

For the Consumer

Applies to antihemophilic factor: intravenous powder for solution

Along with its needed effects, antihemophilic factor (the active ingredient contained in Obizur) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking antihemophilic factor:

More common
  • Fever
Less common or rare
  • Changes in facial skin color
  • chills
  • fast or irregular breathing
  • nausea
  • puffiness or swelling of the eyelids or around the eyes
  • sensation of burning, warmth, heat, numbness, tightness, or tingling
  • skin rash, hives, or itching
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Incidence not known
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • blurred vision
  • chest pain or discomfort
  • confusion
  • cough
  • deep or fast breathing with dizziness
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • noisy breathing
  • numbness of the feet, hands, and around the mouth
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • slow or irregular heartbeat
  • sweating
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness

Some side effects of antihemophilic factor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
Less common
  • Burning, stinging, or swelling at the injection site
  • diarrhea
  • dizziness or lightheadedness
  • dry mouth or bad taste in the mouth
  • lack or loss of strength
  • nosebleed
  • redness of the face
  • vomiting
Rare
  • Change in taste
  • loss of taste
Incidence not known
  • Abdominal or stomach pain
  • feeling of warmth
  • increased sweating
  • irritability
  • muscle or bone pain
  • redness of the eye
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • trouble seeing

For Healthcare Professionals

Applies to antihemophilic factor: intravenous kit, intravenous powder for injection

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, and asthenia.[Ref]

Respiratory

Respiratory side effects have included dyspnea and rhinitis.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia.[Ref]

Local

Local side effects have included injection site pain.[Ref]

General

General side effects have included pyrexia and chills.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, and vomiting.[Ref]

Dermatologic

Dermatologic side effects have include pruritus, rash, and urticaria.[Ref]

Cardiovascular

Cardiovascular side effects have included hemorrhage, hypotension, and vasodilatation.[Ref]

Some side effects of Obizur may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)