Monoclate-P

Name: Monoclate-P

Side effects

Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In some cases, inhibitors of FVIII may occur.

What should i avoid while using human antihemophilic factor (hemofil-m, koate-dvi, monarc-m, monoclate-p)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Monoclate-P Drug Class

Monoclate-P is part of the drug class:

  • Blood coagulation factors

Monoclate-P Dosage

The dose and duration of treatment of Monoclate-P your doctor recommends will be based on the following:

•  your weight

•  the severity of factor VIII deficiency

•  the location of the bleeding

•  your overall clinical condition

•  how you respond to this medication

The recommended dose of Monoclate-P when being used for control and prevention of bleeding episodes is 10 to 50 IU per kg of body weight, depending on the severity and location of the bleed. This dose may be repeated every 8 to 12 hours as determined by your doctor until the bleeding is resolved.

When Monoclate-P is being given during surgery to prevent bleeding, the recommended dose is one dose (determined by your doctor) given one hour prior to surgery, with a second dose that is half the size of the first dose being given 5 hours after the first dose. The dose may need to be repeated until bleeding is resolved or you are healed as determined by your doctor.

Your doctor may perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

Uses For Monoclate-P

Antihemophilic factor (AHF) injection is used to treat and prevent serious bleeding episodes in patients with a bleeding problem called hemophilia A. The bleeding episode may be related to an injury (trauma) or a surgical procedure. AHF is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

This medicine is available only with your doctor's prescription.

If OVERDOSE is suspected

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.

How do I store and/or throw out Monoclate-P?

All products:

  • Store in a refrigerator or at room temperature.
  • Do not freeze.
  • After mixing, do not refrigerate.
  • 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.

Koate or Monoclate-P:

  • If stored at room temperature, throw away any unused vials after 6 months or after the expiration date, whichever comes first.

Monoclate-P - Clinical Pharmacology

Factor VIII:C is the coagulant portion of the Factor VIII complex circulating in plasma. It is noncovalently associated with the von Willebrand protein responsible for von Willebrand factor activity. These two proteins have distinct biochemical and immunological properties and are under separate genetic control. Factor VIII:C acts as a cofactor for Factor IX to activate Factor X in the intrinsic pathway of blood coagulation.8 Hemophilia A, a hereditary disorder of blood coagulation due to decreased levels of Factor VIII:C, results in profuse bleeding into joints, muscles or internal organs as a result of a trauma. Monoclate-P® provides an increase in plasma levels of AHF, thereby enabling temporary correction of Hemophilia A bleeding.

Clinical evaluation of Monoclate-P® concentrate for its half-life characteristics in hemophilic patients showed it to be comparable to other commercially available Antihemophilic Factor (Human) concentrates. The mean half-life obtained from six patients was 17.5 hours with a mean recovery of 1.9 units/dl rise/U/kg.

The pasteurization process used in the manufacture of this concentrate has demonstrated in vitro inactivation of human immunodeficiency virus (HIV) and several model viruses. In two separate studies, HIV was reduced by ≥7.0 log10 to an undetectable level and by 10.5 log10, respectively. In addition to HIV, studies were also performed using three lipid containing model viruses and one non-lipid, encapsulated model virus. Vesicular stomatitis (VSV) was reduced by ≥6.79 log10 to undetectable, Sindbis was reduced by ≥6.48 log10 to undetectable and Vaccinia was reduced by ≥5.36 log10 to undetectable. Murine encephalomyocarditis (EMC), a non-lipid, encapsulated model virus, was reduced by ≥7.1 log10 to undetectable.

Evidence of the capability of the purification and preparative steps used in the production of Monoclate-P® to reduce viral bioburden was obtained in studies involving the addition of known quantities of virus to cryoprecipitate. These studies were conducted using an earlier form of the concentrate which had not undergone liquid pasteurization (Monoclate®, Antihemophilic Factor (Human), Monoclonal Antibody Purified, Factor VIII:C, Heat-Treated). These studies provide evidence of the viral removal potential of the purification and preparative steps of the manufacturing process (exclusive of heat treatment) which are common to both concentrates. In one study, the viruses used were human immunodeficiency virus (HIV), Sindbis virus, vesicular stomatitis virus (VSV) and pseudorabies virus (PsRV). A comparison of the cumulative mean reductions for all viruses tested with the individual values obtained in each experiment indicates that the combined effects of the manufacturing steps, which purify the Factor VIII:C and prepare the concentrate in a final sterile container as a lyophilized powder, contribute viral reduction capabilities of approximately 5 to 6 logs. In a separate study, aluminum hydroxide treatment followed by antibody affinity chromatography reduced vaccinia virus infectivity by 4.81 logs. These studies indicate that the purification and preparative steps of the manufacturing process are capable of providing a non-specific, viral reduction of approximately 5 to 6 logs, independent of the pasteurization process.

Monoclate-P® contains trace amounts of mouse protein9 (≤50 ng per 100 I.U. of AHF). In a study using an earlier form of the concentrate which had not undergone pasteurization (Monoclate®), a number of patients seronegative for Anti-HIV-1 were monitored to determine whether they would develop antibody or experience adverse reactions as a result of repeated exposure. These patients were treated on multiple occasions. Pre-study serum measurements of 27 patients for human anti-mouse IgG showed that, prior to treatment, 6 of them had either detectable antibody to mouse proteins or cross-reactive proteins. These patients continued to demonstrate similar or lower antibody levels during the study. Of the remaining 21 patients, 6 were shown to have low antibody levels on one or more occasions. In no case was observance of low antibody level associated with an anamnestic response or with any clinical adverse reaction. Patients were observed for time periods ranging from 2 to 30 months.

The viral safety of Monoclate-P® has been evaluated in two open-label studies using patients (aged 1 day to 20 years) with moderate to severe hemophilia A previously unexposed to blood or blood products. Thirty patients received Monoclate-P® therapy for 5 to 34 months as necessary according to the normal practices of the treatment center. These patients were followed for serum ALT elevations and a range of viral serologies. Six patients received another blood product prior to or during the study. Twenty-four patients were evaluable for assessment of viral safety of Monoclate-P®. No patients seroconverted to HIV, hepatitis nonA/nonB, or hepatitis B. Factor VIII:C inhibitors developed in 7 patients (23%) with 3 being high (>10 BU) titer.

Precautions

General

Most Antihemophilic Factor (Human) concentrates contain naturally occurring blood group specific antibodies. However, the processing of Monoclate-P® significantly reduces the presence of blood group specific antibodies in the final product. Nevertheless, when large or frequently repeated doses of product are needed, patients should be monitored by means of hematocrit and direct Coombs tests for signs of progressive anemia.

Formation of Antibodies to Mouse Protein

Although no hypersensitivity reactions have been observed, because Monoclate-P® contains trace amounts of mouse protein (≤50 ng per 100 I.U. of AHF), the possibility exists that patients treated with Monoclate-P® may develop hypersensitivity to the mouse proteins.

Information For Patients

Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and should be advised to discontinue use of the concentrate and contact their physician if these symptoms occur.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals.

Although the overwhelming number of hepatitis A and parvovirus B19 cases are community acquired, there have been reports of these infections associated with the use of some plasma-derived products. Therefore, physicians should be alert to the potential symptoms of parvovirus B19 and hepatitis A infections and inform patients under their supervision receiving plasma derived products to report potential symptoms promptly.

Symptoms of parvovirus B19 include fever, drowsiness, chills and runny nose followed two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physicians if such symptoms occur.

Pregnancy Category C

Animal reproduction studies have not been conducted with Monoclate-P®. It is also not known whether Monoclate-P® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Monoclate-P® should be given to a pregnant woman only if clearly needed.

Pediatric Use

The safety and effectiveness of Monoclate-P® for the treatment of hemophilia A has been demonstrated in 33 pediatric patients. As in adults, pediatric patients should be dosed based upon weight (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of Monoclate-P® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Dosing should be appropriate to the clinical situation.

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