Monoclate-P

DRUG DESCRIPTION

Monoclate-P, Antihemophilic Factor (Human), Factor VIII:C Pasteurized, Monoclonal Antibody Purified, is a sterile, stable, lyophilized concentrate of Factor VIII:C with reduced amounts of VWF:Ag and purified of extraneous plasma-derived protein by use of affinity chromatography. A murine monoclonal antibody to VWF:Ag is used as an affinity ligand to first isolate the Factor VIII Complex. Factor VIII:C is then dissociated from VWF:Ag, recovered, formulated and provided as a sterile lyophilized powder.1,2,3 The concentrate as formulated contains Albumin (Human) as a stabilizer, resulting in a concentrate with a specific activity between 4 and 10 units/mg of total protein. In the absence of this added Albumin (Human) stabilizer, specific activity has been determined to exceed 3000 units/mg of protein.4 Monoclate-P has been prepared from pooled human plasma and is intended for use in therapy of classical hemophilia (Hemophilia A).

All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used in the manufacture of this product and found to be nonreactive (negative). The aim of the HBV test is to detect low levels of viral material, however, the significance of a nonreactive (negative) result has not been established.

This concentrate has been pasteurized by heating at 60C for 10 hours in aqueous solution form during its manufacture in order to further reduce the risk of viral transmission.5 However, no procedure has been shown to be totally effective in removing viral infectivity from coagulant factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS).

Monoclate-P (antihemophilic factor) is a highly purified preparation of Factor VIII:C. When stored as directed, it will maintain its labeled potency for the period indicated on the container and package labels.6,7

Upon reconstitution of the 250, 500 and 1000 I.U. concentrates, a clear, colorless solution is obtained, containing 50 to 150 times as much Factor VIII:C as does an equal volume of plasma.

Upon reconstitution of the 1500 I.U. concentrate, a clear, colorless solution is obtained, containing 120 to 180 times as much Factor VIII:C as does an equal volume of plasma.

Each vial contains the labeled amount of antihemophilic factor (AHF) activity as expressed in terms of International Units (I.U.) of antihemophilic activity. One unit of antihemophilic activity is equivalent to that quantity of AHF present in one mL of normal human plasma. When reconstituted as recommended, the resulting solution contains approximately 300 to 450 millimoles of sodium ions per liter and has 2 to 3 times the tonicity of saline. It contains approximately 2-5 millimoles of calcium ions per liter, contributed as calcium chloride, approximately 1 to 2% Albumin (Human), 0.8% mannitol, and 1.2 mM histidine. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. Monoclate-P (antihemophilic factor) also contains trace amounts ( ? 50 ng per 100 I.U. of AHF) of the murine monoclonal antibody used in its purification (see CLINICAL PHARMACOLOGY).

Monoclate-P (antihemophilic factor) is to be administered only intravenously.

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin...

Read All Potential Side Effects and See Pictures of Monoclate-P

What are the precautions when taking antihemophilic factor (Monoclate-P)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Monoclate-P


Monoclate-P Consumer (continued)

SIDE EFFECTS: Flushing of the face, nausea, vomiting, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of anemia (e.g., tiredness, low energy, pale skin color, shortness of breath), new or worsening bleeding/bruising.

This medication is made from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including fever, persistent sore throat, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details.

Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Monoclate-P Patient Information Including Side Effects

Brand Names: Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P

Generic Name: antihemophilic factor (human) (Pronunciation: an tee hee moe FIL ik FAK tor)

  • What is human antihemophilic factor (Monoclate-P)?
  • What are the possible side effects of human antihemophilic factor (Monoclate-P)?
  • What is the most important information I should know about human antihemophilic factor (Monoclate-P)?
  • What should I discuss with my health care provider before using human antihemophilic factor (Monoclate-P)?
  • How should I use human antihemophilic factor (Monoclate-P)?
  • What happens if I miss a dose (Monoclate-P)?
  • What happens if I overdose (Monoclate-P)?
  • What should I avoid while using human antihemophilic factor (Monoclate-P)?
  • What other drugs will affect human antihemophilic factor (Monoclate-P)?
  • Where can I get more information?

What is human antihemophilic factor (Monoclate-P)?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

This medication works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Human antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia.

Human antihemophilic factor is not for use in people with von Willebrand disease.

Human antihemophilic factor may also be used for other purposes not listed in this medication guide.

What are the possible side effects of human antihemophilic factor (Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea or stomach pain.
  • tingly or jittery feeling;
  • blurred vision;
  • headache; or
  • swelling, stinging, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about human antihemophilic factor (Monoclate-P)?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past, or if you are allergic to mouse proteins.

Before using human antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Human antihemophilic factor will not treat von Willebrand disease.

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medication is helping your condition and is not causing harmful effects, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Human antihemophilic factor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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