Monoclate-P

Monoclate-P is used to prevent or control bleeding episodes in patients with hemophilia A. Monoclate-P may cause serious allergic reactions.

Monoclate-P Overview

Updated: 

Monoclate-P is a prescription medication used to prevent bleeding episodes in children and adults with hemophilia A (cogenital factor VIII deficiency). 

Monoclate-P belongs to a group of drugs called clotting factors. It works by replacing a protein in the blood that is needed to control bleeding that people with hemophilia A are missing.

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

Common side effects of Monoclate-P include chills, nausea, and stinging at the injection site.

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  • Other
  • Factor Vii Deficiency
  • Hemophilia A
  • Von Willebrand Diseases

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Monoclate-P Cautionary Labels

precautions

Uses of Monoclate-P

Monoclate-P is a prescription medication used to prevent and control bleeding in adults and children with hemophilia A, a genetic disorder that increases bleeding and is caused by a missing or defective protein called factor VIII clotting factor. Monoclate-P may also be used to prevent bleeding during surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

coagulation factor VIII

For more information on this medication choose from the list of selections below.

Monoclate-P Drug Class

Monoclate-P is part of the drug class:

Side Effects of Monoclate-P

Serious side effects have been reported with Monoclate-P. See the "Monoclate-P Precautions" section.

Common side effects of Monoclate-P include the following:

  • chills
  • nausea
  • stinging at the injection site

This is not a complete list of Monoclate-P side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Monoclate-P Interactions

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Monoclate-P Precautions

Serious side effects have been reported with Monoclate-P including the following:

Infections. Because Monoclate-P is made from human blood, there is a chance that Monoclate-P may contain infectious agents, such as viruses, that can cause disease. Immediately tell your doctor if you develop any signs or symptoms of an infection, including the following:

  • fever
  • chills
  • nausea or vomiting
  • stomach pain
  • dark urine
  • yellowing of the skin or the white part of the eyes
  • fatigue

Hypersensitivity Reactions. Monoclate-P can cause serious allergic reactions. Tell your healthcare provider immediately about any signs or symptoms of an allergic reaction, which include the following:

  • itching
  • hives
  • chest tightness
  • difficulty breathing
  • low blood pressure
  • swelling in the face, eyes, lips, tongue, arms, or legs

Neutralizing antibodies. Your body may form inhibitors to factor VIII, known as antibodies. Antibodies are proteins made by the body as a natural part of the immune system in response to something it recognizes as foreign. If your form these inhibitors, Monoclate-P may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

Do not take Monoclate-P if you:

  • are allergic to Monoclate-P or to any of its ingredients
  • are allergic to mice or hamsters

Monoclate-P 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 Monoclate-P, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before taking Monoclate-P, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Monoclate-P or to any of its ingredients
  • have or have had any medical problems
  • are allergic to mice or hamsters
  • have been told that you have inhibitors to factor VIII
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Monoclate-P and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Monoclate-P falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Monoclate-P should be given to a pregnant woman only if clearly needed.

Monoclate-P and Lactation

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

It is not known if Monoclate-P 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 Monoclate-P.

 

Monoclate-P Usage

Monoclate-P comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. 

If you miss an appointment to receive a dose of Monoclate-P, contact your healthcare provider for instructions on when to receive your next dose.

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.

Monoclate-P Overdose

If Monoclate-P is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

  • Keep all appointments with your doctor and laboratory.
  • Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Monoclate-P.