Monoclate-P Antihemophilic Factor (Human)

Description

What is Monoclate-P?

Monoclate-P contains human antihemophilic factor, also known as factor VIII. This naturally occurring blood protein is essential for clot formation. In individuals with hemophilia A, Monoclate – P temporarily replaces the deficient factor VIII, enabling blood to clot and stopping bleeding episodes.

Uses

Monoclate-P is primarily employed to:

• Treat and prevent bleeding episodes in individuals with hemophilia A.
• Control bleeding during surgery or dental procedures in hemophilia A patients.

How it Works

Monoclate – P functions by elevating the levels of factor VIII in the bloodstream. This increase aids in the formation of blood clots, which are necessary to halt bleeding.

Dosage and Administration

The dosage of Monoclate-P is tailored to each patient, considering factors such as weight, the severity of the bleeding episode, and the presence of inhibitors. It is administered intravenously.

Dosage Guidelines

Condition	Typical Dosage
Bleeding Episodes	20-40 IU/kg every 8-12 hours until bleeding stops
Pre-surgical Prophylaxis	50 IU/kg one hour before surgery
Post-surgical Maintenance	20-40 IU/kg every 8-12 hours for 7-10 days
Long-term Prophylaxis	20-40 IU/kg two or three times per week

Note: These dosages are general guidelines. The exact dosage should be determined by a healthcare professional.

Side Effects

Monoclate-P may cause various side effects. Here are the common ones:

More Common Side Effects

• Headache
• Mild nausea or stomach pain
• Tingly or jittery feeling
• Blurred vision
• Chills
• Allergic reactions
• Injection site reactions (swelling, stinging, or irritation)

Less Common or Rare Side Effects

• 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

Incidence Not Known

• 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
• Stomach pain
• Trouble seeing

If you experience any of these side effects, consult your healthcare provider. They can provide guidance on managing these symptoms and determine if Monoclate-P is the appropriate treatment for you.

Warnings and Precautions

When using Monoclate-P, it is crucial to be aware of certain precautions to ensure safe and effective treatment.

Allergic Reactions

• Severe Allergic Reactions: Do not use Monoclate-P if you have had a severe allergic reaction to it in the past.
• Mouse Proteins: Avoid using Monoclate – P if you are allergic to mouse proteins.

Disease Interactions

• Hepatic Disease: Use cautiously if you have liver disease.
• Blood Types: Patients with blood types A, B, and AB should use Monoclate-P with caution.
• Factor VIII Inhibitors: Patients receiving factor VIII inhibitors should be monitored closely.

Pregnancy and Breastfeeding

• Pregnancy: Monoclate-P may be harmful to a fetus. Consult your doctor if you are pregnant or plan to become pregnant during treatment.
• Breastfeeding: It is unknown if Monoclate – P passes into breast milk. Consult your doctor before breastfeeding.

Other Precautions

• Vaccinations: Your doctor may recommend receiving a hepatitis vaccination before starting treatment with Monoclate-P.
• Storage: Follow all instructions about storing Monoclate-P, whether in a refrigerator or at room temperature.

Monitoring

• Antibodies: Your body may develop antibodies to Monoclate-P, making it less effective. Contact your doctor if the medication seems less effective in controlling your bleeding.

General Advice

• Always inform your healthcare provider about all medications, supplements, and herbs you are using.
• Report any unusual symptoms or side effects to your healthcare provider immediately.

By following these precautions, you can help ensure that Monoclate-P is used safely and effectively. If you have any further questions or need assistance, feel free to ask.

Storage Instructions for Monoclate-P Antihemophilic Factor

Proper storage of Monoclate-P is crucial to ensure its effectiveness. Here are the general guidelines:

Refrigeration

• Store the medicine and the diluent in their original container in the refrigerator.
• Do not freeze the product.

Room Temperature

• You may also store the medicine and diluent at room temperature until the expiration date on the label.
• Some brands of this medication are good for only several months if stored at room temperature. Always check the specific instructions for your brand.

Before Use

• Before preparing your dose, take the items out of the refrigerator and allow them to reach room temperature.
• After mixing, do not refrigerate the liquid. Use it within 3 hours (unless the product instructions direct you otherwise) and throw away any unused portion.

Protection from Light

• Protect the product from light to maintain its stability.

Always follow the specific storage instructions provided with your medication and consult your pharmacist or healthcare provider if you have any questions.

What Should I Do if My Monoclate-P Has Expired?

If your Monoclate – P has expired, it’s important not to use it. Here are the steps you should take:

• Do Not Use Expired Medication: Using expired medication can be ineffective or potentially harmful.
• Dispose of It Properly: Follow your local guidelines for disposing of expired medications. Many pharmacies offer take-back programs for safe disposal.
• Consult Your Healthcare Provider: Contact your doctor or pharmacist to get a new prescription or to discuss alternative treatments.
• Check Storage Conditions: Ensure that any new medication is stored properly according to the guidelines to prevent it from expiring prematurely.

Monoclate-P Antihemophilic Factor Interactions

Drug Interactions

Monoclate-P can interact with other medications. There are six known drug interactions, categorized as follows:

Major Interaction

• Carfilzomib: This interaction is highly clinically significant. It is generally advised to avoid combinations as the risk of the interaction outweighs the benefit.

Moderate Interactions

• Efgartigimod alfa
• Emicizumab
• Pegloticase
• Pegvaliase
• Rozanolixizumab

These interactions are moderately clinically significant. Usually, it is recommended to avoid combinations unless under special circumstances.

Disease Interactions

Monoclate-P also has interactions with certain diseases. There are five known disease interactions:

• Cardiovascular Complications
• Inhibitory Antibodies
• Blood Isoagglutinin
• Immunodeficiency
• Thromboembolic Events

Precautions

Always consult your healthcare provider before starting or stopping any medication. It is essential to inform your doctor about all the medications, herbs, non-prescription drugs, or dietary supplements you are using.

Is There a Generic Version Available?

Yes, there is a generic version of Monoclate-P available. The generic name for Monoclate – P is antihemophilic factor (human).

Summary

Category	Details
Uses	Treating and preventing bleeding episodes in hemophilia A; controlling surgical or dental bleeding
Dosage	Varies based on individual needs; typically 20-40 IU/kg every 8-12 hours
Common Side Effects	Headache, mild nausea, stomach pain, allergic reactions, injection site reactions
Storage	Refrigerate; can also be stored at room temperature; protect from light
Drug Interactions	Carfilzomib (major); Efgartigimod alfa, Emicizumab, Pegloticase, Pegvaliase, Rozanolixizumab (moderate)
Disease Interactions	Cardiovascular complications, inhibitory antibodies, blood isoagglutinin, immunodeficiency, thromboembolic events
Generic Availability	Yes, as antihemophilic factor (human)

By adhering to the prescribed dosage, being aware of potential side effects, and following storage guidelines, patients can maximize the benefits of Monoclate-P. Always consult with your healthcare provider for personalized medical advice and any concerns regarding this treatment.