Mononine

Name: Mononine

Mononine Drug Class

Mononine is part of the drug class:

  • Blood coagulation factors

Inform MD

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

  • have or have had any medical problems
  • have any allergies, including allergies to mouse protein
  • are pregnant or breastfeeding

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

Mononine 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.

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

Other Requirements

  • Store at refrigerated temperature 2° to 8°C (35 to 46°F). Do not freeze.
  • Do not use after the expiration date printed on the carton or vial.
  • Do not share Mononine with other people, even if they have the same symptoms as you do.
  • Keep this and all medications out of reach of children.

What should I discuss with my healthcare provider before using Mononine (coagulation factor IX)?

You should not use this medicine if:

  • you have had an allergic reaction to clotting factor medicine;

  • you have signs of excessive blood clotting; or

  • you are allergic to hamster proteins.

To make sure coagulation factor IX is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • coronary artery disease (hardening of the arteries); or

  • history of heart attack or stroke.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using coagulation factor IX.

It is not known whether coagulation factor IX passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Coagulation factor IX is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What are some other side effects of Mononine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Chills.
  • Mild fever.
  • Flushing.
  • Feeling tired or weak.
  • Tingling.
  • Burning, stinging, or redness where this medicine goes into the body.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Contraindications

Known hypersensitivity to mouse protein is a contraindication to Mononine®.

Precautions

Extensive clinical experience suggests that there is a lower risk of thromboembolic complications with the use of Mononine® than with prothrombin complex concentrates. However, as with all products containing Factor IX, caution should be exercised when administering Mononine® to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or DIC.8,9 In each of these situations, the potential benefit of treatment with Mononine® should be weighed against the potential risk of these complications.

Mononine® should be administered intravenously at a rate that will permit observation of the patient for any immediate reaction. Rates of infusion of up to 225 IU per minute have been regularly tolerated with no adverse reactions. If any reaction takes place that is thought to be related to the administration of Mononine®, the rate of infusion should be decreased or the infusion stopped, as dictated by the response of the patient. The infusion should be stopped promptly and appropriate countermeasures and supportive therapy should be administered should evidence of an acute hypersensitivity reaction be observed. Patients known to have major deletion mutations of the factor IX gene may be at increased risk for inhibitor formation and acute hypersensitivity reactions. (See WARNINGS.)

During the course of treatment, determination of daily Factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions. Individual patients may vary in their response to Mononine®, achieving different levels of in vivo recovery and demonstrating different half-lives.

The use of high doses of Factor IX Complex concentrates has been reported to be associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. Generally a Factor IX level of 25-50% [IU/dL] is considered adequate for hemostasis, including major hemorrhages and surgery. Attempting to maintain Factor IX levels of >75-100% [IU/dL] during treatment is not routinely recommended nor required. To achieve Factor IX levels that will remain above 25% [IU/dL] between once a day administrations, each daily dose should attempt to raise the 30-minute post-infusion Factor IX level to 50-60% [IU/dL] (see DOSAGE AND ADMINISTRATION).

No controlled studies have been available regarding the use of ε-amino caproic acid or other antifibrinolytic agents following an initial infusion of Mononine® for the prevention or treatment of oral bleeding following trauma or dental procedures such as extractions.

Information For Patients

Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.

Some viruses such as hepatitis A are particularly difficult to remove or inactivate at this time. Although the overwhelming number of hepatitis A 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 hepatitis A infections and inform patients under their supervision receiving plasma-derived products to report potential symptoms promptly.

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 Mononine®. It is also not known whether Mononine® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mononine® should be given to a pregnant woman only if clearly needed.

Pediatric Use

Evaluation of the safety and effectiveness of Mononine® treatment in 51 pediatric patients between the ages of 1 day and 20 years, as a part of virus safety trials and trials for surgery, trauma or spontaneous bleeding, showed that excellent hemostasis was achieved with no thrombotic complications.10 Included in the experience with patients aged birth to 20 years are two long-term virus safety studies demonstrating lack of virus transmission. Dosing in children is based on body weight and is generally based on the same guidelines as for adults (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of Mononine® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.

Package Label - Principal Display Panel - MID

NDC 0053-7668-02
One vial with diluent

Mononine®
Coagulation Factor IX
(Human)

Monoclonal Antibody Purified

For Intravenous Administration Only.     Rx only

Storage: Mononine® stored in a refrigerator at 2-8°C (36-46°F) is
stable for the period indicated by the expiration date on the label.
Within this period Mononine® may be stored at room temperature not
to exceed 25°C (77°F), for up to 1 month. Avoid freezing.

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

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