Mononine

• CSL Behring LLC

Serious side effects have been reported with Mononine. See the “Mononine Precautions” section.

Common side effects of Mononine include:

• headache
• fever
• chills
• flushing
• nausea
• vomiting
• a tingling sensation
• lethargy
• hives
• stinging or burning and the injection site

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

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

If you take too much Mononine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Mononine 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.

Call your doctor for instructions if you miss a dose of this medicine.

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

Other drugs may interact with coagulation factor IX, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This section provides information on the proper use of a number of products that contain factor ix. It may not be specific to Mononine. Please read with care.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

To prepare this medicine:

• Take the dry medicine and the liquid (diluent) out of the refrigerator and bring them to room temperature, as directed by your doctor.
• When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the container of dry medicine to prevent foaming.
• Swirl the container gently to dissolve the medicine. Do not shake the container.

Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared.

A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• The condition for which you are using this medicine.
• Your body weight.
• The amount of factor IX your body is able to make.
• How much, how often, and where in your body you are bleeding.
• Whether or not your body has built up a defense (antibody) against this medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.

• It is used to treat hemophilia.
• It is used to treat or prevent bleeding.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Change in color of mouth to blue.
• Chest pain or pressure.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.

Mononine® is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Mononine® is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections and by inactivating and/or removing certain viruses during manufacture (see DESCRIPTION section for virus reduction measures). The manufacturing procedure for Mononine® includes processing steps designed to reduce further the risk of virus transmission. Stringent procedures, utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of virus transmission. The primary virus reduction step of the Mononine® manufacturing process is the use of two sequential virus retentive ultrafilter membranes designed to separate viruses from Factor IX. In addition, the purification procedure (several chromatography steps) used in the manufacture of Mononine® also provides virus reduction capacity. Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 800-504-5434 (in the U.S. and Canada). The physician should discuss the risks and benefits of this product with the patient.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly nonA, nonB hepatitis. (See Information For Patients.)

Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).

Hypersensitivity and allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if any of these symptoms occur.

Preliminary information suggests a relationship may exist between the presence of major deletion mutations in the factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.

Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in Hemophilia B patients with factor IX inhibitors and a history of severe allergic reactions to factor IX. The safety and efficacy of using Mononine® in attempted immune tolerance induction has not been established.