Proplex T (Intravenous, Injection)

Factor IX is a protein that your body makes naturally. It helps your blood clot to stop bleeding. Injections of factor IX are used to treat hemophilia B, also known as Christmas disease. This condition means your body does not produce enough factor IX. If you lack enough factor IX and get injured, your blood may not clot properly, which can lead to bleeding into and damage of your muscles and joints.

Injections of a type of factor IX called factor IX complex are also used to treat some people with hemophilia A. Hemophilia A, sometimes called classical hemophilia, occurs when the body does not produce enough factor VIII, which also prevents proper blood clotting. Factor IX complex injections may be given to patients for whom the usual treatment for hemophilia A is no longer working. Additionally, factor IX complex injections may be used for other conditions as decided by your doctor.

The factor IX product that your doctor will provide is either sourced from human blood or made through a synthetic process. The factor IX from human blood has been treated to reduce the risk of containing harmful viruses such as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). The synthetic factor IX product does not carry these viruses.

You can only get factor IX with a prescription from your doctor.

If you were recently diagnosed with hemophilia B, you should get hepatitis A and hepatitis B vaccines to further lower your risk of getting hepatitis A or hepatitis B from factor IX products.

Over time, your body may develop a defense (antibody) against this medicine. Tell your doctor if this medicine appears to be less effective than usual.

It is advised that you carry identification indicating that you have hemophilia A or hemophilia B. If you have any questions about what type of identification to carry, consult your health care professional.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Blood clots may be more likely to happen in premature and newborn babies, who are generally more sensitive than adults to the effects of injections of factor IX.

Geriatric

This medicine has been tested and has not shown different side effects or issues in older adults compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Studies in women indicate that this medication poses minimal risk to the infant when used while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or non-prescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood clots or a history of medical issues caused by blood clots or
• Liver disease—This may increase the risk of bleeding or developing blood clots.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Changes in facial skin color
• Fast or irregular breathing
• Puffiness or swelling of the eyelids or around the eyes
• Shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• Skin rash, hives, and/or itching

Check with your doctor immediately if any of the following side effects occur:

More common

• Bluish coloring (especially of the hands and feet)
• Convulsions
• Dizziness or lightheadedness when getting up from a lying or sitting position
• Increased heart rate
• Large blue or purplish patches in the skin (at places of injection)
• Nausea or vomiting
• Pains in chest, groin, or legs (especially calves)
• Persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine
• Severe pain or pressure in the chest and/or the neck, back, or left arm
• Severe, sudden headache
• Shortness of breath or fast breathing
• Sudden loss of coordination
• Sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg

Check with your doctor immediately if any of the following side effects occur:

Less common

• Burning or stinging at place of injection
• Changes in blood pressure or pulse rate
• Chills
• Drowsiness
• Fever
• Headache
• Nausea or vomiting
• Redness of face
• Shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Alphanine SD
• Alprolix
• Bebulin
• Bebulin VH
• Benefix
• Idelvion
• Ixinity
• Mononine
• Profilnine SD
• Proplex T
• Rebinyn
• Rixubis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

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.