Rebinyn (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, which is sometimes called Christmas disease. This condition occurs when your body does not produce enough factor IX. If you do not have enough factor IX and get injured, your blood may not clot properly, leading to bleeding and possible damage to your muscles and joints.

Injections of a specific type of factor IX, known as factor IX complex, are also used to treat some people with hemophilia A. In hemophilia A, sometimes called classical hemophilia, the body does not produce enough factor VIII, and, similar to hemophilia B, the blood cannot clot properly. Factor IX complex injections may be given to patients for whom the usual treatment for hemophilia A is no longer working. These injections may also be used for other conditions as decided by your doctor.

The factor IX product that your doctor provides can come from human blood or be made artificially. The factor IX obtained from human blood has been treated to reduce the risk of 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 artificially made factor IX does not contain these viruses.

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

If you have recently been diagnosed with hemophilia B, you should get vaccinations for hepatitis A and hepatitis B to 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. Inform your doctor if this medicine appears to be less effective than it usually is.

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

In deciding to use a medicine, you must consider the risks of taking it against the benefits it may provide. This is a decision to be made with your doctor. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, including 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 does not appear to cause different side effects or problems in older people compared to younger adults.

Breast Feeding

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

Studies in women indicate that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having other medical conditions may affect how this medicine works for you. Be sure to tell your doctor about any other medical issues, especially:

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

Along with its needed effects, a medicine may cause some unwanted effects. While not all of these side effects may occur, 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.