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Overview: Rebinyn is a medicine that is given as an injection to treat or prevent bleeding in certain people with hemophilia B. It works by replacing factor IX, which temporarily helps your blood to clot properly. Pain where you get this medicine is a common side effect. Get emergency help if you have trouble breathing, chest pain, vision changes, or sudden weakness on one side of your body.

Uses

What is Rebinyn used for?

Rebinyn (factor IX human recombinant, glycopegylated) is commonly used to treat or prevent certain types of bleeding in people with hemophilia B, which is a condition that causes your blood to not clot properly. It may be used for the following.

  • To prevent or treat bleeding episodes
  • To prevent or treat bleeding during or after surgery

Rebinyn may also be used for other conditions as determined by your health care provider.

How does Rebinyn work (mechanism of action)?

Hemophilia B is caused when your body does not make enough of a protein called factor IX, which normally helps your body form blood clots to stop bleeding. Rebinyn works by replacing factor IX, which temporarily helps your blood to clot properly.

How is Rebinyn supplied (dosage forms)?

Brands and other names

  • Rebinyn

Dosage forms and strengths

  • 500 IU single-dose vials
  • 1000 IU single-dose vials
  • 2000 IU single-dose vials
  • 3000 IU single-dose vials

How should I store Rebinyn?

If you or a caregiver will store Rebinyn at home, store the vial in the original package until you are ready to use the medicine. Store Rebinyn in the refrigerator between 36 F and 46 F (2 C and 8 C) for up to 24 months. Do not freeze. Throw away after the expiration date on the carton or vial.

You may keep Rebinyn at room temperature up to 86 F (30 C) for up to six months. Do not keep Rebinyn back in the refrigerator if it has been stored at room temperature. Throw it away if it is not used within six months.

 Once the medicine is prepared for use, use it within four hours or throw it away. 

Side Effects

What are the most common side effects of Rebinyn?

The most common side effects of Rebinyn are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Rash or itching

There may be other side effects of Rebinyn that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Rebinyn?

While less common, the most serious side effects of Rebinyn are described below, along with what to do if they happen.

Severe Allergic Reactions. Rebinyn may cause allergic reactions, which can be serious. Stop using Rebinyn and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Antibodies. Your body may make antibodies (proteins made by your immune system to attack a foreign substance) against Rebinyn while you are using it. These antibodies can keep Rebinyn from working the way it should. Your health care provider may do blood tests to monitor your factor IX levels and look for these antibodies. Keep all your appointments, including those for lab work, while you are using it. Tell your health care provider if you are bleeding more often or Rebinyn does not seem to be working as well as it used to. 

Blood Clots. Rebinyn may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in your lungs (pulmonary embolism) or deep veins (deep venous thrombosis or DVT). Stop using Rebinyn and get emergency help if you have any of the following signs of blood clots. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

Warnings & Precautions

Who should not use Rebinyn?

Allergies to Ingredients. People who are allergic to any of the following should not use Rebinyn.

  • Factor IX human recombinant, glycopegylated
  • Hamster proteins
  • Rebinyn
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Rebinyn.

What should I know about Rebinyn before using it?

Do not use Rebinyn unless it has been prescribed to you by a health care provider. Use it as prescribed. This medicine is given into one of your veins. If you use Rebinyn at home, make sure that you or a caregiver understands how to properly prepare and use it. Read the “Instructions for Use” that come with your medicine. If you have any questions, talk to your health care provider.

Do not share Rebinyn with other people, even if they have the same condition as you. It may harm them.

Keep Rebinyn out of the reach of children. As this medicine may be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Your health care provider will likely monitor your blood tests while you are being treated with Rebinyn. Keep all appointments to have your blood checked.

If you are using Rebinyn at home to treat a bleeding episode, call your health care provider or get medical care right away if your bleeding does not stop.

What should I tell my health care provider before using Rebinyn?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Rebinyn is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • History of blood clots
  • Have inhibitors or antibodies to factor IX
  • Liver problems

Other Medicines and Supplements. Rebinyn may interact with other medicines and supplements. Before using Rebinyn, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Rebinyn could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Rebinyn passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Rebinyn while breastfeeding.

How can I get more information about Rebinyn?

For more information about Rebinyn, you can visit the drugmaker’s website at www.rebinyn.com or call them at 844-REB-INYN.

Interactions

Does Rebinyn interact with foods or drinks?

There are no known interactions between Rebinyn and foods or drinks.

It is unknown if drinking alcohol will affect Rebinyn. Alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol that you drink.

Does Rebinyn interact with other medicines (drug interactions)?

Rebinyn may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Rebinyn?

If you or someone else has used too much Rebinyn, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Rebinyn?

Missing doses of Rebinyn can cause it to not work. So, it is important not to miss or skip doses.

If a health care provider gives you Rebinyn, they will make sure you are receiving it as scheduled. If you miss an appointment to get your Rebinyn dose, call to make another appointment as soon as possible. 

If you get your Rebinyn doses at home and miss a dose, use the missed dose as soon as you remember. Use your next dose as scheduled. Do not use an extra or double dose to make up for a missed dose. If you have any questions, call your health care provider for instructions.

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