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Overview: Alprolix 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. Common side effects include headache and pain where you get this medicine. Get emergency help if you have trouble breathing, chest pain, vision changes, or sudden weakness on one side of your body.

Uses

What is Alprolix used for?

Alprolix (factor IX human (recombinant), Fc fusion protein) 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

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

How does Alprolix 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. Alprolix works by replacing factor IX, which temporarily helps your blood to clot properly.

How is Alprolix supplied (dosage forms)?

Brands and other names

  • Alprolix

Dosage forms and strengths

  • 250 IU single-dose vials
  • 500 IU single-dose vials
  • 1000 IU single-dose vials
  • 2000 IU single-dose vials
  • 3000 IU single-dose vials
  • 4000 IU single-dose vials

How should I store Alprolix?

If you or a caregiver will store Alprolix at home, store the vial in the original package until you are ready to use the medicine. Store Alprolix in the refrigerator between 36 F and 46 F (2 C and 8 C). Do not freeze. Once the medicine is prepared for use, use it within three hours or throw it away.

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

Side Effects

What are the most common side effects of Alprolix?

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

  • Headache
  • Pain, itching, swelling, or redness near the injection site
  • Numbness or tingling in your mouth

There may be other side effects of Alprolix 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 Alprolix?

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

Severe Allergic Reactions. Alprolix may cause allergic reactions, which can be serious. Stop using Alprolix 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 Alprolix while you are using it. These antibodies can keep Alprolix 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 of your appointments, including those for lab work, while you are using it. Tell your health care provider if you are bleeding more often or Alprolix does not seem to be working as well as it used to.

Blood Clots. Alprolix 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 Alprolix 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 Alprolix?

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

  • Alprolix
  • Factor IX human, recombinant
  • Any of the ingredients in the specific product dispensed

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

What should I know about Alprolix before using it?

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

Keep Alprolix 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 Alprolix. Keep all appointments to have your blood checked.

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

Look at your pee (urine) when you go to the bathroom. If your pee looks pink or has blood in it, call your health care provider right away. You may also have pain in your side. These symptoms may mean that you have a clot in your urinary tract system.

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

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 Alprolix 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. Alprolix may interact with other medicines and supplements. Before using Alprolix, 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 Alprolix 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 Alprolix 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 Alprolix while breastfeeding.

How can I get more information about Alprolix?

For more information about Alprolix, you can visit the drugmaker’s website at www.alprolix.com or call them at 855-692-5776.

Interactions

Does Alprolix interact with foods or drinks?

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

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

Does Alprolix interact with other medicines (drug interactions)?

Alprolix 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 Alprolix?

If you or someone else has used too much Alprolix, 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 Alprolix?

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

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

If you get your Alprolix doses at home and miss a dose, call your health care provider for instructions.