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Overview: AlphaNine SD is used to treat certain types of bleeding in people with hemophilia B. It works by replacing a protein called factor IX, which temporarily helps your blood to clot properly. Common side effects include chills, nausea, and stinging at the injection site. Serious side effects are rare but can include severe allergic reactions and blood clots.

Uses

What is AlphaNine SD used for?

AlphaNine SD (coagulation factor IX, human) 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.

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

How does AlphaNine SD work (mechanism of action)?

Hemophilia B is caused when your body does not make enough of a protein called factor IX, which normally helps cause your blood to clot. AlphaNine SD works by replacing factor IX, which temporarily helps your blood to clot properly.

How is AlphaNine SD supplied (dosage forms)?

Brands and other names

  • AlphaNine SD
  • Mononine

Dosage forms and strengths

  • 500 IU single-dose vials
  • 1000 IU single-dose vials
  • 1500 IU single-dose vials

How should I store AlphaNine SD?

AlphaNine SD is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of AlphaNine SD?

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

  • Chills
  • Nausea
  • Pain or stinging near the injection site

There may be other side effects of AlphaNine SD 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 AlphaNine SD?

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

Severe Allergic Reactions. AlphaNine SD may cause allergic reactions, which can be serious. Severe allergic reactions can happen right away, or they can happen several weeks after you start treatment. 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Disseminated Intravascular Coagulation (DIC). AlphaNine SD can cause a serious condition called disseminated intravascular coagulation (DIC), which causes blood clots in the blood vessels throughout your body. DIC can lead to serious bleeding. Call your health care provider right away if you have any of the following symptoms.

  • Bruises
  • Vomiting
  • Dizziness
  • Confusion
  • Low blood pressure
  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots

Blood Clots. AlphaNine SD may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Stop taking AlphaNine SD 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 AlphaNine SD?

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

  • AlphaNine SD
  • Coagulation factor IX, human
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in AlphaNine SD.

What should I know about AlphaNine SD before using it?

Do not use AlphaNine SD unless it has been prescribed to you by a health care provider. Use it as prescribed.

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

AlphaNine SD is usually given by a health care provider in a hospital or clinic.

Your health care provider should monitor your blood tests while you are being treated with AlphaNine SD. Keep all appointments to have your blood checked.

AlphaNine SD is made from human blood. There is a small risk that AlphaNine SD may contain a virus or a substance called Creutzfeldt-Jakob disease agent, which can cause a rare brain disorder. Talk to your health care provider if you have concerns.

What should I tell my health care provider before using AlphaNine SD?

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 determine if AlphaNine SD 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.

  • Liver problems

Pregnancy. It is not known if or how AlphaNine SD 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 AlphaNine SD passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about AlphaNine SD?

For more information about AlphaNine SD, you can visit the drugmaker’s website at www.alphaninesd.com or call them at 888-474-3657.

Interactions

Does AlphaNine SD interact with foods or drinks?

There are no known interactions between AlphaNine SD and foods or drinks.

It is unknown if drinking alcohol will affect AlphaNine SD.

Does AlphaNine SD interact with other medicines (drug interactions)?

There are no known interactions between AlphaNine SD and other 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 AlphaNine SD?

If you or someone else has used too much AlphaNine SD, 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 AlphaNine SD?

AlphaNine SD is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving AlphaNine SD as scheduled.

If you miss an appointment to get your AlphaNine SD dose, call to make another appointment as soon as possible.