Alphanine SD

Name: Alphanine SD

What is the most important information I should know about Alphanine SD (coagulation factor IX)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Commonly used brand name(s)

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

Before Using Alphanine SD

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Coagulation Factor IX RecombinantFactor IX Fc Fusion Protein RecombinantFactor IX Albumin Fusion Protein RecombinantCoagulation Factor IX Recombinant, GlycoPEGylated

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Factor IX

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clots or a history of medical problems caused by blood clots or
  • Liver disease—Risk of bleeding or developing blood clots may be increased

Alphanine SD Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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.

Uses of AlphaNine SD

  • It is used to treat hemophilia.
  • It is used to treat or prevent bleeding.

What do I need to tell my doctor BEFORE I take AlphaNine SD?

  • If you have an allergy to AlphaNine SD (factor IX (human)) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are allergic to mouse proteins, talk with the doctor.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take AlphaNine SD with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Coagulation Factor IX (Human) AlphaNine® SD

Solvent Detergent Treated/Virus Filtered

Indications and usage

Alphanine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. Alphanine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.

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