Pronunciation:

an-tee-hee-moe-FIL-ik FAK-tor (ree-KOM-bi-nant) Fc-VWF-XTEN FUE-zhun PROE-teen - ehtl

Brand Names:

• Altuviiio

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

Antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl injection is used to treat, control, prevent, and decrease the frequency of bleeding episodes, and prevent bleeding during surgery in patients with hemophilia A (congenital Factor XIII deficiency).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Altuviiio™ injection in children.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Altuviiio™ injection in geriatric patients.

Breast-feeding—

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.

Other 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.

Other interactions—

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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It is given through a needle placed into one of your veins. You may also be taught how to give this medicine at home.

This medicine comes with a patient information leaflet and instructions for use. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 1 vial and 1 prefilled syringe:

• Take the vial and prefilled syringe out of the refrigerator and warm them to room temperature. Do not use other source of heat (eg, hot water).
• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.
• Peel the lid of the vial adapter. Keep the vial on a flat surface. Hold the vial with one hand and using the other hand, place the vial adapter in its package over the vial.
• Push the vial adapter straight down until the spike on the vial adapter punctures the center of the vial stopper. The spike should be placed directly above the center of the rubber stopper.
• Lift the package cover away from the vial and throw away the cover.
• Place the tip of the plunger rod into the end of the prefilled diluent syringe. Turn the rod to the right until firmly attached.
• Hold the prefilled syringe directly under the cap with the cap pointing up. Bend the cap until it snaps off.
• On a flat surface, insert the tip of the prefilled syringe into the vial. Turn the syringe to the right until it is firmly attached to the vial.
• Slowly push down on the plunger to inject all liquid from the syringe into the vial. Swirl the bottle gently to dissolve the medicine. Do not shake.
• Check the mixture to make sure it is clear and colorless to slightly yellowish. Do not use the medicine if you can see particles in it.
• Turn the vial upside down. Slowly pull down on the plunger to draw all the mixture from the vial to the syringe.
• Gently unscrew the syringe from the vial by turning it to the right. Do not touch the tip of the syringe or inside of the cap.
• Give the injection as directed by your doctor.

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.

• For injection dosage form (powder for solution):
  • For bleeding episodes in patients with hemophilia A:
    • Adults and children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature or in the refrigerator, away from heat, moisture, and direct light. Keep from freezing. If stored at room temperature, the medicine will expire at 6 months or after the expiration date, whichever comes first.

Do not return the room temperature medicine in the refrigerator.

Use the mixture within 3 hours after it is prepared. Do not store in the refrigerator after mixing and use later.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests are needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Side Effects of This Medicine:

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

Difficulty breathing

pain in the chest, groin, or legs, especially in the calves

severe, sudden headache

sudden, loss of coordination

sudden, severe weakness or numbness in the arm or leg

vision changes

Incidence not known

Chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of he eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

difficulty in moving

joint pain

muscle pain or stiffness

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.