Patient Medication Information: uses, side effects, how to take - Afstyla
What is AFSTYLA used for?
AFSTYLA (Antihemophilic Factor VIII (Recombinant), SingleChain) is a medicine used to replace clotting Factor VIII that is missing in patients with hemophilia A. Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.
AFSTYLA does not contain human plasma-derived proteins.
AFSTYLA is used to prevent and control bleeding in all patients with hemophilia A. AFSTYLA can reduce the number of bleeding episodes when used regularly (prophylaxis) and reduce the risk of joint damage due to bleeding. Your healthcare provider may give you AFSTYLA when you have surgery.
AFSTYLA is not indicated for treatment of Von Willebrand disease.
How does AFSTYLA work?
AFSTYLA is injectable clotting (coagulation) Factor VIII made using recombinant technology. Factor VIII is involved in blood clotting. Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed. AFSTYLA works by replacing factor VIII in hemophilia A patients to enable their blood to clot.
What are the ingredients in AFSTYLA?
Medicinal ingredients: Antihemophilic Factor VIII (Recombinant), SingleChain
Non-medicinal ingredients: Calcium chloride, L-Histidine, Polysorbate 80, Sodium chloride, Sucrose.
AFSTYLA comes in the following dosage forms:
AFSTYLA (Antihemophilic Factor VIII (Recombinant), SingleChain) is a preservative-free, sterile, non-pyrogenic, white or slightly yellow lyophilized powder or friable mass (“loose cake”) to be reconstituted with Sterile Water for Injection (diluent) for intravenous injection. AFSTYLA is available in single-use vials containing the labeled amount of Factor VIII activity, expressed in IU on the vial and carton. Each vial contains nominally 250, 500, 1000, 1500, 2000, 2500 or 3000 IU of AFSTYLA, which must be reconstituted with the respective supplied volume of WFI (diluent) listed in the table below before it is administered:
| Lyophilized AFSTYLA Format | Diluent Volume for Reconstitution | Concentration of Product Once Reconstituted |
| 250 IU | 2.5 mL | 100 IU/mL |
| 500 IU | 2.5 mL | 200 IU/mL |
| 1000 IU | 2.5 mL | 400 IU/mL |
| 1500 IU | 5 mL | 300 IU/mL |
| 2000 IU | 5 mL | 400 IU/mL |
| 2500 IU | 5 mL | 500 IU/mL |
| 3000 IU | 5 mL | 600 IU/mL |
The package contains one single-use product vial of AFSTYLA, one vial of Sterile Water for Injection (Diluent), one Mix2Vial® filter transfer set, one package insert and an inner carton. The inner carton contains one syringe and one infusion set.
All the components of the AFSTYLA product package are latex free.
WARNINGS AND PRECAUTIONS
Do not use AFSTYLA if:
- You have had a life-threatening allergic reaction to it in the past
- You are allergic to its ingredients or hamster proteins
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AFSTYLA. Talk about any health conditions or problems you may have, including if you:
- have any allergies, including allergies to hamster proteins
are pregnant or planning to become pregnant. It is not known if AFSTYLA may harm your unborn baby.
- are breastfeeding. It is not known if AFSTYLA passes into the milk and if it can harm your baby.
Allergic reactions may occur with AFSTYLA. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or decrease in blood pressure.
Your body may form inhibitors to Factor VIII. An inhibitor is a part of the body’s defense system. If you form inhibitors, it may stop AFSTYLA from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. Inhibitor development has been observed in previously untreated patients and these patients are at the greatest risk for inhibitor development.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take AFSTYLA:
AFSTYLA is administered directly into the bloodstream (intravenously). AFSTYLA should be administered as ordered by your healthcare provider. You should be trained on how to do intravenous injections by your healthcare provider or hemophilia treatment center. Many patients with hemophilia A learn to inject AFSTYLA by themselves or with the help of a family member.
For intravenous use after reconstitution only.
Home administration of AFSTYLA
Do not attempt to give an infusion unless you have been taught how by your healthcare provider or hemophilia treatment center.
Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using AFSTYLA. If you are unsure of the instructions, call your healthcare provider before using AFSTYLA. Talk to your healthcare provider before traveling. Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container.
Administration
- Always work on a clean flat surface and wash your hands before performing the reconstitution procedures. Use aseptic technique when administering AFSTYLA.
- Administer AFSTYLA at room temperature within 4 hours after reconstitution.
- For injection of AFSTYLA, the provided administration sets are recommended to be used because treatment failure can occur as a consequence of factor VIII adsorption to the internal surface of some injection equipment.
- Administer by intravenous injection.
- As with any coagulation product, care should be taken that no blood should enter the syringe, as there is the possibility of fibrin clot formation.
- AFSTYLA is for single use only. Contains no preservatives. Discard partially used vials.
- Record the name and batch number of the product after administration to maintain a link between the patient and the batch of the medicinal product.
Preparation and Reconstitution
- Reconstitute AFSTYLA using aseptic technique with the diluent and Mix2Vial® transfer set provided in the product package. The AFSTYLA solution must not be further diluted and should be administered by a separate injection/infusion line.
- Do not mix AFSTYLA with other medicinal products.
- Do not use AFSTYLA beyond the expiration date on the vial label and carton.
- Visually inspect the reconstituted solution for particulate matter prior to administration. The solution should be colorless, clear or slightly opalescent and free from visible particles. Do not use if visibly cloudy or if discoloration or particulate matter is observed. If a package is opened or damaged, do not use and please contact your healthcare provider.
The procedures provided in the table below are general guidelines for the preparation and reconstitution of AFSTYLA.
AFSTYLA Reconstitution Instructions:
| Follow the steps below and use aseptic techniques to administer AFSTYLA. | |||
| A | PREPARATION Prepare the vials/Mix2Vial® and infusion supplies. Ensure that the diluent and AFSTYLA vials are at room temperature. Prepare syringes, infusion sets and other supplies for the administration. | ||
| B | RECONSTITUTION: follow these steps to reconstitute AFSTYLA. | ||
| 1 | Clean Stoppers: Remove the flip caps from both vials (AFSTYLA and diluent). Wipe the rubber stoppers with an antiseptic and allow the rubber stopper to dry. | ||
| 2 | Open the Mix2Vial® package by peeling away the lid. To maintain sterility, leave the Mix2Vial® set in its clear outer package. |  | |
| 3 | Prepare Diluent Vial: Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® keeping it in the package. Push the plastic spike at the blue end of the Mix2Vial® set firmly through the center of the diluent vial stopper. |  | |
| 4 | Remove the Mix2Vial® packaging: While holding the diluent vial, carefully remove the outer package from the Mix2Vial® set. Make sure that you pull off only the package, not the Mix2Vial® set. |  |
| 5 | Transfer Diluent into AFSTYLA Vial: Place the product vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® set attached to it and push the plastic spike of the clear end of the Mix2Vial® end firmly through the stopper of the AFSTYLA vial. The diluent will transfer into the AFSTYLA vial automatically. |  |
| 6 | Dissolve AFSTYLA: With the diluent and AFSTYLA vial still attached to the Mix2Vial® set, gently swirl the AFSTYLA vial to ensure the product is fully dissolved. Do not shake the vial. |  |
| 7 | Unscrew empty diluent (Blue) vial: With one hand, grip the clear end of the Mix2Vial® set and with the other hand grip the blue end of the Mix2Vial® set and unscrew the set into two pieces. |  |
| 8 | Load the syringe: Draw air into an empty, sterile syringe. Use the syringe provided with the product. With the AFSTYLA vial upright, screw the syringe to the Mix2Vial® set. Inject air into the product vial. While keeping the syringe plunger pressed, invert the AFSTYLA vial and draw the solution into the syringe by pulling the plunger back slowly. |  |
| 9 | Prepare the administration set equipped with microbore tubing: Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial® set. Attach the syringe to the provided infusion set or another suitable administration set. | |
| 10 | After reconstitution, administration should begin promptly or within 4 hours. | |
| C | Administer AFSTYLA using aseptic technique:
| |
Usual dose:
Your healthcare provider will tell you how much AFSTYLA to use based on your weight, the severity of your hemophilia A, and where you are bleeding. You may need to have blood tests done after getting AFSTYLA to be sure that your blood level of Factor VIII is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking AFSTYLA. Carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing AFSTYLA.
Overdose:
No symptoms of overdose with AFSTYLA have been reported.
| If you think you have taken too much AFSTYLA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
Do not take a double dose to make up for a forgotten dose. Proceed with the next dose immediately and continue as advised by your doctor or pharmacist.
 |
Storage
- Store in the refrigerator at +2 ⁰C to +8 ⁰C. Do not freeze. Store vial in original carton to protect from light. AFSTYLA may be stored at room temperature, not to exceed 25 °C, for a single period of up to 3 months.
- If removing the product from the refrigerator for storage at room temperature please note the new room temperature expiration date (should be 3 months from the date product is removed from the refrigerator) on the carton in the area provided.
- After storage at room temperature, do not return the product to the refrigerator.
- Do not use AFSTYLA beyond the expiration date printed on the vial or the new expiration date that was noted on the carton following removal from refrigeration, whichever is earlier.
Product after reconstitution: the product administration should begin promptly or within 4 hours.
What are possible side effects from using AFSTYLA?
Common side effects of AFSTYLA are rash, pyrexia (fever), dizziness, hypersensitivity (allergic reactions), and paraesthesia (tingling, pricking or numbing skin sensation). Other possible side effects include injection site pain, erythema (reddening of the skin), pruritus (itching), chills, and feeling hot. A single serious adverse reaction of hypersensitivity was reported in clinical trials with AFSTYLA.
Your body may form inhibitors to Factor VIII. An inhibitor is a part of the body’s defense system. If you form inhibitors, it may stop this medicine from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.
These are not all the possible side effects you may feel when taking AFSTYLA. If you experience any side effects not listed here, contact your healthcare professional. Please also see section WARNINGS AND PRECAUTIONS.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
We recommend that CSL Behring Canada, Inc. be copied when reporting suspected side effects, at the following address:
AdverseReporting@CSLBehring.com
If you want more information about AFSTYLA:
Talk to your healthcare professional.
Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.CSLBehring.ca, or by calling 1-866-773-7721.