Afstyla

Name: Afstyla

Warnings

Included as part of the PRECAUTIONS section.

Afstyla Overview

Afstyla is a brand name medication. For more information about Afstyla see its generic Antihemophilic Factor (Recombinant)

Manufacturer

  • CSL Behring LLC

What do I need to tell my doctor BEFORE I take Afstyla?

  • If you have an allergy to Afstyla (antihemophilic factor (recombinant) (afstyla)) 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 hamsters, 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 Afstyla with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Afstyla) best taken?

Use Afstyla as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.
  • This medicine may be given at home.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Wash your hands before and after use.
  • If stored in a refrigerator, let this medicine come to room temperature before mixing. Do not heat Afstyla.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Most products will be clear and colorless after mixing. Some products may be clear to slightly cloudy and colorless after mixing. Some products may be colorless to a faint yellow after mixing. Be sure you know what the product will look like after mixing.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • After mixing, do not refrigerate.
  • Use within 4 hours of making.
  • Throw away any part of opened vial not used after use.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in color of mouth to blue.
  • Chest pain or pressure or a fast heartbeat.
  • Dizziness or passing out.
  • Feeling cold.
  • Fever or chills.
  • Flushing.
  • Pale skin.
  • Restlessness.
  • Shortness of breath.
  • Trouble swallowing.
  • Upset stomach or throwing up.

How do I store and/or throw out Afstyla?

  • If this medicine is given at home, store unopened containers at room temperature or in the refrigerator. Do not freeze.
  • Store in original container.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • Protect from light.
  • If stored at room temperature, throw away any unused vials after 3 months or after the expiration date, whichever comes first.
  • Do not put Afstyla back in the refrigerator after it has been stored at room temperature.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take Afstyla or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Afstyla (antihemophilic factor (recombinant) (afstyla)). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Side effects

The most common adverse reactions ( > 0.5% of subjects) reported in clinical trials were dizziness and hypersensitivity.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

The safety, efficacy and pharmacokinetics of AFSTYLA have been evaluated in 258 previously treated patients (PTPs) with severe hemophilia A ( < 1% endogenous Factor VIII activity) who received at least one dose of AFSTYLA as part of either routine prophylaxis, on-demand treatment of bleeding episodes or perioperative management in two completed clinical trials (an adult/adolescent study [ ≥ 12 to 65 years of age] and a pediatric study [ < 12 years of age]), and an ongoing extension study (0 to ≤ 65 years of age). Patients with a history of, or current FVIII inhibitors, or any first order family history of FVIII inhibitors, patients with known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein, and patients with evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1 of the study were excluded from study participation.

Eighty-four (32.6%) subjects were children < 12 years of age (35 [13.6%] 0 to < 6 years and 49 [19.0%] ≥ 6 to < 12 years), 14 (5.4%) were adolescents ( ≥ 12 to < 18 years), and 160 (62.0%) were adults ( ≥ 18 to ≤ 65 years). There have been a total of 28,418 exposure days (EDs), with at least 28,492 injections of AFSTYLA administered. In the completed studies, a total of 185 subjects achieved at least 50 EDs, of whom 60 subjects achieved ≥ 100 EDs.

Adverse reactions (ARs) (summarized in Table 4) were reported for 14 of 258 (5.4%) subjects in all studies. An adverse reaction of hypersensitivity resulted in the withdrawal of one subject. No subject developed neutralizing antibodies (inhibitors) to Factor VIII or antibodies to host cell proteins. No events of anaphylaxis or thrombosis were reported.

Table 4: Adverse Reactions Reported for AFSTYLA (N=258)

MedDRA System Organ Class Adverse Reactions Number of Subjectsn (%)
Immune system disorders Hypersensitivity 4 (1.6)
Nervous system disorders Dizziness 2 (0.8)
Paresthesia 1 (0.4)
Skin and subcutaneous tissue disorders Rash 1 (0.4)
Erythema 1.(0.4)
Pruritus 1 (0.4)
General disorders and administra-tion site conditions Pyrexia 1 (0.4)
Injection-site pain 1 (0.4)
Chills 1 (0.4)
Feeling hot 1 (0.4)

Immunogenicity

All subjects were monitored for inhibitory and binding antibodies to AFSTYLA, and binding antibodies to CHO host cell proteins prior to the first infusion of AFSTYLA, at defined intervals during the studies and at the end of study visit.

No subjects developed neutralizing antibodies (inhibitors) to Factor VIII or antibodies against chinese hamster ovary (CHO) host cell proteins at any time during the clinical studies. Four subjects in the adult/adolescent study and 10 subjects in the pediatric study were negative for non-neutralizing anti-drug antibodies (ADAs) at screening and turned positive during the clinical study. Two of the adult/adolescent subjects and 3 of the pediatric subjects who developed ADAs were negative at end of study visit. No adverse events were associated with the development of ADAs. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, it may be misleading to compare the incidence of antibodies to AFSTYLA with the incidence of antibodies to other products.

Read the entire FDA prescribing information for Afstyla (Antihemophilic Factor Recombinant Intravenous Injection)

Read More »
(web3)