Afstyla
- Generic Name: antihemophilic factor recombinant intravenous injection
- Brand Name: Afstyla
Afstyla (Antihemophilic Factor Recombinant Intravenous Injection) side effects drug center
Afstyla Side Effects Center
What Is Afstyla?
Afstyla [antihemophilic factor (recombinant), single chain for intravenous injection] is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes, and perioperative management of bleeding.
What Are Side Effects of Afstyla?
Common side effects of Afstyla include:
- dizziness
- hypersensitivity
- numbness and tingling
- rash
- redness
- itching
- fever
- injection site pain
- chills, and
- feeling hot
Dosage for Afstyla
The dose of Afstyla is based on the patient's body weight and desired Factor VIII rise.
What Drugs, Substances, or Supplements Interact with Afstyla?
Afstyla may interact with other drugs. Tell your doctor all medications and supplements you use.
Afstyla During Pregnancy and Breastfeeding
During pregnancy, Afstyla should be used only if prescribed. Tell your doctor if you are pregnant before using Afstyla. It is unknown if it would harm a fetus. It is unknown if Afstyla passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Afstyla [antihemophilic factor (recombinant), single chain for intravenous injection] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Afstyla Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- increased bleeding episodes;
- any bleeding that will not stop;
- chest pain; or
- a light-headed feeling, like you might pass out.
Common side effects may include:
- nose bleeds;
- nausea, vomiting, diarrhea;
- headache, dizziness;
- muscle or joint pain;
- rash;
- flushing (sudden warmth, redness, or tingly feeling);
- fever, chills;
- cough;
- weakness; or
- pain, swelling, itching, or redness where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Afstyla (Antihemophilic Factor Recombinant Intravenous Injection)
Afstyla Professional Information
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 3) 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 3. Adverse Reactions Reported for AFSTYLA (N=258)
| MedDRA System Organ Class | Adverse Reactions | Number of Subjects n (%) |
| 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 administration 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 chinese hamster ovary (CHO) host cell proteins prior to the first infusion of AFSTYLA, at defined intervals during the studies and at the end of study visit.
Preliminary data from an ongoing clinical trial in previously untreated patients (PUPs) aged ≤5 years indicate that 12 of 23 treated subjects (52% with a 95% confidence interval of 31%, 73%) developed an inhibitor. Of these, 6 subjects (26%) had peak inhibitor values in the high titer range, and 6 subjects (26%) had peak values in the low titer range. Of the 12 subjects who tested positive for inhibitors, 11 subjects have remained in the trial; 8 experienced successful eradication of the inhibitor; three subjects with high titer inhibitors remain inhibitor positive and have continued treatment with AFSTYLA.
No PTPs developed neutralizing antibodies (inhibitors) to Factor VIII or antibodies against CHO host cell proteins at any time during the completed 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.
Postmarketing Experience
The following adverse reaction has been identified during post-approval use of AFSTYLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic systems disorders: Factor VIII inhibitor development
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Afstyla (Antihemophilic Factor Recombinant Intravenous Injection)
© Afstyla Patient Information is supplied by Cerner Multum, Inc. and Afstyla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.