Medical Editor: John P. Cunha, DO, FACOEP
What Is Alphanate?
Alphanate (antihemophilic factor) (HUMAN) is a naturally occurring protein in the blood that helps blood to clot used to treat or prevent bleeding in people with hemophilia A.
What Are Side Effects of Alphanate?
Alphanate may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- low energy,
- pale skin color,
- shortness of breath,
- easy bruising,
- unusual bleeding,
- persistent sore throat,
- unusual tiredness,
- unusual drowsiness,
- joint pain,
- persistent nausea or vomiting,
- stomach pain,
- yellowing of the eyes or skin (jaundice),
- dark urine,
- severe dizziness, and
- chest pain or pressure
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Alphanate include:
- flushing of the face
- vomiting, and
- fast heartbeat which may be lessened by giving this medication more slowly.
Other side effects of Alphanate include:
- injection site reactions (burning, redness, irritation)
- chills, and
Seek medical attention if you notice side effects of Alphanate that include symptoms of a serious allergic reaction, such as:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing, and
- chest discomfort/tightness
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Alphanate
Dosage of Alphanate is individualized, and is administered intravenously.
What Drugs, Substances, or Supplements Interact with Alphanate?
Alphanate may interact with other drugs that affect bleeding or blood clotting. Tell your doctor all medications and supplements you use.
Alphanate During Pregnancy and Breastfeeding
During pregnancy, Alphanate should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Alphanate (antihemophilic factor) (HUMAN) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
Serious adverse drug reactions (ADRs) observed in patients receiving ALPHANATE include anaphylaxis/hypersensitivity reactions. Thromboembolic events also have been observed in patients receiving ALPHANATE for VWD [see WARNINGS AND PRECAUTIONS].
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse drug reaction (ADR) rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a prospective clinical study with ALPHANATE, 23 subjects were exposed to 1217 infusions (median=42, range 2-160). The total number of exposure days was 1133, and the total number of months on study across all subjects was 234 (19.5 subject years). No ADRs or inhibitors to FVIII were reported during the study.
Von Willebrand Disease
In the prospective clinical study of ALPHANATE[using both ALPHANATE Solvent Detergent (A-SD, a previous generation product) and ALPHANATE Solvent Detergent/Heat Treated (A-SD/HT, the current generation product)] in subjects with von Willebrand Disease, ADRs occurred in 5 of 36 subjects (13.9%) treated with ALPHANATE.
Sixty-one total ADRs were reported in 204 infusions. The majority of ADRs were rated as mild (55 of 61 [90.2%]). Six ADRs (9.8%) were rated as moderate. No reactions rated as serious were reported. The adverse drug reaction grading scale is defined as follows:
- Mild: the event was noted but the administration of the compound was not interrupted; the event resolved spontaneously or no treatment was required beyond administration of nonprescription analgesics.
- Moderate: the administration of the compound was not necessarily interrupted; the event required momentary treatment with prescription drugs and produced no sequelae.
Overall, the proportion of infusions associated with ADRs was 14 of 204 infusions (6.9%).
The most common ADRs reported (> 1% of infusions) were pruritus, headache, backpain, paresthesia, respiratory distress, facial edema, pain, rash, and chills.
One incident of pulmonary embolism was reported that was considered to have a possible relationship to the product. This subject received a dose of 60 IU VWF:RCo/kg body weight and the FVIII:C level achieved was 290%.
In the retrospective study conducted to determine the efficacy and safety of ALPHANATE (A-SD/HT) in a surgical or invasive procedure setting as perioperative prophylaxis against excessive bleeding, [see Clinical Studies], 3 out of 39 subjects (7.7%) experienced 6 adverse drug reactions. Four were considered mild and 2 were considered moderate. No subject discontinued their treatment due to an adverse drug reaction. The adverse drug reactions were pruritus, paresthesia (2 events) and hemorrhage (all considered mild), and one event each of moderate hematocrit decrease and orthostatic hypotension.
One adverse drug reaction (pain) related to the treatment with heat-treated ALPHANATE (A-SD/HT) was reported in the four pediatric subjects with von Willebrand Disease during the course of the prospective study and in none of the five pediatric subjects in the retrospective clinical study.
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.
The most common post-marketing ADRs reported include allergic/hypersensitivity reactions, nausea, fever, joint pain, fatigue, and infusion site pain.
Read the entire FDA prescribing information for Alphanate (Antihemophilic Factor)
© Alphanate Patient Information is supplied by Cerner Multum, Inc. and Alphanate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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