December 1, 2021

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Price, dosage, side consequences, uses, and additional

Fabrazyme can cause gentle or really serious facet results. The next lists include some of the crucial side effects that may well take place with Fabrazyme. These lists do not include all achievable side results.

For more facts about the attainable side outcomes of Fabrazyme, speak with your health care provider or pharmacist. They can give you strategies on how to offer with any side results that might be relating to or bothersome.

Note: The Foodstuff and Drug Administration (Fda) tracks facet consequences of drugs it has permitted. If you would like to notify the Fda about a aspect result you have experienced with Fabrazyme, you can do so by MedWatch.

Mild side outcomes

Moderate facet results* of Fabrazyme can incorporate:

  • cough, stuffy nose, or sore throat
  • dizziness
  • headache
  • rash or itching
  • inflammation in your lower legs, toes, or fingers
  • tingling or prickly experience in your fingers, feet, or other entire body components
  • tiredness
  • muscle pain or muscle mass spasm (involuntary muscle mass tightening)
  • tinnitus (ringing in your ears)
  • generalized discomfort, back discomfort, or discomfort in your arms or ft
  • chills or feeling cold†
  • fever, emotion very hot, or flushing (non permanent warmth, redness, or deepening of skin color)†
  • higher respiratory infection†

Most of these side results have a tendency to be manageable. They might go away as you continue Fabrazyme remedy. But some moderate facet consequences can be signs of a lot more major aspect effects. For instance, a rash or itching can be signals of an infusion-similar reaction or allergic reaction. Also, other delicate facet results can be indications of Fabry ailment, these kinds of as tinnitus and experience cold or incredibly hot.

If you have new or worsening indicators, chat with your physician or pharmacist. If your indicators become severe or appear lifetime threatening, look for unexpected emergency professional medical care, or simply call 911 ideal absent.

* This is a partial listing of moderate side effects from Fabrazyme. To master about other moderate side effects, communicate with your medical doctor or pharmacist, or check out Fabrazyme’s prescribing details.
† For a lot more info about this aspect influence, see “Side impact details” below.

Serious side results

Fabrazyme can induce serious side outcomes, some of which are prevalent. Simply call your health practitioner proper absent if you have major facet consequences. Or, get in touch with 911 or your local unexpected emergency amount if your indications experience lifetime threatening or if you think you are acquiring a health-related crisis.

Serious side results and their signs can include things like:

For additional information about these significant aspect outcomes, see “Side outcome details” below.

Side results in children

Fabrazyme is accepted for use in little ones ages 2 and older, as very well as grown ups. In medical reports of Fabrazyme use in the two children and adults, the aspect outcomes were generally the similar in both equally age teams. For lists of feasible facet outcomes, see “Mild aspect effects” and “Serious side effects” previously mentioned.

Aspect effect facts

Here’s some element on selected facet outcomes this drug may well trigger.

Infusion-related reactions

Reactions to intravenous (IV) infusions of Fabrazyme are a widespread aspect impact of the drug.

IV infusions are injections offered slowly and gradually into your vein. Infusion-associated reactions to Fabrazyme may induce mild or really serious signs or symptoms, this sort of as:

  • hives (itchy welts on your skin)
  • itching
  • reduced or substantial blood tension
  • rapidly heart rate
  • difficulties respiratory
  • chills, experience chilly, or shivering
  • fever, emotion incredibly hot, or flushing (short-term heat, redness, or deepening of skin colour)
  • inflammation in your reduced legs, palms, or ft
  • ache in your hands or ft
  • chest pain or a restricted throat
  • headache
  • nausea, vomiting, or diarrhea
  • tingling in your hands or toes
  • stomach (stomach) pain
  • stuffy nose
  • tiredness

Fabrazyme infusions are specified by a healthcare specialist, and they typically previous from 1.5 several hours to numerous hrs. You are going to be monitored in the course of and soon after your infusion for symptoms of a response. Indicators could occur at any time during an infusion. Indicators can also come about after an infusion is above, which includes later in the working day.

As you carry on Fabrazyme treatment method, you may perhaps working experience less infusion-connected reactions. But it is also possible for these reactions to maintain occurring through treatment.

You may well be more most likely to experience infusion-linked reactions if your body has specific antibodies to Fabrazyme. Antibodies are proteins that your immune process will make in response to overseas substances. Your health practitioner may possibly purchase sure tests to check for these antibodies.

Also, if you have coronary heart condition, you could be at improved chance for major infusion-relevant reactions. In advance of starting Fabrazyme, explain to your medical professional if you have coronary heart difficulties.

Management of infusion reactions

Tell a healthcare professional if you have any new or uncommon signs in the course of or right after Fabrazyme infusions.

To support stop and take care of reactions, your health practitioner or health care experienced may perhaps:

  • give you premedications (prescription drugs to choose just before beginning your Fabrazyme infusion) to support avoid selected significant reactions to the drug*
  • give you medicines throughout your infusion
  • infuse Fabrazyme at a slower fee than typical, or stop your infusion for a shorter time

But if you have a serious infusion response with Fabrazyme, your doctor might quit your remedy and give you unexpected emergency professional medical treatment, such as oxygen. In some scenarios soon after a significant reaction, your medical professional might choose to have you get Fabrazyme once again, but at a decrease dosage and slower charge than normal. This is termed a rechallenge dosage. For extra specifics, see the “Fabrazyme dosage” part over.

* For far more information about premedications that may be made use of with Fabrazyme, see the “Fabrazyme use with other drugs” portion underneath.

Higher respiratory infections

In the course of Fabrazyme procedure, you may be much more possible to get higher respiratory bacterial infections (these as sinus bacterial infections) or indicators of these infections. Signs and symptoms may contain a cough, stuffy nose, upper body congestion, or a sore throat. These are frequent aspect consequences of the drug.

Whilst using Fabrazyme, inform your medical doctor if you have delicate signs or symptoms that bother you. They could counsel an above-the-counter treatment, this kind of as a cough suppressant or nasal decongestant. If you produce a bacterial infection, you may perhaps have to have a prescription antibiotic to take care of it.

If you have serious signs or symptoms, or if your symptoms get even worse or never go away, discuss with your health care provider right absent. A stuffy nose and upper body congestion could be signs and symptoms of Fabry disorder, or they could be signs of an infusion-connected reaction, which can be significant (see “Infusion-connected reactions” above). Your doctor can aid figure out how serious your signs or symptoms are and what treatment options are essential.

Alterations in system temperature

Fabrazyme may possibly result in modifications in your body temperature. This may well contain chills, experience chilly, and fever. These are common aspect effects of Fabrazyme.

Also, infusion-similar reactions are typical with Fabrazyme. And modifications in your entire body temperature for the duration of or just after an infusion can be indicators of these reactions. (See “Infusion-similar reactions” previously mentioned for details.)

Some symptoms of Fabry disorder can also have an impact on your physique temperature. These indicators may well contain an inability to make sweat or to cope with hot or chilly temperatures. Overheating with exercise and emotions of becoming scorching or chilly (this sort of as a fever) can also be symptoms of Fabry disease.

If you have any of the higher than indicators or alterations in your human body temperature, converse with your medical professional suitable away. They can figure out the result in and advise the suitable treatments for you.

Allergic response

As with most medications, some people today can have an allergic response with Fabrazyme. To control this aspect result, you’ll only obtain the drug from a health care expert who has access to unexpected emergency medical care. In the course of a Fabrazyme infusion, inform your medical professional ideal away if you have any of the indicators under.

Symptoms of a gentle allergic response can incorporate:

  • rash
  • itchiness
  • flushing (non permanent heat, redness, or deepening of pores and skin shade)

Significant allergic reactions, such as anaphylaxis, are rare but probable. Anaphylaxis is a daily life threatening allergic response. Indicators of a severe allergic reaction can incorporate:

  • inflammation beneath your skin, usually in your eyelids, lips, hands, or toes
  • inflammation of your tongue, mouth, or throat
  • problems breathing

Right after a Fabrazyme infusion or among appointments, connect with your medical doctor proper away if you have any indications of an allergic reaction. This is significant, mainly because the reaction could develop into intense. Connect with 911 or your community emergency number if your signs and symptoms come to feel existence threatening or if you consider you’re possessing a medical emergency.

Keep in mind that you may perhaps be far more probable to have an allergic reaction if you have particular antibodies to Fabrazyme. Antibodies are proteins that your immune procedure would make in response to overseas substances. In some circumstances, your health practitioner may buy specified assessments to verify for antibodies to the drug.