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Fabrazyme Coupon - Fabrazyme 35mg vial

Fabrazyme

agalsidase beta
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease
Used for Inherited Metabolic Diseases, Lysosomal Storage Disease

Fabrazyme (agalsidase beta) is an enzyme replacement therapy (ERT) that's FDA-approved for the treatment of a rare, inherited condition called Fabry disease in adults and children. It's administered as an intravenous (IV) infusion by a healthcare provider every 2 weeks. The dosing is calculated by your weight. Side effects include a higher risk of infections, chills, fever, and headache.

Last reviewed on January 4, 2024
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What is Fabrazyme (agalsidase beta)?

What is Fabrazyme (agalsidase beta) used for?

  • Fabry disease in people 2 years of age and older

How Fabrazyme (agalsidase beta) works

Fabrazyme (agalsidase beta) is an enzyme replacement therapy for people with Fabry disease. It replaces the missing alpha-galactosidase A (alpha-Gal A) enzyme in the body. This enzyme helps clear the buildup of fats called globotriaosylceramide (GL-3) that causes damage to the body in Fabry disease.

Drug Facts

Common BrandsFabrazyme
Drug ClassEnzyme replacement therapy
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Fabrazyme (agalsidase beta)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Upper respiratory tract infection (53%)
  • Chills (49%)
  • Fever (39%)
  • Headache (39%)
  • Cough (33%)
  • Feeling of "pins and needles" (31%)
  • Low energy (24%)
  • Swelling in arms, feet, or ankles (21%)
  • Dizziness (21%)
  • Rash (20%)
  • Arm or leg pain (19%)
  • Muscle pain (18%)
  • Lower respiratory tract infection (18%)
  • Back pain (16%)
  • High blood pressure (14%)
  • Itching (10%)

Other Side Effects

  • Fast heart rate
  • Chest discomfort
  • Shortness of breath
  • Wheezing
  • Ringing in the ears
  • Hearing problems
  • Burning sensation
  • Anxiety
  • Depression

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious allergic reaction (anaphylaxis): trouble breathing, tightness in the throat, hives, itching, fast heartbeat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

chest pain, discomfort, or tightness

confusion

cough producing mucus

difficulty breathing

difficulty in moving

dizziness

faintness or lightheadedness when getting up suddenly from a lying or sitting position

feeling unusually cold shivering

headache

hives or welts, itching, skin rash

irregular heartbeat

joint pain

muscle ache, cramps, pains, or stiffness

nervousness

pounding in the ears

redness of the skin

stomach pain

sweating

swelling of the ankles, feet, and lower legs

swollen joints

unusual tiredness or weakness

Incidence unknown

Blue lips, fingernails, or skin

chills

cloudy or bloody urine

cough

decreased cardiac output

decreased frequency or amount of urine

difficulty in speaking

difficulty swallowing

dilated neck veins

double vision

feeling of constant movement of self or surroundings

fever

high blood pressure

inability to move the arms, legs, or facial muscles

increased thirst

irregular, fast, or slow, or shallow breathing

lack or loss of strength

loss of appetite

lower back or side pain

nausea

no breathing

no pulse or blood pressure

noisy breathing

pain in the joints

pain or discomfort in the arms, jaw, back, or neck

problems with muscle control or coordination

seizures

sensation of spinning

severe or sudden headache

shakiness and unsteady walk

slow or slurred speech

swollen, painful, or tender lymph glands in the neck, armpit, or groin

temporary blindness

throat tightness

trembling

trouble breathing

unconsciousness

vomiting

weakness in the arm and/or leg on one side of the body, sudden and severe

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Acid or sour stomach

belching

body aches or pain

body produces substance that can bind to drug making it less effective or cause side effects

burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings

congestion

discouragement

dryness or soreness of the throat

fear

feeling sad or empty

fever, not related to infusion

heartburn

hoarseness

indigestion

irritability

loss of interest or pleasure

pain or tenderness around eyes and cheekbones

paleness of skin

runny nose

sensation of change in temperature

skeletal pain

sneezing

stuffy nose

trouble concentrating

trouble sleeping

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Fabrazyme (agalsidase beta)

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Pros

Can help lower fats (GL-3) to near-normal levels in the body after just 5 months

Might be able to get the infusion at home after the first several treatments

Can be used in children as young as 2 years old

Given every 2 weeks

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Cons

Can cause infusion-related side effects

Infusion can take several hours, depending on how well you tolerate the medication

No lower-cost generic available; brand-name medication only

pharmacist-tips

Pharmacist tips for Fabrazyme (agalsidase beta)

pharmacist
  • Make sure to mark your appointments in your calendar to see your provider and get your Fabrazyme (agalsidase beta) infusions. Missing infusions might make the medication work less well for you.

    • Tell your provider if you're not feeling well, feel hot or cold, or have chest pain during the Fabrazyme (agalsidase beta) infusion. You might be having a reaction to the infusion. Your provider can adjust how fast the infusion runs or give you medications like acetaminophen (Tylenol) or diphenhydramine (Benadryl) to help relieve these symptoms.

      • Your provider might recommend that you take acetaminophen (Tylenol) or an antihistamine before each infusion to help prevent or lessen the severity of reactions to the Fabrazyme (agalsidase beta) infusion. These infusion reactions should also get better with time as you continue treatment with Fabrazyme (agalsidase beta).

        • Get help right away if you experience signs of a serious allergic reaction, including fever, chills, stomach pain, diarrhea, nausea, swelling, itching, rash, trouble breathing, and feeling agitated.

          • Ask your provider or infusion center if you're interested in learning about cost savings and resources for Fabrazyme (agalsidase beta). The manufacturer might be able to offer help with cost, access, and other resources for certain people who are eligible.

            faqs

            Frequently asked questions about Fabrazyme (agalsidase beta)

            When was Fabrazyme (agalsidase beta) FDA approved?
            Fabrazyme (agalsidase beta) was granted an accelerated approval by the FDA in 2003. After more clinical studies were conducted to confirm that the medication's clinical benefits for people with Fabry disease outweigh its risks, the FDA gave Fabrazyme (agalsidase beta) a full approval in 2021.
            How do you administer Fabrazyme (agalsidase beta)?
            Fabrazyme (agalsidase beta) is given as a slow infusion through the veins. The infusion is typically administered by a healthcare provider at a medical office, infusion center, or hospital. Fabrazyme (agalsidase beta) isn't a medication you can pick up at the pharmacy and give to yourself at home. But after several infusions, your provider might let you get treatment at home. Talk to your provider to see whether it's an option to arrange for a nurse to administer your infusion at home.
            How long does a Fabrazyme (agalsidase beta) infusion take?
            How long your Fabrazyme (agalsidase beta) infusion takes depends on your weight and how well you're tolerating the infusion. The infusion should take at least an hour and a half. It might take a little longer for the infusion to finish if you're experiencing infusion-related reactions. This is because your provider will slow down or temporarily stop the infusion to manage your symptoms. Plan ahead of time and bring something to do to help pass the time, such as a book or an electronic device.
            Is Fabrazyme (agalsidase beta) an enzyme?
            Fabrazyme (agalsidase beta) is an enzyme replacement therapy. It's a lab-made version of the alpha-Gal A enzyme that your body normally makes. The medication replaces the missing alpha-Gal A enzyme in people with Fabry disease.
            Is Fabrazyme (agalsidase beta) safe during pregnancy?
            Animal and human studies haven't suggested that Fabrazyme (agalsidase beta) raises the risk of harm to unborn babies when it's taken during pregnancy. But some animal studies showed evidence of liver damage in mothers after taking the medication at doses much higher than those used in humans. If you're prescribed Fabrazyme (agalsidase beta) during pregnancy, you're encouraged to enroll in the Fabry registry. This registry keeps track of your health and your baby's health. To enroll, visit the registry's website or call 1-800-745-4447, extension 15500. Also, make sure to have a discussion with your provider if you're pregnant or planning to get pregnant during your Fabrazyme (agalsidase beta) treatment.
            What does Fabry disease do to a person?
            Fabry disease is a rare, inherited condition. The body can't make enough of a protein called alpha-galactosidase A (alpha-Gal A) to help get rid of certain fats (GL-3) from your body. As a result, the fats start to collect in blood vessels, the kidneys, the heart, and many other organs. Extra fats can cause nerve pain; small, red spots on the skin; hearing loss; and digestive problems. Over time, the buildup of fats can also cause serious problems, such as kidney damage, heart problems like heart attack, and stroke. Everyone can have different signs and symptoms of this condition. It's important to follow up with a provider often if you have Fabry disease, even if you don't have any signs and symptoms. Your providers can discuss with you about treatment options like Fabrazyme (agalsidase beta).
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            What are the risks and warnings for Fabrazyme (agalsidase beta)?

            Fabrazyme (agalsidase beta) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Serious allergic reaction

            • Risk factors: People with anti-Fabrazyme antibodies in their blood

              Serious allergic reactions to Fabrazyme (agalsidase beta) are possible. These reactions can include life-threatening problems like anaphylaxis (closing of the throat and trouble breathing) and angioedema (swelling of the lips, tongue, face, or throat). The risk for severe allergic reactions might be higher in people with anti-Fabrazyme antibodies — antibodies your immune system made against the medication as an allergic response — in the blood. Tell your provider right away if you begin to have any trouble breathing, trouble swallowing, severe swelling, or hives.

              risk-warning

              Infusion-related reactions

              • Risk factors: People with anti-Fabrazyme antibodies in their blood

                In clinical studies, over half of people who took Fabrazyme (agalsidase beta) experienced reactions during their infusions. These reactions can include fever, chills, dizziness, nausea, stomach pain, muscle pain, changes in heartbeat, or a feeling of "pins and needles," among others.

                Tell your provider if you feel unwell at any point during your Fabrazyme (agalsidase beta) infusion. Your provider can adjust the infusion rate, temporarily stop the infusion, or give you medications to manage your symptoms. Call a provider if you have any reactions after your infusion as well.

                If you've had an infusion reaction, your provider might give you medications to prevent reactions before your infusion at your next treatment session. Your provider might also observe you after your infusion to see how you respond to the medication in case you need appropriate treatment.

                dosage

                Fabrazyme (agalsidase beta) dosage forms

                Typical dosing for Fabrazyme (agalsidase beta)

                The dose is based on your body weight. The typical dose is 1 mg/kg of weight every 2 weeks as an infusion into your veins (intravenous or IV infusion).

                interactions

                Interactions between Fabrazyme (agalsidase beta) and other drugs

                Fabrazyme (agalsidase beta) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Fabrazyme (agalsidase beta). Please note that only the generic name of each medication is listed below.

                Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

                alternatives

                What are alternatives to Fabrazyme (agalsidase beta)?

                There are a number of medications that your doctor can prescribe in place of Fabrazyme (agalsidase beta). Compare a few possible alternatives below.
                Fabrazyme (agalsidase beta)
                Used for:
                • Fabry disease in people 2 years of age and older

                Used for:
                • Treatment of Fabry disease in certain people

                images

                Fabrazyme (agalsidase beta) images

                white - Fabrazyme 35mg Powder for Injection
                This medicine is White Vial.white - Fabrazyme 35mg Powder for Injection

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                References

                Best studies we found
                View All References (6)

                National Institute of Neurological Disorders and Stroke. (2024). Fabry disease.

                National Kidney Foundation. (n.d.). Fabry disease.

                National Organization for Rare Disorders. (2019). Fabry disease.

                Sanofi. (2020). Long-term data on Fabrazyme® (agalsidase beta) for people with Fabry disease.

                Sanofi. (2024). Prescribing information: Fabrazyme (agalsidase beta) 5mg/ 35mg powder for concentrate for solution for infusion.

                Search Orphan Drug Designations and Approvals. (n.d.). Agalsidase beta. U.S. Food and Drug Administration.

                GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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