FABRAZYME 35 MG

Storage/Handling:

Unused vials to be refrigerated at 2-8ºC (36-46ºF)
Reconstituted vials and diluted solutions to be used immediately

Uses of FABRAZYME 35 MG:

Used as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).

Product Introduction:

Fabrazyme 35mg - Agalsidase beta is a medication used to treat Fabry disease, a hereditary disorder that causes the accumulation of a fatty substance called GL-3 in certain parts of the body. If left untreated, this condition can lead to serious complications such as kidney disease, heart attack, or stroke.

The medication works by replacing an enzyme that the body is unable to produce naturally. This enzyme is essential for breaking down the fatty substance (GL-3) in the body, and its absence leads to the buildup of this substance. Agalsidase beta helps prevent symptoms such as pain (especially in the hands and feet), dark red spots on the skin, decreased ability to sweat, cloudiness of the front part of the eye, stomach and intestinal problems, ringing in the ears (tinnitus), and hearing loss.

By replacing the missing enzyme, Agalsidase beta helps to reduce the amount of GL-3 in the body, which in turn prevents the onset of symptoms and reduces the risk of complications. Patients with Fabry disease should consult their healthcare provider to determine if this medication is appropriate for them and to discuss potential risks and benefits.

Each sterile vial of this medication contains a white to off-white lyophilized cake or powder that is nonpyrogenic. The vial contains a total of 37 mg of agalsidase beta, which allows for an extractable dose of 35 mg per vial. The medication does not contain any preservatives and contains nonmedicinal ingredients such as mannitol, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate.

Side Effects of FABRAZYME 35 MG:

1. Pain at the injection site
2. fever
3. tiredness
4. muscle pain
5. dizziness
6. tinnitus

Cold symptoms including-
1. runny/stuffy nose
2. cough

Stop intake of any medication if any serious allergic reactions as below occur-
1. rash
2. itching/swelling (especially of the face/tongue/throat)
3. severe dizziness
4. Trouble in breathing

Apart from these if you face more severe or life threatening reactions then it is advisable to instantly consult your doctor for the same.

Drug Interactions:

Drug-Drug Interactions: The medication may show a reaction with the following-
amiodarone
chloroquine
gentamicin
hydroxychloroquine

Drug-Food Interactions: No interactions were found but consult the doctor if you have any questions.

Drug-Disease Interactions: It is recommended to consult to your doctor & disclose about any type of disease you been suffering from before the treatment.

How FABRAZYME 35 MG Works:

Fabrazyme helps break down GL3 fat in your body. This allows your body to clear the fat from your system and keep it from building up. This may help prevent lasting damage to your tissues or organs.

How To Use FABRAZYME 35 MG:

The medication should not be self-administered. This medication is given by slow injection into a vein as directed by your doctor, usually every 2 weeks. The injection is given by a health care professional. The dosage is based on your medical condition, weight, and response to treatment.To help prevent reaction during the injection, your doctor will prescribe medications (such as acetaminophen, antihistamine) for you before the injection.

Safety Instructions For FABRAZYME 35 MG:

ALCOHOL Safe if Prescribed Fabrazyme 35mg may not interact with alcohol. However, its intake may worsen some possible side effects so it is advicable to limit or avoid consumption of alcohol. PREGNANCY Safe if Prescribed It is better to inform your doctor if you are pregnant or planning pregnancy before receiving Fabrazyme 35mg. Your doctor will assess the benefits and the risks before prescribing. BREAST FEEDING Consult your Doctor Inform the the doctor that you are breastfeeding before receiving & let him assess the benefits and the risks before prescribing Fabrazyme 35mg. LIVER Caution Fabrazyme 35mg should be used with caution in patients with liver diseases. Your doctor may adjust the dose if necessary based on your condition. KIDNEY Caution Fabrazyme 35mg has no effects or such but should be used with caution in patients with kidney diseases. Inform your doctor & he may adjust the dose if necessary based on your condition Driving Caution There is a possibility of feeling dizziness, so do not drive or operate heavy machinery if you feel dizzy after receiving Fabrazyme 35mg medicine. CHILDREN Unsafe When prescribed Fabrazyme 35mg can be safely used in children (8 yrs and older)

Habit Forming

No

Diet & Lifestyle Advices:

It is always advisable to have heart-healthy foods that lower your chances of stroke, heart disease, and kidney failure.

Avoid, skip or limit foods high in saturated fat and added sugar, such as:

Remember:

1. It is important to seek proper consultation from your doctor before starting, stopping, or changing the usage of any medication.

2. Severe infusion-associated reactions such as chills, vomiting, hypotension, and paresthesia can occur during Fabrazyme administration. Appropriate medical support measures should be readily available during the process.

3. Fabrazyme infusions are typically administered every 2 weeks. Initially, the infusions will be given at your doctor's office or a clinic. Eventually, a healthcare professional may be able to administer the infusions at your home.

4. The duration of Fabrazyme 35mg infusions lasts for several hours and is dependent on the patient's body weight in kilograms and infusion-related reactions.

5. Infusion-related reactions may become less frequent as you continue Fabrazyme treatment, but they may still occur during treatment. To maximize the benefits of Fabrazyme treatment, it should be used regularly. In case of a missed dose, kindly inform your doctor or healthcare professional.

6. Fabry disease symptoms may also affect body temperature, such as an inability to produce sweat or cope with hot or cold temperatures. Overheating with activity and feelings of being hot or cold (such as a fever) can also indicate Fabry disease. If you experience any of these symptoms, talk to your doctor immediately.

FAQs:

1. What is the use of Fabrazyme 35mg?

The purpose of Fabrazyme 35mg in treating Fabry disease is to clear and prevent the buildup of a fatty substance called GL-3, which can accumulate in key organs and cause organ damage.

2. Does Fabrazyme 35mg affect fertility ?

There haven’t been any studies regarding the Fabrazyme treatment affecting the fertility in humans. An animal study was conducted that showed no effects however, it cannot define the effectiveness in humans.

3. What foods should people with Fabry disease avoid?

1. Ultra-processed foods like cake, cookies, and chips. 2. Sugary drinks, including juice and soda. 3. Refined carbohydrates like white bread or white rice. 4. Red or processed meat.

4. How long does it take for Fabrazyme 35mg infusion?

The infusion rate of the medication lasts upto several hours and the minimum amount of time required is 1.5 hour.

5. Is the Fabry disease treatable?

Enzyme replacement therapy (ERT) is the only specific treatment for Fabry disease, and its beneficial effect on different organs/systems has been extensively evaluated. ERT improves the quality of life of patients receiving treatment.

6. Can older adults take Fabrazyme?

Fabrazyme can be prescribed for older adults, including people ages 65 years and older. However, clinical studies of the drug's safety and effectiveness did not include many people in this age group, so it is unclear whether Fabrazyme may affect older adults differently than younger adults. If you are an older adult with Fabry disease, talk to your doctor about the best treatment plan for you.

7. Does Fabrazyme cure Fabry disease?

Fabrazyme is not a cure for Fabry disease, and is typically taken as a long-term treatment for the condition. Currently, there is no cure for Fabry disease, but researchers are studying new potential treatments, including gene therapies.