Sacrosidase

What is sacrosidase?

Sacrosidase is a prescription medicine that is used to treat sucrase deficiency.

Description

Sacrosidase is an enzyme with the chemical name of β,D-fructofuranoside fructohydrolase. The enzyme is derived from baker’s yeast (Saccharomyces cerevisiae). It has been reported that the primary amino acid structure of this protein consists of 513 amino acids with an apparent molecular weight of 100,000 Da for the glycosylated monomer (range 66,000- 116,000 Da). Reports also suggest that the protein exists in solution as a monomer, dimer, tetramer, and octomer ranging from 100,000 Da to 800,000 Da. It has an isoelectric point (pI) of 4.5.

Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

Sucraid is a pale yellow to colorless, clear solution with a pleasant, sweet taste. Each milliliter (mL) of Sucraid contains 8,500 International Units (I.U.) of the enzyme sacrosidase, the active ingredient.

Sucraid may contain small amounts of papain. Papain is known to cause allergic reactions in some people. Papain is a protein-cleaving enzyme that is introduced in the manufacturing process to digest the cell wall of the yeast and may not be completely removed during subsequent process steps. Sucraid contains sacrosidase in a vehicle comprised of glycerin, water, citric acid, and sodium hydroxide to maintain the pH at 4.0 to 4.7. Glycerol (glycerin) in the amount consumed in the recommended doses of Sucraid has no expected toxicity.

This enzyme preparation is fully soluble with water, milk, and infant formula. DO NOT HEAT SOLUTIONS CONTAINING SUCRAID. Do not put Sucraid in warm or hot liquids (see DOSAGE AND ADMINISTRATION, Administration Instructions).

Before taking sacrosidase, tell your doctor:

• If you are allergic to sacrosidase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a glycerin, papain, or yeast allergy, talk with your doctor.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take sacrosidase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take sacrosidase?

• Tell all of your health care providers that you take sacrosidase. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with sacrosidase. You will need to be sure that you are near health care providers before you take your first and second doses. If you have questions, talk with your doctor.
• If you have high blood sugar (diabetes), sacrosidase may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Follow the diet plan that your doctor told you about.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using sacrosidase while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is sacrosidase best taken?

Use sacrosidase as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals and snacks.
• Mix with 2 to 4 ounces (60 to 120 mL) of water, milk, or formula.
• Avoid taking sacrosidase with fruit juice.
• Do not mix sacrosidase in warm or hot drinks.
• Take about 1/2 of the dose at the start of the meal or snack. Take the rest of the dose during the meal or snack.
• Wash and dry the scoop after each use. Do not store it in the bottle.
• Put the cap back on after you are done using your dose.
• Keep taking sacrosidase as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of sacrosidase that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of sacrosidase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out sacrosidase?

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Protect from heat.
• After opening, throw away any part not used after 28 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

2 ML SINGLE-USE CONTAINER