Amphadase

Included as part of the PRECAUTIONS section.

In the U.S.

• Amphadase
• Hydase
• Hylenex
• Vitrase

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Tissue Permeability Modifier

Pharmacologic Class: Enzyme

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hyaluronidase injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hyaluronidase injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Benzocaine
• Bupivacaine
• Bupivacaine Liposome
• Butacaine
• Chloroprocaine
• Cocaine
• Dibucaine
• Etidocaine
• Lidocaine
• Mepivacaine
• Prilocaine
• Procaine
• Proparacaine
• Propoxycaine
• Ropivacaine
• Tetracaine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

The presence of other medical problems may affect the use of hyaluronidase. Make sure you tell your doctor if you have any other medical problems.

• Infection at the injection site—The chance of side effects may be increased.

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.

• If you need to store Amphadase at home, talk with your doctor, nurse, or pharmacist about how to store it.

Amphadase® is a preparation of purified bovine testicular hyaluronidase, a protein enzyme. The exact chemical structure of this enzyme is unknown. However, the amino acid sequence for the primary structure of the enzyme has been deduced from the sequence of purified peptides.

Amphadase® (hyaluronidase injection) is supplied as a sterile, clear, colorless, ready for use solution. Each vial contains 150 USP units of hyaluronidase per mL with 8.5 mg sodium chloride, 1 mg edetate disodium, 0.4 mg calcium chloride, monobasic sodium phosphate buffer, and not more than 0.1 mg thimerosal (mercury derivative).

Amphadase® has an approximate pH of 6.8 and an osmolality of 295 to 355 mOsm.

Important Precautions Regarding Amphadase®

Instruct patient that Amphadase® is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.

Instruct patient that there may be mild local injection site signs and symptoms, such as redness, swelling, itching, or pain localized to the site of injection.

What Patients Should Know About Adverse Reactions

The most frequently reported adverse reactions have been mild local injection site reactions such as redness, swelling, itching, or pain.

Anaphylactic-like reactions, and allergic reactions, such as hives, have been reported rarely in patients receiving hyaluronidases.

Patients Should Inform Their Doctors If Taking Other Medications

You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with Amphadase®. These medications have been found to be incompatible with hyaluronidase.

If you are taking salicylates (e.g., aspirin), steroids (e.g., cortisone or estrogens), or antihistamines your doctor may need to prescribe larger amounts of hyaluronidase for equivalent dispersing effect.

Amphastar Pharmaceuticals, Inc.
Rancho Cucamonga, CA 91730, U.S.A.
Rev. 5/14

6990906P

Amphadase® HYALURONIDASE INJECTION, USP

150 USP units/mL

Not for IV use.

7390906G/8-15

1 mL

NDC 0548-9090-10

Rx Only

Store in Refrigerator

AMPHASTAR PHARMACEUTICALS

Rancho Cucamonga, CA 91730 U.S.A.

0548-9090-10

You should not receive this medication if you are allergic to it.

Your doctor may perform a skin test to see if you are allergic to hyaluronidase before you receive the medication.

FDA pregnancy category C. It is not known whether hyaluronidase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hyaluronidase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.