Amphadase injectable

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• pain, itching, or redness where the injection was given; or

• swelling in your hands, feet, or body areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with hyaluronidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Amphadase is injected under the skin, into a muscle, or into other tissues of the body.

A healthcare provider will give you this injection.

Amphadase should not be injected into a vein (as an intravenous injection).

Get emergency medical help if you have signs of an allergic reaction ro Amphadase: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common Amphadase side effects may include:

• pain, itching, or redness where the injection was given; or

• swelling in your hands, feet, or body areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with hyaluronidase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to hyaluronidase: injectable powder for injection, injectable solution

Local

Local reactions are the most common side effects. The most common side effect during hypodermoclysis is edema.[Ref]

Other

Hyaluronidase (the active ingredient contained in Amphadase) increases the side effects of coadministered drugs.[Ref]

Hypersensitivity

Hypersensitivity reactions have included urticaria and angioedema in less than 0.1% of patients. Anaphylactic-like reactions have rarely been reported after intravenous or retrobulbar injection.[Ref]

One clinic has reported a possible increase in cases of angioedema related to the use of pharmacy-compounded hyaluronidase in cataract surgery as opposed to that seen with the use of manufactured products.[Ref]

Ocular

Ocular side effects have included case reports of hypersensitivity reactions after retrobulbar injections, which manifested as increased intraorbital pressure and swelling, periorbital edema, and localized pruritus.[Ref]

Some side effects of Amphadase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.