Hyaluronidase injectable

Because you will receive hyaluronidase in a clinical setting, you are not likely to miss a dose.

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.

Usual Adult Dose for Extravasation:

Stop infusion and make five 0.2 mL injections of a 15 unit/mL solution subcutaneously or intradermally around the extravasation area, using a new 25 to 26 gauge needle for each injection. Administer within 1 hour of extravasation for best results.

Other nonpharmacologic measures (i.e., aspiration of remaining drug from IV catheter, applying warm or cold compresses, elevation of affected site) appropriate for the drug should also be employed to treat the extravasation and minimize tissue exposure.

Usual Adult Dose for Hypodermoclysis:

After inserting the needle, begin clysis with tip of needle lying free and movable between the skin and muscle. The fluid should start in readily without pain or lump. Then hyaluronidase should be injected into the rubber tubing close to the needle.

Alternate method: Inject hyaluronidase under skin before clysis. 150 to 200 units will facilitate absorption of 1000 mL or more of solution.

The dose, rate of injection, and type of solution should be individualized. Hypovolemia may occur if electrolyte-free solutions are given. Adding adequate quantities of electrolytes and/or controlling the volume and rate of administration will prevent hypovolemia.

Usual Adult Dose for Subcutaneous Urography:

Inject 75 units over each scapula, followed by injection of the contrast medium at the same sites.

Usual Pediatric Dose for Extravasation:

Stop infusion and make five 0.2 mL injections of a 15 unit/mL solution subcutaneously or intradermally around the extravasation area, using a new 25 to 26 gauge needle for each injection. Administer within 1 hour of extravasation for best results.

Some centers utilize a 150 units/mL hyaluronidase solution and, without further dilution, administer 0.2 mL injections subcutaneously or intradermally into the extravasation site at the leading edge as soon as possible (within 1 hour) after extravasation is recognized.

Other nonpharmacologic measures (i.e., aspiration of remaining drug from IV catheter, applying warm or cold compresses, elevation of affected site) appropriate for the drug and patient should also be employed to treat the extravasation and minimize tissue exposure.

Usual Pediatric Dose for Hypodermoclysis:

Premature infants or neonates: The daily clysis dosage should not exceed 25 mL/kg and rate of administration should not exceed 2 mL per minute.

Less than 3 years: Volume of clysis should not exceed 200 mL.

Infants and children: 15 units are added to each 100 mL of replacement fluid to be administered or 150 units is injected under skin, followed by subcutaneous isotonic fluid administration at a rate appropriate for age, weight, and clinical condition of the patient; 150 units facilitates absorption of more than 1000 mL of solution.

The dose, rate of injection, and type of solution should be individualized. The rate and volume of clysis should be controlled to avoid overhydration. Hypovolemia may occur if electrolyte-free solutions are given. Adding adequate quantities of electrolytes and/or controlling the volume and rate of administration will prevent hypovolemia.

Usual Pediatric Dose for Subcutaneous Urography:

Inject 75 units over each scapula, followed by injection of the contrast medium at the same sites.

Applies to hyaluronidase: powder for solution, solution

Along with its needed effects, hyaluronidase 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 while taking hyaluronidase:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or welts
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking hyaluronidase:

• Blurred vision
• chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• nausea or vomiting
• redness of the skin
• sweating
• swelling
• unusual tiredness or weakness
• unusually warm skin

Some side effects of hyaluronidase 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:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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

Inject 75 units over each scapula, followed by injection of the contrast medium at the same sites.

Premature infants or neonates: The daily clysis dosage should not exceed 25 mL/kg and rate of administration should not exceed 2 mL per minute.

Less than 3 years: Volume of clysis should not exceed 200 mL.

Infants and children: 15 units are added to each 100 mL of replacement fluid to be administered or 150 units is injected under skin, followed by subcutaneous isotonic fluid administration at a rate appropriate for age, weight, and clinical condition of the patient; 150 units facilitates absorption of more than 1000 mL of solution.

The dose, rate of injection, and type of solution should be individualized. The rate and volume of clysis should be controlled to avoid overhydration. Hypovolemia may occur if electrolyte-free solutions are given. Adding adequate quantities of electrolytes and/or controlling the volume and rate of administration will prevent hypovolemia.

Data not available