Pronunciation:

kol-AJ-e-nase klos-TRID-ee-um his-toe-LIT-ik-um - aaes

Brand Names:

• Qwo

Classifications:

Pharmacologic—

Collagenase, Clostridium histolyticum

Uses of This Medicine:

Collagenase clostridium histolyticum-aaes injection is used to treat moderate to severe cellulite (dimpled skin caused by fatty deposits) in the buttocks of adult women.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of collagenase clostridium histolyticum-aaes injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

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.

Other 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.

• Acenocoumarol
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Bivalirudin
• Certoparin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Enoxaparin
• Fondaparinux
• Heparin
• Lepirudin
• Nadroparin
• Parnaparin
• Phenindione
• Phenprocoumon
• Protein C
• Reviparin
• Rivaroxaban
• Tinzaparin
• Warfarin

Other interactions—

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:

• Bleeding problems or
• Blood clotting problems—Use with caution. May increase risk for more side effects.

• Dupuytren's contracture (permanent bending of the fingers) or
• Infection at the injection site or
• Peyronie's disease (penis problem)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot under the skin of your buttock (treatment area).

You may receive up to 12 injections per treatment area, which may include up to 2 treatment areas per visit. The injections are given every 21 days for 3 treatment visits.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause bruising at the injection site. Be careful not to bump or come in contact with hard objects or surfaces. Sit or lie down gently.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Incidence not known

Cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

trouble breathing

unusual tiredness or weakness

Some side effects 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:

More common

Bruising, pain, itching, redness, discoloration, swelling, hardness, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.