Abobotulinumtoxina (Intramuscular Route)

This medicine is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

AbobotulinumtoxinA is a botulinum toxin A product . It works on the nervous system to relax the muscles.

This medicine is available only with your doctor`s prescription and will be administered by your doctor .

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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 have not been performed on the relationship of age to the effects of abobotulinumtoxinA in children with cervical dystonia. Safety and efficacy have not been established.

Use of abobotulinumtoxinA to treat glabellar lines is not recommended in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of abobotulinumtoxinA have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have side effects related to the eyes, which may require caution in patients receiving abobotulinumtoxinA for glabellar lines.

Pregnancy

Breastfeeding

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.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Amyotrophic lateral sclerosis (Lou Gehrig`s disease) or


• Dermatochalasis (a skin problem) or


• Lambert-Eaton syndrome (nerve-muscle disorder) or


• Motor neuropathy (muscle and nerve problem) or


• Myasthenia gravis (severe muscle weakness) or


• Sebaceous skin, thick (oily or fatty skin) or


• Surgery on the face, history ofa€”May increase risk for more serious side effects.

• Breathing problems (e.g., asthma, emphysema) or


• Dysphagia (trouble with swallowing) or


• Ptosis (droopy eyelid)a€”Use with caution. May make these conditions worse.

• Cow`s milk protein allergy, history of or


• Infection at the injection sitea€”Should not be used in patients with these conditions.

Proper Use

Your doctor will give you this medicine in a hospital or clinic setting. This medicine is given as a shot into one of your muscles.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have been reported within hours to weeks after receiving this medicine. If you start to have muscle weakness or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems . Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well .

One part of this medicine is made from donated human blood . Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

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

Side Effects

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:

More common

• Difficulty with swallowing


• Hoarseness


• Muscle or bone pain


• Muscle weakness


• Sore throat


• Voice changes

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin


• Body aches or pain


• Chills


• Cough


• Cough producing mucus


• Diarrhea


• Difficult or labored breathing


• Ear congestion


• Fever


• General feeling of discomfort or illness


• Headache


• Itching, scaling, severe redness, soreness, or swelling of the skin


• Joint pain


• Loss of appetite


• Loss of voice


• Muscle aches and pains


• Nasal congestion


• Nausea


• Shivering


• Shortness of breath


• Sneezing


• Stiff muscles


• Stuffy or runny nose


• Sweating


• Tightness in the chest


• Trouble with sleeping


• Unusual tiredness or weakness


• Vomiting


• Wheezing

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Flushing or redness of the skin


• Partial or slight paralysis of the face


• Unusually warm skin

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

• 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


• Blurred vision


• Decreased vision


• Double vision


• Dry eyes


• Dry mouth


• Eye pain


• Itching of the eyes


• Problems with focusing the eyes


• Seeing double

Less common

• Dizziness


• Drooping upper eyelids


• Pain or tenderness around the eyes and cheekbones


• Swelling of the eyelids

Incidence not known

• Change in color vision


• Difficulty seeing at night


• Dizziness or lightheadedness


• Feeling of constant movement of self or surroundings


• Increased sensitivity of the eyes to sunlight


• Sensation of spinning

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.