Drug Information

Drug Interaction:

Concomitant treatment of XEOMIN and aminoglycoside antibiotics, spectinomycin,

or other agents that interfere with neuromuscular transmission

(e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely

because the effect of XEOMIN may be potentiated

Indication:

Proprietary Name- Xeomin

Established Name - Incobulinumoxina

Applicant- Merz Pharmaceticals GMBH

Indication-

Treatment for Cervical Dystonia

Approved by FDA on30-7-2010 (Ref- FDA approved List- 2010)

Adverse Reaction:

Cervical Dystonia: The most commonly observed adverse reactions

(.5% of patients and > placebo) are dysphagia, neck pain, muscle weakness,

injection site pain, and musculoskeletal pain

Blepharospasm: The most commonly observed adverse reactions

(.5% of patients and > placebo) are eyelid ptosis, dry eye, dry mouth, diarrhea,

headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection

Glabellar Lines: The most commonly observed adverse reaction

(>1% of patients and > placebo) is headache

Contra-Indications:

CONTRAINDICATIONS

Known hypersensitivity to the active substance botulinum neurotoxin type A or to an

of the excipients

Infection at the proposed injection sites

WARNINGS AND PRECAUTIONS

For All Indications:

The potency Units of XEOMIN are not interchangeable with other preparations of

botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be

compared to or converted into Units of any other botulinum toxin products

Immediate medical attention may be required in cases of respiratory, speech or

swallowing difficulties

Use with caution in patients with compromised respiratory function or dysphagia

Concomitant neuromuscular disorders may exacerbate clinical effects of treatment

Cervical Dystonia

Patients with smaller neck muscle mass and patients who require bilateral injections

into the sternocleidomastoid muscles are at greater risk of dysphagia.

Limiting the dose injected into the sternocleidomastoid muscle may decrease

the occurrence of dysphagia.

Blepharospasm

Corneal exposure and ulceration

Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking

and corneal exposure with possible ulceration or perforation.

Lower lid injections should not be repeated if diplopia occurred with previous

botulinum toxin injections.

.

Dosages/ Overdosage Etc:

INDICATIONS AND USAGE

XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking

agent indicated for the:

Treatment of adults with cervical dystonia, to decrease the severity of abnormal

head position and neck pain in both botulinum toxin-naive and previously treated patients

Treatment of blepharospasm in adults previously treated with onabotulinumtoxinA (BotoxR)

Temporary improvement in the appearance of moderate to severe glabellar lines

associated with corrugator and/or procerus muscle activity in adult patients

DOSAGE AND ADMINISTRATION

Reconstituted XEOMIN is intended for intramuscular injection.

For the indications of cervical dystonia and blepharospasm, the optimum dose

and number of injection sites in the treated muscle(s) should be individualized

for each patient and determined by the physician

Cervical Dystonia

The recommended total dose is 120 Units per treatment session.

Higher doses did not provide additional efficacy and were associated with an

increased incidence of adverse reactions.

Usually injected into the sternocleidomastoid, splenius capitis, levator scapulae,

scalenus, and/or the trapezius muscle(s)

Dose, number, and location of injection sites should be based on the number and

location of muscles involved, severity of dystonia, and response to any previous botulinum

toxin injections.

Blepharospasm

When initiating XEOMIN therapy, the dose, number, and location of injections should be

based on the previous dosing of onabotulinumtoxinA (Botox). In clinical trials

of XEOMIN for blepharospasm, XEOMIN was not administered to patients who had no

previously received onabotulinumtoxinA (Botox).

In the XEOMIN clinical trials, the mean dose per injection site was

5.6 Units, the mean number of injections per eye was 6, and the mean dose per eye was 33.5 Units.

Glabellar Lines

The total recommended XEOMIN dose is 20 Units per treatment session divided

into five equal intramuscular injections of 4 Units each. The five injection sites are:

DOSAGE FORMS AND STRENGTHS

„h 50 Units, lyophilized powder in single-use vial (3) „h 100 Units, lyophilized powder

in single-use vial two injections in each corrugator muscle and one injection in the

procerus muscle.

Retreatment with XEOMIN should be administered no more frequently than every three months

If the previous dose of onabotulinumtoxinA (Botox) is not known, the recommended

starting dose is 1.25-2.5 Units per injection site.

Patient Information:

PATIENT COUNSELING INFORMATION

1.Patients or caregivers should be advised to seek immediate medical care if swallowing,

speech or respiratory disorders arise.

2.Previously immobile or sedentary patients should be reminded to gradually resume

activities following the injection of XEOMIN for the treatment of cervical dystonia

and blepharospasm.

3.Patients should be informed that injections of XEOMIN may cause dyspnea,

or mild to severe dysphagia, with the risk of aspiration

4.Patients should be counseled that if loss of strength, muscle weakness, blurred vision,

or drooping eyelids occur, they should avoid driving a car or engaging in other

potentially hazardous activities

5.Patients should be informed that injections of XEOMIN may cause reduced blinking

or effectiveness of blinking, and that they should seek immediate medical attention

if eye pain or irritation occur following treatment

Pharmacology/ Pharmacokinetics:

PATIENT COUNSELING INFORMATION

1.Patients or caregivers should be advised to seek immediate medical care if swallowing,

speech or respiratory disorders arise.

2.Previously immobile or sedentary patients should be reminded to gradually resume

activities following the injection of XEOMIN for the treatment of cervical dystonia

and blepharospasm.

3.Patients should be informed that injections of XEOMIN may cause dyspnea,

or mild to severe dysphagia, with the risk of aspiration

4.Patients should be counseled that if loss of strength, muscle weakness, blurred vision,

or drooping eyelids occur, they should avoid driving a car or engaging in other

potentially hazardous activities

5.Patients should be informed that injections of XEOMIN may cause reduced blinking

or effectiveness of blinking, and that they should seek immediate medical attention

if eye pain or irritation occur following treatment

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1 Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies in pregnant women. XEOMIN should

be used during pregnancy only if the potential benefit justifies the potential risk

to the fetus.

2. Nursing Mothers

It is not known whether botulinum toxin type A is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when

XEOMIN is administered to a nursing woman.

3.Pediatric Use

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been

established

4. Geriatric Use Cervical Dystonia

For patients over 65 years of age treated with XEOMIN, the most common adverse events-

were dysphagia (4 patients, 21%) and asthenia (2 patients, 11%). One XEOMIN-treated

patient (5%) experienced severe dizziness.

Incobotulinumoxina -Xeomin- @- Immunomodulator (July 2010)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation