XEOMIN Powder for solution for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Merz Pharmaceuticals, LLC

Λέξεις κλειδιά

0259-1605 0259-1610 0259-4150 0259-4110 0259-1620

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1. Indications and Usage

1.1 Chronic Sialorrhea XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. 1.2 Upper Limb Spasticity Upper Limb Spasticity in Adult Patients XEOMIN is indicated ...

2. Dosage and Administration

2.1 Instructions for Safe Use The potency Units of XEOMIN for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin ...

3. Dosage Forms and Strengths

For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.

4. Contraindications

XEOMIN is contraindicated in patients with: Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description ...

5. Warnings and Precautions

5.1 Spread of Toxin Effect Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. ...

6. Adverse Reactions

The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling: Spread of Effects from Toxin [see Warnings and Precautions (5.1)] Lack of Interchangeability ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

6.3. Postmarketing Experience

The following adverse reactions have been reported during post-approval use of XEOMIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

7.1 Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of XEOMIN and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., tubocurarine-type ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the ...

8.2. Lactation

Risk Summary There are no data on the presence of XEOMIN in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should ...

8.4. Pediatric Use

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, blepharospasm, or glabellar frown lines [see Warnings ...

8.5. Geriatric Use

Chronic Sialorrhea Of the total number of 184 patients in the placebo-controlled study in chronic sialorrhea in adult patients [see Clinical Studies (14.1)], 107 were 65 years of age and over ...

10. Overdosage

Excessive doses of XEOMIN may be expected to produce neuromuscular weakness with a variety of symptoms, particularly when treated intramuscularly. Respiratory support may be required where excessive doses ...

11. Description

The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture supernatant ...

12.1. Mechanism of Action

XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs ...

12.3. Pharmacokinetics

Using currently available analytical technology, it is not possible to detect XEOMIN in the peripheral blood following intramuscular or intraglandular injection at the recommended doses.

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Studies to evaluate the carcinogenic potential of XEOMIN have not been conducted. Mutagenesis Genotoxicity studies have not been conducted for XEOMIN. Impairment of Fertility In a fertility ...

14. Clinical Studies

14.1 Chronic Sialorrhea Chronic Sialorrhea in Adult Patients The efficacy and safety of XEOMIN for the treatment of chronic sialorrhea in adult patients were evaluated in a double-blind, placebo-controlled ...

16.1. How Supplied

XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are ...

16.2. Storage and Handling

Unopened vials of XEOMIN should be stored at or below 25°C (77°F). Refrigeration of unopened vials is not required. Do not use after the expiration date on the vial. Reconstituted XEOMIN may be stored ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Swallowing, Speaking, or Breathing Difficulties or Other Unusual Symptoms Advise patients to inform their healthcare provider ...

BOXED WARNING SECTION

WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent ...