AbobotulinumtoxinA

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular:

Dysport: 300 units (1 ea); 500 units (1 ea) [contains albumin human, lactose monohydrate, milk protein]

Pharmacology

Mechanism of Action

AbobotulinumtoxinA (previously known as botulinum toxin type A) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus, which appears to affect only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls.

Pharmacokinetics/Pharmacodynamics

Absorption

Not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection

Onset of Action

Peak effect: Cervical dystonia: 2 to 4 weeks; Upper limb spasticity: 1 week

Duration of Action

Cervical dystonia, glabellar lines: ≥4 months; Lower limb spasticity: ≥5 ½ months; Upper limb spasticity: ≥5 months

Use: Labeled Indications

Cervical dystonia: Treatment of adults with cervical dystonia.

Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adults <65 years of age.

Spasticity:

Adult: Treatment of upper and lower limb spasticity.

Pediatric: Treatment of upper (excluding spasticity caused by cerebral palsy) and lower limb spasticity in patients ≥2 years of age.

Use: Off Label

Acquired nystagmusc

Botulinum toxin type A has been found to be objectively and subjectively effective in treating acquired nystagmus and its consequent oscillopsia and impaired vision in a few small case series and case reports Ruben 1994. Botulinum toxin type A may be useful in certain patients who have contraindications to other therapies, but it cannot be recommended for routine symptomatic treatment of acquired nystagmus until data from controlled studies enrolling larger numbers of patients can confirm its efficacy and long-term safety.

Anal fissuresbyes

Data from a meta-analysis of controlled trials and a systematic review support the use of botulinum toxin A in the management of anal fissures in patients who have not responded to topical nitrates or calcium channel blockers Sahebally 2018, Yiannakopoulou 2012.

Guidelines by the American Society of Colon and Rectal Surgeons and a position statement from the Association of Coloproctology of Great Britain and Ireland on the management of anal fissures consider botulinum toxin A injection an option for the treatment of anal fissures in patients who have not responded to first-line therapies. It is important to note that botulinum toxin A formulations are not interchangeable

Lateral canthal linesb

Data from 2 randomized, blinded clinical trials suggest that abobotulinumtoxinA may be beneficial in the short-term (4 to 5 months) resolution of lateral canthal lines (crow’s feet wrinkles); one trial suggests better and longer efficacy than onabotulinumtoxinA Ascher 2009, Kassir 2013.

Sialorrhea (drooling)byes

Data from a meta-analysis support the use of botulinum toxin A in decreasing the severity of sialorrhea in patients with various neurological conditions Vashita 2013.

European Federation of Neurological Societies guidelines on the clinical management of amyotrophic lateral sclerosis recommend botulinum toxin A in patients refractory to first-line therapy for sialorrhea

Tardive dyskinesiac

Evidence from small, noncontrolled trials suggests some benefit with botulinum toxin A for treatment of localized tardive dyskinesia (eg, orofacial, head and neck, cervical). Evaluation of data is limited because several studies do not specify what botulinum toxin type A product was used. Use of abobotulinumtoxinA has been evaluated primarily in small noncontrolled trials and case reports demonstrating benefit in most patients. AAN clinical practice guidelines find the data inadequate to support or refute the use of botulinum toxin type A for treatment of tardive dyskinesia.

Contraindications

Known hypersensitivity (eg, anaphylaxis) to botulinum toxin or any component of the formulation, including cow milk protein; infection at the proposed injection site(s)

Dosage and Administration

Dosing: Adult

Cervical dystonia: IM: Initial: 500 units divided among affected muscles in toxin-naïve or toxin-experienced patients. May re-treat at intervals of ≥12 weeks.

Dosage adjustments: Adjust dosage in 250-unit increments; do not administer at intervals <12 weeks; dosage range used in studies: 250 to 1,000 units.

Glabellar lines: Adults <65 years of age: IM: Inject 10 units into each of 5 sites (2 injections in each corrugator muscle and 1 injection in the procerus muscle) for a total dose of 50 units; do not administer at intervals <3 months; efficacy has been demonstrated with up to 4 repeated administrations.

Spasticity: IM: Individualize dose based on patient size, number and location of muscle involvement, severity of spasticity, local muscle weakness, response to prior treatment, and/or adverse reaction history. May repeat therapy at intervals ≥12 weeks; in clinical studies, the majority of patients were re-treated between 12 to 16 weeks; however, some patients had a longer duration of response (eg, 20 weeks). For upper limb spasticity, total doses of 500 and 1,000 units divided among selected muscles were used in clinical trials. For lower limb spasticity, total doses of 1,000 and 1,500 units divided among selected muscles were used in clinical trials. The maximum recommended total dose (upper and lower limbs combined) is 1,500 units.

Upper limbs:

Brachialis: 200 to 400 units (1 to 2 injections per muscle).

Brachioradialis: 100 to 200 units (1 to 2 injections per muscle).

Biceps brachii: 200 to 400 units (1 to 2 injections per muscle).

Flexor carpi radialis: 100 to 200 units (1 to 2 injections per muscle).

Flexor carpi ulnaris: 100 to 200 units (1 to 2 injections per muscle).

Flexor digitorum profundus: 100 to 200 units (1 to 2 injections per muscle).

Flexor digitorum superficialis: 100 to 200 units (1 to 2 injections per muscle).

Pronator teres: 100 to 200 units (1 injection per muscle).

Lower limbs:

Flexor digitorum longus: 130 to 200 units (1 to 2 injections per muscle).

Flexor halluces longus: 70 to 200 units (1 injection per muscle).

Gastrocnemius, medial head: 100 to 150 units (1 injection per muscle).

Gastrocnemius, lateral head: 100 to 150 units (1 injection per muscle).

Soleus: 330 to 500 units (3 injections per muscle).

Tibialis posterior: 200 to 300 units (2 injections per muscle).

Anal fissure (off-label use): IM: 90 to 150 units in 2 divided doses injected into the internal anal sphincter on each side of the anterior midline (Brasinda 2004; Yiannakopoulou 2012).

Lateral canthal lines (off-label use): IM: 5 to 15 units injected at 3 sites around each eye for a total dose of 30 to 90 units per treatment, with intervals of ≥3 months between treatments. Refer to published studies for details on injection locations (Ascher 2009; Kassir 2013).

Sialorrhea (off-label use): Intraglandular (Ventral) (off-label route): 15 to 75 units injected per gland (submandibular, parotid or both) either unilaterally or bilaterally with intervals of 4 to 6 months between treatments (Reddihough 2010; Vashishta 2010).

Tardive dyskinesia (off-label use): IM: 20 to 50 units injected per site (total dosage range: 80 to 100 units). Dose, duration, and number of injections are dependent on muscle size and severity (Hennings 2008; Rapaport 2000). Subsequent doses up to 80 units have been used in order to find the optimum dosage (Slotema 2008). Additional data may be necessary to further define the role of abobotulinumtoxinA in the treatment of this condition.

Dosing: Geriatric

Cervical dystonia: Refer to adult dosing. No specific adjustment recommended.

Glabellar lines: Not recommended in patients ≥65 years of age.

Spasticity: Refer to adult dosing.

Dosing: Pediatric

Note: Potency units are specific to product and assay method utilized; do not interchange botulinum toxin products.

Spasticity: Note: Individualize dose based on the following: Patient size, number and location of muscles involved, severity of spasticity, local muscle weakness, response to prior treatment, and/or adverse reaction history. The lowest recommended dose should be used when initiating treatment (regardless of indication). In a 3-month interval, the maximum total dose is 30 units/kg or 1,000 units, whichever is less; however, a higher maximum total dose of 1,500 units per treatment cycle has been utilized in more severe cases with a positive safety profile (Papavasiliou 2013).

Lower extremity including spasticity due to cerebral palsy:

Children ≥2 years and Adolescents <18 years: IM: 10 to 15 units/kg per limb; reported total dose range: 5 to 30 units/kg (Dursun 2019); maximum total dose per treatment cycle: 30 units/kg or 1,000 units, whichever is less. May repeat therapy at intervals ≥12 weeks; in clinical studies, the majority of patients were re-treated between 16 to 22 weeks; however, some patients had a longer duration of response.

The majority of efficacy trials evaluated equinus foot and the following individual dose-range per muscle per limb are recommended (Dabrowski 2018; Delgado 2016; Tilton 2017; manufacturer's labeling). Refer to prescribing information for specific diagrams of recommended injection sites:

In an open-label continuation phase trial evaluating patients after the first 4 treatment cycles, titration of the total dose of abobotulinumtoxinA in 5 unit/kg increments based on clinical response for combined lower and upper limb spasticity was described; injections were administered in other muscles groups as appropriate including hamstrings, tibialis posterior, hip adductors, iliopsoas, or upper limb muscle groups; maximum dose per treatment cycle: 30 units/kg or 1,000 units, whichever was less (Dursun 2019).

Upper extremity unrelated to cerebral palsy:

Children ≥2 years weighing ≥10 kg and Adolescents: IM: Total dose: 8 units/kg or 16 units/kg per session divided amongst targeted muscles; maximum total dose per session: 16 units/kg not to exceed 640 units. May repeat therapy when effect of previous treatment diminishes but no sooner than 16 weeks from previous administration; in clinical trials, the usual range was 16 to 28 weeks; however, some patients experienced therapeutic effects for a longer duration (eg, ≥34 weeks after treatment).

The following individual dose range per muscle per limb are suggested. Refer to prescribing information for specific diagrams of recommended injection sites.

Reconstitution

Reconstitute with sterile, preservative free 0.9% sodium chloride. No more than 2.5 mL of diluent should be introduced into the vial. Swirl gently to dissolve; do not shake. Preparation instructions vary by indication and strength; use appropriate reconstitution methods. Use immediately after reconstitution in the syringe.

Cervical dystonia: Reconstitute 300-unit vial with 0.6 mL of diluent to obtain a concentration of 500 units/mL (50 units per 0.1 mL); reconstitute 500-unit vial with 1 mL of diluent to obtain a concentration of 500 units/mL (50 units per 0.1 mL); alternatively, may reconstitute 500-unit vial with 2 mL of diluent to obtain a concentration of 250 units/mL (25 units per 0.1 mL).

Glabellar lines: Reconstitute 300-unit vial with 2.5 mL of diluent to obtain a concentration of 10 units per 0.08 mL (12 units per 0.1 mL); alternatively, may reconstitute 300-unit vial with 1.5 mL of diluent to obtain a concentration of 10 units per 0.05 mL (20 units per 0.1 mL).

Lower limb spasticity: Reconstitute 300-unit vial with 1.5 mL of diluent or 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL; or reconstitute 300-unit vial with 3 mL of diluent to obtain a concentration of 100 units/mL Alternatively, the 500-unit vial can be further diluted to obtain a concentration of 100 units/mL. To do this, reconstitute the 500-unit vial with 5 mL of diluent. Using a 5 mL syringe, draw up an additional 2.5 mL of the diluent; then draw up 2.5 mL of the reconstituted solution. Do not invert; mix gently.

Upper limb spasticity: Reconstitute 300-unit vial with 1.5 mL of diluent to obtain a concentration of 200 units/mL; or reconstitute 300-unit vial with 3 mL diluent to obtain a concentration of 100 units/mL. Reconstitute the 500-unit vial with 2.5 mL of diluent to obtain a concentration of 200 units/mL. Alternatively, the 500-unit vial can be further diluted to obtain a concentration of 100 units/mL. To do this, reconstitute the 500-unit vial with 5 mL of diluent. Using a 5 mL syringe, draw up an additional 2.5 mL of the diluent; then draw up 2.5 mL of the reconstituted solution. Do not invert; mix gently.

Administration

Cervical dystonia: Use an appropriately sized gauge needle to administer intramuscularly. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Simultaneous EMG-guided application may be helpful in locating active muscle not identified by physical examination alone.

Glabellar lines: Use a 30-gauge needle to administer intramuscularly. Apply pressure on the superior medial orbital rim, and inject into each of 5 sites (2 injections in each corrugator muscle and 1 in the procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be at least 1 cm above the bony supraorbital ridge. Do not inject toxin closer than 1 cm above the central eyebrow.

Spasticity (upper or lower limb): Use an appropriately sized sterile syringe and needle to administer intramuscularly. Although actual location of the injection sites can be determined by palpation, the use of an injection guiding technique (eg, electromyography or electrical stimulation) is recommended to target the injection sites. Do not administer >1 mL (upper or lower limb spasticity) in any single injection site.

Dietary Considerations

Contains lactose; patients allergic to cow's milk protein should not receive product.

Storage

Store undiluted vials under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. After reconstitution, store vials in original container under refrigeration, protect from light, and use within 24 hours (does not contain preservative); single-use vials. Do not freeze after reconstitution.

Drug Interactions

Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy

Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Monitor therapy

Muscle Relaxants (Centrally Acting): May enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Monitor therapy

Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Adverse Reactions

Cervical dystonia:

>10%:

Gastrointestinal: Dysphagia (15% to 39%), xerostomia (13% to 39%)

Local: Discomfort at injection site (13% to 22%)

Nervous system: Voice disorder (6% to 28%), fatigue (12%), headache (11%), facial paresis (5% to 11%)

Neuromuscular & skeletal: Myasthenia (11% to 56%)

Ophthalmic: Eye disease (6% to 17%)

1% to 10%:

Immunologic: Antibody development (binding or neutralizing; 3%)

Local: Pain at injection site (5%)

Nervous system: Dizziness (4%)

Neuromuscular & skeletal: Musculoskeletal pain (7%), amyotrophy (1%)

Respiratory: Dyspnea (3%; onset: ~1 week; duration: ~3 weeks)

Frequency not defined:

Cardiovascular: Decreased heart rate

Endocrine & metabolic: Increased serum glucose

Glabellar lines:

1% to 10%:

Dermatologic: Contact dermatitis (2% to 3%)

Gastrointestinal: Nausea (2%)

Genitourinary: Hematuria (2%)

Infection: Influenza (2% to 3%)

Local: Pain at injection site (3%), discomfort at injection site (2% to 3%), injection site reaction (2% to 3%), swelling at injection site (2% to 3%)

Nervous system: Headache (9%)

Ophthalmic: Blepharoptosis (2%), eyelid edema (2%)

Respiratory: Nasopharyngitis (10%), upper respiratory tract infection (3%), bronchitis (2% to 3%), cough (2% to 3%), pharyngolaryngeal pain (2% to 3%), sinusitis (2%)

Upper limb spasticity:

>10%: Respiratory: Upper respiratory tract infection (children and adolescents: 9% to 11%)

1% to 10%:

Cardiovascular: Hypertension (adults: 1% to 2%), syncope (adults: 1% to 2%)

Dermatologic: Eczema (children and adolescents: <3%; injection site), rash at injection site (children and adolescents: <3%)

Endocrine & metabolic: Increased serum triglycerides (adults: 1% to 2%)

Gastrointestinal: Nausea (children and adolescents: 1% to 3%), constipation (adults: 2%), diarrhea (adults: 1% to 2%)

Hematologic & oncologic: Bruise (adults: 1% to 2%)

Immunologic: Antibody development (4% to 7%; neutralizing: ≤4%)

Infection: Influenza (1% to 3%), infection (adults: 2%)

Local: Bruising at injection site (children and adolescents: <3%), pain at injection site (children and adolescents: <3%), swelling at injection site (children and adolescents: <3%)

Nervous system: Headache (children and adolescents: 3% to 6%; adults: 2%), myasthenia (2% to 6%), epilepsy (2% to 4%), falling (adults: 3%), fatigue (<3%), depression (adults: 2% to 3%), hypoesthesia (adults: 2%), seizure (adults: 2%)

Neuromuscular & skeletal: Limb pain (children and adolescents: <3%), myalgia (children and adolescents: <3%), back pain (adults: 2%), asthenia (adults: 1% to 2%)

Respiratory: Pharyngitis (children and adolescents: 6% to 10%), flu-like symptoms (children and adolescents: <3%), cough (adults: 2%)

Miscellaneous: Accidental injury (adults: 2%)

Frequency not defined: Local: Injection site reaction

Lower limb spasticity:

>10%:

Respiratory: Nasopharyngitis (children and adolescents: 9% to 16%), cough (children and adolescents: 7% to 14%)

Miscellaneous: Fever (children and adolescents: 7% to 12%)

1% to 10%:

Cardiovascular: Peripheral edema (adults: 2%)

Gastrointestinal: Constipation (adults: 2%)

Hepatic: Increased serum alanine aminotransferase (adults: 2%)

Immunologic: Antibody development (4%; neutralizing: ≤2%)

Nervous system: Falling (adults: 6% to 9%), epilepsy (children and adolescents: ≤7%), seizure (children and adolescents: ≤7%), myasthenia (adults: 7%), fatigue (adults: 1% to 4%), headache (adults: 3%), depression (adults: 2% to 3%), insomnia (adults: 2%)

Neuromuscular & skeletal: Limb pain (6% to 7%), arthralgia (adults: 2% to 4%)

Respiratory: Bronchitis (children and adolescents: 7% to 8%), flu-like symptoms (adults: 2%)

Any indication: <1%, postmarketing and/or case reports: Abnormal gait, amyotrophy, anaphylaxis, antibody development, blurred vision, burning sensation, connective tissue disease (excessive granulation tissue), corneal disease, decreased lacrimation, diplopia, disturbance in attention, dry eye syndrome, dysarthria, dysphagia, dyspnea, edema (soft tissue), erythema of skin, facial paresis, feeling abnormal, feeling of heaviness, flu-like symptoms, hypersensitivity reaction, hypertonia, hypoesthesia, photophobia, reduced blinking, respiratory failure, serum sickness, severe dyspnea, urinary incontinence, urticaria, vertigo

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity (eg, serum sickness, urticaria, soft tissue edema, dyspnea) and anaphylactic reactions may occur rarely; immediate treatment (including epinephrine 1 mg/mL) should be available.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Cardiovascular events: Rarely, arrhythmia and myocardial infarction have been reported with use of onabotulinumtoxinA (another botulinum toxin formulation), sometimes in patients with preexisting cardiovascular disease.
• Dysphagia: Common when used for cervical dystonia and may persist for several weeks after administration. In severe cases, patients may require alternative feeding methods (eg, feeding tube). Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae. Risk of aspiration resulting from severe dysphagia is increased in patients when swallowing is already compromised. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia.
• Ophthalmic: Dry eye, reduced tear production, reduced blinking, and corneal disorders may occur when treating glabellar lines; persistent symptoms may require ophthalmologic evaluation.
• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include asthenia, blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence which may develop within hours or weeks following injection. Risk likely greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions. Systemic effects have occurred following use in approved and unapproved uses including lower than the maximum recommended total dose. Immediate medical attention required if respiratory, speech, or swallowing difficulties appear.

Disease-related concerns:

• Neuromuscular disease: Use with caution in patients with neuromuscular diseases (eg, myasthenia gravis, Eaton-Lambert syndrome) and neuropathic disorders (eg, amyotrophic lateral sclerosis).
• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment of cervical dystonia using botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.

Dosage form specific issues:

• Albumin: Product contains albumin and may carry a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease.
• Lactose: Product may contain lactose; do not administer to patients allergic to cow's milk protein.
• Product interchangeability: Botulinum products (abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.

Special populations:

• Elderly: Temporary reduction in glabellar lines: Efficacy was not observed in older adults (≥65 years of age) and an increased frequency of ocular adverse events was reported in older adults compared to younger adults.

Other warnings/precautions:

• Chronic therapy: Long-term effects of chronic therapy unknown.
• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s); use is contraindicated if infection is present.
• Hyperhidrosis: Safety in the treatment of hyperhidrosis has not been established. The possibility of an immune reaction resulting from an intradermal injection is unknown.
• Temporary reduction in glabellar lines: Appropriate use: Do not use more frequently than every 3 months. Patients with marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or the inability to substantially lessen glabellar lines by physically spreading them apart were excluded from clinical trials. Use with caution in patients with surgical alterations to the facial anatomy. Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure and ulceration. Spatial disorientation, double vision, or past pointing may occur if one or more extraocular muscles are paralyzed.

Pregnancy

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to lower the number of lines and wrinkles of the face.
• It is used to treat spasms of the neck.
• It is used to treat muscle stiffness in the elbow, wrist, finger, or calf muscles.
• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Injection site irritation
• Headache
• Nausea
• Dizziness
• Flu-like signs
• Painful extremities
• Common cold symptoms
• Stuffy nose
• Runny nose
• Sore throat
• Dry mouth
• Vomiting

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection
• Seizures
• Blood in the urine
• Change in voice
• Trouble swallowing
• Trouble breathing
• Trouble speaking
• Severe muscle pain
• Muscle weakness
• Loss of strength and energy
• Dry eyes
• Reduced tearing
• Reduced blinking
• Sensitivity to bright lights
• Vision changes
• Eye pain
• Depression
• Severe eye irritation
• Blurred vision
• Leaking of urine
• Double vision
• Drooping eyelids
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.