MYOBLOC- rimabotulinumtoxinb injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

RIMABOTULINUMTOXINB (UNII: 0Y70779M1F) (RIMABOTULINUMTOXINB - UNII:0Y70779M1F)

Tilgjengelig fra:

Solstice Neurosciences, LLC

INN (International Name):

rimabotulinumtoxinB

Sammensetning:

rimabotulinumtoxinB 2500 [USP'U] in 0.5 mL

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

MYOBLOC is indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults. MYOBLOC is indicated for the treatment of chronic sialorrhea in adults. MYOBLOC is contraindicated in patients with: - A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3), Description (11)] - Infection at the proposed injection site(s) Risk Summary There are no adequate data on the developmental risks associated with the use of MYOBLOC in pregnant women. No developmental toxicity was observed in pregnant rats administered MYOBLOC by intramuscular injection during gestation and lactation, at doses producing maternal toxicity. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When MYOBLOC was administered by intramuscular injection to pregnant rats (0, 300, 1000, or 3000 Units/kg/day) or rabbits (0, 0.03, 0.1, 0.3, or 1.0 Units/kg/day) throughout gestation, no adverse effects on embryofetal development were observed. The highest dose tested in rat, which was associated with maternal toxicity, was 36 times the maximum recommended human dose (MRHD) for cervical dystonia (5000 Units) on a body weight (Units/kg) basis. The highest dose tested in rabbit was substantially less than the MRHD for cervical dystonia on a Units/kg basis; maternal toxicity was observed at all but the lowest dose tested. Risk Summary There are no data on the presence of MYOBLOC in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MYOBLOC and any potential adverse effects on the breastfed infant from MYOBLOC or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Cervical Dystonia In the controlled studies for MYOBLOC in patients with cervical dystonia, 152 (75%) were under the age of 65, and 52 (26%) were 65 years of age or older [see Clinical Studies (14.1)] . For these age groups, the most frequently reported adverse reactions occurred at similar rates in both age groups. Efficacy results did not suggest any large differences between these age groups. Very few patients age 75 or older were enrolled; therefore, no conclusions regarding the safety and efficacy of MYOBLOC within this age group can be determined. Chronic Sialorrhea Of the 166 MYOBLOC-treated patients in the placebo-controlled studies for treatment of chronic sialorrhea [see Clinical Studies (14.2)] , 105 (63%) were 65 years of age or older, and 43 (26%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients over 65 years of age and younger patients, but greater sensitivity of some older patients cannot be ruled out.

Produkt oppsummering:

MYOBLOC (rimabotulinumtoxinB) injection is supplied as a clear and colorless to light-yellow solution in single-dose glass vials. MYOBLOC is available in three presentations (Table 10). No U.S. Standard of Potency Store under refrigeration at 2°C to 8°C (36°F- 46°F) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. All vials of expired MYOBLOC and equipment used in the administration of MYOBLOC should be carefully discarded according to standard medical waste practices. Do not use after the expiration date stamped on the vial.

Autorisasjon status:

Biologic Licensing Application

Informasjon til brukeren

Solstice Neurosciences, LLC
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MEDICATION GUIDE
MYOBLOC ® (MY-O-BLOCK)
(RIMABOTULINUMTOXINB)
INJECTION, FOR INTRAMUSCULAR OR INTRAGLANDULAR USE
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Rev: 3/2021
What is the most important information I should know about MYOBLOC?
MYOBLOC may cause serious side effects that can be life threatening.
Call your doctor or get medical
help right away if you have any of these problems after treatment with
MYOBLOC:
•
Problems swallowing, speaking, or breathing. These problems can happen
hours to weeks after an
injection of MYOBLOC if the muscles that you use to breathe and
swallow become weak after
the injection. Death can happen as a complication if you have severe
problems with swallowing
or breathing after treatment with MYOBLOC.
•
People with certain breathing problems may need to use muscles in
their neck to help
them breathe. These people may be at greater risk for serious
breathing problems with
MYOBLOC.
•
Swallowing problems may last for several months. People who cannot
swallow well may
need a feeding tube to receive food and water. If swallowing problems
are severe, food or
liquids may go into your lungs. People who already have swallowing or
breathing
problems before receiving MYOBLOC have the highest risk of getting
these problems.
•
Spread of toxin effects. In some cases, the effect of botulinum toxin
may affect areas of the body
away from the injection site and cause symptoms of a serious condition
called botulism. The
symptoms of botulism include:
•
loss of strength and muscle weakness all
over the body
•
double vision
•
blurred vision and drooping eyelids
•
hoarseness or change or loss of voice
(dysphonia)
•
trouble saying words clearly (dysarthria)
•
loss of bladder control
•
trouble breathing
•
trouble swallowing (dysphagia)
These symptoms can happen hours to weeks after you receive an
injection of MYOBLOC.
These problems could make it unsafe for you to drive a car or do other
dangerous activitie

Preparatomtale

MYOBLOC- RIMABOTULINUMTOXINB INJECTION, SOLUTION
SOLSTICE NEUROSCIENCES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYOBLOC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYOBLOC
.
MYOBLOC (RIMABOTULINUMTOXINB) INJECTION, FOR INTRAMUSCULAR OR INTRAGLANDULAR
USE
INITIAL U.S. APPROVAL: 2000
WARNING: DISTANT SPREAD OF TOXIN EFFECT
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE EFFECTS OF MYOBLOC AND ALL BOTULINUM TOXIN PRODUCTS MAY SPREAD
FROM THE AREA OF
INJECTION TO PRODUCE SYMPTOMS CONSISTENT WITH BOTULINUM TOXIN EFFECTS.
THESE
SYMPTOMS HAVE BEEN REPORTED HOURS TO WEEKS AFTER INJECTION. SWALLOWING
AND
BREATHING DIFFICULTIES CAN BE LIFE THREATENING AND THERE HAVE BEEN
REPORTS OF DEATH.
THE RISK OF SYMPTOMS IS PROBABLY GREATEST IN CHILDREN TREATED FOR
SPASTICITY BUT
SYMPTOMS CAN ALSO OCCUR IN ADULTS, PARTICULARLY IN THOSE PATIENTS WHO
HAVE AN
UNDERLYING CONDITION THAT WOULD PREDISPOSE THEM TO THESE SYMPTOMS (
5.1).
INDICATIONS AND USAGE
MYOBLOC is an acetylcholine release inhibitor indicated for:
Treatment of cervical dystonia to reduce the severity of abnormal head
position and neck pain
associated with cervical dystonia in adults ( 1.1)
Treatment of chronic sialorrhea in adults ( 1.2)
DOSAGE AND ADMINISTRATION
Cervical Dystonia: for patients with demonstrated tolerance of
botulinum toxin injection, recommended
total dosage is 2,500 Units to 5,000 Units divided among effected
muscles ( 2.2)
Chronic Sialorrhea: recommended dosage is 1,500 Units to 3,500 Units;
500 Units to 1,500 Units per
parotid gland and 250 Units per submandibular gland; no more frequent
than every 12 weeks ( 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 2,500 Units/0.5 mL; 5,000 Units/mL; or 10,000 Units/2 mL
(5,000 Units/mL) in a single-dose vial (
3)
CONTRAINDICATIONS
MYOBLOC is contraindicated in patients with:
Known hypersensitivity to any botulinum toxin preparation or to any of
the components in the
formulation ( 4, 5.3)
Infection at