VIBATIV- telavancin hydrochloride injection, powder, lyophilized, for solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

telavancin hydrochloride (UNII: 0701472ZG0) (telavancin - UNII:XK134822Z0)

Disponible depuis:

Cumberland Pharmaceuticals Inc.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

VIBATIV is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) , or Enterococcus faecalis (vancomycinsusceptible isolates only). VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable. Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration [see Warnings and Precautions (5.5) and Drug Interactions (7.1) ]. VIBATIV is contraindicated in patients with known hypersensitivity to telavancin. Risk Summary Based on findings in animal reproduction studies, VIBATIV may cause fetal harm. There are no available data on VIBATIV use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses providing approximately 1- to 2-fold the human exposure at the maximum recommended clinical dose (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryo-fetal development studies in rats, rabbits, and minipigs, telavancin demonstrated the potential to cause limb and skeletal malformations when given intravenously during the period of organogenesis at doses up to 150, 45, or 75 mg/kg/day, respectively. These doses resulted in exposure levels approximately 1- to 2-fold the human exposure (AUC) at the maximum recommended clinical dose. Malformations observed at <1% (but absent or at lower rates in historical or concurrent controls), included brachymelia (rats and rabbits), syndactyly (rats, minipigs), adactyly (rabbits), and polydactyly (minipigs). Additional findings in rabbits included flexed front paw and absent ulna, and in the minipigs included misshapen digits and deformed front leg. Fetal body weights were decreased in rats. In a prenatal/perinatal development study, pregnant rats received intravenous telavancin at up to 150 mg/kg/day (approximately the same AUC as observed at the maximum clinical dose) from the start of organogenesis through lactation. Offspring showed decreases in fetal body weight and an increase in the number of stillborn pups. Brachymelia was also observed. Developmental milestones and fertility of the pups were unaffected. Risk Summary There are no data on the presence of telavancin in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIBATIV and any potential adverse effects on the breastfed child from VIBATIV or from the underlying maternal conditions. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Contraception Females VIBATIV may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment and for 2 days after the final dose. Infertility Males Based on findings in rats, VIBATIV may impair male fertility [see Nonclinical Toxicology (13.1)]. The effect on fertility was reversible in rats. The safety and effectiveness of VIBATIV have not been established in pediatric patients. In particular, there is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function. Increased mortality in adult patients with HABP/VABP and renal impairment and decreased clinical response in adults with cSSSI and renal impairment were observed [see Boxed Warning and Warnings and Precautions (5.1, 5.2)] . Of the 929 patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of cSSSI, 174 (19%) were ≥65 years of age and 87 (9%) were ≥75 years of age. In the cSSSI trials, lower clinical cure rates were observed in patients ≥65 years of age compared with those <65 years of age. Overall, treatment-emergent adverse events occurred with similar frequencies in patients ≥65 (75% of patients) and <65 years of age (83% of patients). Fifteen of 174 (9%) patients ≥65 years of age treated with VIBATIV had adverse events indicative of renal impairment compared with 16 of 755 (2%) patients <65 years of age [see Warnings and Precautions (5.3), Clinical Trials (14.1) ]. Of the 749 HABP/VABP patients treated with VIBATIV at a dose of 10 mg/kg once daily in clinical trials of HABP/VABP, 397 (53%) were ≥65 years of age and 230 (31%) were ≥75 years of age. Treatment-emergent adverse events as well as deaths and other serious adverse events occurred more often in patients ≥ 65 years of age than in those <65 years of age in both treatment groups. Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. The mean plasma AUC values of telavancin were similar in healthy young and elderly subjects. Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration (2), Clinical Pharmacology (12.3) ]. The HABP/VABP and cSSSI trials included patients with normal renal function and patients with varying degrees of renal impairment. Patients with underlying renal dysfunction or risk factors for renal dysfunction had a higher incidence of renal adverse events [see Warnings and Precautions (5.3) ]. In the HABP/VABP studies higher mortality rates were observed in the VIBATIV-treated patients with baseline CrCl ≤50 mL/min. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk [see Warnings and Precautions (5.1, )]. VIBATIV-treated patients in the cSSSI studies with baseline creatinine clearance ≤50 mL/min had lower clinical cure rates. Consider these data when selecting antibacterial therapy in patients with baseline moderate/severe renal impairment (CrCl ≤50 mL/min) [see Warnings and Precautions (5.2 )]. Dosage adjustment is required in patients with ≤50 mL/min renal impairment [see Dosage and Administration (2 )]. There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients receiving hemodialysis [see Overdosage (10), Clinical Pharmacology (12.3) ]. Hydroxypropyl-beta-cyclodextrin is excreted in urine and may accumulate in patients with renal impairment. Serum creatinine should be closely monitored and, if renal toxicity is suspected, an alternative agent should be considered [see Warnings and Precautions (5.3), Clinical Pharmacology (12.3) ]. The HABP/VABP and cSSSI trials included patients with normal hepatic function and with hepatic impairment. No dosage adjustment is recommended in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3) ].

Descriptif du produit:

Store original packages at refrigerated temperatures of 2°C to 8°C (35°F to 46°F). Excursions to ambient temperatures (up to 25°C (77°F) are acceptable. Avoid excessive heat.

Statut de autorisation:

New Drug Application

Notice patient

Cumberland Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 01/2021
MEDICATION GUIDE
VIBATIV® (vy-'ba-tiv)
(telavancin)
for injection, for intravenous use
Read this Medication Guide before you receive VIBATIV. This
information does not take the place of
talking to your healthcare provider about your medical condition or
your treatment.
What
is
the
most
important
information
I
should
know
about
VIBATIV?
VIBATIV can cause serious side effects, including:
•
Increased risk of death. VIBATIV was associated with an increased risk
of death compared to
vancomycin in people who already had kidney problems and were treated
for bacterial pneumonia
that you can get when you are in the hospital.
•
New or worsening kidney problems. Your healthcare provider should do a
blood test to check
your kidneys before you start, while you receive, and after you stop
receiving VIBATIV.
•
VIBATIV may harm your unborn baby. If you are a woman who can become
pregnant, your
healthcare provider should do a pregnancy test before you start
receiving VIBATIV.
•
Talk to your healthcare provider if you are pregnant or plan to become
pregnant. Your
healthcare provider will decide if VIBATIV is the right medicine for
you.
•
Women who can become pregnant should use effective birth control
(contraception) while
receiving VIBATIV and for 2 days after the last dose of VIBATIV. Talk
to your
healthcare provider if you have questions about birth control.
What is VIBATIV?
VIBATIV is a prescription antibacterial medicine used alone, or with
other medicines, to treat adults
with certain types of germs (bacteria) that cause:
•
serious skin infections
•
Hospital-Acquired Bacterial Pneumonia (HABP)
•
Ventilator-Associated Bacterial Pneumonia (VABP)
It is not known if VIBATIV is safe or effective in children.
Who should not receive VIBATIV? Do not receive VIBATIV if you:
•
are allergic to telavancin or any of the ingredients in VIBATIV. See
the end of this Medication
Guide

Résumé des caractéristiques du produit

VIBATIV- TELAVANCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
CUMBERLAND PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIBATIV (TELAVANCIN)
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIBATIV.
VIBATIV (TELAVANCIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2009
WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING
MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, AND EMBRYO-FETAL
TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR THE COMPLETE BOXED WARNING_
PATIENTS WITH PRE-EXISTING MODERATE/SEVERE RENAL IMPAIRMENT (CRCL≤50
ML/MIN) WHO
WERE TREATED WITH VIBATIV FOR HOSPITAL-ACQUIRED BACTERIAL
PNEUMONIA/VENTILATOR-
ASSOCIATED BACTERIAL PNEUMONIA HAD INCREASED MORTALITY OBSERVED VERSUS
VANCOMYCIN. USE OF VIBATIV IN PATIENTS WITH PRE-EXISTING
MODERATE/SEVERE RENAL
IMPAIRMENT (CRCL ≤50 ML/MIN) SHOULD BE CONSIDERED ONLY WHEN THE
ANTICIPATED
BENEFIT TO THE PATIENT OUTWEIGHS THE POTENTIAL RISK. (5.1, 8.4)
NEPHROTOXICITY: NEW ONSET OR WORSENING RENAL IMPAIRMENT HAS OCCURRED.
MONITOR
RENAL FUNCTION IN ALL PATIENTS. (5.3)
EMBRYO-FETAL TOXICITY: VIBATIV MAY CAUSE FETAL HARM. IN ANIMAL
REPRODUCTION
STUDIES, ADVERSE DEVELOPMENTAL OUTCOMES WERE OBSERVED IN 3 ANIMAL
SPECIES AT
CLINICALLY RELEVANT DOSES. VERIFY PREGNANCY STATUS PRIOR TO INITIATING
TREATMENT AND
ADVISE FEMALES OF REPRODUCTIVE POTENTIAL TO USE EFFECTIVE
CONTRACEPTION (5.4, 8.1,
8.3).
INDICATIONS AND USAGE
VIBATIV is a lipoglycopeptide antibacterial drug indicated for the
treatment of the following infections in
adult patients caused by designated susceptible bacteria:
Complicated skin and skin structure infections (cSSSI) (1.1)
Hospital-acquired and ventilator-associated bacterial pneumonia
(HABP/VABP) caused by susceptible
isolates of _Staphylococcus aureus_. VIBATIV should be reserved for
use when alternative treatments are
not suitable. (1.2)
To reduce the development of drug-resistant bacteria and maintai