FENSOLVI- leuprolide acetate kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

LEUPROLIDE ACETATE (UNII: 37JNS02E7V) (LEUPROLIDE - UNII:EFY6W0M8TG)

Commercializzato da:

TOLMAR Inc.

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). - Hypersensitivity to GnRH, GnRH agonists or any of the components of FENSOLVI. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported [see Adverse Reactions (6.2)] . - Pregnancy: FENSOLVI may cause fetal harm [see Use in Specific Populations (8.1)] . Risk Summary FENSOLVI is contraindicated in pregnancy [see Contraindications (4)] . FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1)]. The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US 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 When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats. Risk Summary There are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FENSOLVI and any potential adverse effects on the breastfed infant from FENSOLVI or from the underlying maternal condition. Pregnancy Testing Exclude pregnancy in women of reproductive potential prior to initiating FENSOLVI if clinically indicated [see Use in Specific Populations (8.1) ] . Contraception Females FENSOLVI may cause embryo-fetal harm when administered during pregnancy. FENSOLVI is not a contraceptive. If contraception is indicated, advise females of reproductive potential to use a non-hormonal method of contraception during treatment with FENSOLVI [see Use in Specific Populations (8.1)] . Infertility Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased while on treatment with FENSOLVI. Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks [see Clinical Pharmacology (12.1)] . There is no evidence that pregnancy rates are affected following discontinuation of FENSOLVI. Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression. The safety and effectiveness of FENSOLVI for the treatment of CPP has been established in pediatric patients 2 years of age and older. Use of FENSOLVI for this indication is supported by evidence from an adequate and uncontrolled open-label, single-arm study of 64 pediatric patients with CPP with an age range of 4 to 9 years [see Clinical Studies (14)] . The safety and effectiveness of FENSOLVI have not been established in pediatric patients less than 2 years old.

Dettagli prodotto:

For injectable suspension, 45 mg of leuprolide acetate supplied in a kit (NDC 62935-153-50) containing: Syringe A Tray Syringe B Tray Syringe A is prefilled with diluent for reconstitution (ATRIGEL Delivery System) Syringe B is prefilled with 45 mg lyophilized leuprolide acetate powder White plunger rod (To be used with Syringe B) Safety needle (18G x 5/8") Desiccant pack Desiccant pack Store refrigerated at 2 - 8 °C (35.6 – 46.4 °F). Once outside the refrigerator, this product may be stored in its original packaging at room temperature 15 – 30 °C (59 – 86 °F) for up to eight weeks prior to reconstitution and administration.

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

TOLMAR PHARMACEUTICALS INC.
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MEDICATION GUIDE
Medication Guide
FENSOLVI® (fen-SOL-vee)
(leuprolide acetate)
injectable suspension, for subcutaneous use
What is the most important information I should know about FENSOLVI?
FENSOLVI may cause serious side effects, including:
•
In the first few weeks after your child receives their first FENSOLVI
injection, FENSOLVI can
cause an increase in some hormones. During this time, you may notice
more signs of puberty in your
child including vaginal bleeding. Call your child’s healthcare
provider if signs of puberty continue
after 2 months of receiving FENSOLVI.
•
Some people taking gonadotropin releasing hormone (GnRH) agonists like
FENSOLVI have had
new or worsened mental (psychiatric) problems. Mental (psychiatric)
problems may include
emotional symptoms such as:
•
crying
•
irritability
•
restlessness (impatience)
•
anger
•
acting aggressively
Call your child’s healthcare provider right away if your child has
any new or worsening emotional
symptoms while taking FENSOLVI.
•
Some people taking GnRH agonists like FENSOLVI have had seizures. The
risk of seizures may be
higher in people who:
•
have a history of seizures
•
have a history of epilepsy
•
have a history of brain tumors or brain vessel (cerebrovascular)
problems
•
are taking a medicine that has been associated with seizures such as
bupropion or selective
serotonin reuptake inhibitors (SSRIs)
Seizures have also happened in people who have not had any of these
problems.
Call your child’s healthcare provider right away if your child has a
seizure while taking FENSOLVI.
•
Increased pressure in the fluid around the brain can happen in
children taking GnRH agonists
medicines including FENSOLVI. Call your child’s doctor right away if
your child has any of the
following symptoms during treatment with FENSOLVI:
• headache
• ringing in the ears
• eye problems, including blurred vision, double vision and
decreased eyesight
• dizziness
• eye pain
• nausea
What is FENSOLVI?

Scheda tecnica

FENSOLVI- LEUPROLIDE ACETATE
TOLMAR PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENSOLVI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FENSOLVI.
FENSOLVI (LEUPROLIDE ACETATE) FOR INJECTABLE SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1985
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 04/2022
INDICATIONS AND USAGE
FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated
for the treatment of pediatric
patients 2 years of age and older with central precocious puberty. (1)
DOSAGE AND ADMINISTRATION
Must be administered by a healthcare professional. (2.1)
The dose of FENSOLVI is 45 mg administered by subcutaneous injection
once every six months. (2.1)
Monitor response to FENSOLVI with a GnRH agonist stimulation test,
basal serum luteinizing hormone
(LH) levels or serum concentration of sex steroid levels at 1 to 2
months following initiation of therapy
and as needed to confirm adequate suppression of pituitary
gonadotropins, sex steroids, and
progression of secondary sexual characteristics. (2.2)
Measure height every 3 to 6 months and monitor bone age periodically.
(2.2)
See Full Prescribing Information for reconstitution and administration
instructions. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: 45 mg of leuprolide acetate supplied in a
kit. (3)
CONTRAINDICATIONS
Hypersensitivity reactions (4)
Pregnancy (4, 8.1)
WARNINGS AND PRECAUTIONS
_Initial Rise of Gonadotropins and Sex Steroid Levels:_ During the
early phase of therapy, gonadotropins
and sex steroids rise above baseline because of the initial
stimulatory effect of the drug. Therefore, an
increase in clinical signs and symptoms of puberty including vaginal
bleeding may be observed during
the first weeks of therapy or after subsequent doses. Instruct
patients and caregivers to notify the
physician if these symptoms continue beyond the second month after
FENSOLVI administration. (5.1)
_Psychiatric events:_