SAXENDA- liraglutide injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

LIRAGLUTIDE (UNII: 839I73S42A) (LIRAGLUTIDE - UNII:839I73S42A)

Disponible des:

A-S Medication Solutions

Vía de administración:

SUBCUTANEOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

SAXENDA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Limitations of Use SAXENDA is contraindicated in: Risk Summary SAXENDA is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm [see Clinical Considerations] . There are no available data with liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. SAXENDA should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with SAXENDA should be discontinued. Animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 3 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD [see Animal Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk A minimum weight gain, and no weight loss, is recommended for all pregnant women, including those who are already overweight or obese, due to the necessary weight gain that occurs in maternal tissues during pregnancy. Animal Data Liraglutide has been shown to be teratogenic in rats at or above 0.8-times systemic exposures in obese humans resulting from the maximum recommended human dose (MRHD) of 3 mg/day based on plasma area under the time-concentration curve (AUC) comparison. Liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below exposure in obese humans at the MRHD based on plasma AUC comparison. Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the exposure in obese humans at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly. Fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. Mottled liver and minimally kinked ribs occurred at the highest dose. The incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day. Pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the exposure in obese humans at the MRHD of 3 mg/day at all doses, based on plasma AUC comparison. Liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. The incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), greater than or equal to 0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), greater than or equal to 0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels). Irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. Visceral abnormalities occurred in blood vessels, lung, liver, and esophagus. Bilobed or bifurcated gallbladder was seen in all treatment groups, but not in the control group. In pregnant female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide from gestation day 6 through weaning or termination of nursing on lactation day 24, estimated systemic exposures were 0.8-, 3-, and 11-times exposure in obese humans at the MRHD of 3 mg/day, based on plasma AUC comparison. A slight delay in parturition was observed in the majority of treated rats. Group mean body weight of neonatal rats from liraglutide-treated dams was lower than neonatal rats from control group dams. Bloody scabs and agitated behavior occurred in male rats descended from dams treated with 1 mg/kg/day liraglutide. Group mean body weight from birth to postpartum day 14 trended lower in F2 generation rats descended from liraglutide-treated rats compared to F2 generation rats descended from controls, but differences did not reach statistical significance for any group. Risk Summary There are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or effects on milk production. Liraglutide was present in the milk of lactating rats (see Data ). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SAXENDA and any potential adverse effects on the breastfed infant from SAXENDA or from the underlying maternal condition. Data In lactating rats, liraglutide was present unchanged in milk at concentrations approximately 50% of maternal plasma concentrations. The safety and effectiveness of SAXENDA as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management have been established in pediatric patients aged 12 years and older with body weight above 60 kg and an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (see Table 2). Use of SAXENDA for this indication is supported by a 56-week double-blind, placebo-controlled clinical trial in 251 pediatric patients aged 12 to 17 years, a pharmacokinetic study in pediatric patients, and studies in adults with obesity [see Clinical Pharmacology (12.3), Clinical Studies (14.1,14.2)]. In the pediatric clinical trial, there was one death due to suicide in a SAXENDA-treated patient [see Warnings and Precautions (5.8)] ; one SAXENDA-treated patient had an event of pancreatitis [see Warnings and Precautions (5.2)] ; more episodes of hypoglycemia confirmed by self blood glucose monitoring occurred in SAXENDA-treated patients compared to placebo [see Warnings and Precautions (5.4), Adverse Reactions (6.1)] ; and mean increases in resting heart rate of 3 to 7 bpm from baseline were observed with SAXENDA-treated patients [see Warnings and Precautions (5.5)] . The safety and effectiveness of SAXENDA have not been established in patients less than 12 years of age. In the SAXENDA clinical trials, 232 (6.9%) of the SAXENDA-treated patients were 65 years of age and over, and 17 (0.5%) of the SAXENDA-treated patients were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. There is limited experience with SAXENDA in patients with mild, moderate, and severe renal impairment, including end‑stage renal disease. However, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure with liraglutide, which may sometimes require hemodialysis [see Warnings and Precautions (5.6), Adverse Reactions (6.2)] . SAXENDA should be used with caution in this patient population [see Clinical Pharmacology (12.3)] . There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, SAXENDA should be used with caution in this patient population [see Clinical Pharmacology (12.3)] . SAXENDA slows gastric emptying. SAXENDA has not been studied in patients with pre-existing gastroparesis. Step 1. Prepare your pen with a new needle Always use a new needle for each injection. This will prevent contamination, infection, leakage of Saxenda, and blocked needles leading to the wrong dose. Never use a bent or damaged needle. Do not attach a new needle to your pen until you are ready to take your injection. Step 2. Check the Saxenda flow with each new pen. Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that Saxenda flows. If no drop appears, you will not inject any Saxenda, even though the dose counter may move. This may mean that there is a blocked or damaged needle. A small drop may remain at the needle tip, but it will not be injected. Only check the Saxenda flow before your first injection with each new pen. Step 3. Select your dose Always use the dose counter and the dose pointer to see how many mg you select. You will hear a “click” every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear. Do not use the pen scale to set the dose. It does not show exactly how much Saxenda is left in your pen. Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg can be selected with the dose selector. The selected dose must line up exactly with the dose pointer to make sure that you get a correct dose. The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select for each dose. You can select up to 3 mg each dose. When your pen contains less than 3 mg the dose counter stops before 3 mg is shown. The dose selector clicks differently when turned forward, backwards or past the number of mg left. Do not count the pen clicks. How much Saxenda is left? If you need more Saxenda than what is left in your pen Only if trained or told by your healthcare provider, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your healthcare provider. Be very careful to calculate correctly. If you are not sure how to split your dose using 2 pens, then select and inject the dose you need with a new pen. Step 4. Inject your dose Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0. You may see a drop of Saxenda at the needle tip after injecting. This is normal and does not affect your dose. Step 5. After your injection If you do not have a sharps container, follow a 1-handed needle recapping method. Carefully slip the needle into the outer needle cap. Dispose of the needle in a sharps container as soon as possible. Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. Always remove the needle from your pen. This prevents contamination, infection, leakage of Saxenda, and blocked needles leading to the wrong dose. If the needle is blocked, you will not inject any Saxenda. Always dispose of the needle after each injection . Important Caring for your pen How should I store my Saxenda pen? This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration. December 2020

Resumen del producto:

Product: 50090-4257 NDC: 50090-4257-0 3 mL in a SYRINGE, PLASTIC / 5 in a CARTON

Estat d'Autorització:

New Drug Application

Informació per a l'usuari

A-S Medication Solutions
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MEDICATION GUIDE
MEDICATION GUIDE
SAXENDA (sax-end-ah)
(liraglutide) injection for subcutaneous use
Do not share your SAXENDA pen with others even if the needle has been
changed.
You may give other people a serious infection or get a serious
infection from them.
What is the most important information I should know about SAXENDA?
Serious side effects may happen in people who take SAXENDA, including:
Possible thyroid tumors, including cancer. Tell your healthcare
provider if you get a
lump or swelling in your neck, hoarseness, trouble swallowing, or
shortness of breath.
These may be symptoms of thyroid cancer. In studies with rats and
mice, SAXENDA
and medicines that work like SAXENDA caused thyroid tumors, including
thyroid
cancer. It is not known if SAXENDA will cause thyroid tumors or a type
of thyroid
cancer called medullary thyroid carcinoma (MTC) in people.
Do not use SAXENDA if you or any of your family have ever had a type
of thyroid
cancer called medullary thyroid carcinoma (MTC), or if you have an
endocrine system
condition called Multiple Endocrine Neoplasia syndrome type 2
(MEN 2).
What is SAXENDA?
SAXENDA is an injectable prescription medicine used for adults with
obesity or
overweight (excess weight) who also have weight related medical
problems, and
children aged 12 to 17 years with a body weight above 132 pounds (60
kg) and obesity
to help them lose weight and keep the weight off.
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SAXENDA should be used with a reduced calorie diet and increased
physical
activity.
•
SAXENDA and VICTOZA have the same active ingredient, liraglutide, and
should not be used together or with other GLP-1 receptor agonist
medicines.
•
It is not known if SAXENDA is safe and effective when taken with other
prescription, over-the-counter medicines, or herbal weight loss
products.
•
It is not known if SAXENDA is safe and effective in children under 12
years of
age.
•
It is not known if SAXENDA is safe and effective in children aged 12
to 17
years with type 2 diabetes.
Who should n

Fitxa tècnica

SAXENDA- LIRAGLUTIDE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAXENDA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAXENDA.
SAXENDA (LIRAGLUTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2010
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Dosage and Administration (2.2)……………..06/2022
Contraindications (4)………………………….06/2022
INDICATIONS AND USAGE
SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist
indicated as an adjunct to a reduced-
calorie diet and increased physical activity for chronic weight
management in:
Adult patients with an initial body mass index (BMI) of
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Pediatric patients aged 12 years and older with:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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®
LIRAGLUTIDE CAUSES THYROID C-CELL TUMORS AT CLINICALLY RELEVANT
EXPOSURES IN BOTH
GENDERS OF RATS AND MICE. IT IS UNKNOWN WHETHER SAXENDA CAUSES THYROID
C-CELL
TUMORS, INCLUDING MEDULLARY THYROID CARCINOMA (MTC), IN HUMANS, AS THE
HUMAN
RELEVANCE OF LIRAGLUTIDE-INDUCED RODENT THYROID C-CELL TUMORS HAS NOT
BEEN
DETERMINED (5.1).
SAXENDA IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR FAMILY
HISTORY OF MTC OR
IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE 2 (MEN 2).
COUNSEL
PATIENTS REGARDING THE POTENTIAL RISK OF MTC AND THE SYMPTOMS OF
THYROID TUMORS
(4, 5.1, 13.1).
30 kg/m or greater (obese), or
2
27 kg/m or greater (overweight) in the presence of at least one
weight-related comorbid condition
(e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) (1).
2
body weight above 60 kg and
an initial BMI corresponding to 30 kg/m for adults (obese) by
international cut-offs (1).
2
SAXENDA contains liraglutide and should not be coadministered with
other liraglutide-containing
products or with