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Victoza ® (liraglutide [rDNA origin] injection), solution for subcutaneous
2015-06-16 14:31:36 来源: 作者: 【 】 浏览:352次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Victoza safely and effectively. See full prescribing information for Victoza.
    Victoza ® (liraglutide [rDNA origin] injection), solution for subcutaneous use
    Initial U.S. Approval: 2010
    WARNING: RISK OF THYROID C-CELL TUMORS
    See full prescribing information for complete boxed warning.
    Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza 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 , 13.1).
    Victoza 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).
    RECENT MAJOR CHANGES

    Boxed Warning 03/2015

    Indications and Usage: Important Limitations of Use (1.1) 03/2015

    Warnings and Precautions: Risk of Thyroid C-cell Tumors (5.1) 03/2015

    Warnings and Precautions:
    Never Share a Victoza Pen Between Patients (5.3) 02/2015

    INDICATIONS AND USAGE

    Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).

    Important Limitations of Use (1.1):

    Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (5.1).
    Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis (5.2).
    Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
    Has not been studied in combination with prandial insulin.

    DOSAGE AND ADMINISTRATION
    Administer once daily at any time of day, independently of meals (2).
    Inject subcutaneously in the abdomen, thigh or upper arm (2).
    The injection site and timing can be changed without dose adjustment (2).
    Initiate at 0.6 mg per day for one week. This dose is intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control. After one week, increase the dose to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg (2).
    DOSAGE FORMS AND STRENGTHS
    Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL) (3).
    CONTRAINDICATIONS

    Victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4).

    Victoza is contraindicated in patients with a prior serious hypersensitivity reaction to Victoza or any of the product components (4).
    WARNINGS AND PRECAUTIONS

    Thyroid C-cell Tumors: See Boxed Warning (5.1).
    Pancreatitis: Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis (5.2).
    Never share a Victoza pen between patients, even if the needle is changed (5.3).
    Serious Hypoglycemia: Can occur when Victoza is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia (5.4).
    Renal Impairment: Has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza in patients with renal impairment (5.5).
    Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). The patient should discontinue Victoza and other suspect medications and promptly seek medical advice (5.6).
    Macrovascular Outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza or any other antidiabetic drug (5.7).
    ADVERSE REACTIONS
    The most common adverse reactions, reported in ≥5% of patients treated with Victoza and more commonly than in patients treated with placebo, are: headache, nausea, diarrhea and anti-liraglutide antibody formation (6).
    Immunogenicity-related events, including urticaria, were more common among Victoza-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials (6).

    To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-877-484-2869 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS
    Victoza delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use caution (7).
    USE IN SPECIFIC POPULATIONS
    Limited data in patients with renal or hepatic impairment. (8.6, 8.7).
     
    See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

    Revised: 3/2015

  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    1.1 Important Limitations of Use

    Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans. Prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk [see Warnings and Precautions (5.1)].
    Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza. Victoza has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.
    Victoza is not a substitute for insulin. Victoza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
    The concurrent use of Victoza and prandial insulin has not been studied.
  • 2 DOSAGE AND ADMINISTRATION

    Victoza can be administered once daily at any time of day, independently of meals, and can be injected subcutaneously in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment.

    For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week. The 0.6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control. After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.

    When initiating Victoza, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions (5.4) and Adverse Reactions (6)].

    When using Victoza with insulin, administer as separate injections. Never mix. It is acceptable to inject Victoza and insulin in the same body region but the injections should not be adjacent to each other.

    Victoza solution should be inspected prior to each injection, and the solution should be used only if it is clear, colorless, and contains no particles.

    If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make-up for the missed dose.

    Based on the elimination half-life, patients should be advised to reinitiate Victoza at 0.6 mg if more than 3 days have elapsed since the last Victoza dose. This approach will mitigate any gastrointestinal symptoms associated with reinitiation of treatment. Upon reinitiation, Victoza should be titrated at the discretion of the prescribing healthcare provider.

  • 3 DOSAGE FORMS AND STRENGTHS

    Solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL).

  • 4 CONTRAINDICATIONS

    Victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

    Victoza is contraindicated in patients with a prior serious hypersensitivity reaction to Victoza or to any of the product components.

  • 5 WARNINGS AND PRECAUTIONS

     

    5.1 Risk of Thyroid C-cell Tumors

    Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see

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