"April 20, 2012 -- Public Citizen, the Washington, D.C.-based consumer advocacy group, is petitioning the FDA to immediately remove the type 2 diabetes drug Victoza (liraglutide) from the market. The petition claims that the injectable medication "...
Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations Of Use
- Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
- Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and nonfatal 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.
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 and ADVERSE REACTIONS].
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.
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).
Storage And Handling
Victoza is available in the following package sizes containing disposable, pre-filled, multi-dose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL).
2 x Victoza pen NDC
3 x Victoza pen NDC 0169-4060-13
Each Victoza pen is for use by a single patient. A Victoza pen must never be shared between patients, even if the needle is changed.
Prior to first use, Victoza should be stored in a refrigerator between 36°F to 46°F (2°C to 8°C) (Table 14). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Victoza and do not use Victoza if it has been frozen.
After initial use of the Victoza pen, the pen can be stored for 30 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Keep the pen cap on when not in use. Victoza should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the Victoza pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy. Always use a new needle for each injection to prevent contamination.
Table 14 : Recommended Storage Conditions for the
|Prior to first use||After first use|
|Refrigerated 36°F to 46°F (2°C to 8°C)||Room Temperature 59°F to 86°F (15°C to 30°C)||Refrigerated 36°F to 46°F (2°C to 8°C)|
|Until expiration date||30 days|
Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark. Date of Issue: February 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/13/2015
Additional Victoza Information
Report Problems to the Food and Drug Administration
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