Home FDA labels 082bc713-cea6-4af8-b2be-65622cb897d0 FDA label 082bc713-cea6-4af8-b2be-65622cb897d0 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID 2b8d9730-686b-444b-9941-7b5877255924
SPL ID 082bc713-cea6-4af8-b2be-65622cb897d0
Version 1
Effective date 2011-09-14
Source export date 2026-09-28
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Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
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warnings WARNINGS Hypoglycemia is the most common adverse effect of insulin therapy, including LEVEMIR. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. LEVEMIR is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal, human), or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted. Needles and Levemir FlexPen must not be shared.
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adverse reactions ADVERSE REACTIONS Adverse events commonly associated with human insulin therapy include the following: Body as Whole : allergic reactions (see PRECAUTIONS, Allergy ). Skin and Appendages : lipodystrophy, pruritus, rash. Mild injection site reactions occurred more frequently with LEVEMIR than with NPH human insulin and usually resolved in a few days to a few weeks (see PRECAUTIONS, Allergy ). Other: Hypoglycemia: (see WARNINGS and PRECAUTIONS ). In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, the incidence of severe hypoglycemia with LEVEMIR was comparable to the incidence with NPH, and, as expected, greater overall in patients with type 1 diabetes (Table 4). Weight gain: In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, LEVEMIR was associated with somewhat less weight gain than NPH (Table 4). Whether these observed differences represent true differences in the effects of LEVEMIR and NPH insulin is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established. Table 4: Safety Information on Clinical Studies Weight (kg) Hypoglycemia (events/subject/month) Treatment # of subjects Baseline End of treatment Major Minor Type 1 Study A LEVEMIR N=276 75.0 75.1 0.045 2.184 NPH N=133 75.7 76.4 0.035 3.063 Study C LEVEMIR N=492 76.5 76.3 0.029 2.397 NPH N=257 76.1 76.5 0.027 2.564 Study D Pediatric LEVEMIR N=232 N/A N/A 0.076 2.677 NPH N=115 N/A N/A 0.083 3.203 Type 2 Study E LEVEMIR N=237 82.7 83.7 0.001 0.306 NPH N=239 82.4 85.2 0.006 0.595 Study F LEVEMIR N=195 81.8 82.3 0.003 0.193 NPH N=200 79.6 80.9 0.006 0.235
adverse reactions table <table border="single" width="438.000" ID="id_52ccae67-5cfa-46b3-ad7a-f5c611c5020b"> <caption ID="id_47dd6ccf-95b8-4694-958a-7ff50e8d0481">Table 4: Safety Information on Clinical Studies </caption> <col width="15.1%"/> <col width="15.1%"/> <col width="12.3%"/> <col width="14.4%"/> <col width="14.4%"/> <col width="14.4%"/> <col width="14.4%"/> <tbody> <tr ID="id_6d07c774-e40b-4dce-9ad4-8e95e90c7b56"> <td align="justify" valign="top" styleCode="Botrule Toprule Rrule"/> <td align="left" valign="top" colspan="2" styleCode="Botrule Rrule"/> <td align="center" valign="top" colspan="2" styleCode="Botrule Rrule"> <content styleCode="bold">Weight </content> <content styleCode="bold">(kg)</content> </td> <td align="center" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Hypoglycemia (events/subject/month)</content> </td> </tr> <tr ID="id_301d34ca-b6c8-4ba1-a013-42ef42ba659f"> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="center" valign="middle" styleCode="Botrule Rrule">Treatment </td> <td align="center" valign="top" styleCode="Botrule Rrule"># of subjects </td> <td align="center" valign="middle" styleCode="Botrule Rrule">Baseline</td> <td align="center" valign="middle" styleCode="Botrule Rrule">End of treatment</td> <td align="center" valign="middle" styleCode="Botrule Rrule">Major </td> <td align="center" valign="middle" styleCode="Botrule">Minor </td> </tr> <tr ID="id_14f002e6-83b5-4aa5-82b1-be9bf51440b3"> <td align="left" valign="top" colspan="7" styleCode="Botrule"> <content styleCode="bold">Type 1</content> </td> </tr> <tr ID="id_b036d6f9-3072-48be-aee0-d6aaa7e0acf9"> <td align="left" valign="top" rowspan="2" styleCode="Botrule Rrule">Study A</td> <td align="left" valign="top" styleCode="Botrule Rrule">LEVEMIR</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=276</td> <td align="center" valign="middle" styleCode="Botrule Rrule">75.0</td> <td align="center" valign="middle" styleCode="Botrule Rrule">75.1</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.045</td> <td align="center" valign="top" styleCode="Botrule">2.184</td> </tr> <tr ID="id_44b237f3-f80c-4553-874a-3db211ef426c"> <td align="left" valign="top" styleCode="Botrule Rrule">NPH</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=133</td> <td align="center" valign="top" styleCode="Botrule Rrule">75.7</td> <td align="center" valign="top" styleCode="Botrule Rrule">76.4</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.035</td> <td align="center" valign="top" styleCode="Botrule">3.063</td> </tr> <tr ID="id_56f6c5bc-28b8-43c1-b593-917e3a6d6335"> <td align="left" valign="top" rowspan="2" styleCode="Botrule Rrule">Study C</td> <td align="left" valign="top" styleCode="Botrule Rrule">LEVEMIR</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=492</td> <td align="center" valign="top" styleCode="Botrule Rrule">76.5</td> <td align="center" valign="top" styleCode="Botrule Rrule">76.3</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.029</td> <td align="center" valign="top" styleCode="Botrule">2.397</td> </tr> <tr ID="id_8341b53e-d648-4698-ba15-3f25f1c38908"> <td align="left" valign="top" styleCode="Botrule Rrule">NPH</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=257</td> <td align="center" valign="top" styleCode="Botrule Rrule">76.1</td> <td align="center" valign="top" styleCode="Botrule Rrule">76.5</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.027</td> <td align="center" valign="top" styleCode="Botrule">2.564</td> </tr> <tr ID="id_1a5fcfd0-30af-4ba1-acbf-6f2dab5c28ef"> <td align="left" valign="top" rowspan="2" styleCode="Botrule Rrule">Study D Pediatric</td> <td align="left" valign="top" styleCode="Botrule Rrule">LEVEMIR</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=232</td> <td align="center" valign="top" styleCode="Botrule Rrule">N/A</td> <td align="center" valign="top" styleCode="Botrule Rrule">N/A</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.076</td> <td align="center" valign="top" styleCode="Botrule">2.677</td> </tr> <tr ID="id_01edd6e3-4b95-45db-8e2a-816fc66bae0a"> <td align="left" valign="top" styleCode="Botrule Rrule">NPH</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=115</td> <td align="center" valign="top" styleCode="Botrule Rrule">N/A</td> <td align="center" valign="top" styleCode="Botrule Rrule">N/A</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.083</td> <td align="center" valign="top" styleCode="Botrule">3.203</td> </tr> <tr ID="id_1225a2e6-211a-49fe-812f-8d726bc4d00f"> <td align="left" valign="top" colspan="7" styleCode="Botrule"> <content styleCode="bold">Type 2</content> </td> </tr> <tr ID="id_f6f87ff7-21e1-4fd7-bf03-e1c745fecb83"> <td align="left" valign="top" rowspan="2" styleCode="Botrule Rrule">Study E</td> <td align="left" valign="top" styleCode="Botrule Rrule">LEVEMIR</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=237</td> <td align="center" valign="top" styleCode="Botrule Rrule">82.7</td> <td align="center" valign="top" styleCode="Botrule Rrule">83.7</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.001</td> <td align="center" valign="top" styleCode="Botrule">0.306</td> </tr> <tr ID="id_62ab60d1-4802-4dce-afab-074437fefc27"> <td align="left" valign="top" styleCode="Botrule Rrule">NPH</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=239</td> <td align="center" valign="top" styleCode="Botrule Rrule">82.4</td> <td align="center" valign="top" styleCode="Botrule Rrule">85.2</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.006</td> <td align="center" valign="top" styleCode="Botrule">0.595</td> </tr> <tr ID="id_d56df82f-09b9-462c-a014-dee2867337a9"> <td align="left" valign="top" rowspan="2" styleCode="Botrule Rrule">Study F</td> <td align="left" valign="top" styleCode="Botrule Rrule">LEVEMIR</td> <td align="center" valign="top" styleCode="Botrule Rrule">N=195</td> <td align="center" valign="top" styleCode="Botrule Rrule">81.8</td> <td align="center" valign="top" styleCode="Botrule Rrule">82.3</td> <td align="center" valign="top" styleCode="Botrule Rrule">0.003</td> <td align="center" valign="top" styleCode="Botrule">0.193</td> </tr> <tr ID="id_6fb1c6fd-fdf8-49a8-921b-0ae11647346b"> <td align="left" valign="top" styleCode="Botrule Rrule">NPH</td> <td align="center" valign="top" styleCode="Rrule">N=200</td> <td align="center" valign="top" styleCode="Rrule">79.6</td> <td align="center" valign="top" styleCode="Rrule">80.9</td> <td align="center" valign="top" styleCode="Rrule">0.006</td> <td align="center" valign="top" styleCode="Botrule">0.235</td> </tr> </tbody> </table>
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